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

A European version of nelfinavir was found to have high levels of an impurity known to cause cancer in animals. Nelfinavir in the U.S. was found to have lower levels of the impurity, which is created during the manufacturing process but can be minimized.

It is not known whether this impurity has caused harm to anyone taking nelfinavir, and it is important to keep treating your condition. Children and pregnant women should not take nelfinavir as a "first-line" treatment until further notice. If you already take nelfinavir your doctor may recommend that you keep taking it. Do not change any of your medications without your doctor's advice.

Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine. These drugs can cause life-threatening side effects if you use them while you are taking nelfinavir.

There are many other medicines that can interact with nelfinavir. 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.

Taking nelfinavir 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 nelfinavir?

Nelfinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Nelfinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

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

Nelfinavir may also be used for other purposes not listed in this medication guide.

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

Do not take this medication if you are allergic to nelfinavir.

Some other medications can cause life-threatening side effects if you use them while you are taking nelfinavir. Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine.

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

• liver disease;

• diabetes;

• a bleeding disorder such as hemophilia; or

• high cholesterol or triglycerides.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take nelfinavir.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant. Nelfinavir can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking nelfinavir.

If you are pregnant, your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

Do not give this medication to a child younger than 2 years old. You should not breast-feed while you are using nelfinavir. 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.

The powder form of nelfinavir may contain phenylalanine. Talk to your doctor before using this form of nelfinavir if you have phenylketonuria (PKU).