FDA Approves GlaxoSmithKline's Agenerase

Treating HIV infection. Agenerase is used in combination with other medicines. Agenerase is an HIV-protease inhibitor. It works by inhibiting the growth of HIV.

Agenerase is an anti-HIV medication. It is in a category of HIV medications called protease inhibitors (PIs). Agenerase prevents T-cells that have been infected with HIV from producing new HIV.

Agenerase is manufactured by GlaxoSmithKline Pharmaceuticals and was originally developed by Vertex Pharmaceuticals. The U.S. Food and Drug Administration (FDA) approved it for the treatment of HIV infection in 1999.

The manufacturer of Agenerase has also developed Lexiva (fosamprenavir), a "prodrug" of Agenerase. This means that fosamprenavir must be broken down inside the body before it can become active. Doing so increases the amount of drug in the blood, while at the same time decreasing the number of pills that must be swallowed every day. Lexiva was approved by the FDA in October 2003 and is now the preferred form of amprenavir.

Agenerase is no longer available in the United States. Because Lexiva is now the preferred form of amprenavir, GlaxoSmithKline began phasing out the sale and distribution of the 150mg Agenerase capsules beginning in late 2004. In October 2007, GSK ended the U.S. sale and distribution of the 50mg capsules and the liquid version of Agenerase, on account of the June 2007 approval of a liquid version of Lexiva. Liquid Agenerase will remain available in countries where liquid Lexiva is not yet available.

AGENERASE is a medication used to treat HIV infection. HIV is the virus that causes AIDS (acquired immune deficiency syndrome). AGENERASE is taken by mouth as a soft gel capsule or oral solution. It belongs to a class of anti-HIV medicines called protease inhibitors.

The usual dosage for adults and adolescents (at least 13 years of age) is eight 150-mg soft gel capsules twice a day (morning and night), in combination with other anti-HIV medicines. AGENERASE can be taken with or without food, but should not be taken with a high-fat meal because this could reduce the effectiveness.

What is Agenerase?

Agenerase is an oral medication that is used in combination with other antiretroviral agents for the treatment of HIV-1 infection. When used together with other medicine, Agenerase may help lower the amount of HIV found in your blood, increase CD4 (T) cell counts, and keep your immune system as healthy as possible to help fight infection.

Agenerase does not have these effects in all patients. Agenerase does not cure HIV or AIDS. Also, it does now reduce the risk of passing HIV to others through blood or sexual contact.

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

Agenerase can cause serious and life-threatening side effects when taken simultaneously with certain medicines.