DOSAGE AND ADMINISTRATION
The recommended dose for VIRAMUNE 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 lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.
The recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.
Table 1 Calculation of the Volume of VIRAMUNE Oral Suspension (50 mg/5 mL) Required for Pediatric Dosing Based on Body Surface and a Dose of 150 mg/m2
| BSA range (m2) || Volume (mL) |
|0.06 – 0.12||1.25|
|0.12 – 0.25||2.5|
|0.25 – 0.42||5|
|0.42 – 0.58||7.5|
|0.58 – 0.75||10|
|0.75 – 0.92||12.5|
|0.92 – 1.08||15|
|1.08 – 1.25||17.5|
VIRAMUNE 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 enzyme tests, is essential at baseline and during the first 18 weeks of treatment with VIRAMUNE. 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 VIRAMUNE treatment [ see Warnings and Precautions (5) ]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
Patients with Rash
VIRAMUNE should be discontinued if a patient experiences severe rash or any rash accompanied by constitutional findings [ see Boxed Warning, Warnings and Precautions , and Patient Counseling Information ]. A patient experiencing mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) should not have their VIRAMUNE dose increased until the rash has resolved [ see Warnings and Precautions and Patient Counseling Information ]. 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, VIRAMUNE should be permanently discontinued. Do not restart VIRAMUNE after recovery [ see Warnings and Precautions ].
Patients with Dose Interruption
Patients who interrupt VIRAMUNE dosing for more than 7 days should restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).
Patients on Dialysis
An additional 200 mg dose of VIRAMUNE 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 ]. Patients with CrCL ≥20 mL/min do not require an adjustment in VIRAMUNE dosing.
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg, white, oval, biconvex, tablets embossed with 54 193 on one side
Oral suspension: 50 mg/5 mL, white to off-white oral suspension