NEVIMUNE Tablets
Each tablet contains:
Nevirapine……….. 200 mg

NEVIMUNE Oral Suspension
Each 5 ml contains:
Nevirapine………. 50 mg

NEVIMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Additional important information regarding the use of nevirapine for the treatment of HIV-1 infection is given below

• Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled studies, NEVIMUNE 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 200 mg daily dosing has been demonstrated to reduce the frequency of rash (see WARNINGS AND PRECAUTIONS AND DOSAGE AND ADMINISTRATION ).
• If rash persists beyond the 14 day lead-in period, do not dose escalate to 200 mg twice daily. The 200 mg once daily dosing regimen should not be continued beyond 28 days after which point an alternative regimen should be sought.

Adults

The recommended dose for nevirapine is 200 mg once daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by 200 mg twice daily, in combination with other antiretroviral agents. For concomitantly administered antiretroviral therapy, the full prescribing information for those drugs should be consulted.

Pediatric patients

The recommended oral dose for pediatric patients aged 15 days and older is 150 mg/m 2 once daily for 14 days followed by 150 mg/m 2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient .

Mosteller Formula: BSA (m 2 ) =

Table 1: Calculation of the Volume of NEVIMUNE Oral Suspension (50 mg/5 mL) Required for Pediatric Dosing Based on Body Surface and a Dose of 150 mg/m 2

NEVIMUNE Oral suspension should be shaken gently prior to administration. It is important to administer the entire measured dose of suspension by using an oral dosing syringe or dosing cup. An oral dosing syringe is recommended, particularly for volumes of 5 ml or less. If a dosing cup is used, it should be thoroughly rinsed with water and the rinse should also be administered to the patient.

Monitoring of patients

Intensive clinical and laboratory monitoring, including liver function tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver function tests at baseline, prior to dose escalation, and at 2 weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment (see WARNINGS AND PRECAUTIONS ). In some cases, hepatic injury has progressed despite discontinuation of treatment.

Dosage Adjustment

Patients with Rash

Nevirapine should be discontinued if patients experiences severe rash or any rash accompanied by constitutional findings (see WARNINGS AND PRECAUTIONS ). A patient experiencing mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (4 mg/kg/day in pediatric patients) should not have their nevirapine dose increased until the rash has resolved (see WARNINGS AND PRECAUTIONS ) . The total duration of the once daily lead-in dosing period should not exceed 28 days, after which point an alternative regimen should be sought.

Patients with Hepatic Events

If a clinical (symptomatic) hepatic event occurs, nevirapine should be permanently discontinued. Do not restart nevirapine after recovery (see WARNINGS AND PRECAUTIONS ).

Patients with Dose Interruption

Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing, using one 200 mg tablet daily (4 mg/kg/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (4 or 7 mg/kg twice daily, according to age, for pediatric patients).

Patients on Dialysis

NEVIMUNE is contraindicated in patients with moderate or severe (Child Pugh Class B or C, respectively) hepatic impairment ( see WARNINGS AND PRECAUTIONS ).

NEVIMUNE Tablets…………………… Container of 30 tablets
NEVIMUNE Oral Suspension ………..Bottle of 100 ml