Delavirdine Mesylate

Class: Nonnucleoside Reverse Transcriptase Inhibitors
VA Class: AM800
Chemical Name: 1 - [3 - [(1 - Methylethyl)amino] - 2 - pyridinyl] - 4 - [[5 - [(methylsulfonyl)amino] - 1H - indol - 2 - yl]carbonyl] - piperazinemonomethanesulfonate
Molecular Formula: C22H28N6O3S•CH4 O3S
CAS Number: 147221-93-0
Brands: Rescriptor

Introduction

Antiretroviral; nonnucleoside reverse transcriptase inhibitor (NNRTI).1 200

Uses for Delavirdine Mesylate

Treatment of HIV Infection

Treatment of HIV-1 infection in conjunction with other antiretrovirals.1

Not recommended for initial antiretroviral regimens (less supportive data and less potent virologic activity than other NNRTIs, inconvenient dosing).200

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Consider the following before initiating in antiretroviral-naive patients: Data insufficient comparing delavirdine regimens to the preferred 3-drug regimens;1 portion of clinical study patients responding to regimen of delavirdine and 2 nucleoside reverse transcriptase inhibitors (NRTIs) with sustained plasma HIV-1 levels <400 copies/mL over 1 year has been relatively low.1

Delavirdine Mesylate Dosage and Administration

Administration

Oral Administration

Administer orally with or without food.1

For patients unable to swallow tablets, 100-mg tablets may be administered as slurry or dispersion in water.1 To prepare dispersion containing 400 mg, place four 100-mg tablets in a glass containing ≥90 mL of water, let stand for a few minutes, then stir until a uniform dispersion occurs.1 6 Dispersion should be consumed promptly; rinse glass with more water and swallow the rinse.1

The 200-mg tablets are not readily dispersed in water1 33 and should be swallowed intact.1

Patients with achlorhydria should take delavirdine with an acidic beverage (e.g., orange or cranberry juice).1

Dosage

Available as delavirdine mesylate; dosage expressed in terms of delavirdine mesylate.1

Pediatric Patients

Treatment of HIV Infection
Oral

Adolescents ≥16 years of age: 400 mg 3 times daily.1

Adults

Treatment of HIV Infection
Oral

400 mg 3 times daily.1

Special Populations

Hepatic Impairment

Data insufficient to make dosage recommendation for patients with hepatic impairment;200 use with caution.1 200

Renal Impairment

Dosage adjustments not needed.200

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1

Cautions for Delavirdine Mesylate

Contraindications

  • Known hypersensitivity to delavirdine or any ingredient in the formulation.1

  • Concomitant use with drugs highly dependent on CYP3A for metabolism and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g., alprazolam, cisapride, ergot alkaloids, midazolam, pimozide, triazolam).1 (See Specific Drugs under Interactions.)

Warnings/Precautions

Warnings

Interactions

Concomitant use with certain drugs not recommended (e.g., lovastatin, simvastatin, rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine, St. John’s wort) or requires particular caution (sildenafil).1 (See Specific Drugs under Interactions.)

Sensitivity Reactions

Dermatologic Reactions

Severe rash, erythema multiforme, Stevens-Johnson syndrome reported; these severe reactions resolved after drug discontinued.1

Patients experiencing severe rash or rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, or muscle or joint aches should discontinue delavirdine and seek medical assistance.1

Mild rash also reported.1 Rash usually occurs during first month of therapy, mainly on upper body and proximal arms with decreasing intensity of lesions on neck and face and progressively less on rest of trunk and limbs.1

Rash usually resolves in <2 weeks and generally does not require dosage reduction or contraindicate use of the drug.1 If delavirdine therapy is interrupted because of rash, most patients are able to resume therapy with the drug.1

Mild or moderate rash can be treated with diphenhydramine hydrochloride, hydroxyzine hydrochloride, and/or topical corticosteroids.1

General Precautions

HIV Resistance

Possibility of HIV resistant to delavirdine and possible cross-resistance to other NNRTIs.1

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, breast enlargement, and general cushingoid appearance.1

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.1

Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) have been reported to occur in the setting of immune reconstitution; time to onset is variable and can occur many months after initiation of antiretroviral therapy.1

Specific Populations

Pregnancy

Category C.1

Antiretroviral Pregnancy Registry at 800-258-4263 or .1 202

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1 202

Pediatric Use

Safety and efficacy not established in children <16 years of age.1

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.1

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1

Hepatic Impairment

Extensively metabolized in liver; use with caution in those with hepatic impairment.1

Common Adverse Effects

Rash, asthenia/fatigue, nausea.1

Interactions for Delavirdine Mesylate

Metabolized by CYP3A and CYP2D6.1

Inhibits CYP3A and, to a lesser extent, CYP2C9, CYP2D6, CYP2C19.1

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP3A;1 possible alteration in metabolism of delavirdine and/or other drug.1

Specific Drugs

Drug

Interaction

Comments

Amphetamines

Possible increased amphetamine concentrations1

Use with caution1

Antacids (Maalox TC)

Decreased delavirdine concentrations1

Take delavirdine at least 1 hour before or after antacids1

Antiarrhythmic agents (amiodarone, flecainide, systemic lidocaine, propafenone, quinidine)

Possible increased concentrations of antiarrhythmic agent; potential for serious or life-threatening effects (e.g., cardiac arrhythmias) with certain agents1

Use concomitantly with caution; monitor plasma concentrations of antiarrhythmic agent1

Anticoagulants, oral

Possible increased warfarin concentrations 1

Monitor INR; adjust warfarin dosage accordingly1

Anticonvulsants (carbamazepine, phenytoin, phenobarbital)

Decreased delavirdine concentrations; possible loss of virologic response and development of resistance to the antiretroviral and other NNRTIs1

Do not use concomitantly with delavirdine1

Antifungals, azoles (fluconazole, ketoconazole, voriconazole)

Fluconazole: Pharmacokinetic interaction not clinically important1

 

 

Ketoconazole: Increased delavirdine concentrations1

 

Voriconazole: Increased voriconazole concentrations53

Voriconazole: Monitor frequently for voriconazole adverse effects53

Antimycobacterials (rifabutin, rifampin, rifapentine)

Rifabutin: Decreased delavirdine AUC; increased rifabutin AUC1

Rifampin: Decreased delavirdine AUC 1

Possible loss of virologic response and increased risk of delavirdine or NNRTI resistance1

Concomitant use with rifabutin, rifampin, or rifapentine not recommended1 34 35 200

Atazanavir

No in vitro evidence of antagonistic antiretroviral effects203

Benzodiazepines (alprazolam, midazolam, triazolam)

Potential for serious and/or life-threatening adverse effects such as prolonged or increased sedation or respiratory depression1

Concomitant use contraindicated1

Calcium-channel blocking agents (amlodipine, diltiazem, felodipine, isradipine, nifedipine, nimodipine, nisoldipine, verapamil)

Possible increased concentrations of calcium-channel blocking agent1

Use concomitantly with caution; clinical monitoring recommended1

Cisapride

Potential for serious or life-threatening reactions (e.g., cardiac arrhythmias)1

Concomitant use contraindicated1

Co-trimoxazole

Interaction unlikely1

 

Corticosteroids (dexamethasone, fluticasone)

Dexamethasone: Possible decreased delavirdine concentrations 1

Dexamethasone: Use with caution; delavirdine may be less effective1

 

Fluticasone nasal spray/oral inhalation: Possible increased fluticasone concentrations1

Fluticasone nasal spray/oral inhalation: Use with caution; consider alternative to fluticasone, especially when long-term corticosteroid therapy is anticipated1

Darunavir

No in vitro evidence of antagonistic antiretroviral effects204

Didanosine

Decreased delavirdine concentrations if given at same time as buffered didanosine preparations;1 clinically important pharmacokinetic interaction not observed when buffered didanosine administered 1 hour after delavirdine1

In vitro evidence of additive to synergistic antiretroviral effects1

Administer buffered didanosine (pediatric oral solution admixed with antacid) at least 1 hour before or after delavirdine1

Efavirenz

 

Do not use concomitantly1 200

Emtricitabine

In vitro evidence of additive to synergistic antiretroviral effects218

Ergot alkaloids (dihydroergotamine, ergonovine, ergotamine, methylergonovine)

Concomitant use contraindicated1

If treatment of uterine atony and excessive postpartum bleeding is indicated in a woman receiving delavirdine, use methylergonovine maleate (Methergine) only if alternative treatments cannot be used and if potential benefits outweigh risks; use methylergonovine at lowest dosage and shortest duration possible202

Estrogens/Progestins

Hormonal contraceptives: Possible increased concentrations of ethinyl estradiol1

Clinical importance unknown1

Etravirine

Possible increased etravirine concentrations214

Do not use concomitantly1 200 214

Fluoxetine

Increased delavirdine trough concentrations1

 

Fosamprenavir

Studies using amprenavir (active metabolite of fosamprenavir) indicate increased amprenavir concentrations and AUC and decreased delavirdine concentrations and AUC;205 possible decreased antiretroviral efficacy and increased risk of antiretroviral resistance205

In vitro evidence of synergistic antiretroviral effects205

Fosamprenavir (with or without low-dose ritonavir): Concomitant use contraindicated205

Histamine H2-receptor antagonists (cimetidine, famotidine, nizatidine, ranitidine)

Possible decreased GI absorption of delavirdine1

Long-term concomitant use not recommended1

HMG-CoA reductase inhibitors (statins)

Atorvastatin, fluvastatin, lovastatin, simvastatin: Possible increased concentrations of the antilipemic agents; increased risk of myopathy and/or rhabdomyolysis1

Atorvastatin: Use lowest possible atorvastatin dosage;1 consider using pravastatin instead1

Fluvastatin: Use lowest possible fluvastatin dosage;1 consider using pravastatin instead1

Lovastatin: Do not use concomitantly1

Simvastatin: Do not use concomitantly1

Immunosuppressive agents (cyclosporine, sirolimus, tacrolimus)

Potential for increased concentrations of cyclosporine, sirolimus, or tacrolimus1

Monitor plasma concentrations of immunosuppressive agent1

Indinavir

Delavirdine inhibits indinavir metabolism and may increase indinavir concentrations; no effect on delavirdine pharmacokinetics1 206

Use reduced indinavir dosage of 600 mg every 8 hours with usual delavirdine dosage (400 mg 3 times daily)1 206

Lamivudine

In vitro evidence of additive to synergistic antiretroviral effects1

 

Lopinavir/ritonavir

Possible increased concentrations of lopinavir and ritonavir1

Appropriate dosages for concomitant use with respect to safety, efficacy, and pharmacokinetics not established1

Macrolides (clarithromycin)

No change in delavirdine pharmacokinetic; increased clarithromycin AUC1

Dosage adjustment not needed in patients with normal renal function; reduce clarithromycin dosage by 50% in patients with Clcr 30–60 mL/minute and by 75% in patients with Clcr <30 mL/minute1

Maraviroc

Possible increased maraviroc concentrations1

No in vitro evidence of antagonistic antiretroviral effects224

Recommended maraviroc dosage is 150 mg twice daily in patients receiving delavirdine224

Methadone

Possible increased methadone concentrations1

Methadone dosage may need to be reduced1

Nelfinavir

Increased nelfinavir concentrations; decreased delavirdine concentrations1 208

Increased toxicity (i.e., neutropenia) observed45

In vitro evidence of synergistic antiretroviral effects208

Appropriate dosages for concomitant use with respect to safety, efficacy, and pharmacokinetics not established1 208

Nevirapine

Do not use concomitantly1 200

Pimozide

Potential for serious or life-threatening reactions (e.g., cardiac arrhythmias)1

Concomitant use contraindicated1

Proton-pump inhibitors (omeprazole, lansoprazole)

Possible decreased GI absorption of delavirdine1

Long-term concomitant use not recommended1

Quinupristin and dalfopristin

Possible increased delavirdine concentrations39

 

Raltegravir

In vitro evidence of additive to synergistic antiretroviral effects225

Rilpivirine

Possible increased rilpivirine concentrations226

Do not use concomitantly1 200 226

Ritonavir

Increased ritonavir concentrations1

Appropriate dosages for concomitant use with respect to safety, efficacy, and pharmacokinetics not established1

Saquinavir

Increased saquinavir AUC;1 210 no clinically important effect on delavirdine concentrations1

Ritonavir-boosted saquinavir: Concomitant use not evaluated210

Appropriate dosages for concomitant use with respect to safety, efficacy, and pharmacokinetics not established1 210

St. John’s wort (Hypericum perforatum)

Possible loss of virologic response and increased risk of delavirdine or NNRTI resistance1

Do not use concomitantly1

Sildenafil

Possible increased sildenafil concentrations and increased risk of sildenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)1

Use caution; do not exceed 25 mg once every 48 hours1

Tenofovir

In vitro evidence of additive to synergistic antiretroviral effects221

 

Tipranavir

In vitro evidence of additive antiretroviral effects211

 

Trazodone

Possible increased trazodone concentrations1

Adverse effects (nausea, dizziness, hypotension, syncope) reported with concomitant use of trazodone and other CYP3A inhibitors (e.g., ritonavir)1

Use with caution; consider using decreased trazodone dosage1

Zidovudine

No pharmacokinetic interaction1 6

In vitro evidence of additive to synergistic antiretroviral effects1

 

Delavirdine Mesylate Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from GI tract; peak plasma concentrations achieved within 1 hour.1

Bioavailability of delavirdine tablets is 85% relative to that of an oral solution of the drug.1 Bioavailability of 100-mg tablets is increased by approximately 20% when allowed to disintegrate in water and administered as a slurry.1

Food

Food does not have an appreciable effect on plasma concentrations or AUC.1

Distribution

Extent

Not fully characterized.1

Distributed into CSF in low concentrations.1

Distributed into milk in rats; not known whether distributed into human milk.1

Plasma Protein Binding

98%.1

Elimination

Metabolism

Metabolized by CYP3A and CYP2D6.1

Elimination Route

Excreted in feces (44%) and urine (51%).1

Half-life

5.8 hours.1

Stability

Storage

Oral

Tablets

20–25°C in tight container; protect from high humidity.1

Actions and Spectrum

  • Pharmacologically related to other NNRTIs (e.g., efavirenz, etravirine, nevirapine, rilpivirine); differs structurally from these drugs; also differs pharmacologically and structurally from other currently available antiretrovirals.1 6 7 8 10 11 12 214

  • Active against HIV-1; inactive against HIV-2.1 8 31

  • Inhibits replication of HIV-1 by interfering with viral RNA- and DNA-directed polymerase activities of reverse transcriptase.1 6 7 8 10 11 12 15

  • HIV-1 with reduced susceptibility to delavirdine have been selected in vitro and have emerged during therapy with the drug.1 6 8 19 31

  • Strains of HIV-1 resistant to delavirdine may be cross-resistant to some other NNRTIs.1 6 7

  • Cross-resistance between delavirdine and NRTIs unlikely since the drugs bind at difference sites on reverse transcriptase and have different mechanisms of action.1 15 Cross-resistance between delavirdine and HIV protease inhibitors (PIs) unlikely since the drugs have different target enzymes and mechanisms of action.1

Advice to Patients

  • Critical nature of compliance with HIV therapy and importance of remaining under the care of a clinician.1 Importance of taking as prescribed; do not alter or discontinue antiretroviral regimen without consulting clinician.1

  • Importance of using in conjunction with other antiretrovirals—not for monotherapy.1

  • Antiretroviral therapy is not a cure for HIV infection; opportunistic infections and other complications associated with HIV disease may still occur.1

  • Advise patients that effective antiretroviral regimens can decrease HIV concentrations in blood and genital secretions and strict adherence to such regimens in conjunction with risk-reduction measures may decrease, but cannot absolutely eliminate, the risk of secondary transmission of HIV to others.200 Importance of continuing to practice safer sex (e.g., using latex or polyurethane condoms to minimize sexual contact with body fluids), never sharing personal items that can have blood or body fluids on them (e.g., toothbrushes, razor blades), and never reusing or sharing needles.1 200

  • Importance of reading patient information provided by the manufacturer.1

  • Importance of patients with achlorhydria taking delavirdine with an acidic beverage.1

  • If a dose is missed, the next dose should be taken as soon as possible.1 If a dose is skipped, do not take a double dose to make up for the missed dose.1

  • Importance of discontinuing delavirdine and consulting a clinician if severe rash or rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches occurs.1

  • Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products (e.g., St. John’s wort), and any concomitant illnesses.1

  • Advise patients receiving PDE5 inhibitors (e.g., sildenafil) that they may be at increased risk of PDE5 inhibitor-associated adverse effects (e.g., hypotension, visual disturbances, priapism) and that any symptoms should be promptly reported to their clinician.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Advise HIV-infected women not to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Delavirdine Mesylate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

100 mg

Rescriptor

ViiV

200 mg

Rescriptor

ViiV

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Rescriptor 200MG Tablets (VIIV HEALTHCARE): 30/$59.99 or 90/$170.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions February 4, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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50. Moyle G, De Cian W, Hawkins D et al. Final 54-week analysis of a placebo-controlled trial (13C) of delavirdine (DLV) plus two nucleoside analogs (NA) versus two NA in drug-naïve and -experienced individuals. Proceedings of the 39th ICAAC. San Francisco, CA: 1999.

52. Smith D, Hales G, Roth N et al. A randomized trial of nelfinavir, ritonavir, or delavirdine in combination with saquinavir-SGC and stavudine in treatment-experienced HIV-1-infected patients. HIV Clin Trials. 2001; 2:97-107. [PubMed 11590517]

53. Pfizer. Vfend (voriconazole) for injection, tablets, and for oral suspension prescribing information. New York, NY; 2011 Nov.

200. Panel on Antiretroviral Guidelines for Adults and Adolescents, US Department of Health and Human Services (HHS). Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (April 18, 2012). Updates may be available at HHS AIDS Information (AIDSinfo) website.

202. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission, US Department of Health and Human Services (HHS). Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States (September 14, 2011). Updates may be available at HHS AIDS Information (AIDSinfo) website.

203. Bristol-Myers Squibb. Reyataz (atazanavir sulfate) capsules prescribing information. Princeton, NJ; 2012 Mar.

204. Janssen. Prezista (darunavir) oral suspension and tablets prescribing information. Titusville, NJ; 2012 Jun.

205. ViiV Healthcare. Lexiva (fosamprenavir calcium) tablets and oral suspension prescribing information. Research Triangle Park, NC; 2012 Feb.

206. Merck Sharp & Dohme. Crixivan (indinavir sulfate) capsules prescribing information. Whitehouse Station, NJ; 2012 Apr.

208. ViiV Healthcare. Viracept (nelfinavir mesylate) tablets and oral powder prescribing information. Research Triangle Park, NC; 2012 Apr.

210. Genentech USA. Invirase (saquinavir mesylate) capsules and tablets prescribing information. South San Francisco, CA; 2012 Feb.

211. Boehringer Ingelheim. Aptivus (tipranavir) capsules and oral solution prescribing information. Ridgefield, CT; 2012 Apr.

214. Janssen. Intelence (etravirine) tablets prescribing information. Raritan, NJ; 2012 Mar.

218. Gilead Sciences. Emtriva (emtricitabine) capsules and oral solution prescribing information. Foster City, CA; 2012 Jul.

221. Gilead Sciences. Viread (tenofovir disoproxil fumarate) tablets prescribing information. Foster City, CA; 2012 Jan.

224. ViiV Healthcare. Selzentry (maraviroc) tablets prescribing information. Research Triangle Park, NC; 2011 Nov.

225. Merck Sharp & Dohme. Isentress (raltegravir) film-coated tablets and chewable tablets prescribing information. Whitehouse Station, NJ; 2012 Apr.

226. Tibotec Therapeutics. Edurant (rilpivirine) tablets prescribing information. Raritan, NJ; 2011 May.

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