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(nevirapine) Extended-Release Tablets, for Oral Use
LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS
Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female gender and higher CD4+ cell counts at initiation of therapy place patients at increased risk; women with CD4+ cell counts greater than 250 cells/mm³ , including pregnant women receiving nevirapine in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both genders, all CD4+ cell counts and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking nevirapine for post-exposure prophylaxis (PEP). Use of nevirapine for occupational and non-occupational PEP is contraindicated [see CONTRAINDICATIONS]. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue nevirapine and seek medical evaluation immediately [see WARNINGS AND PRECAUTIONS].
Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediately. Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with immediate-release VIRAMUNE 200 mg daily dosing has been observed to decrease the incidence of rash and must be followed [see WARNINGS AND PRECAUTIONS].
Patients must be monitored intensively during the first 18 weeks of therapy with nevirapine to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events. Do not restart nevirapine following clinical hepatitis, or transaminase elevations combined with rash or other systemic symptoms, or following severe skin rash or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment.
VIRAMUNE XR is the brand name for nevirapine extended-release tablets. Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds.
The chemical name of nevirapine is 11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C15H14N4O. Nevirapine has the following structural formula:
VIRAMUNE XR Tablets are for oral administration. Each tablet contains 100 mg or 400 mg of nevirapine and the inactive ingredients lactose monohydrate, hypromellose, iron oxide, and magnesium stearate.
What are the possible side effects of nevirapine (Viramune, Viramune XR)?
Get emergency medical help if you have any of these signs of an allergic reaction: tired feeling, joint or muscle pain, muscle weakness, skin rash, bruising, severe tingling, numbness, mouth sores, trouble breathing, or swelling of your face, lips, tongue, or throat.
Stop taking nevirapine and call your doctor at once if you have a serious side effect such as:
- nausea, pain in your upper stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- fever, chills, body aches, flu symptoms;
- any other...
Last reviewed on RxList: 2/6/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Viramune XR Information
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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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