2 DOSAGE AND ADMINISTRATION • The 14-day lead in period must be strictly followed; it has been demonstrated to reduce the frequency of rash. ( 2.4 , 5.2 ) • 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. ( 2.4 ) • If dosing is interrupted for greater than 7 days, restart 14-day lead-in dosing ( 2.4 ) Adults (≥16 yrs) Pediatric Total daily dose should not exceed 400 mg for any patient. (≥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 2.1 Adult Patients The recommended dose for Nevirapine 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. The 14-day lead-in period with Nevirapine 200 mg daily dosing must be strictly followed as the lead-in period has been observed to decrease the incidence of rash [ see Dosage and Administration ( 2.4 )and Warnings and Precautions ( 5.2 ) ]. 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, at which point, an alternative regimen should be sought. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed. 2.2 Pediatric Patients The recommended oral dose for pediatric patients 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. Formula Image 2.3 Monitoring of Patients Intensive clinical and laboratory monitoring, including liver enzyme 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 enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout Nevirapine treatment [ see Warnings and Precautions ( 5 ) ]. In some cases, hepatic injury has progressed despite discontinuation of treatment. 2.4 Dosage Adjustment Patients with Rash Discontinue Nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings [ see Warnings and Precautions ( 5.2 ) ]. Do not increase Nevirapine dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m 2 /day in pediatric patients) until the rash has resolved [ see Warnings and Precautions ( 5.2 ) ]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought. Patients with Hepatic Events If a clinical (symptomatic) hepatic event occurs, permanently discontinue Nevirapine. Do not restart Nevirapine after recovery [ see Warnings and Precautions ( 5.1 ) ]. Patients with Dose Interruption For patients who interrupt Nevirapine dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m 2 /day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m 2 twice daily for pediatric patients). Patients with Renal Impairment Patients with CrCL greater than or equal to 20 mL per min do not require an adjustment in Nevirapine dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of Nevirapine following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [ see Clinical Pharmacology ( 12.3 ) ].