Nevirapine

What it is and how it works

Mechanism of Action Nevirapine is an antiviral drug [ see Clinical Pharmacology ].

Mechanism class: Non-Nucleoside Reverse Transcriptase Inhibitors · Cytochrome P450 3A Inducers · Cytochrome P450 2B6 Inducers

Indications

Nevirapine tablets, USP are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial (BI 1090) that demonstrated prolonged suppression of HIV-1 RNA and two smaller supportive trials, one of which (BI 1046) is described below. Additional important information regarding the use of Nevirapine tablets, USP for the treatment of HIV-1 infection: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine tablets, USP should not be initiated in adult females with CD4 + cell counts greater than 250 cells/mm 3 or in adult males with CD4 + cell counts greater than 400 cells/mm 3 unless the benefit outweighs the risk [ see Boxed Warning and Warnings and Precautions ]. The 14-day lead-in period with Nevirapine tablets, USP 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [ see Dosage and Administration and Warnings and Precautions ].

Dosage and administration (summary)

If any patient experiences rash during the 14-day lead-in period, do not increase dose until the rash has resolved. Do not continue the lead-in dosing regimen beyond 28 days If dosing interrupted for greater than 7 days, restart 14-day lead-in dosing Adults (≥16 yrs) Pediatric* (>15 days) First 14 days 200 mg once daily 150 mg/m 2 once daily After 14 days 200 mg twice daily 150 mg/m 2 twice daily *Total daily dose should not exceed 400 mg for any patient. Adults The recommended dose for Nevirapine tablets, USP is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents.

Contraindications

Patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment (4.1, 5.1, 8.7) Use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens, an unapproved use (4.2, 5.1) Hepatic Impairment Nevirapine, USP is contraindicated in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [ see Warnings and Precautions and Use in Specific Populations ].

Warnings and precautions

The most serious adverse reactions associated with Nevirapine are hepatitis/hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure may be associated with signs of hypersensitivity which can include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction.

Pregnancy

Pregnancy Teratogenic Effects, Pregnancy Category B. No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits. The maternal and developmental no-observable-effect level dosages produced systemic exposures approximately equivalent to or approximately 50% higher in rats and rabbits, respectively, than t…

Storage and supply

Nevirapine Tablets, USP, 200 mg , are supplied as white to off-white oval shaped tablets engraved “N2” with a single bisect separating ‘N’ and ‘2’ on one side and plain on the other side. They are available as follows: Bottles of 60 NDC 65162-209-06 Storage Store below 30 ° C. Protect from light. Store in a safe place out of the reach of children.

Source: Nevirapine (Nevirapine) — US FDA prescribing information, 2012-08-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.