Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection
The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.
Non-Nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs)
Last Updated: May 22, 2018; Last Reviewed: May 22, 2018
|Nevirapine (NVP, Viramune)
For additional information see Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/daf/
|Tablets: Immediate-release 200 mg, extended-release (XR) 100 mg and 400 mg
Suspension: 10 mg/mL
Tablets: Immediate-release 200 mg, extended-release (XR) 400 mg only
Suspension: Generic suspension is no longer available in the United States
Note: While the suspension formulation of brand name nevirapine (Viramune) is available, it is not typically stocked in local pharmacies or hospitals. Have the pharmacy ask their drug wholesaler to order directly from the Boehringer-Ingleheim distribution center. The distribution center should be able to ship the formulation directly to the pharmacy.
|Dosing Recommendations||Selected Adverse Events|
|Neonate and Infant (≤14 Days) Dose for Prevention:
Note: In most situations, nevirapine is given once daily for 2 weeks to allow for autoinduction of the enzymes involved in its metabolism. This may not be necessary in children aged <2 years (see footnotea and text below).
Immediate Release Tablets and Suspension Formulations
Aged <1 Month (This Investigational Dose is Not Food and Drug Administration-Approved):
Aged ≥6 Years:
|a Nevirapine is usually initiated at a lower dose and increased in a stepwise fashion to allow for induction of cytochrome P450 metabolizing enzymes, which results in increased drug clearance. The stepwise increase in dose decreases the occurrence of rash. Clinicians should initiate therapy with the age-appropriate dose of the immediate-release formulation once daily (half-daily dose) for the first 14 days of therapy. If there is no rash or untoward effect, at 14 days of therapy, increase to the age-appropriate full dose, administered twice daily, of the immediate-release preparation. However, in children aged ≤2 years, some experts initiate nevirapine without a lead-in (see Dosing Considerations: Lead-In Requirement and Special Considerations for Dosing: Neonates and Premature Infants sections below). In patients who are already receiving full-dose, immediate-release nevirapine, extended-release tablets can be used without the 200-mg lead-in period. Patients must swallow nevirapine extended-release tablets whole. They must not be chewed, crushed, or divided. Patients must never take more than 1 form of nevirapine at the same time. Dose should not exceed 400 mg daily.
b Symptomatic hepatitis, including fatal hepatic necrosis, occurs at a significantly higher frequency in antiretroviral (ARV)-naive women with pre-nevirapine CD4 T lymphocyte (CD4) cell counts >250 cells/mm3 and in ARV-naive men with pre-nevirapine CD4 counts >400 cells/mm3. Nevirapine should not be initiated in these patients unless the benefit clearly outweighs the risk.