Drugs Details

Drugs Info of Sancuso
Drugs Details
  • Drugs Type  : FDA
  • Date : 27th Mar 2015 04:56 am
  • Brand Name : Sancuso
  • Generic Name : granisetron (transdermal) (Pronunciation: gra NIS e tron)
Descriptions

Sancuso contains granisetron, which is an anti-nauseant and antiemetic agent. Chemically it is 1methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide with a molecular weight of 312.4. Its empirical formula is C18H24N4O, while its chemical structure is:

 

Sancuso (Granisetron) Structural Formula Illustration

 

Granisetron is a white to off-white solid that is insoluble in water. Sancuso is a thin, translucent, matrix-type transdermal patch that is rectangular-shaped with rounded corners, consisting of a backing, the drug matrix and a release liner.

 

What are the possible side effects of transdermal granisetron (Sancuso)?

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.

Remove the skin patch and call your doctor at once if you have a serious side effect such as:

  • severe redness, itching, swelling, or other irritation where the patch is worn;
  • uneven heart rate;
  • fever, pale skin, easy bruising or bleeding; or
  • feeling like you might pass out.

Less serious side effects may include:

  • diarrhea, constipation;
  • nausea,...

Read All Potential Side Effects and See Pictures of Sancuso »

What are the precautions when taking granisetron transdermal system (Sancuso)?

Before using granisetron, 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: stomach/intestinal problems (such as ileus, swelling).

This medication may be affected by sunlight or may make the application site more sensitive to sunlight. While wearing the patch, keep it covered (such as under clothing) to avoid exposing it to sunlight and sunlamps. Avoid tanning booths. After removing the patch, keep the application site covered for another 10 days.

If you are going to have an MRI test,...

Read All Potential Precautions of Sancuso »

 

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

Indications

Sancuso® (Granisetron Transdermal System) is indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.

Dosage Administration

The transdermal system (patch) should be applied to clean, dry, intact healthy skin on the upper outer arm. Sancuso should not be placed on skin that is red, irritated or damaged.

Each patch is packed in a pouch and should be applied directly after the pouch has been opened.

The patch should not be cut into pieces.

Adults

Apply a single patch to the upper outer arm a minimum of 24 hours before chemotherapy. The patch may be applied up to a maximum of 48 hours before chemotherapy as appropriate. Remove the patch a minimum of 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.

How Supplied

Dosage Forms and Strengths

Sancuso is a 52 cm²patch containing 34.3 mg of granisetron. The patch releases 3.1 mg of granisetron per 24 hours for up to 7 days.

Storage And Handling

Sancuso (Granisetron Transdermal System) is supplied as a 52 cm²patch containing 34.3 mg of granisetron. Each patch is printed on one side with the words “Granisetron 3.1 mg/24 hours”. Each patch is packaged in a separate sealed foil-lined plastic pouch.

Sancuso is available in packages of 1 (NDC 42747-726-01) patch.

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [see USP Controlled Room Temperature].

Sancuso should be stored in the original packaging.

Manufactured by: Aveva Drug Delivery Systems Inc., Miramar, FL 33025 Manufactured for: ProStrakan Inc., Bridgewater, NJ 08807. Revised: 08/2013

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

Side Effects

Clinical Trials Experience

The safety of Sancuso was evaluated in a total of 404 patients undergoingchemotherapy who participated in two double-blind, comparator studies with patch treatment durations of up to 7 days. The control groups included a total of 406 patients who received a daily dose of 2 mg oral granisetron, for 1 to 5 days.

Adverse reactions considered by the investigators as drug-related occurred in 8.7% (35/404) of patients receiving Sancuso and 7.1% (29/406) of patients receiving oral granisetron. The most common adverse reaction was constipation that occurred in 5.4% of patients in the Sancuso group and 3.0% of patients in the oral granisetron group.

Table 1 lists the treatment emergent adverse reactions that occurred in at least 3% of patients treated with Sancuso or oral granisetron.

Table 1: Incidence of Adverse Reactions in Double-Blind, Active Comparator Controlled Studies in Cancer Patients Receiving Chemotherapy (Events ≥ 3% in either group)

BODY SYSTEM 
PREFERRED TERM
SANCUSO TDS
N=404 (%)
ORAL GRANISETRON
N=406 (%)
Gastrointestinal disorders
  Constipation 5.4 3.0
Nervous system disorders
  Headache 0.7 3.0

 

5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. Three ECGs were performed on 588 randomized patients in the Phase 3 study: at baseline before treatment, the first day of chemotherapy, and 5 to 7 days after starting chemotherapy. QTcF prolongation greater than 450 milliseconds was seen in a total of 11 (1.9%) patients after receiving granisetron, 8 (2.7%) on oral granisetron and 3 (1.1%) on the patch. No new QTcF prolongation greater than 480 milliseconds was observed in any patient in this study. No arrhythmias were detected in this study.

Granisetron Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction 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.

Adverse events reported in clinical trials with other formulations of granisetron include the following:

Gastrointestinal: abdominal pain, diarrhea, constipation, elevation of ALT and AST levels, nausea and vomiting

Cardiovascular: Hypertension, hypotension, angina pectoris, atrial fibrillation and syncope have been observed rarely

Central Nervous System: dizziness, insomnia, headache, anxiety,somnolence and asthenia

Hypersensitivity: rare cases of hypersensitivity reactions, sometimes severe (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) have been reported

Other: fever; events often associated with chemotherapy have also been reported: leucopenia, decreased appetite, anemia, alopecia,thrombocytopenia.

Read the Sancuso (granisetron transdermal system) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

Granisetron does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system in vitro. There have been no definitive drug-drug interaction studies to examine pharmacokinetic or pharmacodynamic interaction with other drugs. However, in humans, granisetron hydrochloride injection has been safely administered with drugs representingbenzodiazepines, neuroleptics and anti-ulcer medications commonly prescribed with antiemetic treatments. Granisetron hydrochloride injection also does not appear to interact with emetogenic cancer therapies. In agreement with these data, no clinically relevant drug interactions have been reported in clinical studies with Sancuso.

Because granisetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP1A1 and CYP3A4), inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of granisetron. In addition, the activity of the cytochrome P-450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by granisetron hydrochloride in vitro. In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of granisetron hydrochloride. However, the clinical significance of in vivo pharmacokinetic interactions with ketoconazole is not known. In a human pharmacokinetic study, hepatic enzyme induction with phenobarbital resulted in a 25% increase in total plasma clearance of intravenous granisetron hydrochloride. The clinical significance of this change is not known.

Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) [see WARNINGS ANDPRECAUTIONS].

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

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Gastrointestinal

The use of granisetron in patients may mask a progressive ileus and/or gastric distention caused by the underlying condition.

Skin Reactions

In clinical trials with Sancuso, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use. The incidence of reactions was comparable with placebo.

If severe reactions, or a generalized skin reaction occur (e.g. allergic rash, including erythematous, macular, papular rash or pruritus), the patch must be removed.

Exposure To Sunlight

Granisetron may be affected by direct natural or artificial sunlight. Patients must be advised to cover the patch application site, e.g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal because of a potential skin reaction (see Section on Phototoxicity).

Serotonin Syndrome

The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT3 receptorantagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.

Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia,labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia),neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of Sancuso and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue Sancuso and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if Sancuso is used concomitantly with other serotonergic drugs. [see DRUG INTERACTIONS, PATIENT INFORMATION].

Patient Counseling Information

See FDA-approved patient labeling

Gastrointestinal

Because the use of granisetron may mask a progressive ileus and/or gastric distention caused by the underlying condition, patients should be instructed to tell their physician if they have pain or swelling in their abdomen.

Skin Reactions

Patients should be instructed to remove the patch if they have a severe skin reaction, or a generalized skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or pruritus).

When patients remove the patch, they should be instructed to peel it off gently.

Exposure To Sunlight

Granisetron may be degraded by direct sunlight or exposure to sunlamps. In addition, an in vitro study using Chinese hamster ovary cells suggests that granisetron has the potential for photogenotoxicity (see Section onPhototoxicity).

Patients must be advised to cover the patch application site, e.g. with clothing, if there is a risk of exposure to sunlight or sunlamps throughout the period of wear and for 10 days following its removal.

Serotonin Syndrome
  • Advise patients of the possibility of serotonin syndrome with concomitant use of Sancuso and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms, with or without gastrointestinal symptoms.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis And Impairment Of Fertility

In a 24-month carcinogenicity study, rats were treated orally with granisetron 1, 5 or 50 mg/kg/day (6, 30 or 300 mg/m²/day). The 50 mg/kg/day dose was reduced to 25 mg/kg/day (150 mg/m²/day) during week 59 due to toxicity. For a 50 kg person of average height (1.46 m² body surface area), these doses represent about 2.6, 13 and 65 times the recommended clinical dose (3.1 mg/day, 2.3 mg/m²/day, delivered by the Sancuso patch, on a body surface area basis). There was a statistically significant increase in the incidence of hepatocellular carcinomas and adenomas in males treated with 5 mg/kg/day (30 mg/m²/day, about 13 times the recommended human dose with Sancuso, on a body surface area basis) and above, and in females treated with 25 mg/kg/day (150 mg/m²/day, about 65 times the recommended human dose with Sancuso, on a body surface area basis). No increase in liver tumors was observed at a dose of 1 mg/kg/day (6 mg/m²/day, about 2.6 times the recommended human dose with Sancuso, on a body surface area basis) in males and 5 mg/kg/day (30 mg/m²/day, about 13 times the recommended human dose with Sancuso, on a body surface area basis) in females.

In a 12-month oral toxicity study, treatment with granisetron 100 mg/kg/day (600 mg/m²/day, about 261 times the recommended human dose with Sancuso, on a body surface area basis) produced hepatocellular adenomas in male and female rats while no such tumors were found in the control rats. A 24-month mouse carcinogenicity study of granisetron did not show a statistically significant increase in tumor incidence, but the study was not conclusive.

Because of the tumor findings in rat studies, Sancuso should be prescribed only at the dose and for the indication recommended (see INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION).

Granisetron was not mutagenic in an in vitro Ames test and mouselymphoma cell forward mutation assay, and in vivo mouse micronucleus test and in vitro and ex vivo rat hepatocyte UDS assays. It, however, produced a significant increase in UDS in HeLa cells in vitro and a significant increased incidence of cells with polyploidy in an in vitro human lymphocytechromosomal aberration test.

Granisetron at subcutaneous doses up to 6 mg/kg/day (36 mg/m²/day, about 16 times the recommended human dose of Sancuso, on a body surface area basis), and oral doses up to 100 mg/kg/day (600 mg/m²/day, about 261 times the recommended human dose of Sancuso, on a body surface area basis) was found to have no effect on fertility and reproductive performance of male and female rats.

Phototoxicity

When tested for potential photogenotoxicity in vitro in a Chinese hamster ovary (CHO) cell line, at 200 and 300 mcg/ml, granisetron increased the percentage of cells with chromosomal aberration following photoirradiation.

Granisetron was not phototoxic when tested in vitro in a mouse fibroblast cell line. When tested in vivo in guinea-pigs, Sancuso patches did not show any potential for photoirritation or photosensitivity. No phototoxicity studies have been performed in humans.

Use In Specific Populations

Pregnancy

Pregnancy Category B

Reproduction studies with granisetron hydrochloride have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m²/day, about 24 times the recommended human dose delivered by the Sancuso patch, based on body surface area) and oral doses up to 125 mg/kg/day (750 mg/m²/day, about 326 times the recommended human dose with Sancuso based on body surface area). Reproduction studies have been performed in pregnant rabbits at intravenous doses up to 3 mg/kg/day (36 mg/m²/day, about 16 times the human dose with Sancuso based on body surface area) and at oral doses up to 32 mg/kg/day (384 mg/m²/day, about 167 times the human dose with Sancuso based on body surface area). These studies did not reveal any evidence of impaired fertility or harm to the fetus due to granisetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Sancuso should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether granisetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sancuso is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Sancuso in pediatric patients under 18 years of age have not been established.

Geriatric Use

Clinical studies of Sancuso did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, cautious treatment selection for an elderly patient is prudent because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Failure or Hepatically-Impaired Patients

Although no studies have been performed to investigate the pharmacokinetics of Sancuso in patients with renal or hepatic impairment, pharmacokinetic information is available for intravenous granisetron (seeCLINICAL PHARMACOLOGY: Pharmacokinetics).

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

 
 

OverDose

There is no specific antidote for granisetron overdosage. In the case of overdosage, symptomatic treatment should be given.

Overdosage of up to 38.5 mg of granisetron hydrochloride, as a single intravenous injection, has been reported without symptoms or only the occurrence of a slight headache.

In clinical trials there were no reported cases of overdosage with Sancuso.

ContrainDications

Sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the patch.

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

Clinical Pharamacology

Mechanism Of Action

Granisetron is a selective 5–hydroxytryptamine3 (5-HT3) receptor antagonistwith little or no affinity for other serotonin receptors, including 5-HT1, 5-HT1A, 5-HT1B/C, 5-HT2; for alpha1-, alpha2-, or betaadrenoreceptors; fordopamine-D2; or for histamine-H1; benzodiazepine; picrotoxin or opioidreceptors.

Serotonin receptors of the 5-HT3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.

Pharmacodynamics

The effect of granisetron on QTc prolongation was evaluated in a randomized, single-blind, positive (moxifloxacin 400 mg) -and placebo controlled parallel study in healthy subjects. A total of 240 subjects were administered Sancuso patch, intravenous granisetron (10 mcg/kg over 30 seconds). In a study with demonstrated ability to detect small effects, the upper bound of the 90% confidence interval for the largest placebo adjusted, baseline corrected QTc based on Fridericia correction method (QTcF) for Sancuso was below 10 ms, the threshold for regulatory concern.

No evidence of an effect on plasma prolactin or aldosterone concentrations has been found in studies using granisetron.

The effect on oro-cecal transit time following application of Sancuso has not been studied. Granisetron hydrochloride injection exhibited no effect on oro-cecal transit time in healthy subjects given a single intravenous infusion of 50 mcg/kg or 200 mcg/kg. Single and multiple oral doses of granisetron hydrochloride slowed colonic transit in healthy subjects.

Pharmacokinetics

Absorption

Granisetron crosses intact skin into the systemic circulation by a passive diffusion process.

Following a 7-day application of Sancuso in 24 healthy subjects, high inter-subject variability in systemic exposure was observed. Maximal concentration was reached at approximately 48 hours (range: 24-168 hours) following patch application. Mean Cmax was 5.0 ng/mL (CV: 170%) and mean AUC0-168hr was 527 ng-hr/mL (CV:173%).

Mean Plasma Concentration of Granisetron (mean ± SD)

View Enlarged Table

 

Based on the measure of residual content of the patch after removal, approximately 66% (SD: ± 10.9) of granisetron is delivered following patch application for 7 days.

Distribution

Plasma protein binding is approximately 65%. Granisetron distributes freely between plasma and red blood cells.

Metabolism

Granisetron metabolism involves N-demethylation and aromatic ring oxidation followed by conjugation. In vitro liver microsomal studies show that granisetron's major route of metabolism is inhibited by ketoconazole, suggestive of metabolism mediated by the cytochrome P-450 3A subfamily. Animal studies suggest that some of the metabolites may also have 5-HT3 receptor antagonist activity.

Elimination

Clearance is predominantly by hepatic metabolism. Based on a study with intravenous injection, approximately 12% of the dose is excreted unchanged in the urine of healthy subjects in 48 hours. The remainder of the dose is excreted as metabolites, 49% in the urine, and 34% in the feces.

Subpopulations

Gender

There is evidence to suggest that female subjects had higher granisetron concentrations than males following patch application. However, no statistically significant difference in clinical efficacy outcome was observed between genders.

Pediatrics

No studies have been performed to investigate the pharmacokinetics of Sancuso in pediatrics.

Elderly, and Renal or Hepatic

Impairment Although no studies have been performed to investigate the pharmacokinetics of Sancuso in elderly subjects, and in patients with renal or hepatic impairment, the following pharmacokinetic information is available for intravenous granisetron.

In the elderly, and in patients with renal failure or hepatic impairment, the pharmacokinetics of granisetron were determined following a single 40 mcg/kg intravenous dose of granisetron hydrochloride.

Elderly

In elderly volunteers (mean age 71 years) pharmacokinetic parameters following a single 40 mcg/kg intravenous dose of granisetron hydrochloride, lower clearance and longer half-life were observed compared to younger healthy volunteers.

Renal Failure Patients

Total clearance of granisetron was not affected in patients with severe renal failure who received a single 40 mcg/kg intravenous dose of granisetron hydrochloride.

Hepatically-Impaired Patients

In patients with hepatic impairment due to neoplastic liver involvement, total plasma clearance following a single 40 mcg/kg intravenous dose of granisetron hydrochloride was approximately halved compared to patients without hepatic impairment. Given the wide variability in pharmacokinetic parameters of granisetron and the good tolerance of doses well above the recommended dose, dose adjustment in patients with hepatic functional impairment is not necessary.

Clinical Studies

The effectiveness of Sancuso in the prevention of chemotherapy-induced nausea and vomiting (CINV) was evaluated in a Phase 3 randomized, parallel group, double-blind, double-dummy study conducted in the U.S. and abroad. The study compared the efficacy, tolerability and safety of Sancuso with that of 2 mg oral granisetron once daily in the prevention of nausea and vomiting in a total of 641 patients receiving multi-day chemotherapy.

The population randomized into the trial included 48% males and 52% females aged 16 to 86 years receiving moderately (ME) or highly emetogenic (HE) multi-day chemotherapy. Seventy-eight (78%) of patients were White, 12% Asian, 10% Hispanic/Latino and 0% Black.

The granisetron patch was applied 24 to 48 hours before the first dose of chemotherapy, and kept in place for 7 days. Oral granisetron was administered daily for the duration of the chemotherapy regimen, one hour before each dose of chemotherapy. Efficacy was assessed from the first administration until 24 hours after the start of the last day's administration of the chemotherapy regimen.

The primary endpoint of the trial was the proportion of patients achieving no vomiting and/or retching, no more than mild nausea and no rescue medication from the first administration until 24 hours after the start of the last day's administration of multi-day chemotherapy. Using this definition, the effect of Sancuso was established in 60.2% of patients in the Sancuso arm and 64.8% of patients receiving oral granisetron (difference -4.89%; 95% confidence interval –12.91% to +3.13%).

An assessment of patch adhesion in 621 patients receiving either active or placebo patches showed that less than 1% of patches became detached over the course of the 7 day period of patch application.

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

Patient Information

Sancuso® 
[san-KOO-so] 
(granisetron) Transdermal System

IMPORTANT: For skin use only

Read the Patient Information that comes with Sancuso before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions about Sancuso, ask your healthcare provider.

What is Sancuso?

Sancuso is a prescription medicine used to prevent nausea and vomiting in people receiving some types of chemotherapy treatment. Sancuso is a skin patch that slowly releases the medicine contained in the adhesive (glue), through clean and intact skin areas into your bloodstream while you wear the patch.

Important: Sancuso contains granisetron, the same medicine in Kytril. Do not take Kytril at the same time you use Sancuso unless your healthcare provider tells you it is alright.

 

Sancuso transdermal system - Illustration

 

Who should not use Sancuso?

Do not use Sancuso if you are allergic to any of the ingredients in Sancuso. See the end of this leaflet for a list of ingredients in Sancuso.

What should I tell my healthcare provider before using Sancuso?

Tell your healthcare provider about all your medical conditions, including if you:

  • are allergic to medical adhesive tape, adhesive dressings or other skin patches
  • have pain or swelling in your stomach area (abdomen).
  • are pregnant. It is not known if Sancuso will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. It is not known if Sancuso passes into your breast milk.

Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins and herbal supplements. Other medicines may affect how Sancuso works. Sancuso may also affect how other medicines work.

How should Sancuso be used?

Use Sancuso exactly as prescribed. See the detailed Patient Instructions for Applying Sancuso at the end of this Patient Information leaflet.

What should I avoid while using Sancuso?

Avoid sunlight. The medicine in Sancuso (granisetron) may not work as well and/or may affect your skin if exposed to direct sunlight or the light from sunlamps or tanning beds. It is important to do the following:

  • While you wear the patch, keep it covered with clothing if you will be in sunlight or near a sunlamp, including tanning beds.
  • Keep the skin where Sancuso was applied covered for another 10 days after the patch is taken off to protect from exposure to direct sunlight.

What are the possible side effects of Sancuso?

Sancuso can cause serious side effects:

  • Using Sancuso may make it harder to identify certain stomach and bowel problems that are from other causes. Tell your healthcare provider if you have any stomach area (abdominal) pain or swelling while using Sancuso.
  • Skin reactions. Skin reactions can happen just at the patch application site or outside the patch application site. Tell your healthcare provider if you get any redness, rashes, bumps, blisters or itching at the patch application site, and especially if they spread outside the place where the patch was or if they appear outside the patch application site. You may need to stop using Sancuso.

Common side effects of Sancuso are:

  • constipation
  • headache.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Sancuso. 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 Sancuso?

  • Keep Sancuso in the package it comes in.
  • Store Sancuso at 20-25oC (68-77°F).

Keep Sancuso out of the reach of children.

General information about Sancuso

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Sancuso for a condition for which it is not prescribed. Do not give Sancuso to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Sancuso. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Sancuso that is written for health professionals.

For more information, go to www.sancuso.com or call 1-800-SANCUSO.

Patient Instructions for Applying Sancuso

When do I apply the Sancuso patch?

  • Apply Sancuso at least 1 day (24 hours) before your scheduled chemotherapy treatment.
  • You may apply Sancuso up to 2 days (48 hours) before your scheduled chemotherapy.
  • Wear the patch all the time during your chemotherapy.
  • Sancuso may be worn for up to 7 days, depending on how long your chemotherapy treatment lasts (up to 5 days)
  • Remove the patch at least 1 day (24 hours) after your chemotherapy is finished.
  • Keep the patch covered, such as under clothing, while you are wearing it to avoid a skin reaction to sunlight or sunlamps. Keep the skin where Sancuso was applied (application site) covered up for another 10 days after the patch is taken off to prevent a skin reaction. See “What should I avoid while using Sancuso?”

Where do I apply the Sancuso patch?

  • Apply Sancuso to a clean, dry, healthy area of skin on the outside part of your upper arm.

 

Patch application site - Illustration

 

  • The area you choose should not be oily, recently shaved or have any skin problems such as being damaged (cut or scraped) or irritated (redness or a rash).
  • Do not apply Sancuso to areas that have been treated with creams, oils, lotions, powders or other skin products that could keep the patch from sticking well to your skin.

How do I apply the Sancuso patch?

The Sancuso patch comes inside a pouch which is inside the carton.

1. Do not remove the patch from the pouch until you are ready to use it.

2. Do not cut the Sancuso patch into pieces.

3. Remove the pouch from the carton.

 

Remove the pouch from the carton -  Illustration

 

4. Tear the pouch open using the slit provided, and remove the patch. Each pouch contains one Sancuso patch stuck onto a rigid plastic film, and a separate thin, clear protective liner.

 

View Enlarged Table

 

5. Remove the thin, clear protective liner to expose the printed side of the patch. Throw away the liner. The protective liner is only included in the pouch to separate the patch from the inside of the pouch, and is not part of the patch.

 

Remove the thin, clear protective liner - Illustration

 

6. The unprinted, sticky side of the patch is covered by a two-piece rigid plastic film. Bend the patch in the middle and remove one half of the rigid plastic film. Be careful not to stick the patch to itself and avoid touching the sticky side of the patch.

 

remove one half of the rigid plastic film -  Illustration

 

7. While holding the remaining half of the rigid plastic film, apply the patch to your skin. Remove the second half of the rigid plastic film and press the whole patch firmly in place with your fingers and smooth down. Press firmly making sure it sticks well to the skin, especially around the edges.

 

Apply the patch - Illustration

 

8. Wash your hands right away after applying the patch to remove any medicine that may have stuck to your fingers.

9. Keep the patch in place for the whole time you are having chemotherapy. Remove the patch at least 1 day (24 hours) after your chemotherapy is finished. The patch can be worn for up to 7 days, depending on the number of days your chemotherapy treatment lasts.

10. Do not re-use the patch after you remove it. See below for instructions on the right way to remove and throw away the patch.

What to do if the Sancuso patch does not stick well?

If the patch does not stick well, you may use surgical bandages or medical adhesive tape to keep the patch in place. Place tape or bandages on the edges of the patch. Do not completely cover the patch with bandages or tape and do not wrap completely around your arm. If the patch comes more than half off or it becomes damaged see your healthcare provider.

Can I bathe or shower while wearing Sancuso?

You can continue to shower and wash normally while wearing the Sancuso patch. It is not known how other activities, for example swimming, strenuous exercise or using a sauna or whirlpool, may affect Sancuso. Avoid these activities while wearing Sancuso.

How do I remove and dispose of Sancuso?

  1. When you remove the patch, peel it off gently.
  2. The used patch will still contain some of the medicine. After removing the used Sancuso patch, fold it in half so that the sticky side sticks to itself. Throw away the Sancuso patch in the garbage, out of the reach of children and pets. Do not re-use the patch.
  3. After removing the patch you may find some adhesive is left on your skin. Gently wash the area with soap and water to remove it. Do not use alcohol or other dissolving liquids, such as nail polish remover. These may cause skin irritation.
  4. Wash your hands after handling the patch.
  5. You may see mild redness on the skin where the patch is removed. This redness should go away within three days. If redness continues, tell your healthcare provider.

What are the ingredients in Sancuso?

Active ingredient: granisetron.

Inactive ingredients: acrylate-vinylacetate copolymer, polyester, titanium dioxide, polyamide resin and polyethylene wax.

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.

 

GRANISETRON - TRANSDERMAL

 

(gra-NIS-e-tron)

 

COMMON BRAND NAME(S): Sancuso

 

USES: This medication is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). It works by blocking one of the body's natural substances (serotonin) that can cause vomiting.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow all instructions for how to properly apply and use the patch. Do not cut the patch into smaller sizes. Do not use the patch if it appears broken, cut, or damaged. If you have any questions, consult your doctor or pharmacist.

Apply this medication to the skin, usually 1 to 2 days (24 to 48 hours) before your chemotherapy treatment or as directed by your doctor. Do not open the sealed pouch until you are ready to use the patch. Open the pouch and remove the patch from the protective liner. Apply the patch as directed to a clean and dry area on the outside part of your upper arm. Do not apply the patch to recently shaved or oily/red/irritated/broken areas of skin or to areas where you have applied skin products such as creams or lotions. You can bathe and shower with the patch on. Wash your hands with soap and water after each application.

Wear the patch during your chemotherapy treatment until at least 24 hours after you finish treatment. Do not wear the patch for more than 7 days in a row. Consult your doctor for more details on how long you should wear your patch.

If the patch does not stick well, apply medical tape or surgical bandages to the edges of the patch to keep the patch in place. Do not completely cover the patch.

When it is time to remove the patch, peel it off gently. Fold it in half with the sticky sides together, and discard in the trash away from children and pets. Do not reuse the patch. Wash the application site and your hands with soap and water. The application site may have some mild redness, which should go away within 3 days. Contact your doctor if the redness continues after 3 days.

Use this medication exactly as directed to get the most benefit from it. Do not use more medication than prescribed. Tell your doctor if nausea occurs with your chemotherapy treatment.

Consumer Overview Side Effect

SIDE EFFECTS: Constipation may occur. If this effect persists or worsens, tell your doctor promptly.

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 this unlikely but serious side effect occurs: stomach/abdominal pain or swelling.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 Sancuso (granisetron transdermal system) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before using granisetron, 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: stomach/intestinal problems (such as ileus, swelling).

This medication may be affected by sunlight or may make the application site more sensitive to sunlight. While wearing the patch, keep it covered (such as under clothing) to avoid exposing it to sunlight and sunlamps. Avoid tanning booths. After removing the patch, keep the application site covered for another 10 days.

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

 

 

 

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because a very serious interaction may occur: apomorphine.

If you are currently using the medication listed above, tell you doctor or pharmacist before starting granisetron.

Before using this medication, tell your doctor of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medication patch may be harmful if chewed or swallowed. If overdose or swallowing is suspected, remove the patch if possible, and 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.

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: Tell your doctor if you miss your dose or did not use your dose at the correct time before your scheduled chemotherapy appointment. Your treatment may need to be rescheduled.

 

STORAGE: Store the patch at room temperature between 68-77 degrees F (20-25 degrees C) in the original sealed pouch away from heat. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not open the pouch until you are ready to use the patch. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Sancuso

Generic Name: granisetron (transdermal) (Pronunciation: gra NIS e tron)

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

What is transdermal granisetron (Sancuso)?

 

Granisetron blocks the actions of chemicals in the body that may cause nausea and vomiting.

Granisetron transdermal (skin patch) is used to prevent nausea and vomiting caused by cancer chemotherapy.

Granisetron may also be used for other purposes not listed in this medication guide.

What are the possible side effects of transdermal granisetron (Sancuso)?

 

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.

Remove the skin patch and call your doctor at once if you have a serious side effect such as:

  • severe redness, itching, swelling, or other irritation where the patch is worn;
  • uneven heart rate;
  • fever, pale skin, easy bruising or bleeding; or
  • feeling like you might pass out.

Less serious side effects may include:

  • diarrhea, constipation;
  • nausea, vomiting, stomach pain;
  • loss of appetite;
  • headache;
  • mild itching or skin irritation where the patch is worn;
  • dizziness, drowsiness, anxiety;
  • sleep problems (insomnia); or
  • temporary hair loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Sancuso (granisetron transdermal system) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about transdermal granisetron (Sancuso)?

 

You should not use this medication if you are allergic to granisetron.

Before using granisetron, tell your doctor if you have a stomach or intestinal disorder, if you have recently had stomach or intestinal surgery, or if you have ever had an allergic reaction to any type of medicated skin patch. You may need a dose adjustment or special tests to safely use granisetron.

Avoid exposing the skin patch or your upper arm to sunlight, sunlamps, or tanning beds. Natural or artificial sunlight can cause a skin reaction where the granisetron skin patch is worn. This effect may last for up to 10 days after the patch is removed. Wear protective clothing over your arms while you are wearing the skin patch and for at least 10 days after you remove a patch.

Do not use granisetron during a time when you are not having chemotherapy, unless your doctor has told you to.

Side Effects Centers
  • Sancuso

Patient Detailed How Take

What should I discuss with my healthcare provider before using granisetron (Sancuso)?

 

You should not use this medication if you are allergic to granisetron.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using transdermal granisetron, tell your doctor if you have:

  • a stomach or intestinal disorder;
  • if you have recently had stomach or intestinal surgery; or
  • if you have ever had an allergic reaction to any type of medicated skin patch.

FDA pregnancy category B. Granisetron is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether granisetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use transdermal granisetron on anyone younger than 18 years old.

How should I use transdermal granisetron (Sancuso)?

 

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Apply the granisetron skin patch 24 to 48 hours before your chemotherapy is scheduled to start. To use the patch, open the sealed pouch and remove the protective liner. Apply the transdermal patch to a clean, dry area on the outer side of your upper arm. Avoid placing the patch on skin that is red, irritated or damaged.

Press the patch onto the skin and press it down firmly with your fingers. Make sure the patch is well sealed around the edges.

Leave the patch in place and wear it for at least 24 hours after your chemotherapy ends. You may continue wearing the skin patch for up to 7 days if needed, depending on your chemotherapy schedule. Follow your doctor's instructions.

Do not cut or trim the granisetron skin patch.

If the patch falls off, try sticking it back on. If it does not stay on, replace it with a new one and wear it for the rest of your patch-wearing time. Do not change your schedule, even if you apply a new patch to replace one that has fallen off.

After removing a patch, fold it in half so it sticks together and throw it away in a place where children or pets cannot get to it.

Do not use granisetron during a time when you are not having chemotherapy, unless your doctor has told you to.

Keep each granisetron skin patch in its sealed pouch until you are ready to use it. Store the pouches at room temperature away from moisture, heat, and light.

Side Effects Centers
  • Sancuso

Patient Detailed Avoid Taking

What happens if I miss a dose (Sancuso)?

 

Call your doctor for instructions if you forget to apply a granisetron skin patch at least 24 hours before your chemotherapy is scheduled to start.Do not use extra patches to make up the missed dose.

What happens if I overdose (Sancuso)?

 

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of transdermal granisetron is not expected to produce life-threatening side effects.

What should I avoid while using transdermal granisetron (Sancuso)?

 

Avoid exposing the skin patch or your upper arm to sunlight, sunlamps, or tanning beds. Natural or artificial sunlight can cause a skin reaction where the granisetron skin patch is worn. This effect may last for up to 10 days after the patch is removed. Wear protective clothing over your arms while you are wearing the skin patch and for at least 10 days after you remove a patch.

What other drugs will affect transdermal granisetron (Sancuso)?

 

There may be other drugs that can interact with transdermal granisetron. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about transdermal granisetron.


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: 1.03. Revision date: 12/15/2010.

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