Formulary
Nevirapine: Indications, Dosing, Side Effects and Interactions
Nevirapine clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 5 min read
Nevirapine: Indications, Dosing, Side Effects and Interactions
Nevirapine clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**HIV infection in combination with other antiretroviral drugs (initial dose)**
- **Adult** (By Mouth Using Immediate-Release Medicines): Initially 200 mg once daily for first 14 days, initial dose titration using 'immediate-release' preparation should not exceed 28 days; if rash occurs and is not resolved within 28 days, alternative treatment should be sought. If treatment interrupted for more than 7 days, restart using the lower dose of the 'immediate-release' preparation for the first 14 days as for new treatment.
**HIV infection in combination with other antiretroviral drugs (maintenance dose following initial dose titration if no rash present)**
- **Adult** (By Mouth Using Immediate-Release Medicines): 200 mg twice daily.
- **Adult** (By Mouth Using Modified-Release Medicines): 400 mg once daily.
**HIV infection in combination with other antiretroviral drugs (initial dose) for nevirapine**
- **Child** (By mouth using immediate-release medicines): Initially 150-200 mg/m2 once daily (max. per dose 200 mg) for first 14 days, initial dose titration using 'immediate-release' preparation should not exceed 28 days; if rash occurs and is not resolved within 28 days, alternative treatment should be sought. If treatment interrupted for more than 7 days, restart using the lower dose of the 'immediate-release' preparation for the first 14 days as for new treatment.
**HIV infection in combination with other antiretroviral drugs (maintenance dose following initial dose titration if no rash present) for nevirapine**
- **Child 3-17 years (body surface area 0.58-0.83 m2)** (By mouth using immediate-release medicines): 200 mg once daily.
- **Child 3-17 years (body surface area 0.84-1.17 m2)** (By mouth using immediate-release medicines): 300 mg once daily.
- **Child 3-17 years (body surface area 1.18 m2 and above)** (By mouth using immediate-release medicines): 400 mg once daily.
- **Child 3-17 years (body surface area 0.58-0.83 m2)** (By mouth using modified-release medicines): 200 mg once daily.
- **Child 3-17 years (body surface area 0.84-1.17 m2)** (By mouth using modified-release medicines): 300 mg once daily.
- **Child 3-17 years (body surface area 1.18 m2 and above)** (By mouth using modified-release medicines): 400 mg once daily.
Cautions
Females (at greater risk of hepatic side effects); high CD4 cell count (at greater risk of hepatic side effects) Cautions, further information Hepatic effects Patients with chronic hepatitis B or C, high CD4 cell count, and women are at increased risk of hepatic side effects-if plasma HIV-1 RNA detectable, manufacturer advises avoid in women with CD4 cell count greater than 250 cells/mm 3 or in men with CD4 cell count greater than 400 cells/mm 3 unless potential benefit outweighs risk.
Contraindications
Acute porphyrias ; post-exposure prophylaxis
Side effects
Common or very common Abdominal pain; angioedema; diarrhoea; fatigue; fever; headache; hepatic disorders; hypersensitivity; hypertransaminasaemia; nausea; skin reactions; vomiting Uncommon Anaemia; arthralgia; myalgia; severe cutaneous adverse reactions (SCARs) Frequency not known Eosinophilia; osteonecrosis; weight increased Side-effects, further information Hepatic effects Potentially life-threatening hepatotoxicity including fatal fulminant hepatitis reported usually in first 6 weeks; discontinue permanently if abnormalities in liver function tests accompanied by hypersensitivity reaction (rash, fever, arthralgia, myalgia, lymphadenopathy, hepatitis, renal impairment, eosinophilia, granulocytopenia); suspend if severe abnormalities in liver function tests but no hypersensitivity reaction-discontinue permanently if significant liver function abnormalities recur; monitor patient closely if mild to moderate abnormalities in liver function tests with no hypersensitivity reaction. Rash Rash, usually in first 6 weeks, is most common side-effect; incidence reduced if introduced at low dose and dose increased gradually (after 14 days); Discontinue permanently if severe rash or if rash accompanied by blistering, oral lesions, conjunctivitis, facial oedema, general malaise or hypersensitivity reactions; if rash mild or moderate may continue without interruption but dose should not be increased until rash resolves. Osteonecrosis Osteonecrosis has been reported in patients with advanced HIV disease or following long-term exposure to combination antiretroviral therapy.
Interactions
**Severe interactions:**
- Etravirine Concomitant use of etravirine with nevirapine may cause a significant decrease in the plasma concentrations of etravirine and loss of therapeutic effect of etravirine.
- ENTRY INHIBITORS Enfuvirtide Due to the metabolic pathway no clinically significant pharmacokinetic interactions are expected between enfuvirtide and nevirapine.
- Cobicistat, a cytochrome P450 3A inhibitor significantly inhibits hepatic enzymes, as well as other metabolic pathways.
- Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
- No significant effect on rifabutin and Nevirapine mean PK parameters is seen.
- Itraconazole 200 mg QD Itraconazole AUC 0.39 Itraconazole C min 0.13 Itraconazole C max 0.62 Nevirapine: there was no significant difference in Nevirapine pharmacokinetic parameters.
- ANTACIDS Cimetidine Cimetidine: no significant effect on cimetidine PK parameters is seen.
- Ketoconazole and erythromycin significantly inhibited the formation of nevirapine hydroxylated metabolites.
**Other interactions (75):**
- Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2-4 weeks of initiating multiple-dose therapy.
- Compounds using this metabolic pathway may have decreased plasma concentrations when co- administered with nevirapine.
- Careful monitoring of the therapeutic effectiveness of P450 metabolised medicinal products is recommended when taken in combination with nevirapine.
- The absorption of nevirapine is not affected by food, antacids or medicinal products which are formulated with an alkaline buffering agent.
- ND = Not Determined, = Increased, = Decreased, = No Effect Medicinal products by therapeutic areas Interaction Recommendations concerning co- administration ANTI-INFECTIVES ANTIRETROVIRALS...
- Emtricitabine Emtricitabine is not an inhibitor of human CYP 450 enzymes.
Hepatic impairment
For modified-release preparations, manufacturer advises avoid (no information available). For immediate-release preparations, manufacturer advises caution in moderate impairment and chronic hepatitis (increased risk of hepatic side effects; consider interrupting or discontinuing treatment if hepatic function worsens); avoid in severe impairment (no information available).
Renal impairment
Manufacturer advises avoid modified-release preparation-no information available.
Medicinal forms
Tablet,Tablet,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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