Drugs Details

Drugs Info of Rescriptor
Drugs Details
  • Drugs Type  : FDA
  • Date : 14th Jan 2015 03:08 am
  • Brand Name : Rescriptor
  • Generic Name : delavirdine (Pronunciation: de la VIR deen)
Descriptions

RESCRIPTOR Tablets contain delavirdine mesylate, a synthetic non-nucleoside reverse transcriptase inhibitor (NNRTI) of the human immunodeficiency virus type 1 (HIV-1). The chemical name of delavirdine mesylate is piperazine, 1-[3-[(1-methyl-ethyl)amino]-2- pyridinyl]-4-[[5-[(methylsulfonyl)amino]-1H-indol-2-yl]carbonyl]-, monomethanesulfonate. Its molecular formula is C22H28N6O3S • CH4O3S, and its molecular weight is 552.68. The structural formula is:

 

RESCRIPTOR® (delavirdine mesylate)Structural Formula Illustration

Delavirdine mesylate is an odorless white-to-tan crystalline powder. The aqueous solubility of delavirdine free base at 23°C is 2,942 mcg/mL at pH 1.0, 295 mcg/mL at pH 2.0, and 0.81 mcg/mL at pH 7.4.

Each RESCRIPTOR Tablet, for oral administration, contains 100 or 200 mg of delavirdine mesylate (henceforth referred to as delavirdine). Inactive ingredients consist of carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, and microcrystalline cellulose. In addition, the 100-mg tablet contains Opadry White YS-1-7000-E and the 200-mg tablet contains hypromellose and Opadry White YS-1-18202-A.

What are the possible side effects of delavirdine (Rescriptor)?

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.

Call your doctor at once if you have any of these serious side effects:

  • signs of an infection such as fever, chills, night sweats, sore throat, flu symptoms, weakness, easy bruising or unusual bleeding, loss of appetite, mouth sores;
  • rapid heart rate, tremors, sleep problems (insomnia), feeling anxious or irritable;
  • severe diarrhea, unexplained weight loss, menstrual changes, impotence, loss...

Read All Potential Side Effects and See Pictures of Rescriptor »

What are the precautions when taking delavirdine mesylate (Rescriptor)?

Before taking delavirdine, 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: liver problems.

During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Delavirdine may be part of that treatment. Discuss the risks and benefits with your doctor.

It is not known if delavirdine passes into breast milk. Because breast milk can...

Read All Potential Precautions of Rescriptor »


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

Indications

RESCRIPTOR Tablets are indicated for the treatment of HIV-1 infection in combination with at least 2 other active antiretroviral agents when therapy is warranted.

The following should be considered before initiating therapy with RESCRIPTOR in treatment-naive patients. There are insufficient data directly comparing antiretroviral regimens containing RESCRIPTOR with currently preferred 3-drug regimens for initial treatment of HIV. In studies comparing regimens consisting of 2 nucleoside reverse transcriptase inhibitors (NRTIs) (currently considered suboptimal) to RESCRIPTOR plus 2 NRTIs, the proportion of patients receiving the regimen containing RESCRIPTOR who achieved and sustained an HIV-1 RNA level < 400 copies/mL over 1 year of therapy was relatively low (see Description Of Clinical Studies).

Resistant virus emerges rapidly when RESCRIPTOR is administered as monotherapy. Therefore, RESCRIPTOR should always be administered in combination with other antiretroviral agents.

Dosage Administration

The recommended dosage for RESCRIPTOR Tablets is 400 mg (four 100-mg or two 200-mg tablets) 3 times daily. RESCRIPTOR should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.

The 100-mg RESCRIPTOR Tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100-mg RESCRIPTOR Tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. The 200-mg tablets should be taken as intact tablets, because they are not readily dispersed in water. Note: The 200-mg tablets are approximately one-third smaller in size than the 100-mg tablets.

RESCRIPTOR Tablets may be administered with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.

Patients taking both RESCRIPTOR and antacids should be advised to take them at least1 hour apart.

How Supplied

RESCRIPTOR Tablets are available as follows:

100-mg: white, capsule-shaped tablets marked with “U 3761”

Bottles of 360 tablets - NDC 49702-209-24.

200-mg: white, capsule-shaped tablets marked with “RES200”

Bottles of 180 tablets - NDC 49702-225-17.

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity.

Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709. By: Pfizer Pharmaceuticals LLC Vega Baja, Puerto Rico 00693. August 2012


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

Side Effects

The safety of RESCRIPTOR Tablets alone and in combination with other therapies has been studied in approximately 6,000 patients receiving RESCRIPTOR. The majority of adverse events were of mild or moderate (i.e., ACTG Grade 1 or 2) intensity. The most frequently reported drug-related adverse event (i.e., events considered by the investigator to be related to the blinded study medication or events with an unknown or missing causal relationship to the blinded medication) among patients receiving RESCRIPTOR was skin rash (see Table 8 and PRECAUTIONS: Skin Rash).

Table 8: Percent of Patients With Treatment-Emergent Rash in Pivotal Trials (Studies 21 Part II and 13C)a

Percent of Patients With: Description of Rash Gradeb RESCRIPTOR 400 mg t.i.d.
(n = 412)
Control Group Patients
(n = 295)
Grade 1 rash Erythema, pruritus 69 (16.7%) 35 (11.9%)
Grade 2 rash Diffuse maculopapular rash, dry desquamation 59 (14.3%) 17 (5.8%)
Grade 3 rash Vesiculation, moist desquamation, ulceration 18 (4.4%) 0 (0.0%)
Grade 4 rash Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis requiring surgery, exfoliative dermatitis 0 (0.0%) 0 (0.0%)
Rash of any grade   146 (35.4%) 52 (17.6%)
Treatment discontinuation as a result of rash   13 (3.2%) 1 (0.3%)
a Includes events reported regardless of causality.
b ACTG Toxicity Grading System; includes events reported as “rash,” “maculopapular rash,” and “urticaria.”

Adverse events of moderate to severe intensity reported by at least 5% of evaluable patients in any treatment group in the pivotal trials, which includes patients receiving RESCRIPTOR in combination with zidovudine and/or lamivudine in Study 21 Part II for up to 98 weeks and in combination with zidovudine and either lamivudine, didanosine, or zalcitabine in Study 13C for up to 72 weeks are summarized in Table 9.

Table 9: Treatment-Emergent Events Regardless of Causality, of Moderate-to-Severe or Life-Threatening Intensity Reported by at Least 5% of Evaluablea Patients in Any Treatment Group

View Enlarged Table

Other Adverse Events in Phase II/III Studies: Other adverse events that occurred in patients receiving RESCRIPTOR (in combination treatment) in all Phase II and III studies, considered possibly related to treatment, and of at least ACTG Grade 2 in intensity are listed below by body system.

Body as a Whole: Abdominal cramps, abdominal distention, abdominal pain (localized), abscess, allergic reaction, chills, edema (generalized or localized), epidermal cyst, fever, infection, infection viral, lip edema, malaise, Mycobacterium tuberculosis infection, neck rigidity, sebaceous cyst, and redistribution/accumulation of body fat (see PRECAUTIONS: Fat Redistribution).

Cardiovascular System: Abnormal cardiac rate and rhythm, cardiac insufficiency, cardiomyopathy, hypertension, migraine, pallor, peripheral vascular disorder, and postural hypotension.

Digestive System: Anorexia, bloody stool, colitis, constipation, decreased appetite, diarrhea (Clostridium difficile), diverticulitis, dry mouth, dyspepsia, dysphagia, enteritis at all levels, eructation, fecal incontinence, flatulence, gagging, gastroenteritis, gastroesophageal reflux, gastrointestinal bleeding, gastrointestinal disorder, gingivitis, gum hemorrhage, hepatomegaly, increased appetite, increased saliva, increased thirst, jaundice, mouth or tongue inflammation or ulcers, nonspecific hepatitis, oral/enteric moniliasis, pancreatitis, rectal disorder, sialadenitis, tooth abscess, and toothache.

Hemic and Lymphatic System: Adenopathy, bruising, eosinophilia, granulocytosis, leukopenia, pancytopenia, purpura, spleen disorder, thrombocytopenia, and prolonged prothrombin time.

Metabolic and Nutritional Disorders: Alcohol intolerance, amylase increased, bilirubinemia, hyperglycemia, hyperkalemia, hypertriglyceridemia, hyperuricemia, hypocalcemia, hyponatremia, hypophosphatemia, increased AST (SGOT), increased gamma glutamyl transpeptidase, increased lipase, increased serum alkaline phosphatase, increased serum creatinine, and weight increase or decrease.

Musculoskeletal System: Arthralgia or arthritis of single and multiple joints, bone disorder, bone pain, myalgia, tendon disorder, tenosynovitis, tetany, and vertigo.

Nervous System: Abnormal coordination, agitation, amnesia, change in dreams, cognitive impairment, confusion, decreased libido, disorientation, dizziness, emotional lability, euphoria, hallucination, hyperesthesia, hyperreflexia, hypertonia, hypesthesia, impaired concentration, manic symptoms, muscle cramp, nervousness, neuropathy, nystagmus, paralysis, paranoid symptoms, restlessness, sleep cycle disorder, somnolence, tingling, tremor, vertigo, and weakness.

Respiratory System: Chest congestion, dyspnea, epistaxis, hiccups, laryngismus, pneumonia, and rhinitis.

Skin and Appendages: Angioedema, dermal leukocytoclastic vasculitis, dermatitis, desquamation, diaphoresis, discolored skin, dry skin, erythema, erythema multiforme, folliculitis, fungal dermatitis, hair loss, herpes zoster or simplex, nail disorder, petechiae, non-application site pruritus, seborrhea, skin hypertrophy, skin disorder, skin nodule, Stevens-Johnson syndrome, urticaria, vesiculobullous rash, and wart.

Special Senses: Blepharitis, blurred vision, conjunctivitis, diplopia, dry eyes, ear pain, parosmia, otitis media, photophobia, taste perversion, and tinnitus.

Urogenital System: Amenorrhea, breast enlargement, calculi of the kidney, chromaturia, epididymitis, hematuria, hemospermia, impaired urination, impotence, kidney pain, metrorrhagia, nocturia, polyuria, proteinuria, testicular pain, urinary tract infection, and vaginal moniliasis.

Postmarketing Experience

Adverse event terms reported from postmarketing surveillance that were not reported in the Phase II and III trials are presented below.

Digestive System: Hepatic failure.

Hemic and Lymphatic System: Hemolytic anemia.

Musculoskeletal System: Rhabdomyolysis.

Urogenital System: Acute kidney failure.

Laboratory Abnormalities

Marked laboratory abnormalities observed in at least 2% of patients during Studies 21 Part II and 13C are summarized in Table 10. Marked laboratory abnormalities are defined as any Grade 3 or 4 abnormality found in patients at any time during study.

Table 10:Marked Laboratory Abnormalities Reported by ≥ 2% of Patients

View Enlarged Table

Read the Rescriptor (delavirdine mesylate) Side Effects Center for a complete guide to possible side effects

Interactions

(See also CONTRAINDICATIONS, WARNINGS, and CLINICAL PHARMACOLOGY: Drug Interactions.)

Delavirdine is an inhibitor of CYP3A isoform and other CYP isoforms to a lesser extent including CYP2C9, CYP2D6, and CYP2C19. Coadministration of RESCRIPTOR and drugs primarily metabolized by CYP3A (e.g., HMG-CoA reductase inhibitors and sildenafil) may result in increased plasma concentrations of the coadministered drug that could increase or prolong both its therapeutic or adverse effects.

Delavirdine is metabolized primarily by CYP3A, but in vitro data suggest that delavirdine may also be metabolized by CYP2D6. Coadministration of RESCRIPTOR and drugs that induce CYP3A, such as rifampin, may decrease delavirdine plasma concentrations and reduce its therapeutic effect. Coadministration of RESCRIPTOR and drugs that inhibit CYP3A may increase delavirdine plasma concentrations. (See Table 6, Drugs That Should Not Be Coadministered With RESCRIPTOR, and Table 7, Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction.)

Table 6: Drugs That Should Not Be Coadministered With RESCRIPTOR

Drug Class: Drug Name Clinical Comment
Anticonvulsant agents: Phenytoin, phenobarbital, carbamazepine May lead to loss of virologic response and possible resistance to RESCRIPTOR or to the class of NNRTIs.
Antihistamines: Astemizole, terfenadine CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Antimycobacterials: Rifabutin,a rifampin a May lead to loss of virologic response and possible resistance to RESCRIPTOR or to the class of NNRTIs or other coadministered antiviral agents.
Ergot Derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
GI motility agent: Cisapride CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Herbal Products: St. John's wort (Hypericum perforatum) May lead to loss of virologic response and possible resistance to RESCRIPTOR or to the class of NNRTIs.
HMG-CoA reductase inhibitors: Lovastatin, simvastatin Potential for serious reactions such as risk of myopathy including rhabdomyolysis.
Neuroleptic: Pimozide CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Sedative/hypnotics: Alprazolam, midazolam, triazolam CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.
a See CLINICAL PHARMACOLOGY for magnitude of interaction, Tables 1 and 2.

Table 7: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction

View Enlarged Table

Read the Rescriptor Drug Interactions Center for a complete guide to possible interactions

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

Warnings

ALERT: Find out about medicines that should NOT be taken with RESCRIPTOR. This statement is included on the product's bottle label.

Drug Interactions

Because delavirdine may inhibit the metabolism of many different drugs (e.g., antiarrhythmics, calcium channel blockers, sedative hypnotics, and others), serious and/or life-threatening drug interactions could result from inappropriate coadministration of some drugs with delavirdine. In addition, some drugs may markedly reduce delavirdine plasma concentrations, resulting in suboptimal antiviral activity and subsequent emergence of drug resistance. All prescribers should become familiar with the following tables in this package insert: Table 5, Drugs That Are Contraindicated With RESCRIPTOR; Table 6, Drugs That Should Not Be Coadministered With RESCRIPTOR; and Table 7, Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction. Additional details on drug interactions can be found in Tables 1 and 2 under the CLINICAL PHARMACOLOGY section.

Concomitant use of lovastatin or simvastatin with RESCRIPTOR is not recommended. Caution should be exercised if RESCRIPTOR is used concurrently with other HMG-CoA reductase inhibitors that are also metabolized by the CYP3A4 pathway (e.g., atorvastatin or cerivastatin). The risk of myopathy including rhabdomyolysis may be increased when RESCRIPTOR is used in combination with these drugs.

Particular caution should be used when prescribing sildenafil in patients receiving RESCRIPTOR. Coadministration of sildenafil with RESCRIPTOR is expected to substantially increase sildenafil concentrations and may result in an increase in sildenafil-associated adverse events, including hypotension, visual changes, and priapism (see PRECAUTIONS: DRUG INTERACTIONS and PATIENT INFORMATION, and the complete prescribing information for sildenafil).

Concomitant use of St. John's wort (Hypericumperforatum) or St. John's wort-containing products and RESCRIPTOR is not recommended. Coadministration of St. John's wort with NNRTIs, including RESCRIPTOR, is expected to substantially decrease NNRTI concentrations and may result in suboptimal levels of RESCRIPTOR and lead to loss of virologic response and possible resistance to RESCRIPTOR or to the class of NNRTIs.

Precautions

General

Delavirdine is metabolized primarily by the liver. Therefore, caution should be exercised when administering RESCRIPTOR Tablets to patients with impaired hepatic function.

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including RESCRIPTOR. During the initial phase of the combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barre syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

Resistance/Cross-Resistance

NNRTIs, when used alone or in combination, may confer cross-resistance to other NNRTIs.

Fat Redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and &lduqo;cushingoid appearance&rduqo; have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Skin Rash

Severe rash, including rare cases of erythema multiforme and Stevens-Johnson syndrome, has been reported in patients receiving RESCRIPTOR. Erythema multiforme and Stevens-Johnson syndrome were rarely seen in clinical trials and resolved after withdrawal of RESCRIPTOR. Any patient experiencing severe rash or rash accompanied by symptoms such as fever, blistering, oral lesions, conjunctivitis, swelling, and muscle or joint aches should discontinue RESCRIPTOR and consult a physician. Two cases of Stevens-Johnson syndrome have been reported through postmarketing surveillance out of a total of 339 surveillance reports.

In Studies 21 Part II and 13C (see Description Of Clinical Studies), rash (including maculopapular rash) was reported in more patients who were treated with RESCRIPTOR 400 mg 3 times daily (35% and 32%, respectively) than in those who were not treated with RESCRIPTOR (21% and 16%, respectively). The highest intensity of rash reported in these studies was severe (Grade 3), which was observed in approximately 4% of patients treated with RESCRIPTOR in each study and in none of the patients who were not treated with RESCRIPTOR. Also in Studies 21 Part II and 13C, discontinuations due to rash were reported in more patients who received RESCRIPTOR 400 mg 3 times daily (3% and 4%, respectively) than in those who did not receive RESCRIPTOR (0% and 1%, respectively).

In most cases, the duration of the rash was less than 2 weeks and did not require dose reduction or discontinuation of RESCRIPTOR. Most patients were able to resume therapy after rechallenge with RESCRIPTOR following a treatment interruption due to rash. The distribution of the rash was mainly on the upper body and proximal arms, with decreasing intensity of the lesions on the neck and face, and progressively less on the rest of the trunk and limbs.

Occurrence of a delavirdine-associated rash after 1 month is uncommon. Symptomatic relief has been obtained using diphenhydramine hydrochloride, hydroxyzine hydrochloride, and/or topical corticosteroids.

Information for Patients

A statement to patients and healthcare providers is included on the product's bottle label: ALERT: Find out about medicines that should NOT be taken with RESCRIPTOR. A patient package insert (PPI) for RESCRIPTOR is available for patient information.

Patients should be informed that RESCRIPTOR is not a cure for HIV-1 infection and that patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should be advised to remain under the care of a physician while taking RESCRIPTOR.

Patients should be advised to avoid doing things that can spread HIV-1 infection to others.

  • Do not share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
  • Do not breastfeed. We do not know if RESCRIPTOR can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Patients should be instructed that the major toxicity of RESCRIPTOR is rash and should be advised to promptly notify their physician should rash occur. The majority of rashes associated with RESCRIPTOR occur within 1 to 3 weeks after initiating treatment with RESCRIPTOR. The rash normally resolves in 3 to 14 days and may be treated symptomatically while therapy with RESCRIPTOR is continued. Any patient experiencing severe rash or rash accompanied by symptoms such as fever, blistering, oral lesions, conjunctivitis, swelling, and muscle or joint aches should discontinue medication and consult a physician.

Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time.

Patients should be informed to take RESCRIPTOR every day as prescribed. Patients should not alter the dose of RESCRIPTOR without consulting their doctor. If a dose is missed, patients should take the next dose as soon as possible. However, if a dose is skipped, the patient should not double the next dose.

Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.

Patients taking both RESCRIPTOR and antacids should be advised to take them at least 1 hour apart.

Because RESCRIPTOR may interact with certain drugs, patients should be advised to report to their doctor the use of any prescription, nonprescription medication, or herbal products, particularly St. John's wort.

Patients receiving sildenafil and RESCRIPTOR should be advised that they may be at an increased risk of sildenafil-associated adverse events, including hypotension, visual changes, and prolonged penile erection, and should promptly report any symptoms to their doctor.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Delavirdine was negative in a battery of genetic toxicology tests which included an Ames assay, an in vitro rat hepatocyte unscheduled DNA synthesis assay, an in vitro chromosome aberration assay in human peripheral lymphocytes, an in vitro mutation assay in Chinese hamster ovary cells, and an in vivo micronucleus test in mice.

Lifetime carcinogenicity studies were conducted in rats at doses of 10, 32, and 100 mg/kg/day and in mice at doses of 62.5, 250, and 500 mg/kg/day for males and 62.5, 125, and 250 mg/kg/day for females. In rats, delavirdine was noncarcinogenic at maximally tolerated doses that produced exposures (AUC) up to 12 (male rats) and 9 (female rats) times human exposure at the recommended clinical dose. In mice, delavirdine produced significant increases in the incidence of hepatocellular adenoma/adenocarcinoma in both males and females, hepatocellular adenoma in females, and mesenchymal urinary bladder tumors in males. The systemic drug exposures (AUC) in female mice were 0.5- to 3-fold and in male mice 0.2- to 4-fold of those in humans at the recommended clinical dose. Given the lack of genotoxic activity of delavirdine, the relevance of urinary bladder and hepatocellular neoplasm in delavirdine- treated mice to humans is not known.

Delavirdine at doses of 20, 100, and 200 mg/kg/day did not cause impairment of fertility in rats when males were treated for 70 days and females were treated for 14 days prior to mating.

Pregnancy

Pregnancy Category C

Delavirdine has been shown to be teratogenic in rats. Delavirdine caused ventricular septal defects in rats at doses of 50, 100, and 200 mg/kg/day when administered during the period of organogenesis. The lowest dose of delavirdine that caused malformations produced systemic exposures in pregnant rats equal to or lower than the expected human exposure to RESCRIPTOR (Cmin 15 μM) at the recommended dose. Exposure in rats approximately 5-fold higher than the expected human exposure resulted in marked maternal toxicity, embryotoxicity, fetal developmental delay, and reduced pup survival. Additionally, reduced pup survival on postpartum day 0 occurred at an exposure (mean Cmin) approximately equal to the expected human exposure. Delavirdine was excreted in the milk of lactating rats at a concentration 3 to 5 times that of rat plasma.

Delavirdine at doses of 200 and 400 mg/kg/day administered during the period of organogenesis caused maternal toxicity, embryotoxicity, and abortions in rabbits. The lowest dose of delavirdine that resulted in these toxic effects produced systemic exposures in pregnant rabbits approximately 6-fold higher than the expected human exposure to RESCRIPTOR (Cmin 15 ^M) at the recommended dose. The no-observed-adverse-effect dose in the pregnant rabbit was 100 mg/kg/day. Various malformations were observed at this dose, but the incidence of such malformations was not statistically significantly different from that observed in the control group. Systemic exposures in pregnant rabbits at a dose of 100 mg/kg/day were lower than those expected in humans at the recommended clinical dose. Malformations were not apparent at 200 and 400 mg/kg/day; however, only a limited number of fetuses were available for examination as a result of maternal and embryo death.

No adequate and well-controlled studies in pregnant women have been conducted. RESCRIPTOR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Of 9 pregnancies reported in premarketing clinical studies and postmarketing experience, a total of 10 infants were born (including 1 set of twins). Eight of the infants were born healthy. One infant was born HIV-positive but was otherwise healthy and with no congenital abnormalities detected, and 1 infant was born prematurely (34 to 35 weeks) with a small muscular ventricular septal defect that spontaneously resolved. The patient received approximately 6 weeks of treatment with delavirdine and zidovudine early in the course of the pregnancy.

Antiretroviral Pregnancy Registry

To monitor maternal-fetal outcomes of pregnant women exposed to RESCRIPTOR and other antiretroviral agents, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling (800) 258-4263.

Nursing Mothers

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. Because of both the potential for HIV transmission and any possible adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving RESCRIPTOR.

Pediatric Use

Safety and effectiveness of delavirdine in combination with other antiretroviral agents have not been established in HIV-1-infected individuals younger than 16 years of age.

Geriatric Use

Clinical studies of RESCRIPTOR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be taken when dosing RESCRIPTOR in elderly patients due to the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.


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

OverDose

Human experience of acute overdose with RESCRIPTOR is limited.

Management of Overdosage

Treatment of overdosage with RESCRIPTOR should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. There is no specific antidote for overdosage with RESCRIPTOR. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage. Since delavirdine is extensively metabolized by the liver and is highly protein-bound, dialysis is unlikely to result in significant removal of the drug.

ContrainDications

RESCRIPTOR Tablets are contraindicated in patients with known hypersensitivity to any of its ingredients. Coadministration of RESCRIPTOR is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs are listed in Table 5. Also, see PRECAUTIONS, Table 6, Drugs That Should Not Be Coadministered With RESCRIPTOR.

Table 5: Drugs That Are Contraindicated With RESCRIPTOR

Drug Class Drugs Within Class That Are Contraindicated With RESCRIPTOR
Antihistamines Astemizole, terfenadine
Ergot derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine
GI motility agent Cisapride
Neuroleptic Pimozide
Sedative/hypnotics Alprazolam, midazolam, triazolam


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

Clinical Pharamacology

Microbiology

Mechanism of Action

Delavirdine is an NNRTI of HIV-1. Delavirdine binds directly to reverse transcriptase (RT) and blocks RNA-dependent and DNA-dependent DNA polymerase activities. Delavirdine does not compete with template:primer or deoxynucleoside triphosphates. HIV-2 RT and human cellular DNA polymerases α , γ , or δ are not inhibited by delavirdine. In addition, HIV-1 group O, a group of highly divergent strains that are uncommon in North America, may not be inhibited by delavirdine.

In Vitro HIV-1 Susceptibility

In vitro anti-HIV-1 activity of delavirdine was assessed by infecting cell lines of lymphoblastic and monocytic origin and peripheral blood lymphocytes with laboratory and clinical isolates of HIV-1. IC50 and IC90 values (50% and 90% inhibitory concentrations) for laboratory isolates (n = 5) ranged from 0.005 to 0.030 and 0.04 to 0.10 respectively. Mean IC50 of clinical isolates (n = 74) was 0.038 (range: 0.001 to 0.69 μM); 73 of 74 clinical isolates had an IC50 ≤ 0.18 μM. The IC90 of 24 of these clinical isolates ranged from 0.05 to 0.10 μM. In drug combination studies of delavirdine with zidovudine, didanosine, zalcitabine, lamivudine, interferon-a, and protease inhibitors, additive to synergistic anti-HIV-1 activity was observed in cell culture. The relationship between the in vitro susceptibility of HIV-1 RT inhibitors and the inhibition of HIV replication in humans has not been established.

Drug Resistance

Phenotypic analyses of isolates from patients treated with RESCRIPTOR as monotherapy showed a 50- to 500-fold reduced susceptibility in 14 of 15 patients by Week 8 of therapy. Genotypic analysis of HIV-1 isolates from patients receiving RESCRIPTOR plus zidovudine combination therapy (n = 79) showed resistance-conferring mutations in all isolates by Week 24 of therapy. In patients treated with RESCRIPTOR, the mutations in RT occurred predominantly at amino acid positions 103 and less frequently at positions 181 and 236. In a separate study, an average of 86-fold increase in the zidovudine susceptibility of patient isolates (n = 24) was observed after 24 weeks of combination therapy with RESCRIPTOR and zidovudine. The clinical relevance of the phenotypic and the genotypic changes associated with therapy with RESCRIPTOR has not been established.

Cross-Resistance

RESCRIPTOR may confer cross-resistance to other NNRTIs when used alone or in combination. Mutations at positions 103 and/or 181 have been found in resistant virus during treatment with RESCRIPTOR and other NNRTIs. These mutations have been associated with cross-resistance among NNRTIs in vitro.

Pharmacokinetics

Absorption and Bioavailability

Delavirdine is rapidly absorbed following oral administration, with peak plasma concentrations occurring at approximately 1 hour. Following administration of delavirdine 400 mg 3 times daily (n = 67, HIV-1-infected patients), the mean ±SD steady-state peak plasma concentration (Cmax) was 35 ± 20 μM (range: 2 to 100 μM), systemic exposure (AUC) was 180 ± 100 μM•hr (range: 5 to 515μM •hr), and trough concentration (Cmin) was 15 ± 10 (range: 0.1 to 45 μM). The single-dose bioavailability of delavirdine tablets relative to an oral solution was 85% ± 25% (n = 16, non- HIV-infected subjects). The single-dose bioavailability of delavirdine tablets (100-mg strength) was increased by approximately 20% when a slurry of drug was prepared by allowing delavirdine tablets to disintegrate in water before administration (n = 16, non-HIV-infected subjects). The bioavailability of the 200-mg strength delavirdine tablets has not been evaluated when administered as a slurry because they are not readily dispersed in water (see DOSAGE AND ADMINISTRATION).

Delavirdine may be administered with or without food. In a multiple-dose, crossover study, delavirdine was administered every 8 hours with food or every 8 hours, 1 hour before or 2 hours after a meal (n = 13, HIV-1-infected patients). Patients remained on their typical diet throughout the study; meal content was not standardized. When multiple doses of delavirdine were administered with food, geometric mean Cmax was reduced by approximately 25%, but AUC and Cmin were not altered.

Distribution

Delavirdine is extensively bound (approximately 98%) to plasma proteins, primarily albumin. The percentage of delavirdine that is protein-bound is constant over a delavirdine concentration range of 0.5 to 196 μM. In 5 HIV-1-infected patients whose total daily dose of delavirdine ranged from 600 to 1,200 mg, cerebrospinal fluid concentrations of delavirdine averaged 0.4% ± 0.07% of the corresponding plasma delavirdine concentrations; this represents about 20% of the fraction not bound to plasma proteins. Steady-state delavirdine concentrations in saliva (n = 5, HIV-1-infected patients who received delavirdine 400 mg 3 times daily) and semen (n = 5 healthy volunteers who received delavirdine 300 mg 3 times daily) were about 6% and 2%, respectively, of the corresponding plasma delavirdine concentrations collected at the end of a dosing interval.

Metabolism and Elimination

Delavirdine is extensively converted to several inactive metabolites. Delavirdine is primarily metabolized by cytochrome P450 3A (CYP3A), but in vitro data suggest that delavirdine may also be metabolized by CYP2D6. The major metabolic pathways for delavirdine are N-desalkylation and pyridine hydroxylation. Delavirdine exhibits nonlinear steady-state elimination pharmacokinetics, with apparent oral clearance decreasing by about 22-fold as the total daily dose of delavirdine increases from 60 to 1,200 mg/day. In a study of 14C-delavirdine in 6 healthy volunteers who received multiple doses of delavirdine tablets 300 mg 3 times daily, approximately 44% of the radiolabeled dose was recovered in feces, and approximately 51% of the dose was excreted in urine. Less than 5% of the dose was recovered unchanged in urine. The parent plasma half-life of delavirdine increases with dose; mean half-life following 400 mg 3 times daily is 5.8 hours, with a range of 2 to 11 hours.

In vitro and in vivo studies have shown that delavirdine reduces CYP3A activity and inhibits its own metabolism. In vitro studies have also shown that delavirdine reduces CYP2C9, CYP2D6, and CYP2C19 activity. Inhibition of hepatic CYP3A activity by delavirdine is reversible within 1 week after discontinuation of drug.

Special Populations

Hepatic or Renal Impairment: The pharmacokinetics of delavirdine in patients with hepatic or renal impairment have not been investigated (see PRECAUTIONS).

Age: The pharmacokinetics of delavirdine have not been adequately studied in patients aged < 16 years or > 65 years.

Gender: Data from population pharmacokinetics suggest that the plasma concentrations of delavirdine tend to be higher in females than in males. However, this difference is not considered to be clinically significant.

Race: No significant differences in the mean trough delavirdine concentrations were observed between different racial or ethnic groups.

Drug Interactions

(See also PRECAUTIONS: DRUG INTERACTIONS.)

Specific drug interaction studies were performed with delavirdine and a number of drugs. Table 1 summarizes the effects of delavirdine on the geometric mean AUC, Cmax, and Cmin of coadministered drugs. Table 2 shows the effects of coadministered drugs on the geometric mean AUC, Cmax, and Cmin of delavirdine.

For information regarding clinical recommendations, see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: DRUG INTERACTIONS.

Table 1: Pharmacokinetic Parameters for Coadministered Drugs in the Presence of Delavirdine

View Enlarged Table

Table 2: Pharmacokinetic Parameters for Delavirdine in the Presence of Coadministered Drugs

View Enlarged Table

Description Of Clinical Studies

For clinical Studies 21 Part II and 13C described below, efficacy was evaluated by the percentage of patients with a plasma HIV-1 RNA level < 400 copies/mL through Week 52 as measured by the Roche Amplicor® HIV-1 Monitor (standard assay). An intent-to-treat analysis was performed where only subjects who achieved confirmed suppression and sustained it through Week 52 are regarded as responders. All other subjects (including never suppressed, discontinued, and those who rebounded after initial suppression of < 400 copies/mL) are considered failures at Week 52. Results of an interim analysis of efficacy conducted for studies 21 Part II and 13C by independent Data and Safety Monitoring Boards (DSMBs) revealed that the triple-therapy arms in both studies produced significantly greater antiviral benefit than the dual-therapy arms, and early termination of the studies was recommended.

Study 21 Part II

Study 21 Part II was a double-blind, randomized, placebo-controlled trial comparing treatment with RESCRIPTOR (400 mg 3 times daily, zidovudine 200 mg 3 times daily, and lamivudine 150 mg twice daily versus RESCRIPTOR 400 mg 3 times daily and zidovudine 200 mg 3 times daily versus zidovudine 200 mg 3 times daily and lamivudine 150 mg twice daily in 373 HIV-1-infected patients (mean age 35 years [range: 17 to 67], 87% male, and 60% Caucasian) who were antiretroviral treatment naive (84%) or had limited nucleoside experience (16%). Mean baseline CD4+ cell count was 359 cells/mm³ and mean baseline plasma HIV-1 RNA was 4.4 log10 copies/mL.

Results showed that the mean increases from baseline in CD4 cell counts at 52 weeks were 111 cells/mL for RESCRIPTOR + zidovudine + lamivudine, 27 cells/mL for RESCRIPTOR + zidovudine, and 74 cells/mL for zidovudine + lamivudine.

The results of the intent-to-treat analysis of the percentage of patients with a plasma HIV-1 RNA level < 400 copies/mL are presented in Figure 1. HIV-1 RNA status and reasons for discontinuation of randomized treatment at 52 weeks are summarized in Table 3. Subjects who were never suppressed before discontinuation were placed in the discontinuation category.

Figure 1: Percentage of Patients With HIV-1 RNA Below 400 copies/mL Standard PCR Assay Protocol 21 Part II: Intent-to-Treat Analysis

 

View Enlarged Table

Table 3: Outcomes of Randomized Treatment Through Week 52 for Protocol 21 Part II

Outcome Zidovudine + Lamivudine
(n = 124) %
RESCRIPTOR + Zidovudine
(n = 125) %
RESCRIPTOR + Zidovudine + Lamivudine
(n = 124) %
HIV-1 RNA < 400 copies/mLa 14 2 45
HIV-1 RNA ≥ 400 copies/mLb,c 64 52 31
Discontinued due to adverse eventsc 8 13 10
Discontinued due to other reasonsc,d 14 33 14
a Corresponds to rates at Week 52 in proportion curve.
b Virologic failures at or before Week 52.
c Considered to be treatment failure in the analysis.
d Includes discontinuations due to consent withdrawn, loss to follow-up, protocol violations, non-compliance, pregnancy, never treated, and other reasons.
Study 13C

Study 13C was a double-blind, randomized, placebo-controlled trial comparing treatment with RESCRIPTOR 400 mg 3 times daily, zidovudine 200 mg 3 times daily or 300 mg twice daily, and either didanosine 200 mg twice daily, zalcitabine 0.75 mg 3 times daily, or lamivudine 150 mg twice daily versus zidovudine 200 mg 3 times daily or 300 mg twice daily and either didanosine 200 mg twice daily, zalcitabine 0.75 mg 3 times daily, or lamivudine 150 mg twice daily in 345 HIV-1-infected patients (mean age 35.8 years [range: 18 to 72], 66% male, and 63% Caucasian) who were antiretroviral treatment naive (63%) or had limited antiretroviral experience (37%). Mean baseline CD4+ cell count was 210 cells/mm³ and mean baseline plasma HIV-1 RNA was 4.9 log10 copies/mL.

Results showed that the mean increases from baseline in CD4+ cell counts at 54 weeks were 102 cells/mL for RESCRIPTOR + zidovudine + didanosine or zalcitabine or lamivudine, and 56 cells/mL for zidovudine + didanosine or zalcitabine or lamivudine.

The results of the intent-to-treat analysis of the percentage of patients with a plasma HIV-1 RNA level < 400 copies/mL are presented in Figure 2. HIV-1 RNA status and reasons for discontinuation of randomized treatment at 54 weeks are summarized in Table 4. Subjects who were never suppressed before discontinuation were placed in the discontinuation category.

Figure 2: Percentage of Patients With HIV-1 RNA Below 400 copies/mL Standard PCR Assay Protocol 13C: Intent-to-Treat Analysis

View Enlarged Table

Table 4: Outcomes of Randomized Treatment Through Week 54 for Protocol 13C

Outcome Zidovudine + Didanosine or Zalcitabine or Lamivudine
(n =173) %
Zidovudine + Didanosine or Zalcitabine or Lamivudine + RESCRIPTOR
(n = 172) %
HIV-1 RNA < 400 copies/mLa 10 29
HIV-1 RNA ≥ 400 copies/mLb,c 69 42
Discontinued due to adverse eventsc 7 12
Discontinued due to other reasonsc,d 14 17
a Corresponds to rates at Week 54 in proportion curve.
b Virologic failures at or before Week 54.
c Considered to be treatment failure in the analysis.
d Includes discontinuations due to consent withdrawn, loss to follow-up, protocol violations, non-compliance, pregnancy, never treated, and other reasons.

Results from several smaller supportive studies evaluating the use of RESCRIPTOR in treatment-naive patients suggest that it may have activity when used in combination with protease inhibitors and NRTIs in 3- or 4-drug combinations.

Animal Toxicology

Toxicities among various organs and organ systems in rats, mice, rabbits, dogs, and monkeys were observed following the administration of delavirdine. Necrotizing vasculitis was the most significant toxicity that occurred in dogs when mean nadir serum concentrations of delavirdine were at least 7-fold higher than the expected human exposure to RESCRIPTOR (Cmin 15 μM) at the recommended dose. Vasculitis in dogs was not reversible during a 2.5-month recovery period; however, partial resolution of the vascular lesion characterized by reduced inflammation, diminished necrosis, and intimal thickening occurred during this period. Other major target organs included the gastrointestinal tract, endocrine organs, liver, kidneys, bone marrow, lymphoid tissue, lung, and reproductive organs.


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

Patient Information

RESCRIPTOR®
(ree-SKRIP-tor)
(delavirdine mesylate) Tablets

Generic name: delavirdine mesylate (de-LAH-vur-deen MESS-ihl-ate)

ALERT: Find out about medicines that should NOT be taken with RESCRIPTOR. Please also read the section &lduqo;MEDICINES YOU SHOULD NOT TAKE WITH RESCRIPTOR.&rduqo;

Read this information carefully before taking RESCRIPTOR. Also, read this leaflet each time you renew the prescription, just in case anything has changed. This is a summary and not a replacement for a careful discussion with your healthcare provider (doctor, nurse, pharmacist). You and your healthcare provider should discuss RESCRIPTOR when you start taking this medication and at regular checkups. You should remain under a doctor's care when taking RESCRIPTOR and should not change or stop treatment without first talking with your healthcare provider.

What is RESCRIPTOR and how does it work?

RESCRIPTOR is a medicine used in combination with other anti-HIV medicines to treat people with HIV-1 infection. Infection with HIV-1 leads to the destruction of infection-fighting immune system cells (called CD4+ cells or T cells), which are important to the immune system. After a large number of CD4+ cells have been destroyed, the infected person develops acquired immune deficiency syndrome (AIDS).

RESCRIPTOR helps to block HIV-1 reverse transcriptase, a chemical the virus uses to make more copies of itself. The main goals of anti-HIV medicines like RESCRIPTOR are to decrease the amount of virus in your blood (called viral load) and to increase the number of CD4+ cells as much as possible for as long as possible.

RESCRIPTOR, when taken with other anti-HIV medicines, lowers the HIV-1 viral load in patients. Patients who took RESCRIPTOR as part of combination therapy for HIV-1 also had increases in their CD4+ cell count.

General information about RESCRIPTOR

RESCRIPTOR does not cure HIV-1 or AIDS and you may continue to experienceillnesses associated with HIV-1 infection, including opportunistic infections. Youshould remain under the care of a doctor when using RESCRIPTOR.

Avoid doing things that can spread HIV-1 infection.

  • Do not share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

How should I take RESCRIPTOR?

  • You should stay under a healthcare provider's care when taking RESCRIPTOR. Do not change your treatment or stop treatment without first talking with your healthcare provider.
  • You must take RESCRIPTOR every day exactly as your healthcare provider prescribes it. Follow the directions from your healthcare provider, exactly as written on the label.
  • The usual dose of RESCRIPTOR is two 200-mg tablets 3 times a day or four 100-mg tablets 3 times a day, in combination with other anti-HIV-1 medicines. Either way, your total daily dose of RESCRIPTOR remains the same.
  • You can take RESCRIPTOR with or without food.
  • If you have trouble swallowing tablets, the 100-mg RESCRIPTOR tablets may be dissolved in water. Place 4 tablets in at least 3 ounces of water and allow the tablets to sit in the water for a few minutes. Then, stir the water until the tablets have dissolved and drink the mixture right away. Add a little more water, swirl, and then drink the rest of the mixture to be sure that you get all the medicine. The 200-mg tablets must be swallowed whole. They cannot be dissolved in water.
  • Many people find it easier to take their RESCRIPTOR with breakfast, lunch, and dinner, since food does not interfere with RESCRIPTOR. It is a good idea to get into the habit of taking RESCRIPTOR on a regular schedule to make it easier to remember. Figure out things that happen every day at pill-taking time and take your tablets then. By taking your medicine along with activities you do every day, such as getting up in the morning, brushing your teeth, eating lunch, coming home from work in the evening, or watching a favorite TV show, you will find it easier to remember to take every dose.
  • When your supply of RESCRIPTOR starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to RESCRIPTOR and become harder to treat.
  • Only take medicine that has been prescribed specifically for you. Do not give RESCRIPTOR to others or take medicine prescribed for someone else.

What should I do if I miss a dose of RESCRIPTOR?

If you forget to take a dose of RESCRIPTOR, take it as soon as possible. However, if you skip the dose entirely, do not double the next dose. If you forget a lot of doses, talk to your healthcare provider about how you should continue taking your medicine.

Who should not take RESCRIPTOR?

Together with your healthcare provider, you need to decide whether RESCRIPTOR is right for you.

  • Do not take RESCRIPTOR if you are taking certain medicines. These could cause serious side effects that could cause death. Before you take RESCRIPTOR, you must tell your healthcare provider about all the medicines you are taking or are planning to take. These include other prescription and nonprescription medicines and herbal supplements.
    For more information about medicines you should not take with RESCRIPTOR, please read the section titled &lduqo;MEDICINES YOU SHOULD NOT TAKE WITH RESCRIPTOR.&rduqo;
  • Do not take RESCRIPTOR if you have an allergy to RESCRIPTOR. Also tell your healthcare provider if you have any known allergies to other medicines, foods, preservatives, or dyes.
  • Tell your healthcare provider if you are pregnant or plan to become pregnant. The effects of RESCRIPTOR on pregnant women or their unborn babies are not known.
  • If you are breastfeeding, do not breastfeed. We do not know if RESCRIPTOR can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk. Talk with your healthcare provider about the best way to feed your baby.
  • Talk with your healthcare provider if you have liver or kidney disease. RESCRIPTOR has not been studied in people with liver or kidney disease.
  • Certain medical problems may affect the use of RESCRIPTOR. Be sure to tell your healthcare provider of any other medical problems you may have.

Can I take RESCRIPTOR with other medicines?

RESCRIPTOR may interact with other medicines, including those you take without a prescription. You must tell your healthcare provider about all medicines you are taking or planning to take before you take RESCRIPTOR. It is a good idea to keep acomplete list of all the medicines that you take, including nonprescriptionmedicines, herbal remedies and supplements, and street drugs. Update this list when medicines are added or stopped. Give copies of this list to all of your healthcare providers every time you visit or fill a prescription.

MEDICINES YOU SHOULD NOT TAKE WITH RESCRIPTOR

Do not take the following medicines with RESCRIPTOR because they can cause serious problems or death if taken with RESCRIPTOR:

  • VERSED® (midazolam) Injection and Syrup (for sedation)
  • HALCION® (triazolam) Tablets (for sleep problems)
  • XANAX® (alprazolam) Tablets (for anxiety)
  • D.H.E. 45® Injection, ERGOMAR®, MIGRANAL®, WIGRAINE®, and CAFERGOT® (for migraine headaches)
  • METHERGINE® (for bleeding after childbirth)
  • ORAP® (pimozide) Tablets (for seizures)
  • PROPULSID® (cisapride) Tablets and Suspension (for heartburn)
  • HISMANAL® (astemizole) Tablets (for allergies)
  • SELDANE® (terfenadine) Tablets (for allergies)

Do not take the following medicines when you take RESCRIPTOR. They may reduce the levels of RESCRIPTOR in the blood and make it less effective. Talk with your healthcare provider if you are currently taking these medicines because other medicines may have to be given to take their place:

  • Rifampin (also known as RIMACTANE®, RIFADIN®, RIFATER®, RIFAMATE®) (to treat tuberculosis)
  • Phenobarbital (for seizures)
  • DILANTIN® (phenytoin) (for seizures)
  • TEGRETOL® (carbamazepine) (for seizures)

Do not take RESCRIPTOR with St. John's wort (Hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John's wort. Talk with your healthcare provider if you are taking or planning to take St. John's wort.

Taking St. John's wort may decrease levels of RESCRIPTOR and lead to increased viral load and possible resistance to RESCRIPTOR or cross-resistance to other anti- HIV medicines.

Do not take RESCRIPTOR with cholesterol-lowering medicines MEVACOR® (lovastatin) or ZOCOR® (simvastatin) because of possible serious reactions. There is also an increased risk of drug interactions between RESCRIPTOR and LIPITOR® (atorvastatin), BAYCOL® (cerivastatin), and LESCOL® (fluvastatin); talk to your healthcare provider before you take any of these cholesterol-reducing medicines with RESCRIPTOR.

Medicines that require dosage adjustments:

It is possible that your healthcare provider may need to increase or decrease the dose of other medicines when you are taking RESCRIPTOR. Remember to tell your healthcare provider all the medicines you are taking or planning to take.

Before you take VIAGRA® (sildenafil) with RESCRIPTOR, talk to your healthcare provider about problems these 2 medicines can cause when taken together. You may get increased side effects of VIAGRA, such as low blood pressure, vision changes, and penis erection lasting more than 4 hours. If an erection lasts longer than 4 hours, get medical help right away to avoid permanent damage to your penis. Your healthcare provider canexplain these symptoms to you.

  • If you are taking both VIDEX® (didanosine, ddI) and RESCRIPTOR: TakeVIDEX (buffered tablets) 1 hour before or 1 hour after you take RESCRIPTOR. Taking them together causes lower amounts of RESCRIPTOR in the blood, making both medicines less effective.
  • Protease inhibitors: A number of healthy volunteers and HIV-1-infected patients were studied while taking RESCRIPTOR with one of these protease inhibitors: CRIXIVAN® (indinavir), INVIRASE® and FORTOVASE® (saquinavir), NORVIR® (ritonavir), or VIRACEPT® (nelfinavir). RESCRIPTOR was shown to increase the amount of these protease inhibitors in the blood. RESCRIPTOR is expected to increase the amount of AGENERASE® (amprenavir) and KALETRA® (lopinavir + ritonavir) in the blood. As a result, your healthcare provider may choose to lower the dose of one of these medicines or monitor certain lab tests if these protease inhibitors are taken in combination with RESCRIPTOR.
  • Antacids should be taken at least 1 hour before or 1 hour after you take RESCRIPTOR because they can slow the absorption of RESCRIPTOR.

Based on your history of taking other anti-HIV medicine, your healthcare provider will direct you on how to take RESCRIPTOR and other anti-HIV medicines. These drugs should be taken in a certain order or at specific times. This will depend on how many times a day each medicine should be taken. It will also depend on whether the medicines should be taken with or without food.

What are the possible side effects of RESCRIPTOR?

  • This list of side effects is not complete. If you have questions about side effects, ask your doctor, nurse, or pharmacist. You should report any new or continuing symptoms to your healthcare provider right away. Your healthcare provider may be able to help you manage these side effects.
  • The most important common side effect seen in people taking RESCRIPTOR has been a skin rash. The rash occurs mainly on the upper body and upper arms, and sometimes on the neck and face. The rash appears as a red area on the skin with slight bumps, and it can be itchy. The rash tends to occur early, usually within 1 to 3 weeks after you start taking RESCRIPTOR, and it usually lasts less than2 weeks. Watch your rash carefully and talk to your healthcare provider about how to treat it. If the rash is going to be serious or severe (with fever, blistering,sores in the mouth, redness or swelling of the eyes, or muscle and joint aches), you and your healthcare provider will usually realize it during the first 3 days of the rash. If you have symptoms of a severe rash, you should stop taking RESCRIPTOR and speak with your healthcare provider as soon possible. Be prepared to explain where the rash is, your temperature, and whether or not you have other symptoms.
  • Other side effects include headache, nausea, diarrhea, and tiredness. Of these, nausea was the most common.
  • Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (&lduqo;buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
  • Before you start using any medicine, talk with your healthcare provider about what to expect and discuss ways to reduce the side effects you may have.

How do I store RESCRIPTOR?

  • Keep RESCRIPTOR and all other medicines out of the reach of children. Keep the bottle closed and store at room temperature (between 68°F and 77°F) away from sources of moisture such as a sink or other damp place. Heat and moisture may reduce the effectiveness of RESCRIPTOR.
  • Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of the reach of children.

General advice about prescription medicines:

Discuss all questions about your health with your healthcare provider. If you have questions about RESCRIPTOR or any other medicines you are taking, ask your healthcare provider. You can also call 1-877-844-8872 toll free.


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.

 

DELAVIRDINE 100 MG DISPERSIBLE TABLET - ORAL

 

(deh-LAV-er-deen)

 

COMMON BRAND NAME(S): Rescriptor

 

USES: This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Delavirdine belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Delavirdine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking delavirdine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually 3 times daily or as directed by your doctor. If you cannot swallow the tablets whole, you may dissolve your dose of the 100-milligram tablets in at least 3 ounces (90 milliliters) of water. Let the tablets sit for a few minutes, then stir and drink the mixture right away. Rinse the glass with more water and drink the rinse water to make sure that you have taken the entire dose. Note that the 200-milligram tablets cannot be dissolved and must be swallowed whole.

If you have a condition of little or no stomach acid (achlorhydria), you should take delavirdine with an acidic beverage such as orange or cranberry juice.

If you are also taking an antacid or a buffered form of the medication didanosine, take it at least 1 hour before or after delavirdine.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, diarrhea, headache, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist 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.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression), signs of liver problems (such as persistent nausea, vomiting, stomach/abdominal pain, severe tiredness, yellowing eyes/skin, dark urine).

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

Delavirdine can commonly cause a rash that is usually not serious. A rash may occur within 1 to 3 weeks after you start delavirdine treatment. It appears mainly on the upper body and arms, but may also appear on the neck and face. After consultation with the doctor, most people can continue taking delavirdine and treat the rash if it is not severe. Non-serious rashes usually last less than 2 weeks. However, a severe rash or a rash with signs of a severe reaction requires immediate medical attention. Signs of a severe reaction that usually appear within the first 3 days of a serious rash include: fever, blisters, mouth sores, eye redness/swelling, swelling in other areas of the body, or muscle/joint pain. Since you may not be able to tell a common rash apart from a rare rash that could be a sign of a severe reaction, always seek immediate medical attention if you develop any rash or any of these symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Rescriptor (delavirdine mesylate) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking delavirdine, 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: liver problems.

During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Delavirdine may be part of that treatment. Discuss the risks and benefits with your doctor.

It is not known if delavirdine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: drugs that decrease the amount of acid in your stomach (for example, ulcer drugs/heartburn relievers such as H2 blockers including cimetidine/famotidine, proton pump inhibitors such as omeprazole/lansoprazole).

Other medications can affect the removal of delavirdine from your body, which may affect how delavirdine works. Examples include fosamprenavir, some drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), rifamycins (such as rifabutin, rifampin), St. John's wort, among others.

Delavirdine can slow down the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include antiarrhythmics (such as quinidine), cisapride, some drugs for anxiety/sleep (such as alprazolam, midazolam, triazolam), drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), ergot drugs (such as ergotamine), pimozide, cholesterol-reducing statins (such as atorvastatin, fluvastatin, lovastatin, simvastatin), trazodone, warfarin, among others.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

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.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as liver tests, viral load, T-cell counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all medical and laboratory appointments.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Keep the container cap tightly closed. 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: Rescriptor

Generic Name: delavirdine (Pronunciation: de la VIR deen)

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

What is delavirdine (Rescriptor)?

Delavirdine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Delavirdine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Delavirdine is not a cure for HIV or AIDS.

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

Rescriptor 100 mg

oblong, white, imprinted with U 3761

What are the possible side effects of delavirdine (Rescriptor)?

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.

Call your doctor at once if you have any of these serious side effects:

  • signs of an infection such as fever, chills, night sweats, sore throat, flu symptoms, weakness, easy bruising or unusual bleeding, loss of appetite, mouth sores;
  • rapid heart rate, tremors, sleep problems (insomnia), feeling anxious or irritable;
  • severe diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (enlarged thyroid);
  • weakness or prickly feeling in your fingers or toes;
  • problems with balance or eye movement, trouble speaking or swallowing;
  • severe lower back pain, loss of bladder or bowel control;
  • muscle weakness, tired feeling, joint or muscle pain, feeling short of breath; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild itching or rash;
  • headache, nausea;
  • cold symptoms such as stuffy nose, sneezing, sore throat; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 Rescriptor (delavirdine mesylate) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about delavirdine (Rescriptor)?

There are many other drugs that can cause serious or life threatening medical problems if you take them together with delavirdine. Tell your doctor about all other medicines you use, especially: a sedative, cholesterol-lowering medication, seizure medication, tuberculosis medication, or migraine headache medicine.

Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Side Effects Centers
  • Rescriptor

Patient Detailed How Take

What should I discuss with my healthcare provider before taking delavirdine (Rescriptor)?

You should not use this medication if you are allergic to delavirdine, or if you are using any of the following drugs:

  • cisapride (Propulsid);
  • pimozide (Orap);
  • St. John's wort;
  • alprazolam (Xanax), midazolam (Versed) or triazolam (Halcion);
  • carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin) or phenobarbital (Solfoton);
  • lovastatin (Advicor, Altoprev, Mevacor) or simvastatin (Zocor, Simcor, Vytorin, Juvisync);
  • rifabutin (Mycobutin) or rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
  • ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), or methylergonovine (Methergine).

Using any of these medicines while you are taking delavirdine can cause serious medical problems or death.

To make sure delavirdine is safe for you, tell your doctor if you have any of these other conditions:

  • liver disease;
  • high cholesterol or triglycerides;
  • low stomach acid production; or
  • if you have ever taken efavirenz (Sustiva), etravirine (Intelence), nevirapine (Viramune), or rilpivirine (Edurant) and they were not effective in treating your condition.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take delavirdine (Rescriptor)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take delavirdine as your only HIV medication. HIV/AIDS is usually treated with a combination of different drugs. Your disease may become resistant to delavirdine if you do not take it in combination with other HIV medicines your doctor has prescribed.

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.

Delavirdine can be taken with or without food. If you have a condition of decreased stomach acid, your doctor may recommend taking delavirdine with an acidic beverage such as orange or cranberry juice.

The 100-milligram delavirdine tablets may be dissolved in water to make swallowing easier. Place 4 tablets into at least 3 ounces (just under 1/3 cup) of water. Let the liquid stand for a few minutes, then stir to allow the tablets to disperse evenly in the liquid. Drink this mixture right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

The 200-milligram delavirdine tablets must be swallowed whole. Do not crush, chew, or disperse the tablets in water.

Use delavirdine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To best treat your condition, use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

You may need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Rescriptor

Patient Detailed Avoid Taking

What happens if I miss a dose (Rescriptor)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Rescriptor)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking delavirdine (Rescriptor)?

Avoid taking an antacid within 1 hour before or after you take delavirdine. Some antacids can make it harder for your body to absorb delavirdine.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What other drugs will affect delavirdine (Rescriptor)?

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

  • methadone (Methadose, Dolophine);
  • sildenafil (Viagra, Revatio);
  • ADHD medication such as Adderall;
  • an antibiotic such as clarithromycin (Biaxin) or rifapentine (Priftin);
  • an antidepressant such as nefazodone or trazodone (Desyrel);
  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend);
  • atorvastatin (Lipitor, Caduet) or fluvastatin (Lescol);
  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal);
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cardizem, Cartia, Dilacor, Diltia, Diltzac, Taztia, Tiazac), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan, Tarka), and others;
  • heart rhythm medicine such as amiodarone (Cordarone), flecainide (Tambocor), or propafenone (Rythmol), or quinidine (Quin-G);
  • the hepatitis C medications boceprevir (Victrelis) or telaprevir (Incivek);
  • HIV/AIDS medication such as didanosine (Videx), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, Kaletra), saquinavir (Invirase);
  • medicine to treat or prevent organ transplant rejection;
  • steroid medicine such as dexamethasone (Cortastat, Dexasone, Solurex, DexPak) or fluticasone (Advair, Flovent, Flonase); or
  • stomach medications such as Axid, Pepcid, Prevacid, Prilosec, Tagamet, or Zantac.

This list is not complete and there are many other medicines that can interact with delavirdine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about delavirdine.


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: 8.01. Revision date: 10/15/2012.

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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