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What is tipranavir?

Tipranavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Tipranavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Tipranavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Tipranavir is not a cure for HIV or AIDS.

Tipranavir may also be used for other purposes not listed in this medication guide.

Precautions

Instructions

Side Effects

Interactions

Precautions

Do not use this medication if you are allergic to tipranavir or ritonavir (Norvir), if you have moderate to severe liver disease, or if you are using any of the following drugs:

• amiodarone (Cordarone, Pacerone);
• bepridil (Vascor);
• cisapride (Propulsid);
• flecainide (Tambocor);
• lovastatin (Mevacor, Altocor) or simvastatin (Zocor, Vytorin);
• midazolam (Versed) or triazolam (Halcion);
• pimozide (Orap);
• propafenone (Rythmol);
• quinidine (Cardioquin, Quinidex, Quinaglute);
• rifampin (Rifadin, Rifamate, Rimactane);
• St. John's wort; or
• ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).

These drugs can cause life-threatening side effects if you use them while you are taking tipranavir.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using tipranavir, tell your doctor if you have:

• 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.

FDA pregnancy category C. It is not known whether tipranavir is harmful to an unborn baby. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Tipranavir 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 tipranavir.

You should not breast-feed while you are using tipranavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

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

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a tipranavir overdose are unknown.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

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

Some people taking tipranavir and ritonavir have developed life-threatening medical problems including liver damage and bleeding in the brain. If you are taking these two medications, call your doctor at once if you have any of the following side effects:

• unusual bleeding (such as a nosebleed or blood in your urine or stools);
• sudden headache, confusion, problems with vision, speech, or balance;
• low fever, nausea, stomach pain, loss of appetite;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

Stop taking tipranavir and call your doctor at once if you have any of these serious side effects:

• severe skin rash, blistering, peeling, or sunburn;
• increased urination or extreme thirst;
• easy bruising or bleeding; or
• signs of a new infection, such as fever or chills, cough, skin lesions, or flu symptoms.

Less serious side effects may include:

• mild nausea, vomiting, diarrhea, stomach pain;
• headache, 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.

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Interactions

Many drugs can interact with tipranavir. Below is just a partial list. Tell your doctor if you are using:

• a blood thinner such as warfarin (Coumadin);
• disulfiram (Antabuse);
• fluticasone (Advair, Flonase, Flovent);
• insulin or diabetes medication you take by mouth;
• itraconazole (Sporanox) or ketoconazole (Nizoral);
• methadone (Methadose, Diskets, Dolophine);
• omeprazole (Prilosec);
• rifabutin (Mycobutin);
• vitamin E (especially at high doses);
• an antidepressant such as desipramine (Norpramin), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), trazodone (Desyrel), and others;
• a calcium channel blocker such as diltiazem (Tiazac, Cartia, Dilacor), felodipine (Plendil), nicardipine (Cardene), nisoldipine (Sular), verapamil (Calan, Covera, Isoptin, Verelan);
• cholesterol-lowering medicine such as atorvastatin (Lipitor), rosuvastatin (Crestor), and others;
• drugs that weaken the immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);
• medication used to prevent blood clots, such as clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), and others;
• medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);
• other HIV /AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), fosamprenavir (Lexiva), lopinavir/ritonavir (Kaletra), or saquinavir (Invirase); or
• seizure medications such as carbamazepine (Carbatrol, Tegretol), clonazepam (Klonopin), divalproex (Depakote), ethosuximide (Zarontin), lamotrigine (Lamictal), phenobarbital (Solfoton), phenytoin (Dilantin), or valproic acid (Depakene).

This list is not complete and there are many other medicines that can interact with tipranavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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