Nevirapine
- Atc Codes:J05AG01
- CAS Codes:129618-40-2
- PHARMGKB ID:129618-40-2
Table of contents
- Brand Names
- Drug Combinations
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Toxicological Effects
- Caution and personalized dose adjustment in patients with the following genotypes
- Other genes that may be involved
- Substrate of
- Inhibits
- Induces
- Drug Interactions
- Nutrition/Nutraceutical Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Viramune; Belgium: Viramune; Bulgaria: Viramune; Cyprus: Viramune; Czech Republic: Viramune; Denmark: Viramune; Estonia: Viramune; Finland: Viramune; France: Viramune; Germany: Viramune; Greece: Viramune; Hungary: Viramune; Ireland: Viramune; Italy: Viramune; Latvia: Nevirapine, Viramune; Lithuania: Viramune; Luxembourg: Viramune; Malta: Viramune; Netherlands: Viramune; Poland: Viramune; Portugal: Viramune; Romania: Viramune; Slovakia: Viramune; Slovenia: Viramune; Spain: Viramune; Sweden: Nevirapine, Viramune; UK: Viramune.
North America
Canada: Viramune; USA: Viramune.
Latin America
Argentina: Filide, Nerapin, Nevirapina, Protease, Ritvir, Virainhi, Viramune; Brazil: Viramune; Mexico: Viramune.
Asia
Japan: Viramune.
Drug combinations
Nevirapine, Lamivudine, and Stavudine
Nevirapine, Lamivudine, and Zidovudine
Chemistry
Nevirapine: C~15~H~14~N~4~O. Mw: 266.30. (1) 6H-Dipyrido[3,2-b:2′,3′-e][1,4]diazepin-6-one, 11-cyclopropyl-5,11-dihydro-4-methyl-; (2) 11-Cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2′,3′-e][1,4]diazepin-6-one. CAS-129618-40-2 (1991).
Pharmacologic Category
Antiretrovirals; Non-nucleoside Reverse Transcriptase Inhibitors. (ATC-Code: J05AG01).
Mechanism of action
Has activity against HIV-1 by binding to reverse transcriptase. Consequently blocks RNA-dependent and DNA-dependent DNA polymerase activities including HIV-1 replication.
Therapeutic use
In combination therapy with other antiretroviral agents for treatment of HIV-1.
Pregnancy and lactiation implications
Nevirapine crosses placenta. No increased risk of overall birth defects observed following 1^st^ trimester exposure. Pharmacokinetics not altered during pregnancy and dose adjustment not needed. When used to prevent perinatal transmission in women who do not need therapy for their own health, use not recommended if CD4^+^ lymphocyte counts >250/mm^3^. May also be used in combination with zidovudine in HIV-infected women in labor with no prior antiretroviral therapy, in order to reduce maternal-fetal transmission of HIV. Use contraindicated in nursing women.
Unlabeled use
Contraindications
Hypersensitivity to nevirapine or any component of the formulation. Moderate-to-severe hepatic impairment.
Warnings and precautions
May cause fat redistribution. Severe hepatotoxic reactions may occur (fulminant and cholestatic hepatitis, hepatic necrosis) and in some cases, resulted in hepatic failure and death. Patients with history of chronic hepatitis (B or C) or increased baseline transaminase levels may be at increased risk of hepatotoxic reactions. Female gender and patients with increased CD4^+^-cell counts may be at substantially greater risk of hepatic events (often associated with rash). Patients may develop immune reconstitution syndrome resulting in occurrence of inflammatory response to indolent or residual opportunistic infection; further evaluation and treatment may be required. Rhabdomyolysis occurred in conjunction with skin and/or hepatic adverse events during postmarketing surveillance. Termination of therapy warranted with evidence of severe skin or liver toxicity. Severe life-threatening skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity reactions with rash and organ dysfunction) occurred. Use with caution in patients taking strong CYP3A4 inhibitors, moderate or strong CYP3A4 inducers and major CYP3A4 substrates.