Nelfinavir Mesylate Oral suspension

What is this medicine?

NELFINAVIR (nel FIN a veer) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes
• hemophilia
• liver disease
• phenylketonuria
• an unusual or allergic reaction to nelfinavir, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth after mixing. Follow the directions on the prescription label. Take this medicine with food. Measure the dose of the powder using the scoop provided. In a separate container, mix with a small amount of water, milk, formula, soy formula, soy milk, dietary supplements, or dairy foods like pudding or ice cream. Do not mix with acidic foods like orange juice, apple juice, or apple sauce as a bitter taste may occur. Once mixed, take all of the mixture to make sure that you get the full dose. Take immediately or store for up to 6 hours in the refrigerator. Do not heat. Do not add water or liquid to the original container of powder. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

If you loose the scoop, you can use a measuring teaspoon. Each level teaspoon equals 4 scoops of this powder. Do not use a household spoon. Household spoons are not accurate.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• amiodarone
• cisapride
• dofetilide
• eplerenone
• lovastatin
• medicines for headaches like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• midazolam
• omeprazole
• pimozide
• quinidine
• ranolazine
• red yeast rice
• rifampin
• rifapentine
• simvastatin
• St. John's wort
• triazolam

This medicine may also interact with the following medications:

• azithromycin
• birth control pills or patch
• cyclosporine
• fluticasone
• medicines for cholesterol like atorvastatin, fluvastatin, rosuvastin
• medicines for erectile dysfunction like sildenafil
• medicines for seizures
• methadone
• other medicines for HIV
• rifabutin
• sirolimus
• tacrolimus
• trazodone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

This medicine contains a chemical that may increase your risk of cancer. Pregnant women and children may need to use a different HIV medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing difficulty
• fever

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• increased hunger or thirst
• increased urination
• nausea, vomiting
• skin rash
• stomach upset, gas
• unusually weak or tired
• weight gain around waist, back, or thinning of face, arms, legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store this medicine in the original container at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.