Sustiva Consumer Information

Brand Name: Sustiva® Active Ingredient: efavirenz Strength(s): 50mg, 100mg, and 200mg Dosage Form(s): Capsule Company Name: DuPont Pharmaceuticals Company Availability: Prescription only *Dated Approved by FDA: September 17, 1998 *Approval by FDA does not mean that a new drug will be immediately marketed and available to consumers.

What is Sustiva used for?

Sustiva is used in combination with other anti-HIV medications to treat HIV infection.

Sustiva is not a cure for HIV infection. You may continue to develop infections and other complications associated with HIV disease. There are no data that Sustiva can reduce the risk of transmitting HIV to others through sexual contact or blood contamination.

Special Warnings with Sustiva:

Sustiva should not be taken alone to treat HIV. Because resistance to the HIV virus can occur quickly with single drug treatment, Sustiva should always be taken in combination with at least one other anti-HIV medication. If your current treatment is not working, Sustiva should not be added by itself.

Tell your health care provider if you are trying to become pregnant, are pregnant, or are breast-feeding. You should not become pregnant or breast-feed while taking Sustiva. Before starting Sustiva, women capable of having children should take a pregnancy test. While taking Sustiva you should always use a barrier form of birth control (e.g., condom, diaphragm) along with another effective method of birth control (e.g., oral birth control pill).

Review all medications that you are taking with your health care provider, including those that you take without a prescription. There are potential drug interactions that can cause serious side effects. You must not take Sustiva with:

• astemizole
• cisapride
• midazolam
• triazolam
• ergot derivatives

Doses of other medications may need to be adjusted.

General Precautions with Sustiva:

The long-term effects of Sustiva on HIV infection are not known at this time.

Tell your health care provider right away if you experience delusions, unusual behavior, or suddenly feel depressed.

Avoid taking Sustiva while using alcohol or drugs that affect the mind or behavior.

Sustiva may cause dizziness, problems concentrating and/or drowsiness. Therefore, do not drive or operate heavy machinery until you know how you will react to Sustiva.

Sustiva may cause a skin rash in the first or second week of treatment. The rash generally lasts less than a month. However, some patients develop a severe rash with blistering. Rash occurs more frequently in children than adults. In a small number of patients rash may be severe. If you develop a skin rash tell your health care provider.

If you have or have a history of hepatitis, or if you are taking other medications that are harmful to the liver, see your health care provider for regular monitoring.

Your health care provider may want to check your cholesterol levels regularly while you are taking Sustiva.

How should I take Sustiva?

Take Sustiva once a day in combination with other anti-HIV medications. You may take Sustiva with or without food, but avoid high fat meals because they can effect the amount of Sustiva in your body. If your child is taking Sustiva, your child's health care provider will decide the right dose based on their weight.

What are some possible side effects of Sustiva?

(This is NOT a complete list of side effects reported with Sustiva. Your health care provider can discuss with you a more complete list of side effects.) Tell your health care provider about any side effects you have.

If you experience dizziness, difficulty concentrating, drowsiness, unusual dreams, or trouble sleeping, tell your health care provider. These symptoms can begin during the first few days of taking Sustiva and usually go away after 2-4 weeks of treatment. Taking Sustiva at bedtime can help, and is recommended for the first weeks of treatment

Skin rash is a common side effect of Sustiva especially in children. (See General Precautions)

Other side effects may include:

• Upset stomach
• Dizziness
• Difficulty concentrating
• Feeling tired
• Vomiting
• Trouble sleeping
• Headache
• Diarrhea

For more detailed information about Sustiva, ask your health care provider.