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VIRAMUNE XR is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. This indication is based on one principal clinical trial (1100.1486) that demonstrated prolonged suppression of HIV-1 RNA through 96-weeks and a supportive trial (1100.1526).
Additional important information regarding the use of VIRAMUNE XR for the treatment of HIV-1 infection:
- Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm³ or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [see BOXED WARNING and WARNINGS AND PRECAUTIONS].
- The 14-day lead-in period with immediate-release VIRAMUNE 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
- If rash persists beyond the 14-day lead-in period with immediate-release VIRAMUNE, do not begin dosing with VIRAMUNE XR. The lead-in dosing with 200 mg once-daily immediate-release VIRAMUNE should not be continued beyond 28 days, at which point an alternative regimen should be sought.
DOSAGE AND ADMINISTRATION
Patients not currently taking immediate-release VIRAMUNE
Patients must initiate therapy with one 200 mg tablet of immediate-release VIRAMUNE daily for the first 14 days in combination with other antiretroviral agents (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 400 mg tablet of VIRAMUNE XR once daily. Patients must swallow VIRAMUNE XR tablets whole. They must not be chewed, crushed, or divided. For concomitantly administered therapy, the manufacturer's recommended dosage and monitoring should be followed. VIRAMUNE XR can be taken with or without food.
Switching Patients from immediate-release VIRAMUNE to VIRAMUNE XR
Patients already on a regimen of immediate-release VIRAMUNE twice daily in combination with other antiretroviral agents can be switched to VIRAMUNE XR 400 mg once daily in combination with other antiretroviral agents without the 14-day lead-in period of immediate-release VIRAMUNE.
Patients must never take more than one form of nevirapine at the same time.
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 prior to beginning the 14-day lead-in period with immediate-release VIRAMUNE, prior to initiation of VIRAMUNE XR, and at two weeks after initiation of VIRAMUNE XR therapy. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout VIRAMUNE XR treatment [see WARNINGS AND PRECAUTIONS]. In some cases, hepatic injury has progressed despite discontinuation of treatment.
Patients already on a regimen of immediate-release VIRAMUNE twice daily who switch to VIRAMUNE XR once daily should continue with their ongoing clinical and laboratory monitoring.
Patients with Rash
Discontinue nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings [see BOXED WARNING, WARNINGS AND PRECAUTIONS, and Patient Counseling Information]. Do not initiate therapy with VIRAMUNE XR if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of immediate-release VIRAMUNE (200 mg once daily) until the rash has resolved [see WARNINGS AND PRECAUTIONS and PATIENT 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, permanently discontinue nevirapine. Do not restart nevirapine after recovery [see WARNINGS AND PRECAUTIONS].
Patients with Dose Interruption
For patients who interrupt VIRAMUNE XR dosing for more than 7 days restart the recommended lead-in dosing with immediate-release VIRAMUNE, using one 200 mg tablet daily for the first 14 days.
Patients with Renal Impairment
Patients with CrCL greater than or equal to 20 mL per min and not requiring dialysis do not require an adjustment in dosing. An additional 200 mg dose of immediate-release 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]. VIRAMUNE XR has not been studied in patients with renal dysfunction.
Dosage Forms And Strengths
Tablets: 400 mg, yellow, oval, biconvex, tablets debossed with “V04” on one side and the Boehringer Ingelheim logo on the other side.
Storage And Handling
VIRAMUNE XR tablets, 400 mg, are yellow, oval, biconvex tablets, debossed with “V04” on one side and the Boehringer Ingelheim logo on the other side.
VIRAMUNE XR tablets are supplied in bottles of 30 (NDC 0597-0123-30).
Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. Store in a safe place out of the reach of children.
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Revised: Sep 2012
Last reviewed on RxList: 10/30/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Viramune XR Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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