Nevirapine Sandoz Ltd (Nevirapine)

Nevirapine is an antiretroviral drug indicated for HIV‑1 infection and related therapeutic pathways.

• Adult HIV‑1 infection: used as part of combination antiretroviral therapy to suppress viral load.
• Pediatric HIV‑1 infection: incorporated into age‑appropriate combination regimens to control infection.
• Prevention of mother‑to‑child transmission of HIV: administered to pregnant women in combination therapy to reduce vertical transmission risk.

• Nevirapine binds to a hydrophobic pocket on the HIV‑1 reverse transcriptase enzyme that is distinct from the nucleoside binding site. This non‑competitive binding induces a conformational change that blocks the enzyme’s ability to transcribe viral RNA into DNA, thereby halting the synthesis of proviral DNA and preventing replication of the virus within host cells. The inhibition is reversible and does not require intracellular phosphorylation.

Nevirapine may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

• Rash: mild to moderate skin eruptions.
• Headache: transient headache episodes.
• Nausea: occasional gastrointestinal upset.
• Fatigue: generalized tiredness.
• Diarrhea: loose stools.
• Elevated liver enzymes: mild transaminase increase.

Serious or Rare Side Effects

• Stevens‑Johnson syndrome: severe skin reaction with mucosal involvement.
• Toxic epidermal necrolysis: life‑threatening skin detachment.
• Hepatotoxicity: significant liver injury, jaundice, or hepatitis.
• Severe hypersensitivity: fever, eosinophilia, and systemic symptoms.
• Hematologic abnormalities: anemia or neutropenia.

When prescribing Nevirapine, clinicians should observe several safety considerations to minimize risk.

• Baseline liver function: assess hepatic enzymes before initiation.
• CD4 count monitoring: avoid use in women with CD4 >250 cells/µL due to rash risk.
• Drug hypersensitivity: discontinue at first sign of severe skin reaction.
• Concomitant CNS disease: use caution in patients with active CNS infections.
• Pregnancy and breastfeeding: evaluate risk‑benefit; limited data available.
• Store at below 25°C: keep in original container, protect from moisture and light.

Nevirapine interacts with several medicines, affecting its plasma levels or the efficacy of co‑administered drugs.

Major Interactions (Avoid)

• Rifampicin: induces metabolism, markedly reducing nevirapine exposure.
• Protease inhibitors (e.g., ritonavir): may increase nevirapine levels leading to toxicity.
• St. John’s wort: strong CYP3A4 inducer, lowers nevirapine concentrations.

Moderate Interactions (Monitor Closely)

• Efavirenz: shared metabolic pathway may require dose adjustment.
• Azole antifungals (e.g., ketoconazole): inhibit CYP enzymes, potentially raising nevirapine levels.
• Warfarin: nevirapine may alter anticoagulant effect; monitor INR.