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Drug Notebook

Generic Name: nevirapine

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Viramune
An NNRTI - treats HIV Infection and used for Reduction of Perinatal Transmission of HIV
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FDA Alerts

  • Severe, life-threatening (and in some cases fatal) hepatotoxicity reported, particularly during first 18 weeks of therapy. Patients have presented with nonspecific prodromal signs and symptoms of hepatitis and progressed to hepatic failure; these events often associated with rash. Patients with higher CD4+ T-cell counts and women are at increased risk of these hepatic events. Women with CD4+ T-cell counts >250 cells/mm3 (including pregnant women receiving long-term treatment for HIV infection) are at greatest risk, but hepatotoxicity can occur in both genders, all CD4+ T-cell counts, and at any time during treatment Patients with signs or symptoms of hepatitis or with increased serum transaminase concentrations in conjunction with rash or other systemic symptoms must discontinue nelfinavir and seek immediate medical evaluation.
  • Severe, life-threatening skin reaction, including fatal cases, reported. Reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients with signs or symptoms of severe skin reactions or hypersensitivity must discontinue nelfinavir and seek immediate medical evaluation.
  • Essential that patients are monitored intensively during the first 18 weeks of nevirapine therapy to detect potential life-threatening hepatotoxicity or skin reactions. Extra vigilance needed during first 6 weeks since this is period of greatest risk.
  • Hepatic injury has progressed despite discontinuation of nevirapine in some patients.
  • Do not restart nevirapine following severe hepatic, skin, or hypersensitivity reactions.
  • Strictly follow the recommendations regarding use of a low initial nevirapine dosage (200 mg once daily for the first 14 days).

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(ne VYE ra peen)

What is the most important information I should know about nevirapine?

Nevirapine can cause severe or life-threatening effects on the liver. Call your doctor at once if you have any of these liver symptoms while taking nevirapine: skin rash, nausea, stomach pain, loss of appetite, low fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Nevirapine may also cause severe or life-threatening skin reactions. Contact your doctor if you have any type of skin rash. Even a minor skin rash could be an early sign of a serious reaction. Later signs include fever, sore throat, and headache with a severe blistering, peeling, and red skin rash. This type of reaction is a medical emergency.

There are many other medicines that can interact with nevirapine, or make it less effective. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Taking nevirapine will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

What is nevirapine?

Nevirapine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Nevirapine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Nevirapine is not a cure for HIV or AIDS.

Nevirapine may also be used for purposes other than those listed in this medication guide.

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