Drugs Details

Drugs Info of Fentora, Onsolis
Drugs Details
  • Drugs Type  : FDA
  • Date : 30th Jan 2015 02:57 am
  • Brand Name : Fentora, Onsolis
  • Generic Name : fentanyl (buccal) (Pronunciation: FEN ta nil (BUK al))
Descriptions

ONSOLIS (fentanyl buccal soluble film) is an oral transmucosal form of the potent opioid analgesic, fentanyl citrate, intended for application to the buccal mucosa. ONSOLIS uses the BioErodible MucoAdhesive (BEMA™) bilayer delivery technology which is comprised of water-soluble polymeric films. ONSOLIS consists of a pink bioadhesive layer bonded onto a white inactive layer. The active ingredient, fentanyl citrate, is incorporated into the bioadhesive layer, which adheres to the moist buccal mucosa. The amount of fentanyl delivered transmucosally is proportional to the film surface area. It is believed that the inactive layer isolates the bioadhesive layer from the saliva, which may optimize delivery of fentanyl across the buccal mucosa.

Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4- piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. Fentanyl citrate has the following structural formula:

 

View Enlarged Table

Inactive Ingredients: Carboxymethylcellulose, citric acid, hydroxyethyl cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, red iron oxide, sodium benzoate, sodium hydroxide, sodium saccharin, titanium dioxide, tribasic sodium phosphate, vitamin E acetate, and water.

What are the possible side effects of fentanyl buccal (Fentora, Onsolis)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fentanyl and call your doctor at once if you have a serious side effect such as:

  • weak or shallow breathing;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Less serious side effects may include:

  • nausea, vomiting,...

Read All Potential Side Effects and See Pictures of Onsolis »

What are the precautions when taking fentanyl buccal soluble film (Onsolis)?

Before taking fentanyl, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating...

Read All Potential Precautions of Onsolis »

This monograph has been modified to include the generic and brand name in many instances.

Indications

ONSOLIS (fentanyl buccal soluble film) is an opioid analgesic indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least: 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression could occur in patients not taking chronic opiates. For this reason, ONSOLIS is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.

ONSOLIS is intended to be used only in the care of opioid tolerant patients with cancer and only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.

Dosage Administration

As with all opioids, the safety of patients using such products is dependent on healthcare professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.

Only prescribers enrolled in the FOCUS Program may prescribe ONSOLIS [see WARNINGS AND PRECAUTIONS].

Dose Titration

The goal of dose titration is to find the individual patient's effective and tolerable dose. The dose of ONSOLIS is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and MUST be determined by dose titration.

Starting Dose

Individually titrate ONSOLIS to a dose that provides adequate analgesia with tolerable side effects. All patients MUST begin treatment using one 200 mcg ONSOLIS film. Due to differences in pharmacokinetic properties and individual variability, patients switching from another oral transmucosal fentanyl product must be started on no greater than 200 mcg of ONSOLIS. When prescribing, do not switch patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to ONSOLIS as ONSOLIS is not equivalent on a mcg per mcg basis with any other fentanyl product. ONSOLIS is NOT a generic version of any other oral transmucosal fentanyl product.

From the initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia.

If adequate pain relief is not achieved after one 200 mcg ONSOLIS film, titrate using multiples of the 200 mcg ONSOLIS film (for doses of 400, 600, or 800 mcg). Increase the dose by 200 mcg in each subsequent episode until the patient reaches a dose that provides adequate analgesia with tolerable side effects. Do not use more than four of the 200 mcg ONSOLIS films simultaneously. When multiple 200 mcg ONSOLIS films are used, they should not be placed on top of each other and may be placed on both sides of the mouth.

If adequate pain relief is not achieved after 800 mcg ONSOLIS (i.e., four 200 mcg ONSOLIS films), and the patient has tolerated the 800 mcg dose, treat the next episode by using one 1200 mcg ONSOLIS film. Doses above 1200 mcg ONSOLIS should not be used.

Once adequate pain relief is achieved with a dose between 200 and 800 mcg ONSOLIS, the patient should use or safely dispose of all remaining 200 mcg ONSOLIS films [see Disposal of ONSOLIS]. Patients who require 1200 mcg ONSOLIS, should dispose of all remaining unused 200 mcg ONSOLIS films [see Disposal of ONSOLIS]. The patient should then get a prescription for ONSOLIS films of the dose determined by titration (i.e., 200, 400, 600, 800, or 1200 mcg) to treat subsequent episodes.

Single doses should be separated by at least 2 hours. ONSOLIS should only be used once per breakthrough cancer pain episode, i.e., ONSOLIS should not be redosed within an episode.

During any episode of breakthrough cancer pain, if adequate pain relief is not achieved after ONSOLIS, the patient may use a rescue medication (after 30 minutes) as directed by their healthcare provider.

Dose Titration

View Enlarged Table

Dosage Adjustment

During maintenance treatment, if the prescribed dose no longer adequately manages the breakthrough cancer pain episode for several consecutive episodes, increase the dose of ONSOLIS as described in Dose Titration (2.1). Once a successful dose has been found, each episode is treated with a single film. ONSOLIS should be limited to four or fewer doses per day. Consider increasing the dose of the around-the-clock opioid medicine used for persistent cancer pain in patients experiencing more than four breakthrough cancer pain episodes daily.

Administration Of ONSOLIS

Use the tongue to wet the inside of the cheek or rinse the mouth with water to wet the area for placement of ONSOLIS. Open the ONSOLIS package immediately prior to product use. Place the entire ONSOLIS film near the tip of a dry finger with the pink side facing up and hold in place. Place the pink side of the ONSOLIS film against the inside of the cheek. Press and hold the ONSOLIS film in place for 5 seconds. The ONSOLIS film should stay in place on its own after this period. Liquids may be consumed after 5 minutes.

An ONSOLIS film, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when used as directed [see CLINICAL PHARMACOLOGYPharmacokinetics].

The ONSOLIS film should not be cut or torn prior to use.

The ONSOLIS film will dissolve within 15 to 30 minutes after application. The film should not be manipulated with the tongue or finger(s) and eating food should be avoided until the film has dissolved.

How Supplied

Dosage Forms And Strengths

ONSOLIS is a buccal soluble film with a white side and a pink side. The pink side contains a bioadhesive polymer and the active ingredient. Each strength is marked on the white side of the film with an identifying number. ONSOLIS is available in 200 mcg, 400 mcg, 600 mcg, 800 mcg, and 1200 mcg strengths [see Storage and Handling].

Storage And Handling

ONSOLIS is supplied in individually-sealed child-resistant foil packages. The amount of fentanyl contained in ONSOLIS can be fatal to a child. The entire ONSOLIS film should be used immediately after opening the child-resistant package. Patients and their caregivers must be instructed to keep ONSOLIS out of the reach of children [see BOXED WARNING - WARNINGS: Importance of Proper Patient Selection and Potential For Abuse, WARNINGS AND PRECAUTIONS, and PATIENT INFORMATION].

Store at 20-25°C (68-77°F) with excursions permitted between 15-30°C (59-86°F) until ready to use (see USP Controlled Room Temperature). Protect ONSOLIS from freezing and moisture. Do not use if the foil package has been opened.

Disposal Of ONSOLIS

Patients and members of their household must be instructed to dispose of any unneeded films remaining from a prescription as soon as they are no longer needed. The ONSOLIS film should be removed from its foil package and dropped into the toilet. This should be repeated for each ONSOLIS film. Flush the toilet after all unneeded films have been put into the toilet. Do not flush the ONSOLIS foil packages or cartons down the toilet.

Instructions for disposal are also included in Disposal of Unneeded ONSOLIS Films and in the Medication Guide.

If additional assistance is required, call Meda Pharmaceuticals Inc. at 1-800-526-3840.

How Supplied

ONSOLIS is supplied in five dosage strengths. Each film is individually wrapped in a child-resistant, protective foil package. These foil packages are packed 30 per carton.

ONSOLIS is a bilayer film with one white side and one pink side. The white side is debossed with an identifying number. The dosage strength of each film is indicated by the code on the white side of the film, and the dosage strength is marked on the foil package and the 30-film carton. See package and carton for product information.

 

ONSOLIS Dosage Strength (fentanyl base) Deboss Code(s) Package Color * NDC Number
200 mcg 2 Bright Blue Aqua NDC 0037-5200-30
400 mcg 4 Bright Magenta NDC 0037-5400-30
600 mcg 6 Bright Lime Green NDC 0037-5600-30
800 mcg 8 Bright Orange NDC 0037-5800-30
1200 mcg 12 Bright Purple NDC 0037-5120-30
* Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Studies Experience

The safety of ONSOLIS has been evaluated in 306 opioid tolerant patients with breakthrough cancer pain in the efficacy study and an open-label safety study. The mean duration of therapy was 115 days, with 32 patients treated for more than 1 year.

The adverse reactions seen with ONSOLIS are typical opioid side effects in a population with cancer. Frequently, opioid-associated adverse reactions will cease or decrease in intensity with continued use of ONSOLIS. Expect opioid side effects and manage them accordingly.

The most serious adverse reactions associated with all opioids including ONSOLIS are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. Follow all patients for symptoms of respiratory depression.

Because the clinical trials of ONSOLIS were designed to evaluate safety and efficacy in treating patients with breakthrough pain associated with cancer, all patients were also taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent cancer pain. The adverse event data presented here reflect the actual percentage of patients experiencing each adverse event among patients who received ONSOLIS for breakthrough cancer pain along with a concomitant opioid for persistent cancer pain. There has been no attempt to correct for concomitant use of other opioids, duration of ONSOLIS therapy, or cancer-related symptoms. Adverse reactions are included regardless of severity.

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 1 lists, by maximum dose received, adverse reactions with an overall frequency of 5% or greater that occurred during titration. The ability to assign a dose-response relationship to these adverse reactions is limited by the titration schedules used in these studies. Adverse reactions are listed in descending order of frequency within each body system.

Table 1 : Adverse Reactions Which Occurred During Titration at a Frequency of ≥ 5%

System Organ Class, Preferred Term, n (%) ONSOLIS Dose (mcg) Total
(N=306)
200
(N=303)
400
(N=257)
600
(N=207)
800
(N=138)
1200
(N=79)
> 1200
(N=9)
Gastrointestinal Disorders
  Nausea 16 (5) 12 (5) 6 (3) 5 (4) 4 (5) 0 42 (14)
  Vomiting 7(2) 9 (4) 8 (4) 2 (1) 0 0 26 (8)
Nervous System Disorders
  Dizziness 5 (2) 5 (2) 6 (3) 2 (1) 4 (5) 0 22 (7)
  Somnolence 6 (2) 2 (1) 4 (2) 2 (1) 4 (5) 1 (11) 17 (6)

Table 2 lists, by successful dose, adverse reactions with an overall frequency of ≥ 5% that occurred during long-term treatment (i.e., the double-blind or open-label maintenance periods).

Table 2 : Adverse Reactions Which Occurred During Long-Term Treatment at a Frequency of ≥ 5%

System Organ Class, Preferred Term, n (%) ONSOLIS Dose (mcg) Total
(N=213)
200
(N=23)
400
(N=59)
600
(N=79)
800
(N=91)
1200
(N=81)
> 1200
(N=28)
Gastrointestinal
  Nausea 2 (9) 6 (10) 8 (10) 12(13) 26 (32) 4 (14) 56 (26)
  Vomiting 1 (4) 5 (8) 9 (11) 8 (9) 23 (28) 3 (11) 45 (21)
  Constipation 2 (9) 4 (7) 4 (5) 4 (4) 6 (7) 4 (14) 23(11)
  Diarrhea 1 (4) 1 (2) 4 (5) 4 (4) 10 (12) 0 19 (9)
  Dry mouth 1 (4) 4 (7) 3 (4) 2 (2) 3 (4) 1 (4) 14 (7)
  Abdominal pain 0 0 3 (4) 1 (1) 7 (9) 1 (4) 11 (5)
General/administration site
  Asthenia 0 6 (10) 3 (4) 8 (9) 7 (9) 4 (14) 28(13)
  Fatigue 2 (9) 6 (10) 1 (1) 7 (8) 7 (9) 3 (11) 25(12)
Investigations
  Weight decreased 3 (13) 0 2 (3) 5 (5) 5 (6) 1 (4) 15 (7)
Metabolism/nutrition
  Dehydration 1 (4) 4 (7) 6 (8) 5 (5) 10 (12) 3 (11) 28(13)
  Decreased appetite 0 4 (7) 4 (5) 6 (7) 2 (2) 2 (7) 18 (8)
  Anorexia 2 (9) 1 (2) 3 (4) 4 (4) 6 (7) 1 (4) 17 (8)
Nervous system
  Dizziness 2 (9) 4 (7) 2 (3) 3 (3) 10 (12) 2 (7) 23(11)
  Headache 2 (9) 1 (2) 3 (4) 9 (10) 7 (9) 0 20 (9)
  Somnolence 2 (9) 0 4 (5) 2 (2) 3 (4) 3 (11) 14 (7)
Psychiatric
  Confusional state 1 (4) 0 4 (5) 4 (4) 6 (7) 4 (14) 18 (8)
  Depression 0 3 (5) 1 (1) 4 (4) 7 (9) 3 (11) 18 (8)
  Insomnia 0 2 (3) 2 (3) 3 (3) 4 (5) 2 (7) 12 (6)
  Anxiety 1 (4) 1 (2) 2 (3) 3 (3) 3 (4) 1 (4) 11 (5)
Respiratory
  Dyspnea 3 (13) 4 (7) 3 (4) 8 (9) 6 (7) 3 (11) 26 (12)
  Cough 1 (4) 0 3 (4) 5 (5) 6 (7) 1 (4) 15 (7)
Vascular
  Hypotension 0 3 (5) 3 (4) 1 (1) 3 (4) 1 (4) 11 (5)

In a mucositis study, a group of patients (n=7) with Grade 1 oral mucositis and a matched group of control patients (n=7) without oral mucositis were included in a clinical trial designed to support the safety of ONSOLIS. The adverse event profile was similar in both subsets of patients. There was no evidence that ONSOLIS caused or worsened oral mucosal irritation or pain in either study group.

The duration of exposure to ONSOLIS varied greatly, and included open-label and double-blind studies. The adverse reactions listed below represent those that were reported by ≥ 1% of patients from two clinical trials (the titration and post-titration periods) while receiving ONSOLIS. Events are classified by system organ class.

Cardiac disorders: tachycardia

Eye disorders: vision blurred, diplopia

Gastrointestinal disorders: nausea, vomiting, constipation, diarrhea, dry mouth, abdominal pain, dyspepsia, dysphagia, abdominal distension, intestinal obstruction, flatulence

General disorders and administration site conditions: asthenia, fatigue, malaise

Injury, poisoning and procedural complications: fall, contusion Investigations: weight decreased, blood pressure increased

Metabolism and nutrition disorders: dehydration, decreased appetite, anorexia

Nervous system disorders: dizziness, somnolence, headache, lethargy, amnesia, sedation

Psychiatric disorders: confusional state, depression, insomnia, anxiety, hallucination, agitation, mental status changes

Renal and urinary disorders: urinary retention

Respiratory, thoracic and mediastinal disorders: dyspnea, cough

Skin and subcutaneous tissue disorders: pruritus, rash

Vascular disorders: hypotension, hot flush, deep vein thrombosis, hypertension

Read the Onsolis (fentanyl buccal soluble film) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Fentanyl is metabolized mainly via the human CYP3A4 isoenzyme system; therefore potential interactions may occur when ONSOLIS is given concurrently with agents that affect CYP3A4 activity.

The concomitant use of ONSOLIS with CYP3A4 inhibitors (e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, diltiazem, erythromycin, fluconazole, grapefruit juice, verapamil, or cimetidine) may result in a potentially dangerous increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Patients receiving ONSOLIS who begin therapy with, or increase the dose of, CYP3A4 inhibitors should be carefully monitored for signs of opioid toxicity over an extended period of time. Dosage increase should be done conservatively [see WARNINGS AND PRECAUTIONS].

The concomitant use of ONSOLIS with CYP3A4 inducers (e.g., barbiturates, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's wort, or troglitazone) may result in a decrease in fentanyl plasma concentrations, which could decrease the efficacy of ONSOLIS. Patients receiving ONSOLIS who stop therapy with, or decrease the dose of, CYP3A4 inducers should be monitored for signs of increased ONSOLIS activity and the dose of ONSOLIS should be adjusted accordingly.

Drug Abuse And Dependence

Controlled Substance

Fentanyl is a Schedule II controlled substance that can produce drug dependence of the morphine type. ONSOLIS may be subject to misuse, abuse and addiction.

Abuse And Addiction

Manage the handling of ONSOLIS to minimize the risk of abuse, including restriction of access and accounting procedures as appropriate to the clinical setting and as required by law [see HOW SUPPLIED and Storage and Handling].

Concerns about abuse and addiction should not prevent the proper management of pain. However, all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. “Drug-seeking” behavior is very common in addicts and drug abusers.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse for nonmedical purposes, often in combination with other psychoactive substances. Since ONSOLIS may be abused for non-medical use, careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of patients, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse of this product.

Dependence

Guide the administration of ONSOLIS by the response of the patient.

Physical dependence is not ordinarily a concern when one is treating a patient with chronic cancer pain, and fear of tolerance and physical dependence should not deter using doses that adequately relieve the pain.

Opioid analgesics may cause physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug.

Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e.g., naloxone, nalmefene, or mixed agonist/antagonist analgesics (pentazocine, butorphanol, buprenorphine, nalbuphine).

Physical dependence usually does not occur to a clinically significant degree until after several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required in order to produce the same degree of analgesia, is initially manifested by a shortened duration of analgesic effect, and subsequently, by decreases in the intensity of analgesia.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

See BOXED WARNING - WARNINGS: IMPORTANCE OF PROPER PATIENT SELECTION and POTENTIAL FOR ABUSE

Respiratory Depression(Hypoventilation)

Respiratory depression is the chief hazard of opioid agonists, including fentanyl, the active ingredient in ONSOLIS. Respiratory depression is more likely to occur in patients with underlying respiratory disorders and elderly or debilitated patients, usually following large initial doses in opioid non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration.

Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with the “sighing” pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. This makes overdoses involving drugs with sedative properties and opioids especially dangerous.

Patient/Caregiver Instructions

Patients and their caregivers must be instructed that ONSOLIS contains a medicine in an amount which can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid-tolerant. Patients and their caregivers must be instructed to keep ONSOLIS out of the reach of children. [see HOW SUPPLIED, Storage and Handling, and PATIENT INFORMATION].

Physicians and dispensing pharmacists must specifically question patients or caregivers about the presence of children in the home (on a full time or visiting basis) and counsel them regarding the dangers to children from inadvertent exposure.

ONSOLIS Dispensing

When dispensing, do not substitute an ONSOLIS prescription for any other fentanyl product. Substantial differences exist in the pharmacokinetic profile of ONSOLIS compared to other fentanyl products (e.g., see Figure 1) that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of ONSOLIS for any other fentanyl product may result in fatal overdose. ONSOLIS is NOT a generic version of any other transmucosal fentanyl product.

ONSOLIS Distribution Program

ONSOLIS is available only through a restricted distribution program called the FOCUS Program. Under the FOCUS Program, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive ONSOLIS. This program provides educational materials, patient counseling and facilitated distribution of the drug. To enroll in the FOCUS Program, call 1-877-466-7654 (1-877-4ONSOLIS) or visit www.OnsolisFocus.com. Prescribers and patients are required to understand the risks of therapy with ONSOLIS. Prescribers are required to understand the information in the prescribing information and to:

  • Ensure proper patient selection, including that the patient is opioid tolerant
  • Educate patients about the benefits and risks of treatment with ONSOLIS and ensure that the patient receives the Medication Guide
  • Complete the FOCUS Program prescriber enrollment form; sign and fax the form to the FOCUS Program
  • Obtain the patient's signature on the patient enrollment form; sign and fax the form to the FOCUS Program
  • Follow FOCUS Program-specific procedures for prescribing ONSOLIS using a courier

Additive CNS Depressant Effects

The concomitant use of ONSOLIS with other CNS depressants, including other opioids, sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages may produce increased depressant effects (e.g., hypoventilation, hypotension, and profound sedation). Concomitant use with inhibitors of the cytochrome P450 3A4 (CYP3A4) isoform (e.g., erythromycin, ketoconazole, and certain protease inhibitors) may increase fentanyl levels, resulting in increased depressant effects [see DRUG INTERACTIONS].

Patients on concomitant CNS depressants must be monitored for a change in opioid effects. Consideration should be given to adjusting the dose of ONSOLIS if warranted.

Effects On Ability To Drive And Use Machines

Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Warn patients taking ONSOLIS of these dangers and counsel them accordingly.

Chronic Pulmonary Disease

Because potent opioids can cause respiratory depression, titrate ONSOLIS with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to hypoventilation. In such patients, even normal therapeutic doses of ONSOLIS may further decrease respiratory drive to the point of respiratory failure.

Head Injuries And Increased Intracranial Pressure

Administer ONSOLIS with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.

Cardiac Disease

Intravenous fentanyl may produce bradycardia. Therefore, use ONSOLIS with caution in patients with bradyarrhythmias.

MAO Inhibitors

ONSOLIS is not recommended for use in patients who have received MAO inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.

Patient Counseling Information

See Medication Guide for specific patient instructions.

Patient/Caregiver Instructions

Patients will need to be enrolled in the FOCUS Program to receive ONSOLIS. The patient will receive their prescription via a traceable courier (with proof of delivery and adult signature required). The patient will receive a counseling call at the time of the first prescription to verify that they are opioid tolerant and discuss how to use the drug.

Provide patients and their caregivers with a Medication Guide for ONSOLIS.

Patients and their caregivers must be instructed that ONSOLIS contains medicine in an amount which can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. Patients and their caregivers must be instructed to keep ONSOLIS out of the reach of children. Patients and members of their household must be instructed to dispose of any unneeded films remaining from a prescription as soon as possible [see HOW SUPPLIED and Storage and Handling].

Physicians and dispensing pharmacists must specifically question patients or caregivers about the presence of children in the home (on a full time or visiting basis) and counsel them regarding the dangers to children from inadvertent exposure.

Disposal Of Unneeded ONSOLIS Films

Patients and members of their household must be instructed on the safe disposal of any unneeded films remaining from a prescription as soon as they are no longer needed.

To dispose of the unneeded ONSOLIS films:

  1. Remove the ONSOLIS film from its foil package.
  2. Drop the ONSOLIS film into the toilet.
  3. Repeat steps 1 and 2 for each ONSOLIS film. Flush the toilet after all unneeded films have been put into the toilet.

Do not flush the ONSOLIS foil packages or cartons down the toilet [see HOW SUPPLIED and Storage and Handling].

Detailed instructions for the proper storage, administration, disposal, and important instructions for managing an overdose of ONSOLIS are provided in the Medication Guide. Encourage patients to read this information in its entirety and give them an opportunity to have their questions answered.

In the event that a caregiver requires additional assistance in disposing of excess unneeded films that remain in the home after a patient has expired, instruct them to call Meda Pharmaceuticals Inc. at 1-800-526-3840 or seek assistance from their local Drug Enforcement Agency (DEA) office.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of fentanyl.

Fentanyl citrate was not mutagenic in the in vitro Ames reverse mutation assay in S. typhimurium or E. coli or the mouse lymphoma mutagenesis assay, and was not clastogenic in the in vivo mouse micronucleus assay.

Fentanyl has been shown to impair fertility in rats at doses of 30 mcg/kg IV and 160 mcg/kg subcutaneously. Conversion to the human equivalent doses indicates that this is within the range of the human recommended dosing for ONSOLIS.

Use In Specific Populations

Pregnancy – Category C

There are no adequate and well-controlled studies in pregnant women.

ONSOLIS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No epidemiological studies of congenital anomalies in infants born to women treated with fentanyl during pregnancy have been reported.

Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures in newborn infants characteristic of neonatal abstinence syndrome.

In women treated acutely with intravenous or epidural fentanyl during labor, symptoms of neonatal respiratory or neurological depression were no more frequent than would be expected in infants of untreated mothers.

Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl.

Fentanyl is embryocidal in rats as evidenced by increased resorptions in pregnant rats at doses of 30 mcg/kg IV or 160 mcg/kg SC. Conversion to human equivalent doses indicates this is within the range of the human recommended dosing for ONSOLIS.

Fentanyl citrate was not teratogenic when administered to pregnant animals. In published studies, pregnant rats were treated with fentanyl (10, 100, or 500 mcg/kg/day) via implanted microosmotic minipumps from Day 7 to 21 of their 21-day gestation period. Fentanyl was not teratogenic at doses up to 500 mcg/kg/day [approximately 3-times the maximum recommended human dose (MRHD) of 1200 mcg for ONSOLIS per breakthrough cancer pain episode]. Intravenous administration of fentanyl (10 or 30 mcg/kg) to pregnant female rats from gestation Day 6 to 18, was embryo or fetal toxic, and caused a slightly increased mean delivery time in the 30 mcg/kg/day group, but was not teratogenic.

Labor And Delivery

Fentanyl readily passes across the placenta to the fetus; therefore, use of ONSOLIS during labor and delivery is not recommended.

Nursing Mothers

Fentanyl is excreted in human milk; therefore, ONSOLIS should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants. Symptoms of opioid withdrawal may occur in infants at the cessation of nursing by women using ONSOLIS.

Pediatric Use

Safety and efficacy in pediatric patients below the age of 18 years have not been established.

Geriatric Use

Of the 306 opioid tolerant patients with breakthrough cancer pain in clinical studies of ONSOLIS, 98 (32.0%) were 65 years of age and older. There was no difference in the median titrated dose in patients aged 65 years and older compared to those < 65 years. No clinically meaningful difference was noted in the safety profile of the group 65 years of age and older as compared to younger patients in ONSOLIS clinical trials.

Elderly patients have been shown to be more sensitive to the effects of fentanyl when administered intravenously compared with the younger population. Therefore, exercise caution when individually titrating ONSOLIS in elderly patients to provide adequate efficacy while minimizing risk.

Patients With Renal Or Hepatic Impairment

Insufficient information exists to make recommendations regarding the use of ONSOLIS in patients with impaired renal or hepatic function. Fentanyl is metabolized primarily via the human CYP3A4 isoenzyme system and the inactive metabolite is mostly eliminated in urine. If the drug is used in these patients, it should be used with caution because of the hepatic metabolism and renal excretion of fentanyl.

It is recommended that ONSOLIS be titrated to clinical effect for all patients with special care taken in patients with severe renal or hepatic disease.

Gender

Both male and female opioid tolerant patients with cancer were studied for the treatment of breakthrough cancer pain. No clinically relevant gender differences were noted either in dosage requirement or in observed adverse reactions.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Clinical Presentation

The manifestations of ONSOLIS overdosage are expected to be similar in nature to intravenous fentanyl and other opioids, and are an extension of its pharmacological actions with the most serious significant effect being hypoventilation [see CLINICAL PHARMACOLOGYPharmacodynamics].

Immediate Management

Immediate management of opioid overdose includes removal of the ONSOLIS film, if still in the mouth, ensuring a patent airway, physical and verbal stimulation of the patient, and assessment of level of consciousness, ventilatory and circulatory status.

Treatment Of Overdosage (Accidental Ingestion) In The Opioid NON-Tolerant Person

Provide ventilatory support, obtain intravenous access, and employ naloxone or other opioid antagonists as clinically indicated. The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist's action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary. Consult the package insert of the individual opioid antagonist for details about such use.

Treatment Of Overdose In Opioid Tolerant Patients

Provide ventilatory support and obtain intravenous access as clinically indicated. Judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.

General Considerations For Overdose

Management of severe ONSOLIS overdose includes: securing a patent airway, assisting or controlling ventilation, establishing intravenous access, and GI decontamination by lavage and/or activated charcoal, once the patient's airway is secure. In the presence of hypoventilation or apnea, assist or control ventilation, and administer oxygen as indicated.

Although muscle rigidity interfering with respiration has not been seen following the use of ONSOLIS, this is possible with fentanyl and other opioids. If it occurs, manage by the use of assisted or controlled ventilation, by the administration of an opioid antagonist, and, as a final alternative, by the administration of a neuromuscular blocking agent.

ContrainDications

Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, ONSOLIS is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. This product must not be used in opioid non-tolerant patients.

Patients considered opioid tolerant are those who are taking at least: 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer.

ONSOLIS is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

Fentanyl is a pure opioid agonist whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as morphine, oxycodone, hydromorphone, codeine, and hydrocodone.

Pharmacodynamics

Pharmacological effects of opioid agonists include anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, cough suppression, and analgesia. Like all pure opioid agonist analgesics, with increasing doses there is increasing analgesia, unlike with mixed agonist/antagonists or non-opioid analgesics, where there is a limit to the analgesic effect with increasing doses. With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression.

Conditions which decrease fentanyl clearance including hepatic dysfunction and co-administration of CYP3A4 inhibitors may lead to increased duration of exposure. However, the duration of effect for the initial dose of fentanyl is largely determined by the rate of distribution of the drug. Diminished metabolic clearance may become significant with repeated dosing or at very high single doses.

Analgesia

The analgesic effects of fentanyl are related to the blood level of the drug, if proper allowance is made for the delay into and out of the CNS (a process with a 3 to 5-minute half-life).

In general, the effective concentration and the concentration at which toxicity occurs increase with increasing tolerance with any and all opioids.

The rate of development of tolerance varies widely among individuals. As a result, the dose of ONSOLIS should be individually titrated to achieve the desired effect [see DOSAGE AND ADMINISTRATION].

Central Nervous System

The precise mechanism of the analgesic action is unknown although fentanyl is known to be a mu-opioid receptor agonist. Specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug.

Fentanyl produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem to increases in carbon dioxide and to electrical stimulation.

Fentanyl causes miosis even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings).

Gastrointestinal System

Fentanyl causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and in the duodenum. Digestion of food is delayed in the small intestine and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid induced-effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of the sphincter of Oddi, and transient elevations in serum amylase.

Cardiovascular System

Fentanyl may produce a release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Endocrine System

Opioid agonists have been shown to have a variety of effects on the secretion of hormones. Opioids inhibit the secretion of ACTH, cortisol, and luteinizing hormone in humans. They also stimulate prolactin secretion, growth hormone secretion, and pancreatic secretion of insulin and glucagon in humans and other species, e.g., rats and dogs. Thyroid stimulating hormone has been shown to be both inhibited and stimulated by opioids.

Respiratory System

All opioid mu-receptor agonists, including fentanyl, produce dose-dependent respiratory depression. The risk of respiratory depression is less in patients receiving chronic opioid therapy who develop tolerance to respiratory depression and other opioid effects. During the titration phase of the clinical trials, somnolence, which may be a precursor to respiratory depression, did increase in patients who were treated with higher doses of ONSOLIS. Peak respiratory depressive effects may be seen as early as 15 to 30 minutes from the start of oral transmucosal fentanyl citrate product administration and may persist for several hours.

Serious or fatal respiratory depression can occur even at recommended doses. Fentanyl depresses the cough reflex as a result of its CNS activity. Although not observed with oral transmucosal fentanyl products in clinical trials, fentanyl given rapidly by intravenous injection in large doses may interfere with respiration by causing rigidity in the muscles of respiration. Therefore, physicians and other healthcare providers should be aware of this potential complication [see BOXED WARNING - WARNINGS: Importance of Proper Patient Selection and Potential for Abuse, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and OVERDOSAGE].

Pharmacokinetics

Absorption

The absorption pharmacokinetics of fentanyl from ONSOLIS is a combination of an initial rapid absorption from the buccal mucosa and a more prolonged absorption of swallowed fentanyl from the GI tract. Following buccal application of ONSOLIS, the absolute bioavailability of fentanyl was 71%. Approximately 51% of the total dose of ONSOLIS is absorbed from the buccal mucosa. The remaining 49% of the total dose is swallowed with the saliva and then slowly absorbed from the GI tract. Of the swallowed fentanyl, about 20% of the total dose escapes hepatic and intestinal first-pass elimination and becomes systemically available. An ONSOLIS film, if chewed and swallowed, will likely result in lower peak concentrations and lower bioavailability than when consumed as directed.

The absolute bioavailability study also demonstrated similar pharmacokinetics in the subsets of six male and six female adult normal volunteers.

In a study that compared the relative bioavailability of ONSOLIS and Actiq* (oral transmucosal fentanyl citrate [OTFC]) in 12 adult normal volunteers, the rate and extent of fentanyl absorption were considerably greater with ONSOLIS [62% greater maximum plasma concentration (Cmax) and 40% greater systemic exposure (AUCinf)] (Table 3 and Figure 1).

Table 3 : Fentanyl Plasma Pharmacokinetic Parameters in Healthy Adult Subjects Receiving Single Doses of ONSOLIS or Actiq

Pharmacokinetic Parameter * ONSOLIS (800 mcg) Actiq (800 mcg)
Cmax (ng/mL) 1.67 ± 0.75 1.03 ± 0.25
AUCmf (hr-ng/mL) 14.46 ± 5.4 10.30 ± 3.8
Tfirst (min) 9.0 ± 4.8 13.2 ± 10.8
Tmax (hr) 1.00 (0.75 - 4.00) 2.00 (0.50 - 4.00)
* Data for Tmax presented as median (range); other data are presented as mean ± SD

Figure 1 : Mean Fentanyl Plasma Concentration versus Time Profiles Following Single Doses of ONSOLIS or Actiq in Healthy Adult Subjects

View Enlarged Table

In another study, dose proportionality across the range of the available dosage strengths of ONSOLIS was demonstrated in a balanced crossover design comparing fentanyl plasma concentrations in three dosage strengths (200, 600, and 1200 mcg) in adult normal volunteers (n=12). Mean fentanyl plasma concentrations following these three doses of ONSOLIS are shown in Table 4. The curves for each dose level are similar in shape with increasing doses producing increasing fentanyl plasma concentrations. Cmax and AUCinf increased in a manner that is approximately proportional to the ONSOLIS dose administered. The mean Cmax ranged from 0.38 ng/mL to 2.19 ng/mL over this dose range.

Table 4 : Fentanyl Plasma Pharmacokinetic Parameters in Healthy Adult Subjects Receiving Single Doses of 200-, 600-, and 1200-mcg of ONSOLIS

Pharmacokinetic Parameter * ONSOLIS Dose (mcg)
200 600 1200
Cmax (ng/mL) 0.38 ± 0.07 1.16 ± 0.19 2.19 ± 0.54
AUCinf (hr-ng/mL) 3.46 ± 0.72 11.72 ± 5.29 20.43 ± 4.52
* Based on venous blood samples.

The effect of oral mucositis (Grade 1) on the pharmacokinetic profile of ONSOLIS was studied in a group of patients with cancer, with (n=7) and without (n=7) oral mucositis who were otherwise matched. A single 200 mcg ONSOLIS film was administered, followed by sampling at appropriate intervals. Summary results are presented in Table 5. Application of ONSOLIS on an active site of mucositis was associated with decreases in the Cmax and AUCinf that are not likely to be clinically relevant. The difference in Cmax is less than the intersubject variability and dose adjustment is not required.

Table 5 : Fentanyl Plasma Pharmacokinetic Parameters in Adult Patients with or without Mucositis Receiving Single Doses of ONSOLIS

Patient status Cmax (ng/mL) Tmax (hr) * AUC0-4 (hr-ng/mL)
Mucositis 0.47 ± 0.32 1.00
(0.50 - 4.00)
1.14 ± 0.71
No mucositis 0.69 ± 0.54 1.00
(0.50 - 1.50)
1.29 ± 0.87
* Data for Tmax presented as median (range); other data are presented as mean ± SD
Distribution

Fentanyl is highly lipophilic. Animal data showed that following absorption, fentanyl is rapidly distributed to the brain, heart, lungs, kidneys and spleen followed by a slower redistribution to muscles and fat. The plasma protein binding of fentanyl is 80-85%. The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent. The free fraction of fentanyl increases with acidosis. The mean volume of distribution at steady state (Vss) was 4 L/kg.

Metabolism

Fentanyl is metabolized in the liver and in the intestinal mucosa to norfentanyl by CYP3A4 isoform. Norfentanyl was not found to be pharmacologically active in animal studies [see DRUG INTERACTIONS].

Elimination

Fentanyl is primarily (more than 90%) eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites. Less than 7% of the dose is excreted unchanged in the urine, and only about 1% is excreted unchanged in the feces. The metabolites are mainly excreted in the urine, while fecal excretion is less important. The total plasma clearance of fentanyl was 0.5 L/hr/kg (range 0.3 to 0.7 L/hr/kg). The terminal elimination half-life after ONSOLIS administration is about 14 hours.

Clinical Studies

The efficacy of ONSOLIS was investigated in a clinical trial in opioid tolerant adult patients experiencing breakthrough cancer pain. Breakthrough cancer pain was defined as a transient flare of moderate-to-severe pain occurring in patients with cancer experiencing persistent cancer pain otherwise controlled with maintenance doses of opioid medications including at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for 1 week or longer. All patients were on stable doses of either long-acting oral opioids or transdermal fentanyl for their persistent cancer pain.

A double-blind, placebo-controlled, crossover study was performed in patients with cancer to evaluate the effectiveness of ONSOLIS for the treatment of breakthrough cancer pain. Open-label titration identified a successful dose of ONSOLIS, within the range of 200 to 1200 mcg. A “successful” dose was defined as a dose in which a patient obtained adequate analgesia with tolerable side effects. Table 6 presents the successful dose for both the double-blind efficacy and open-label safety studies. In the double-blind efficacy study, patients who identified a successful dose were randomized to a sequence of nine treatments; six with the successful dose of ONSOLIS and three with placebo. Of the patients who entered the study, 54 percent achieved a successful dose during the titration phase and 4 percent withdrew for lack of effective pain relief. The final titrated dose of ONSOLIS for breakthrough cancer pain was not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and, therefore, the dose was determined by titration starting at 200 mcg.

Table 6 : Dose of ONSOLIS Following Initial Titration

ONSOLIS Dose Double-blind Efficacy Study Total No. (%) (N=81)
200 mcg 4 (5%)
400 mcg 15 (19%)
600 mcg 23 (28%)
800 mcg 19 (23%)
1200 mcg 20 (25%)

The primary outcome measure, the mean sum of pain intensity differences at 30 minutes (SPID30) for ONSOLIS-treated episodes was statistically significantly higher than for placebo-treated episodes (see Figure 2).

Figure 2 : Sum of Pain Intensity Differences (SPID) Following ONSOLIS or Placebo in Adult Patients with Breakthrough Cancer Pain

View Enlarged Table

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Onsolis®
(on sol is)
(fentanyl buccal) Soluble Film 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg

IMPORTANT

Do not use Onsolis unless you are regularly using another opioid pain medicine around-the-clock for your constant cancer pain and your body is used to this medicine (this means that you are opioid tolerant).

Keep Onsolis in a safe place away from children.

Get emergency medical help right away if:

  • a child takes Onsolis. Onsolis can cause an overdose and death in any child who takes it.
  • an adult who has not been prescribed Onsolis uses it.
  • an adult who is not already taking opioids around-the-clock, uses Onsolis.

These are medical emergencies that can cause death. If possible, try to remove Onsolis from the mouth.

Read this Medication Guide completely before you start using Onsolis, and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. Be sure to share this information with members of your household and other caregivers.

What is the most important information I should know about Onsolis?

Onsolis can cause life-threatening breathing problems which can lead to death.

1. Do not use Onsolis if you are not opioid tolerant.

2. If you stop taking your around-the-clock opioid pain medicine for your constant cancer pain, you must stop using Onsolis. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.

3. Use Onsolis exactly as prescribed by your healthcare provider.

  • You must not take more than 1 dose of Onsolis for each episode of breakthrough cancer pain.
  • You must wait 2 hours before treating a new episode of breakthrough pain with Onsolis. See the Medication Guide section “How should I use Onsolis?” and the Patient Instructions for Use at the end of this Medication Guide for detailed information about how to use Onsolis the right way.

4. Do not switch from Onsolis to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of Onsolis is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of Onsolis that may be different than other fentanyl containing medicines you may have been taking.

5. Do not use Onsolis for short-term pain that you would expect to go away in a few days, such as:

  • pain after surgery
  • headache or migraine
  • dental pain

6. Never give Onsolis to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.

Onsolis is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.

  • Prevent theft, misuse or abuse. Keep Onsolis in a safe place to protect it from being stolen. Onsolis can be a target for people who abuse opioid (narcotic) medicines or street drugs.
  • Selling or giving away this medicine is against the law.

7. Onsolis is available only through a program called the Transmucosal Immediate Release Fentanyl) (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program. To receive Onsolis, you must:

  • talk to your healthcare provider
  • understand the benefits and risks of Onsolis
  • agree to all of the instructions
  • sign the Patient-Prescriber Agreement form

What is Onsolis?

  • Onsolis is a prescription medicine that contains fentanyl.
  • Onsolis is used to manage breakthrough pain in adults with cancer (18 years of age and older) who are already routinely taking other opioid pain medicines around-theclock for their constant cancer pain.
  • Onsolis is started only after you have been taking another opioid pain medicine and your body is used to it (you are opioid tolerant). Do not use Onsolis if you are not opioid tolerant.
  • Onsolis contains fentanyl in a small film (about the size of a dime or nickel) that sticks to the inside of your cheek.
  • You must stay under your healthcare provider's care while using Onsolis.

Onsolis is only:

  • available through the TIRF REMS Access program
  • given to people who are opioid tolerant

It is not known if Onsolis is safe and effective in children under the age of 18 years.

Who should not use Onsolis?

Do not use Onsolis:

  • if you are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicine around-the-clock for your constant cancer pain, and your body is used to these medicines.
  • for a short-term pain that you would expect to go away in a few days, such as:
    • pain from surgery,
    • headache or migraine
    • dental pain
  • if you are allergic to any of the ingredients in Onsolis. See near the end of this Medication Guide (before PATIENT INSTRUCTIONS FOR USE) for a complete list of ingredients in Onsolis.

What should I tell my healthcare provider before using Onsolis?

Before using Onsolis, tell your healthcare provider if you:

  • have trouble breathing or lung problems such as asthma, wheezing or shortness of breath
  • have or had a head injury or brain problem
  • have liver or kidney problems
  • have seizures
  • have a slow heart rate or other heart problems
  • have low blood pressure
  • have mental health problems such as major depression, schizophrenia, or hallucinations (seeing or hearing things that are not real)
  • have a past or present drinking problem (alcoholism) or a family history of drinking problems
  • have a past or present drug abuse or addiction problem, or a family history of a drug abuse problem or addiction problem
  • have any other medical conditions
  • are pregnant or plan to become pregnant. Onsolis may cause serious harm to your unborn baby.
  • are breastfeeding or plan to breastfeed. Onsolis passes through your breast milk. It can cause serious harm to your baby. You should not use Onsolis while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening side effects when taken with Onsolis. Sometimes the doses of certain medicines and Onsolis may need to be changed if used together.

  • Do not take any medicine while using Onsolis until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are using Onsolis.
  • Be very careful about taking other medicines that make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizer.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Onsolis?

Before you can begin to use Onsolis:

  • Your healthcare provider will explain the TIRF REMS Access program to you.
  • You will sign the TIRF REMS Access Patient-Prescriber Agreement Form.
  • Onsolis is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacies where you can have your Onsolis prescription filled.

Using Onsolis:

  • Use Onsolis exactly as prescribed by your healthcare provider. Do not use Onsolis more often than prescribed.
  • Your healthcare provider will change the dose until you and your healthcare provider find the right dose for you. Do not change your dose of Onsolis yourself.
  • Do not chew or swallow Onsolis.
  • You must not take a dose of Onsolis more than 1 time for each episode of breakthrough cancer pain.
  • You must wait at least 2 hours between doses before treating a new episode of breakthrough cancer pain with Onsolis.
  • It is important for you to keep taking your around-the-clock opioid pain medicine while using Onsolis.
  • Talk to your healthcare provider if your dose of Onsolis does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose of Onsolis needs to be changed.
  • You must not use Onsolis for more than four episodes of breakthrough cancer pain in one day. Talk to your healthcare provider if you have more than four episodes of breakthrough pain each day. The dose of the around-the-clock opioid pain medicine for your constant pain may need to be changed.
  • If you use too much Onsolis or overdose, you or your caregiver should call for emergency medical help or have someone take you to the nearest hospital emergency room right away.

What should I avoid while using Onsolis?

  • Do not drive, operate machinery, or do other dangerous activities until you know how Onsolis affects you. Onsolis can make you sleepy. Ask your healthcare provider when it is okay to do these activities.
  • Do not drink alcohol while using Onsolis. It can increase your chance of having dangerous side effects.

What are the possible side effects of Onsolis?

Onsolis can cause serious side effects including:

1. Breathing problems that can become life-threatening. See “What is the most important information I should know about Onsolis?”

  • You or a family member should call your healthcare provider or get emergency medical help right away if you: :
    • have trouble breathing
    • have drowsiness with slowed breathing
    • have slow, shallow breathing (little chest movement with breathing)
    • feel faint, dizzy, confused, or have other unusual symptoms
      These can be a sign that you have used too much Onsolis or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not use any more Onsolis until you have talked to your healthcare provider.

2. Decreased blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.

3. Physical dependence. Do not stop using Onsolis or any other opioid without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.

4. A chance of abuse or addiction with Onsolis. The chance is higher if you have ever been addicted to or abused other medicines, street drugs, or alcohol, or have a history of mental health problems.

The most common side effects of Onsolis are:

  • nausea
  • vomiting
  • dizziness
  • loss of too much body fluid (dehydration)
  • shortness of breath
  • sleepiness

Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including Onsolis and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Onsolis.

Talk with your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Onsolis. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Onsolis?

  • Always keep Onsolis in a safe place away from children and from anyone for whom it has not been prescribed. Protect Onsolis from theft.
  • Store Onsolis at room temperature, 59°F to 86°F (15°C to 30°C) until ready to use.
  • Do not freeze Onsolis.
  • Keep Onsolis dry.

How should I dispose of unopened Onsolis films when they are no longer needed?

  • Dispose of any unopened Onsolis films as soon as you no longer need them:
    1. Remove the Onsolis film from its foil package.
    2. Drop the Onsolis film into the toilet.
    3. Repeat steps 1 and 2 for each Onsolis film. Flush the toilet after all unneeded films have been put into the toilet.
  • Do not flush the Onsolis foil packages or cartons down the toilet.
  • If you need help with disposal of Onsolis, call Meda Pharmaceuticals Inc. at 1-800-526-3840 or call your local Drug Enforcement Agency (DEA) office.

General information about the safe and effective use of Onsolis.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use Onsolis only for the purpose for which it was prescribed. Do not give Onsolis to other people, even if they have the same symptoms you have.

Onsolis can harm other people and can even cause death.

Sharing Onsolis is against the law.

This Medication Guide summarizes the most important information about Onsolis. For more information talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about Onsolis that is written for healthcare professionals.

For more information about the TIRF REMS Access program, go to www.TIRFREMSaccess.com or call 1-866-822-1483.

What are the ingredients in Onsolis?

Active ingredient: fentanyl citrate

Inactive ingredients: carboxymethylcellulose, citric acid, hydroxyethyl cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, red iron oxide, sodium benzoate, sodium hydroxide, sodium saccharin, titanium dioxide, tribasic sodium phosphate, vitamin E acetate, and water.

Patient Instructions for Use

Before you use Onsolis, it is important that you read the Medication Guide and these Patient Instructions for Use. Be sure that your read, understand, and follow these Patient Instructions for Use so that you use Onsolis the right way. Ask your healthcare provider or pharmacist if you have any questions about the right way to use Onsolis.

Onsolis comes in a foil package. Do not open the package until ready to use. Once opened, use the entire Onsolis film right away.

To open an Onsolis package:

1. With the back side of the foil package facing you, cut along arrows with scissors.(See figure A)

2. Repeat step above to open the other side of the package.

3. Separate the layers of the foil package and remove the Onsolis film. (See figure B)

Figure A

Cut along arrows with scissors - Illustration

Figure B

Separate the layers of the foil package - Illustration
  • Do not chew or swallow Onsolis. If you do, you will likely get less relief for your breakthrough cancer pain.
  • Do not cut or tear the Onsolis film.
  • To correctly use Onsolis (see figures below):
  • Use your tongue to wet the inside of your cheek or, if needed, rinse your mouth with water to wet the area in your mouth where you will place Onsolis.
  • Hold the Onsolis film in place on a clean, dry finger with the pink side facing up. (See figure C)
  • Carefully place the Onsolis film inside your mouth with the pink side against the inside of your moistened cheek. (See figure D)
  • With your finger, press the Onsolis film against your cheek. Hold it there for 5 seconds.
  • Take your finger away from the Onsolis film. It will stick to the inside of your cheek.
  • Leave the film in place until it dissolves, usually within 15 to 30 minutes after you apply it.
  • You may drink liquids after 5 minutes.
  • If your healthcare provider tells you to use more than one Onsolis film at the same time for your breakthrough cancer pain, do not put the films on top of each other. Onsolis films may be placed on either side of your mouth.
  • Avoid touching or moving the film while it dissolves.
  • Do not eat any food until after the film dissolves.

Figure C

Hold the Onsolis film in place on a clean, dry finger - Illustration

Figure D

View Enlarged Table

If you can not use Onsolis this way, talk with your healthcare provider about other choices to treat your breakthrough cancer pain.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

FENTANYL DISSOLVING FILM - BUCCAL

 

(FEN-ta-nil)

 

COMMON BRAND NAME(S): Onsolis

 

WARNING: See also Uses and How To Use sections.

Fentanyl has a high risk for abuse and severe, possibly fatal, breathing problems. Do not use fentanyl dissolving film unless you have been regularly taking moderate to large amounts of narcotic pain medication. Otherwise, it may cause overdose (even death). The risk for harm is higher if you take the wrong dose/strength, or if you take it along with other drugs that might also affect breathing. It might also be higher when you start this medication and after a dose increase. Get medical help right away if you notice unusual slow/shallow breathing.

Carefully follow the specific directions for using fentanyl buccal films. Since they are not taken the same way, different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that can affect how fentanyl works (see also Drug Interactions section). Do not start, stop, or change the dosage of any medicines you are using without your doctor's approval.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally swallows this drug, get medical help right away.

Because of the risk of misuse, abuse, and overdose, you will need to register with a special distribution program (FOCUS) before receiving your prescription. Only doctors and pharmacies enrolled in FOCUS may prescribe or dispense this medication. Ask your doctor or pharmacist for details.

 

USES: This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of narcotic pain medication. Fentanyl belongs to a class of drugs known as narcotic (opiate) analgesics. It works in the brain to change how your body feels and responds to pain.

This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using fentanyl and each time you get a refill. Learn all usage and disposal instructions. If you have any questions, ask your doctor or pharmacist.

Use fentanyl buccal films as directed by your doctor. Before using, rinse your mouth with water or use your tongue to wet the inside of your cheek. With dry hands, open the blister pack just before using. Use the tip of a dry finger to place one film inside your mouth with the pink side facing against one cheek. Press and hold the film in place for 5 seconds, then remove your finger. The film should stay in place on its own after this. Leave it in place until it is dissolved (usually 15 to 30 minutes). You may drink liquids after the film has been in place for 5 minutes but do not move the strip with your tongue/finger or eat any food until the film has completely dissolved. If your doctor directs you to use more than one film at the same time for your breakthrough cancer pain, do not place one on top of the other. Place the films on either side of your mouth.

Do not cut, tear, bite, chew, or swallow the film whole.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

If you start to have side effects (such as dizziness, feeling sick to your stomach, severe drowsiness) before finishing a dose, your doctor may need to adjust your dose. Remove any remaining film and discard into a sink or toilet. Rinse your mouth with water and spit into a sink or toilet. Rinse the sink or flush the toilet afterward to finish proper disposal. Tell your doctor promptly if this happens.

The dosage is based on your medical condition and response to treatment. Wait at least 2 hours before using fentanyl buccal films again for another episode of sudden (breakthrough) pain. To avoid any confusion and chance of overdose, you should only keep a supply of one strength of this medication. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed.

Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

You should continue to also take your long-acting narcotic medication as directed by your doctor. Other non-narcotic pain relievers (such as acetaminophen, ibuprofen) may also be prescribed with this medication. Ask your doctor or pharmacist if you have any questions about using fentanyl safely with other drugs.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens or if you have more than 4 episodes of breakthrough pain daily.

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Onsolis (fentanyl buccal soluble film) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking fentanyl, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate), gallbladder disease, disease of the pancreas (pancreatitis).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: certain pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol), narcotic antagonists (such as naltrexone).

Other medications can affect the removal of fentanyl from your body, which may affect how fentanyl works. Examples include cimetidine, nefazodone, St. John's wort, azole antifungals including itraconazole/ ketoconazole, calcium channel blockers such as diltiazem/verapamil, HIV drugs such as nelfinavir/ritonavir, macrolide antibiotics including erythromycin, rifamycins including rifampin, certain anti-seizure medicines including carbamazepine, among others.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, allergy or cough-and-cold products, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as codeine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.

This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness.

 

NOTES: Do not share this medication with others. It is against the law and the medication may cause harm to others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

 

MISSED DOSE: Not applicable.

 

STORAGE: Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.

See also Warning and How to Use sections. Properly discard this product when it is expired or no longer needed. Read the Medication Guide for details. To discard this medication, the FDA recommends flushing down the toilet or pouring into a drain. However, consult your pharmacist or local waste disposal company.

 

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Fentora, Onsolis

Generic Name: fentanyl (buccal) (Pronunciation: FEN ta nil (BUK al))

  • What is fentanyl buccal (Onsolis)?
  • What are the possible side effects of fentanyl buccal (Onsolis)?
  • What is the most important information I should know about fentanyl buccal (Onsolis)?
  • What should I discuss with my healthcare provider before using fentanyl buccal (Onsolis)?
  • How should I use fentanyl buccal (Onsolis)?
  • What happens if I miss a dose (Onsolis)?
  • What happens if I overdose (Onsolis)?
  • What should I avoid while using fentanyl buccal (Onsolis)?
  • What other drugs will affect fentanyl buccal (Onsolis)?
  • Where can I get more information?

What is fentanyl buccal (Onsolis)?

Fentanyl is a narcotic (opioid) pain medicine.

Fentanyl buccal is used to treat "breakthrough" cancer pain that is not controlled by other medicines. Fentanyl buccal is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.

Fentanyl buccal may also be used for purposes not listed in this medication guide.

What are the possible side effects of fentanyl buccal (Onsolis)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fentanyl and call your doctor at once if you have a serious side effect such as:

  • weak or shallow breathing;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Less serious side effects may include:

  • nausea, vomiting, constipation;
  • dizziness, drowsiness;
  • headache;
  • feeling weak or tired;
  • swelling in your hands or feet; or
  • pain or mouth sores where the medicine was placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Onsolis (fentanyl buccal soluble film) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about fentanyl buccal (Onsolis)?

Fentanyl buccal is available only under special programs called Fentora REMS or the FOCUS Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Do not use fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Fentanyl buccal tablets are used to treat "breakthrough" cancer pain. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.

Do not use fentanyl buccal if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Before using fentanyl buccal, tell your doctor if you have a breathing disorder, a head injury or brain tumor, seizures, mental illness, a heart rhythm disorder, low blood pressure, liver or kidney disease, or a history of drug or alcohol addiction.

Keep this medicine out of the reach of children or pets. The amount of fentanyl in each fentanyl buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share fentanyl with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Side Effects Centers
  • Fentora
  • Onsolis

Patient Detailed How Take

What should I discuss with my healthcare provider before using fentanyl buccal (Onsolis)?

Do not use fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, and others), hydrocodone (Lortab, Vicodin), oxycodone (Oxycontin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant.

Do not use fentanyl if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

To make sure you can safely take fentanyl buccal, tell your doctor if you have any of these other conditions:

  • a breathing disorder such as chronic obstructive pulmonary disease (COPD);
  • a history of head injury or brain tumor;
  • a heart rhythm disorder;
  • seizures or epilepsy;
  • mental illness such as depression, hallucinations;
  • low blood pressure;
  • liver or kidney disease; or
  • a history of drug or alcohol addiction.

Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share fentanyl buccal with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether fentanyl buccal will harm an unborn baby. Fentanyl may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using fentanyl buccal.

Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. You should not breast-feed while you are using fentanyl buccal.

How should I use fentanyl buccal (Onsolis)?

Fentanyl buccal is available only under special programs called Fentora REMS or the FOCUS Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Use exactly as prescribed. Never use fentanyl in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

If you switch from using Actiq (fentanyl oral transmucosal devices) to using Fentora (fentanyl buccal tablets), you will not use the same fentanyl dose. Fentora is given at lower doses than Actiq. Using too much Fentora can cause a fatal overdose.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use only dry fingers when handling fentanyl buccal tablets or film. Use only 1 tablet or film at a time. Do not swallow the tablet or film whole. Allow the medicine to dissolve in your mouth without breaking, chewing, or sucking on it.

If you feel dizzy, nauseated, or very sleepy while the tablet is still in your mouth, spit the medicine out into a sink or toilet and rinse your mouth with water to remove all remaining pieces of the tablet. Call your doctor for instructions.

If your pain does not completely go away, use a second tablet or film only if your doctor has approved it.

Wait at least 2 hours to treat a new pain episode with fentanyl buccal film. Wait at least 4 hours to treat a new pain episode with fentanyl buccal tablets.

Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine.

Do not stop using fentanyl buccal suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using fentanyl.

Keep this medicine out of the reach of children or pets. The amount of fentanyl in each fentanyl buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine its original package until you are ready to take your dose.

Keep track of the amount of medicine used from each new bottle. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not use a fentanyl buccal tablet that has been left out of the blister pack for more than a few minutes. Flush the tablet down a toilet. Throw away any other unused tablets or by removing them from the blister pack and flushing them down a toilet.

Throw away unused film by removing them from the blister pack and flushing them down a toilet.

Side Effects Centers
  • Fentora
  • Onsolis

Patient Detailed Avoid Taking

What happens if I miss a dose (Onsolis)?

Since fentanyl buccal is used on an as needed basis, you are not likely to miss a dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Onsolis)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal.

Overdose symptoms may include extreme weakness or dizziness, pinpoint pupils, cold and clammy skin, weak pulse, fainting, slow breathing (breathing may stop).

What should I avoid while using fentanyl buccal (Onsolis)?

Do not use fentanyl with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how fentanyl will affect you.

Do not drink alcohol. It can increase drowsiness or breathing problems caused by fentanyl.

Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

What other drugs will affect fentanyl buccal (Onsolis)?

Do not take fentanyl buccal with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

  • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • St. John's wort;
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);
  • antifungal medicine such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
  • an antidepressant such as nefazodone;
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • HIV medication such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or
  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with fentanyl buccal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about fentanyl buccal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 6.02. Revision date: 1/27/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers
  • Fentora
  • Onsolis

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