NEVIRAPINE
1 INDICATIONS & 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 ].
Details
- Status
- Prescription
- First Approved
- 2012-05-22
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, TABLET, EXTENDED RELEASE, TABLET, TABLET, FOR SUSPENSION
Companies
NEVIRAPINE Approval History
What NEVIRAPINE Treats
13 FDA approvalsOriginally approved for its first indication in 2012 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (May 2012)Letter
- • Approved indication (Apr 2014)Letter
- • Approved indication (Oct 2014)
- • Approved indication (Jul 2015)Letter
- • Approved indication (Sep 2015)
- • Approved indication (Oct 2015)Label Letter
- • Approved indication (Nov 2015)Label Letter
- • Approved indication (Nov 2016)
- • Approved indication (Feb 2017)
- • Approved indication (Jul 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Jan 2019)Letter
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; wom...
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 ) ]. SKIN REACTIONS: Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediately. Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with immediate-release nevirapine tablets 200 mg daily dosing ha
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02369406 EIT | U01AI114235 | Ph 2, Ph 3 | active not recruiting | Early Infant HIV Treatment in Botswana |
| NCT01789879 | 0022-14-EP 1R21HD074462-01 | Ph 2 | completed | A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy |
| NCT02712801 | 2015ZX10001001 | Ph 4 | completed | Antiretroviral Regime for Viral Eradication in Newborns |
| NCT03088410 | IRB 2019-2922 R01DK109881, HRDC 00781 | Ph 4 | completed | Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana |
| NCT00672412 | P1069 10620, IMPAACT P1069 | Ph 1, Ph 2 | completed | Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand |
| NCT02431975 LEOPARD | AAAO5011 U01HD080441 | Ph 4 | completed | Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial |
| NCT00661349 | A10-174 (KANELA) | Ph 4 | terminated | Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients |
| NCT01632891 results posted | ACTG A5297 1U01AI068636 | Ph 1, Ph 2 | completed | Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected |
| NCT02116660 RANIA results posted | 0518-284 2013-001637-40, MK-0518-284 | Ph 2 | terminated | Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) |
| NCT01637558 DATiC | DATiC | Ph 4 | completed | Optimal Dosing of 1st Line Antituberculosis and Antiretroviral Drugs in Children (a Pharmacokinetic Study) |
| NCT02202005 | NEVIR5U14EU 2014-002247-18 | Ph 1 | completed | Multiple Dose BE Study With Nevirapine 400mg PR Tablets |
| NCT01772940 | Lubumbashi trial | Ph 4 | completed | Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEVIRAPINE FDA Label Details
Indications & Usage
FDA Label (PDF)1 INDICATIONS & 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 ]. 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 ...
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 sig...
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Full clinical data, patents, trials, and competitive landscape for nevirapine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.