Viral infections:
Indications for: VIRAMUNE XR
HIV-1 infection.
Limitations of Use:
Adult females with CD4+ counts >250cells/mm3 or males with CD4+ counts >400cells/mm3: do not initiate unless benefit outweighs risk.
Adult Dosage:
Swallow whole. ≥18yrs: Initially Viramune 200mg once daily for 14 days, then Viramune XR 400mg once daily. If mild-to-moderate rash develops during the 14-day lead in period, do not start Viramune XR until rash has resolved. Lead-in period not necessary if patient already on a regimen of immediate-release Viramune twice daily. Total duration of once daily lead-in period should not exceed 28 days; consider alternative regimen. If severe rash or hepatic event occurs, discontinue permanently. Retitrate if stopped for >7 days.
Children Dosage:
<6yrs: not recommended. Swallow whole. ≥6–<18yrs: Initially 150mg/m2 Viramune oral susp or immediate-release tabs once daily for 14 days; max 200mg/day, then Viramune XR dose based on BSA: 0.58–0.83m2: 200mg once daily; 0.84–1.16m2: 300mg once daily; ≥1.17m2: 400mg once daily. All: max 400mg/day. If mild-to-moderate rash develops during the 14-day lead in period, do not start Viramune XR until rash has resolved. Lead-in period not necessary if patient already on a regimen of immediate-release Viramune twice daily. Total duration of once daily lead-in period should not exceed 28 days; consider alternative regimen. If severe rash or hepatic event occurs, discontinue permanently. Retitrate if stopped for >7 days.
VIRAMUNE XR Contraindications:
Moderate to severe (Child-Pugh B or C) hepatic impairment. Use as part of occupational or non-occupational post-exposure prophylaxis regimens.
Boxed Warning:
Life-threatening (including fatal) hepatotoxicity and skin reactions.
VIRAMUNE XR Warnings/Precautions:
Risk of severe, life-threatening hepatotoxicity (eg, hepatic necrosis and failure, cholestatic hepatitis) or skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity). Monitor liver function (at baseline, intensively during 1st 18 weeks, and throughout therapy). Suspend and discontinue permanently if signs/symptoms of hepatitis, elevated transaminases combined with rash or other systemic symptoms (eg, fever, blistering, oral lesions, conjunctivitis, swelling, muscle/joint aches or general malaise) occurs; do not restart after recovery. Co-infected with hepatitis B or C. Hepatitis fibrosis or cirrhosis; monitor. Renal dysfunction. Elderly. Pregnancy. Nursing mothers: not recommended.
See Also:
VIRAMUNE XR Classification:
Non-nucleoside reverse transcriptase inhibitor.
VIRAMUNE XR Interactions:
Possible increased adverse reactions with concomitant efavirenz: not recommended. Concomitant other NNRTIs: not recommended. Potentiated by fluconazole (monitor). Antagonizes atazanavir, fosamprenavir without ritonavir, ketoconazole, itraconazole, boceprevir, telaprevir: not recommended, clarithromycin (consider alternative). Antagonized by St. John's wort, rifampin: not recommended. Antagonizes methadone (monitor for withdrawal symptoms; increase methadone dose if needed), oral contraceptives (use nonhormonal contraception; monitor). May antagonize other drugs metabolized by CYP3A4 or CYP2B6. Do not give lopinavir/ritonavir tabs or oral soln once daily with nevirapine (see full labeling). Monitor warfarin, carbamazepine, clonazepam, ethosuximide, rifabutin (caution), other CYP450 substrates.
Adverse Reactions:
Rash, nausea, headache, abnormal liver function tests, fatigue, fever, vomiting, myalgia, abdominal pain; fat redistribution, immune reconstitution syndrome. Children: also granulocytopenia.
Note:
Register pregnant patients exposed to nevirapine by calling (800) 258-4263.
How Supplied:
Tabs—contact supplier; Susp—240mL; XR 100mg—90; 400mg—30
