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Home » Drug Information » FDA-Approved Drugs » 1999
Medical Areas: Immunology/Infectious Diseases

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Drug Information

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Drug Name: Agenerase (amprenavir)

Company: GlaxoSmithKline
Approval Status: Approved April 1999
Treatment Area: Immunology/Infectious Diseases

General Information

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.

Side Effects

Common side effects of AGENERASE are nausea, vomiting, diarrhea, rash, and a tingling sensation around the mouth. Severe or life-threatening rash has been reported.

Contact your doctor if you have nausea, vomiting, diarrhea, or rash. Your doctor may be able to help you manage these symptoms.

AGENERASE should not be administered concurrently with astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, midazolam, and triazolam. Although these drugs have not been specifically studied, coadministration may result in competitive inhibition of metabolism of these products and may cause serious or life-threatening adverse events.

Mechanism of Action

AGENERASE is used only in combination with other anti-HIV medicines. When used in combination therapy, AGENERASE may help lower the amount of HIV found in your blood, raise CD4 (T) cell count, and keep your immune system as healthy as possible so that it can help fight infection. However, AGENERASE does not have these effects in all patients.

Amprenavir is an inhibitor of HIV-1 protease. Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.

Additional Information

Children from 4 to 12 years of age can also take AGENERASE. Your doctor will tell you if the oral solution or capsule is best for your child. Your child’s doctor will decide the right dose based on your child’s weight and age. AGENERASE has not been studied in children under 4 years of age.


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