What is this medication?
Antiretroviral, Reverse Transcriptase Inhibitor, Non-nucleoside (Anti-HIV)
“ALERT: US Boxed Warning
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 nonspecific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Women and patients with higher CD4+ cell counts at initiation of therapy are at increased risk. Women with CD4+ cell counts higher than 250 cells/mm3, including pregnant women receiving nevirapine in combination with other antiretrovirals for treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both genders, at all CD4+ cell counts, and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking nevirapine for postexposure prophylaxis. Use of nevirapine for occupational and nonoccupational postexposure prophylaxis is contraindicated. 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.
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. Check transaminase levels immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with nevirapine 200 mg immediate release daily dosing has been observed to decrease the incidence of rash and must be followed.
Monitoring for hepatotoxicity and skin reactions
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 reactions. Do not restart nevirapine following clinical hepatitis, 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.”
How does this medication work?
Nevirapine, Viramune is a non-nucleoside reverse transcriptase inhibitor that has activity against HIV-1 by binding to reverse transcriptase and does not require intracellular phosphorylation for antiviral activity. It consequently blocks the RNA-dependent and DNA-dependent DNA polymerase activities including HIV-1 replication.
How should I take this medication?
Immediate release: 200 mg twice daily (Initially 200mg once daily for 14 days to assess for side effects)
Extended release: 400 mg once daily; maintenance therapy using the extended release must follow a 14-day initial dosing period (lead-in) using the immediate release formulation unless patient is already maintained on a nevirapine immediate release regimen
How to Take: May be administered with or without food. May be administered with an antacid or didanosine. Shake suspension gently prior to administration; the use of an oral dosing syringe is recommended, especially if the dose is ≤5 mL; if using a dosing cup, after administration, rinse cup with water and also administer rinse. ER tablets must be swallowed whole and not crushed, chewed, or divided.
What should I watch for while using this medication?
Before starting Nevirapine, Viramune make sure your physician is aware of any allergies or medications you currently take, if you have hepatic impairment, a hereditary condition of galactose intolerance, are pregnant, or breastfeeding. Nevirapine, Viramune use has been associated with rare but serious adverse events such as fat redistribution, hepatotoxicity, immune reconstitution syndrome, rhabdomyolysis, and severe skin reactions.
What if I miss a dose?
If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses.
How should I store this medication?
Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.
What are the possible side effects of using this medication?
Increased serum cholesterol, increased LDL cholesterol, decreased serum phosphate, neutropenia, increased serum alanine aminotransferase, nausea, skin rash, fatigue
Note this is not a complete list of side effects, only the most common.
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