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

Efavirenz may cause serious psychiatric symptoms including severe depression, suicidal thoughts, aggression, extreme fear, or unusual behavior. Contact your doctor at once if you have any of these side effects.

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not take efavirenz with astemizole (Hismanal), bepridil (Vascor), cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), voriconazole (Vfend), or ergot medicines such as dihydroergotamine (D.H.E. 45), ergonovine (Ergotrate), ergotamine (Ergomar, Cafergot, Wigraine), or methylergonovine (Methergine). These drugs can cause life-threatening side effects if you use them while you are taking efavirenz.

There are many other medicines that can interact with efavirenz, or make it less effective. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Taking efavirenz will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

What is efavirenz?

Efavirenz is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Efavirenz is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Efavirenz is not a cure for HIV or AIDS.

Efavirenz may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking efavirenz?

Do not use this medication if you are allergic to efavirenz, or if you are using any of the following drugs:

• astemizole (Hismanal);

• bepridil (Vascor);

• cisapride (Propulsid);

• midazolam (Versed) or triazolam (Halcion);

• pimozide (Orap);

• voriconazole (Vfend); or

• ergot medicine such as ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).

Using any of these medicines while you are taking efavirenz can cause serious medical problems or death.

Before taking efavirenz, tell your doctor if you are allergic to any drugs, or if you have

• liver disease (including hepatitis B or C);

• high cholesterol or triglycerides; or

• if you have ever taken delavirdine (Rescriptor) or nevirapine (Viramune) and they were not effective in treating your condition.

If you have any of these conditions, you may not be able to use efavirenz, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use efavirenz without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking efavirenz. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using efavirenz. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether efavirenz had any effect on the baby.

You should not breast-feed while you are using efavirenz. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

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