AGENERASE

Agenerase is used to treat HIV-1 infection in combination with other anti-HIV medications. Agenerase belongs to the class of anti-HIV medications called protease inhibitors and should only be taken in combination with other anti-HIV medications.

Agenerase is not a cure for HIV infection. You may continue to develop infections and other complications associated with HIV disease. Agenerase has not been shown to reduce the risk of transmitting HIV to others through sexual contact or blood contamination. The long-term effects of Agenerase are not known at this time.

There are potential drug interactions that can cause serious side effects. You must not take Agenerase with:

• astemizole (Hismanal™)
• bepridil (Vascor™)
• cisapride (Propulsid™)
• ergot derivatives (Cafergot and others™)
• midazolam (Versed™)
• triazolam (Halcion™)

In addition, if you take certain other medications with Agenerase, serious or life-threateningside effects can also occur. Because of this, it is very important that you tell your doctor about all the medications you are taking, including those you take without a prescription.

• Agenerase should not be taken alone to treat HIV. Because resistance to the HIV virus can occur quickly with single drug treatment, Agenerase should always be taken in combination with other anti-HIV medications. If your current treatment is not working, contact your doctor; Agenerase should not be taken by itself.

• Talk to your doctor if you are taking Viagra™ (sildenafil) with Agenerase. You may be at risk for an increase in Viagra-related side effects such as low blood pressure, changes in vision, or penile erection lasting more than 4 hours.

• Increased blood sugar (hyperglycemia) or diabetes may develop while taking Agenerase. If you take diabetes medication, your dose may need to be adjusted.

• Agenerase can cause a skin rash that is sometimes potentially severe and life-threatening. If you develop a skin rash, tell your health care provider immediately.

• Agenerase may cause hemolytic anemia (a decrease in the number of red blood cells in your body).

• Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding. You should not become pregnant or breast-feed while taking Agenerase. If you are using hormonal contraceptives (e.g., birth control pills), you should use another form of birth control (e.g., condom, diaphragm) while taking Agenerase.

If you are taking a blood-thinning medication or you have low vitamin K, your doctor will decide if the amount of vitamin E in Agenerase interferes with your treatment. Do not take vitamin E supplements while being treated with Agenerase, because Agenerase contains vitamin E.

Agenerase may increase the amount of fat in your body or you may notice changes in the location of your body fat. Tell your doctor if you experience any changes like these.

Do not switch from the capsule to the solution without advice from your doctor. Agenerase capsules and Agenerase oral solution are not the same on a milligram per milligram basis.

Do not take additional vitamin E because the amount of vitamin E contained in Agenerase is more than the Reference Daily Intake of vitamin E.

Do not refrigerate Agenerase capsules or oral solution. Store Agenerase at room temperature.

Tell your doctor or health care provider if you have:

• had an allergic reaction to sulfa drugs
• hemophilia, as hemophiliac patients have sometimes experienced spontaneous bleeding while taking Agenerase
• a history of liver problems. Your health care provider will decide if Agenerase is right for you.

Side effects may include:

• Skin rash (see Special Warnings)
• Nausea
• Vomiting
• Diarrhea
• Tingling sensation around the mouth

Contact your doctor if you have nausea, vomiting, diarrhea, or rash. Your doctor may be able to help you manage these symptoms. Your doctor will advise you whether your symptoms can be managed on therapy or whether Agenerase should be stopped.