pharmacopeia
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/api/v1/drug/nevirapine

Boxed warning

LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female sex and higher CD4+ cell counts at initiation of therapy place patients at increased risk; women with CD4+ cell counts greater than 250 cells/mm3, including pregnant women receiving nevirapine in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both sexes, all CD4+ cell counts and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking nevirapine for post-exposure prophylaxis (PEP). Use of nevirapine for occupational and non-occupational PEP is contraindicated [see Contraindications (4)]. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue nevirapine and seek medical evaluation immediately [ see Warnings and Precautions ( 5.1 ) ].

Mechanism of action

Sourced from openFDA

Nevirapine is an antiretroviral drug [see Microbiology ( 12.4 )].

Estrogen ReceptorNon-Nucleoside Reverse TranscriptaseProgestational Hormone Receptor

Indications

Sourced from openFDA
  • & USAGE Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m 2 or greater [see Clinical Studies ( 14.1 , 14.2 )]. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: • adult females with CD4 + cell counts greater than 250 cells/mm 3 or • adult males with CD4 + cell counts greater than 400 cells/mm 3 [see Warnings and Precautions ( 5.1 )].ICD-10: B20

Contraindications

Sourced from openFDA
  • Nevirapine extended-release tablets are contraindicated: • in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.7 )] . • for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens [see Warnings and Precautions ( 5.1 )].contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION • The 14-day lead-in period with immediate-release nevirapine tablets (200 mg once daily) must be strictly followed; it has been demonstrated to reduce the frequency of rash. ( 2.5 , 5.2 ) • Must be swallowed whole and must not be chewed, crushed, or divided. ( 2.1 ) • Adult patients must initiate therapy with one 200 mg immediate-release nevirapine tablet once daily for the first 14 days, followed by one 400 mg tablet of nevirapine extended-release tablets once daily. ( 2.2 ) • Adult patients already on a regimen of immediate-release nevirapine tablets twice daily can be switched to nevirapine extended-release tablets 400 mg once daily without the 14-day lead-in period of immediate-release nevirapine tablets. ( 2.2 ) • Pediatric patients (ages 6 to less than 18 years with a BSA of 1.17 m 2 or greater) must initiate therapy with immediate-release nevirapine tablets (as 150 mg/m2 of Nevirapine Oral Suspension or as nevirapine tablet) at a dose not to exceed 200 mg per day administered once daily for the first 14 days, followed by nevirapine extended-release tablets 400 mg once daily. ( 2.3 ) • Pediatric patients with a BSA of 1.17 m 2 or greater already on a regimen of twice daily nevirapine tablets Oral Suspension or immediate-release nevirapine can be switched to nevirapine extended-release tablets 400 mg once daily without the 14-day lead-in period of nevirapine Oral Suspension or immediate-release nevirapine tablets.

Warnings & precautions

Sourced from openFDA

• Monitor patients for immune reconstitution syndrome and fat redistribution. ( 5.5 , 5.6 ) 5.1 Hepatotoxicity and Hepatic Impairment Severe, life-threatening, and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, have been reported in patients treated with nevirapine. The risk of symptomatic hepatic events regardless of severity is greatest in the first 6 weeks of therapy. The risk continued to be greater in the nevirapine groups in controlled clinical trials through 18 weeks of treatment. However, hepatic events may occur at any time during treatment. In some cases, patients presented with non-specific, prodromal signs or symptoms of fatigue, malaise, anorexia, nausea, jaundice, liver tenderness or hepatomegaly, with or without initially abnormal serum transaminase levels. Rash was observed in approximately half of the patients with symptomatic hepatic adverse events. Fever and flu-like symptoms accompanied some of these hepatic events. Some events, particularly those with rash and other symptoms, have progressed to hepatic failure with transaminase elevation, with or without hyperbilirubinemia, hepatic encephalopathy, prolonged partial thromboplastin time, or eosinophilia. Rhabdomyolysis has been observed in some patients experiencing skin and/or liver reactions associated with nevirapine use.

Adverse reactions

Sourced from openFDA

• Adult patients: The most common adverse reaction is rash. During the lead-in period with immediate-release nevirapine tablets, the incidence of Grade 2 or higher drug-related rash in adults is 3%. After the lead-in period the incidence of Grade 2 or higher drug-related rash in subjects taking nevirapine extended-release tablets is 3%. The incidence of Grade 2 or higher drug-related clinical hepatitis after the lead-in phase was 2%. ( 6.1 ) • Pediatric patients: The incidence of Grade 2 or higher drug-related rash was 1%. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trial Experience in Adult Patients The most serious adverse reactions associated with nevirapine are hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions.

Use in specific populations

Sourced from openFDA

• No dose adjustment is required for patients with renal impairment with a creatinine clearance greater than or equal to 20 mL per min. Patients on dialysis receive an additional dose of immediate-release nevirapine tablets (200 mg) following each dialysis treatment. ( 2.5 , 8.6 ) • Monitor patients with hepatic fibrosis or cirrhosis carefully for evidence of drug-induced toxicity. Do not administer nevirapine extended-release tablets to patients with Child-Pugh B or C. ( 5.1 , 8.7 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) [see Data]. The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15-20%. The background risk of birth defects and miscarriage for the indicated population is unknown.

Pharmacokinetics

Sourced from openFDA
Metabolism
Adults Absorption and Bioavailability The single-dose pharmacokinetics of nevirapine extended-release tablets was studied in 17 healthy volunteers. Nevirapine was absorbed with a median t max of approximately 24 hrs.

Overdosage

Sourced from openFDA

There is no known antidote for nevirapine overdosage. Cases of immediate-release nevirapine tablets overdose at doses ranging from 800 to 1,800 mg per day for up to 15 days have been reported. Patients have experienced events including edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting and weight decrease. All events subsided following discontinuation of immediate-release nevirapine tablets.

Approval history

Sourced from openFDA
  • May 22, 2012ANDAANDA203080Micro Labs Ltd
  • May 22, 2012ANDAANDA078195Strides Pharma
  • May 22, 2012ANDAANDA202523Mylan Pharms Inc
  • May 22, 2012ANDAANDA078584Hetero Labs Ltd Iii
  • May 22, 2012ANDAANDA077702Aurobindo
  • May 22, 2012ANDAANDA077521Aurobindo
  • Oct 27, 2014ANDAANDA205651Mylan
  • Oct 6, 2017ANDAANDA206879Macleods Pharms Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
8,933 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Foetal Exposure During Pregnancy1,11212%
  2. 2Drug Resistance1,02812%
  3. 3Virologic Failure8009.0%
  4. 4Viral Mutation Identified6947.8%
  5. 5Death4965.6%
  6. 6Exposure During Pregnancy4545.1%
  7. 7Hiv Infection4324.8%
  8. 8Drug Ineffective4064.5%
  9. 9Pathogen Resistance3824.3%
  10. 10Treatment Failure3353.8%
  11. 11Anaemia3333.7%
  12. 12Pyrexia3303.7%
  13. 13Drug Exposure During Pregnancy3143.5%
  14. 14Lipodystrophy Acquired3143.5%
  15. 15Premature Baby2522.8%

Literature

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Recent PubMed references pinned to Nevirapine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 238 ClinicalTrials.gov registrations naming Nevirapine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Nevirapine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • ABCB1CPIC C (provisional)ClinPGx 3
  • CCHCR1CPIC D (provisional)ClinPGx 3
  • CYP2B6CPIC B/C (provisional)ClinPGx 2A
  • HLA-BCPIC C (provisional)ClinPGx 3
  • HLA-DRB1CPIC C (provisional)ClinPGx 2B

Frequently asked questions

How does Nevirapine work?
Nevirapine is an antiretroviral drug [see Microbiology ( 12.4 )].
What is Nevirapine used for?
According to FDA labeling, Nevirapine carries indications including: & USAGE Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m 2 or greater [see Clinical Studies ( 14.1 , 14.2 )]. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: • adult females with CD4 + cell counts greater than 250 cells/mm 3 or • adult males with CD4 + cell counts greater than 400 cells/mm 3 [see Warnings and Precautions ( 5.1 )].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Nevirapine?
Nevirapine is classified as Non-nucleoside reverse transcriptase inhibitors, Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor, Cytochrome P450 2B6 Inducers, Cytochrome P450 3A Inducers, Estrogen Receptor Agonists, Non-Nucleoside Reverse Transcriptase Inhibitors, Progestational Hormone Receptor Agonists, Decreased Reverse Transcription to DNA.
What are the brand names for Nevirapine?
Nevirapine is marketed under brand names including Viramune.
What are the contraindications for Nevirapine?
Nevirapine labeling lists contraindications including: Nevirapine extended-release tablets are contraindicated: • in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.7 )] . • for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens [see Warnings and Precautions ( 5.1 )].. Always consult the full prescribing information and a clinician.
Note. Data for nevirapine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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