Tipranavir (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, planning to become pregnant, or if you have liver disease (including hepatitis B or C), bleeding problems, diabetes, high blood cholesterol, or herpes. Your doctor should know if you think you have been exposed to chickenpox while you are using this medicine. Tell your doctor if you or your child are allergic to sulfa medicines (such as sulfamethoxazole/trimethoprim, Bactrim®, Septra®, or Sulfatrim®).
• Stop using this medicine and check with your doctor if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
• This medicine may cause bleeding in the brain. Make sure your doctor knows if you or your child have a bleeding disorder such as hemophilia, or any medical condition that increases your chance of bleeding. Tell your doctor right away if you or your child have any unusual or unexplained bleeding.
• When you start taking HIV medicines, your immune system may get stronger. If you have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• Birth control pills may not work as well while you are using this medicine. To keep from getting pregnant, use an additional form of birth control with your pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.
• This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests
• Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have more than one of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; fever or chills; itching; joint or muscle pain; severe rash; red skin lesions; sunburn; throat tightness; or sores, ulcers, or white spots in the mouth or on the lips.
• This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely. This is very important because the amount of virus in your blood may increase and become harder to treat.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• Dry mouth, increased thirst and hunger.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness or fainting.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Severe rash.
• Shortness of breath or troubled breathing.
• Sudden or severe headache, or problems with vision, speech, or walking.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, bloating, gas, or upset stomach.
• Gaining weight around your neck, upper back, breast, face, or waist.
• Mild headache, dizziness, or tiredness.
• Mild skin rash or itching, with joint pain or stiffness.
• Severe sunburn.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Tipranavir (tye-PRAN-a-vir)

Treats human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). Tipranavir does not cure HIV or AIDS. It is used with another drug called ritonavir (Norvir®) to slow down the progress of the disease.

Brand Name(s)

Aptivus

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to tipranavir or ritonavir. You should not use this medicine if you have moderate or severe liver disease. Do not use this medicine together with alfuzosin (Uroxatral®), amiodarone (Cordarone®, Pacenone®), bepridil (Vascor®), cisapride (Propulsid®), ergot medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Migranal®, or Wigraine®), flecainide (Tambocor®), oral midazolam (Versed®), lovastatin (Altocor®, Mevacor®), pimozide (Orap®), propafenone (Rythmol®), quinidine (Cardioquin®, Quinaglute dura®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), St. John's wort, or triazolam (Halcion®). Do not give this medicine to a child younger than 2 years of age.

How to Use This Medicine

Liquid Filled Capsule, Liquid

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• If you are using this medicine with ritonavir capsules or oral liquid, you may take it with or without food. However, you should take this medicine with food if you are taking it with ritonavir tablets.
• Swallow the capsule whole. Do not crush, break, or chew it.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Tipranavir is used with ritonavir (Norvir®) to treat HIV infection. Always take these two medicines together at the same time, unless your doctor tells you otherwise. Take all other medicines your doctor has prescribed at the right time of day. This will make your medicines work better.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• When you first bring this medicine home, store the capsules in the refrigerator until you are ready to open the bottle. Once you have opened the medicine bottle, you may store it at room temperature, away from heat, light, or moisture. The medicine is good for up to 60 days after you open the bottle. After 60 days, throw away any unused capsules and get a new bottle of your medicine.
• Store the oral liquid at room temperature. Do not refrigerate or freeze. The liquid must be used within 60 days after first opening the bottle.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using a blood thinner (such as warfarin, Coumadin®), fluticasone (Advair®, Flonase®), medicine to treat impotence (such as sildenafil, tadalafil, vardenafil, Cialis®, Levitra®, or Viagra®), medicine to lower cholesterol (such as atorvastatin, rosuvastatin, Crestor®, or Lipitor®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, valproic acid, Depakene®, Dilantin®, Luminal®, or Tegretol®), or diabetes medicine that you take by mouth (such as glimepiride, glipizide, glyburide, pioglitazone, repaglinide, tolbutamide, Actos®, Avandia®, Diabeta®, Glucophage®, Glucotrol®, or Prandin®).
• Tell your doctor if you are also taking other medicines to treat HIV or AIDS (such as abacavir, atazanavir, didanosine, fosamprenavir, lopinavir, saquinavir, zidovudine, Combivir®, Retrovir®, Trizivir®, or Videx®), medicine to treat a fungus infection (such as fluconazole, itraconazole, ketoconazole, voriconazole, Nizoral®, or Sporanox®), medicine to treat depression (such as desipramine, fluoxetine, paroxetine, sertraline, trazodone, Desyrel®, Paxil®, Prozac®, or Zoloft®), certain blood pressure medicines (such as diltiazem, felodipine, nicardipine, nisoldipine, verapamil, Cardene®, Cardizem®, Cardil®, Isoptin SR®, or Plendil®), strong pain medicines (such as meperidine, methadone, Demerol®, or Dolophine®), bosentan (Tracleer®), buprenorphine and naloxone (Buprex®, Suboxone®), colchicine (Colcrys®), clarithromycin (Biaxin®), midazolam injection, rifabutin (Mycobutin®), disulfiram (Antabuse®), metronidazole (Flagyl®), omeprazole (Prilosec®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), salmeterol (Advair®, Serevent®), sirolimus (Rapamune®), tacrolimus (Prograf®), tadalafil (Adcirca?), or vitamin E supplements.
• Make sure your doctor knows if you also use hormone replacements or birth control pills containing estrogen, such as ethinyl estradiol, Femhrt®, Loestrin®, Ortho-Novum®, or Ovcon®.