aptivus

Aptivus (tipranavir) is an antiviral medication called a protease (PRO-tee-ayz) inhibitor. Tipranavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Aptivus is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Aptivus is not a cure for HIV or AIDS. Tipranavir is used together with a similar drug called ritonavir (Norvir).

Important information

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

Life-threatening side effects can occur if you take Aptivus with: alfuzosin, amiodarone, cisapride, flecainide, sildenafil (Revatio for pulmonary arterial hypertension), atorvastatin, lovastatin, simvastatin, propafenone, rifampin, quinidine, pimozide, midazolam (Versed), triazolam, St. John"s wort, or an ergot medicine such as Ergomar, Ergotrate, Cafergot, D.H.E. 45, Migranal, or Methergine.

Aptivus is taken in combination with ritonavir (Norvir). However, some people taking these medicines 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: unusual bleeding, sudden severe headache, numbness, problems with speech or vision, nausea, upper stomach pain, tired feeling, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before taking this medicine

You should not use Aptivus if you are allergic to tipranavir or ritonavir (Norvir, Kaletra), or if you have moderate to severe liver disease.

Life-threatening side effects can occur if you take Aptivus with any of the following medications:

• alfuzosin (Uroxatral);

• amiodarone (Cordarone, Pacerone);

• cisapride (Propulsid);

• atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), simvastatin (Zocor, Simcor, Vytorin, Juvisync);

• flecainide (Tambocor), propafenone (Rythmol), quinidine (Quinaglute);

• midazolam (Versed) or triazolam (Halcion);

• pimozide (Orap);

• rifampin (Rifadin, Rifamate, Rimactane);

• sildenafil (Revatio for pulmonary arterial hypertension);

• St. John"s wort; or

• ergot medicines for migraine headache (Ergomar, Cafergot, D.H.E. 45, Migranal, Ergotrate, or Methergine).

To make sure you can safely take Aptivus, tell your doctor if you have any of these other conditions:

• liver disease (especially hepatitis B or C);

• diabetes;

• high cholesterol or triglycerides;

• a bleeding disorder such as hemophilia; or

• if you are allergic to sulfa drugs.

It is not known whether Aptivus will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Aptivus 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 this medicine.

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.

How should I take Aptivus?

Take Aptivus exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Aptivus is taken in combination with ritonavir (Norvir). Use tipranavir and ritonavir regularly to get the most benefit. Get your prescriptions refilled before you run out of medicine completely.

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 Aptivus capsule whole. Do not break or chew it.

Measure Aptivus liquid with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

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.

While using Aptivus, you may need frequent blood tests.

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

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor"s advice. Every person with HIV or AIDS 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 of capsules for the first time, you may store the medicine 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.

Aptivus dosing information

Usual Adult Dose for HIV Infection:

Tipranavir 500 mg plus ritonavir 200 mg orally twice a day

Usual Pediatric Dose for HIV Infection:

2 to 18 years: Tipranavir 14 mg/kg plus ritonavir 6 mg/kg or tipranavir 375 mg/m2 plus ritonavir 150 mg/m2 orally twice a day

Pediatric dosage should not exceed the usual adult dosage.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Aptivus?

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 tipranavir.

Taking this medication will not prevent you from passing HIV to other people. 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.

Aptivus side effects

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

Some people taking tipranavir 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:

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

• nausea, upper stomach pain, tired feeling, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

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 may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Aptivus. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• severe lower back pain, loss of bladder or bowel control; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

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.

See also: Side effects (in more detail)

What other drugs will affect Aptivus?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Aptivus, especially:

• fluticasone (Flonase), sildenafil (Viagra), quetiapine (Seroquel), tadalafil (Cialis), vardenafil (Levitra);

• birth control pills or hormone replacement therapy; or

• medicine used to prevent blood clots--alteplase, clopidogrel, dipyridamole, ticlopidine, urokinase, warfarin (Coumadin, Jantoven);

This list is not complete. Many drugs can interact with tipranavir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Aptivus. Give a list of all your medicines to any healthcare provider who treats you.