Nelfinavir

Nelfinavir is an antiviral medicine used to treat HIV (human immunodeficiency virus). HIV can lead to acquired immunodeficiency syndrome (AIDS). Nelfinavir does not cure HIV or AIDS.

Nelfinavir is for adults and children who are at least 2 years old.

Nelfinavir may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

Swallow the nelfinavir tablet whole.

If you cannot swallow a whole tablet, dissolve it in a small amount of water. Stir and drink this mixture right away. Add a little more water to the glass, swirl gently and drink right away.

Mix the oral powder in a cup with a small amount of water, milk, baby formula, soy milk, or a liquid dietary supplement. To avoid a bitter taste, do not mix the powder with acidic liquids such as orange juice, apple juice, or applesauce.

Drink all of the mixed powder right away. If a child taking nelfinavir doesn't finish the entire dose, you may store the mixture in a refrigerator for up to 6 hours.

Doses are based on weight in children. Your child's dose may change if the child gains or loses weight.

Use all HIV medications as directed. Do not change your dose or stop using a medicine without your doctor's advice. Remain under the care of a doctor.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Tell your doctor about all your other medicines. Some drugs should not be used with Nelfinavir.

You should not use nelfinavir if you are allergic to it, or if you have moderate or severe liver disease.

Some drugs should not be used with nelfinavir. Your treatment plan may change if you also use:

• alfuzosin;
• cisapride;
• rifampin;
• sildenafil (Revatio for pulmonary arterial hypertension);
• St. John's wort;
• amiodarone or quinidine;
• lovastatin or simvastatin;
• lurasidone, pimozide;
• oral midazolam, or triazolam; or
• ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine.

Tell your doctor if you have ever had:

• liver disease;
• kidney disease;
• diabetes; or
• a bleeding disorder such as hemophilia.

Nelfinavir oral powder contains phenylalanine and could be harmful if you have phenylketonuria (PKU).

To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

Nelfinavir can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV should not breastfeed. The virus can pass to your baby in your breast milk.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Nelfinavir may cause serious side effects. Call your doctor right away if you have:

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
• if you have hemophilia--easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Nelfinavir can affect your immune system (even weeks or months after you've used nelfinavir). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of nelfinavir may include:

• low white blood cell counts;
• nausea, diarrhea, gas, stomach pain;
• loss of appetite;
• rash; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for HIV Infection:

1250 mg orally twice a day or 750 mg orally 3 times a dayUse: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure:

US CDC recommendations: 1250 mg orally twice a day or 750 mg orally 3 times a dayDuration of therapy: 28 daysComments:-Recommended as part of an alternative regimen for nonoccupational postexposure prophylaxis of HIV infection-This drug should be used with (lamivudine or emtricitabine) plus (zidovudine or stavudine or abacavir or tenofovir or didanosine).-Prophylaxis should be started as soon as possible, within 72 hours of exposure.-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

2 to less than 13 years: 45 to 55 mg/kg orally twice a day or 25 to 35 mg/kg orally 3 times a dayMaximum dose: 2500 mg/day-Oral powder (50 mg/g):9 to less than 10.5 kg: 500 mg orally twice a day or 300 mg orally 3 times a day10.5 to less than 12 kg: 550 mg orally twice a day or 350 mg orally 3 times a day12 to less than 14 kg: 650 mg orally twice a day or 400 mg orally 3 times a day14 to less than 16 kg: 750 mg orally twice a day or 450 mg orally 3 times a day16 to less than 18 kg: 500 mg orally 3 times a day18 to less than 23 kg: 600 mg orally 3 times a day23 kg or more: 750 mg orally 3 times a day-Tablets (250 mg):10 to 12 kg: 500 mg orally twice a day or 250 mg orally 3 times a day13 to 18 kg: 750 mg orally twice a day or 500 mg orally 3 times a day19 to 20 kg: 1000 mg orally twice a day or 500 mg orally 3 times a day21 kg or more: 1000 to 1250 mg orally twice a day or 750 mg orally 3 times a day13 years or older:-Tablets: 1250 mg orally twice a day or 750 mg orally 3 times a dayComments: For twice-daily dosing, the 250 mg tablets are recommended for children weighing 16 kg or more.Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using nelfinavir will not prevent your disease from spreading. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

If you are also taking didanosine, take your nelfinavir dose (with food) 1 hour after or more than 2 hours before you take didanosine.

Many drugs can affect nelfinavir, and some drugs should not be used together. Tell your doctor about all other medicines you are using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.