Nevirapine is an oral medication that is used for the treatment of infections with the human immunodeficiency virus (HIV). It is in a class of drugs called reverse transcriptase inhibitors that also includes zalcitabine (Hivid), zidovudine (Retrovir), didanosine (Videx), and lamivudine (Epivir). It is in a subclass of protease inhibitors called nonnucleoside protease inhibitors that includes efavirenz (Sustiva) and delavirdine (Rescriptor). During infection with HIV, the HIV virus multiplies within the body's cells. The newly-formed viruses then are released from the cells and spread throughout the body where they infect other cells. In this manner, the infection spreads to new, uninfected cells that the body is continually producing, and HIV infection is perpetuated. When producing new viruses, the HIV virus must manufacture new DNA for each virus. Reverse transcriptase is the enzyme that the virus uses to form this new DNA. Nevirapine directly inhibits the activity of reverse transcriptase and blocks the production of DNA and new viruses. Nevirapine does not kill existing HIV virus and it is not a cure for HIV. The FDA approved nevirapine in September 1996.

Viramune, Viramune XR

GENERIC AVAILABLE: Yes

Yes

The most common side effects of nevirapine are:

• rash,
• headaches,
• diarrhea,
• nausea,
• fever,
• abdominal pain, and
• muscle pain (myalgia).

The most serious side effects of nevirapine are:

• liver failure,
• severe skin reactions,
• decreased white blood cells, and
• muscle breakdown (rhabdomyolysis).

Like other antiretroviral drugs, use of nevirapine is associated with redistribution or accumulation of body fat. Immune reconstitution syndrome which is an inflammatory response to infection may occur in patients treated with combination anti-HIV therapy.

The starting dose for adults is 200 mg daily (lead-in period). After 14 days the dose should be increased to 200 mg every 12 hours or 400 mg of extended release once daily. The 14 day lead-in period must be observed in order to reduce the incidence of rash, and it should not be longer than 28 days. Any patient who develops a rash during the lead-in period should not receive twice daily treatment or extended release tablets until the rash has resolved. Nevirapine must be administered in combination with other anti-HIV drugs because the HIV virus quickly becomes resistant nevirapine when it is used alone. Nevirapine may be administered without regard to meals since food does not reduce its absorption.

Nevirapine is excreted in human breast milk. Nursing should be discontinued during nevirapine therapy. In addition, HIV infected mothers should not nurse because of the risk of transmitting HIV to an infant that is not infected.

What preparations of nevirapine are available?

Tablets: 200 mg; Suspension: 10 mg/ml. Tablets (extended release): 400 mg.

How should I keep nevirapine stored?

Tablets and suspension should be stored at room temperature, 15 C to 30 C (59 F to 86 F).