Aptivus is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Aptivus is used together with another drug called ritonavir to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS).

Aptivus is not a cure for HIV or AIDS.

You should not use Aptivus if you have moderate to severe liver disease.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Some people taking Aptivus with ritonavir have developed fatal medical problems including liver damage and bleeding in the brain. Stop taking these medicines and get emergency medical attention if you have: right-sided upper stomach pain, nausea, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), unusual bleeding, sudden severe headache, or problems with speech or vision.

Before taking this medicine

You should not use Aptivus if you are allergic to tipranavir, or if you have:

• moderate to severe liver disease.

Some medicines can cause unwanted or dangerous effects when used with Aptivus. Your doctor may change your treatment plan if you also use:

• alfuzosin;

• cisapride;

• lurasidone;

• pimozide;

• rifampin;

• sildenafil (Revatio for pulmonary arterial hypertension);

• St. John's wort;

• ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine;

• heart medication - amiodarone, flecainide, propafenone, quinidine;

• a sedative - oral midazolam, triazolam; or

• "statin" cholesterol medicine - atorvastatin, lovastatin, simvastatin.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• diabetes;

• high cholesterol or triglycerides;

• a bleeding disorder such as hemophilia; or

• an allergy to sulfa drugs.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Aptivus can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Aptivus should not be given to a child younger than 2 years old.

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

Aptivus is taken in combination with ritonavir (Norvir). Use tipranavir and ritonavir regularly to get the most benefit.

Take your medicine with food if you take tipranavir with ritonavir tablets.

You may take your medicine with or without food if you take tipranavir with ritonavir capsules or liquid.

Swallow the capsules whole. Do not open or chew the capsule.

Measure Aptivus liquid carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Tell your doctor if the child using this medicine has any changes in height or weight. Tipranavir doses are based on body surface area (height and weight) in children, and any changes may affect your dose.

You will need frequent medical tests.

If you need surgery, tell the surgeon ahead of time that you are using this medicine.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store an unopened bottle of Aptivus capsules in the refrigerator. Do not freeze. After opening the bottle, store the capsules at room temperature.

Store Aptivus liquid at room temperature away from moisture and heat. Do not store the liquid in the refrigerator.

Throw away any capsules or liquid you have not used within 60 days after you first opened the medicine bottle.

Usual Adult Dose for HIV Infection:

tipranavir 500 mg plus ritonavir 200 mg orally twice a day

Use: In combination with ritonavir and other antiretrovirals, for the treatment of HIV-1 infection in therapy-experienced patients infected with HIV-1 strains resistant to more than 1 protease inhibitor

Usual Pediatric Dose for HIV Infection:

2 to 18 years:
-Based on weight: Tipranavir 14 mg/kg plus ritonavir 6 mg/kg orally twice a day
-Based on BSA: Tipranavir 375 mg/m2 plus ritonavir 150 mg/m2 orally twice a day
Maximum dose: Tipranavir 500 mg/dose plus ritonavir 200 mg/dose

Comments:
-Special vigilance recommended during dose calculation, medication order transcription, dispensing information, and dosing instructions to reduce risk for medication errors, overdose, and underdose.
-Pediatric dose should not exceed the usual adult dose.

Use: In combination with ritonavir and other antiretrovirals, for the treatment of HIV-1 infection in therapy-experienced patients infected with HIV-1 strains resistant to more than 1 protease inhibitor

You should not use Aptivus if you are allergic to tipranavir, or if you have:

• moderate to severe liver disease.

Some medicines can cause unwanted or dangerous effects when used with Aptivus. Your doctor may change your treatment plan if you also use:

• alfuzosin;

• cisapride;

• lurasidone;

• pimozide;

• rifampin;

• sildenafil (Revatio for pulmonary arterial hypertension);

• St. John's wort;

• ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine;

• heart medication - amiodarone, flecainide, propafenone, quinidine;

• a sedative - oral midazolam, triazolam; or

• "statin" cholesterol medicine - atorvastatin, lovastatin, simvastatin.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• diabetes;

• high cholesterol or triglycerides;

• a bleeding disorder such as hemophilia; or

• an allergy to sulfa drugs.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Aptivus can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Aptivus should not be given to a child younger than 2 years old.

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.

If you also take didanosine, take it 2 hours before or after you take Aptivus.

Avoid taking vitamin E supplements if you are using the liquid form of Aptivus.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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

Some people taking Aptivus with ritonavir have developed fatal medical problems including liver damage and bleeding in the brain. Stop taking this medicine and get emergency medical attention if you have:

• right-sided upper stomach pain, nausea, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• unusual bleeding, sudden severe headache, problems with speech or vision.

Call your doctor at once if you have:

• severe skin rash, blistering, peeling, redness or sunburn;

• skin rash and also joint or muscle pain, fever, or tightness in your throat; or

• increased thirst, increased urination, hunger, dry mouth.

Aptivus affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). 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 Aptivus side effects may include:

• nausea, vomiting, diarrhea, stomach pain;

• skin rash (especially in children);

• headache, fever, tired feeling; 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.

Many drugs can interact with tipranavir, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.