Viracept®(nelfinavir)

VIRACEPT is a prescription HIV-1 medicine used with other HIV-1 medicines to treat human immunodeficiency virus (HIV-1) infection in adults and children 2 years of age and older.• VIRACEPT does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

• are taking certain medicines that can cause serious or life-threatening side effects when used with VIRACEPT, including:◦ alfuzosin◦ amiodarone◦ cisapride◦ ergot-containing medicines (dihydroergotamine, ergotamine, methylergonovine)◦ lovastatin or simvastatin◦ lurasidone◦ oral midazolam◦ pimozide◦ quinidine◦ rifampin◦ sildenafil (Revatio) for pulmonary arterial hypertension◦ St. John's wort (Hypericum perforatum)◦ triazolam

• have liver problems (including hepatitis B or C)• have kidney problems• have phenylketonuria (PKU) - VIRACEPT oral powder contains phenylalanine• have diabetes• have hemophilia• are pregnant or plan to become pregnant• are breastfeeding or plan to breastfeed - do not breastfeed while taking VIRACEPT due to risk of passing HIV-1 to your baby and because the medicine may pass into breast milk• Important for women: Hormonal forms of birth control (such as birth control pills, injections, vaginal rings, or implants) may not work during treatment with VIRACEPT. Use another form of birth control.• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Take VIRACEPT every day exactly as prescribed by your healthcare provider.• Take VIRACEPT with a meal.• VIRACEPT is usually taken 2 to 3 times daily.• The dose for children is based on their weight.• If you cannot swallow tablets, you may dissolve them in a small amount of water. Mix the cloudy mixture well and drink it right away. Rinse the glass with water and drink the rinse to make sure you take the entire dose.• If you miss a dose of VIRACEPT, take it as soon as possible. If you skip a dose, do not double the next dose.

• Use the scoop provided with VIRACEPT Oral Powder for measuring.• Do not mix VIRACEPT Oral Powder in the original container.• Mix VIRACEPT Oral Powder with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements.• Do not mix VIRACEPT Oral Powder with acidic foods or juices (such as orange juice, apple juice, or applesauce) because of the bitter taste.• Your child should drink all of the mixture to be sure that the entire dose is taken.• If the mixture is not consumed right away, it should be refrigerated and used within 6 hours.

VIRACEPT can cause serious side effects, including:• Diabetes and high blood sugar (hyperglycemia). Some people who take VIRACEPT or similar medicines develop new or worsening diabetes.• Increased bleeding. People with hemophilia may have increased bleeding.• Changes in body fat. Changes in body fat distribution may occur, including increased fat in the upper back and neck, breasts, and around the trunk, and loss of fat from the legs, arms, and face.• Changes in your immune system (Immune Reconstitution Syndrome). Your immune system may get stronger and begin to fight infections that have been hidden in your body.• The most common side effects of VIRACEPT in adults include: diarrhea, nausea, rash, gas• The most common side effects of VIRACEPT in children include: diarrhea, low white blood cell count (leukopenia/neutropenia), rash, decreased appetite, stomach pain• These are not all the possible side effects of VIRACEPT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store VIRACEPT tablets and oral powder at room temperature between 59°F to 86°F (15°C to 30°C).• Keep VIRACEPT and all medicines out of the reach of children.

Active ingredient: nelfinavir mesylate• Inactive ingredients in VIRACEPT tablets (625 mg): calcium silicate, crospovidone, magnesium stearate, hypromellose, and triacetin• Inactive ingredients in VIRACEPT oral powder: microcrystalline cellulose, maltodextrin, potassium acesulfame, aspartame, and natural and artificial flavors