Nevirapine

Nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets is 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. Nevirapine is an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older.

Nevirapine is an antiretroviral drug.

The 14-day lead-in period must be strictly followed, it has been demonstrated to reduce the frequency of rash. 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 is interrupted for greater than 7 days, restart 14-day lead-in dosing. Adults (≥16 yrs) Pediatric Patients* (≥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.

Nevirapine tablets are contraindicated: in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment. for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens. Patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment. Use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens, an unapproved use.

Boxed warning (life-threatening (including fatal) hepatotoxicity and skin reactions hepatotoxicity): 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. Monitor patients for immune reconstitution syndrome and fat redistribution. 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 most common adverse reaction is rash. In adults, the incidence of rash is 15% versus 6% with placebo, with Grade 3/4 rash occurring in 2% of subjects. In pediatric subjects the incidence of rash (all causality) was 21%.

Nevirapine is principally metabolized by the liver via the cytochrome P450 isoenzymes, 3A and 2B6. Nevirapine is known to be an inducer of these enzymes. As a result, drugs that are metabolized by these enzyme systems may have lower than expected plasma levels when co-administered with nevirapine. The specific pharmacokinetic changes that occur with co-administration of nevirapine and other drugs are listed in Clinical Pharmacology, Table 5. Clinical comments about possible dosage modifications based on established drug interactions are listed in Table 4. The data in Tables 4 and 5 are based on the results of drug interaction trials conducted in HIV-1 seropositive subjects unless otherwise indicated.

Storage Nevirapine Tablets, USP should be stored at 20 ° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store in a safe place out of the reach of children.