Tipranavir (patient information)

IMPORTANT WARNING:

Tipranavir taken with ritonavir (Norvir) may cause bleeding in the brain. This condition may be life-threatening. Tell your doctor if you have recently had surgery or if you have recently been injured in any way. Also tell your doctor if you have a bleeding disorder such as hemophilia (condition in which the blood does not clot normally). Tell your doctor and pharmacist if you are taking any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin), aspirin, cilostazol (Pletal), clopidogrel (Plavix), or ticlopidine (Ticlid). If you need to get emergency medical treatment for any reason, be sure to tell all of the doctors who treat you that you are taking tipranavir. Call your doctor immediately if you experience unusual bruising or bleeding during your treatment with tipranavir.

Tipranavir taken with ritonavir (Norvir) may cause liver damage that may be life-threatening. Tell your doctor if you have or have ever had hepatitis (swelling of the liver caused by a virus) or any other liver disease. Tell your doctor and pharmacist if you are taking acetaminophen (Tylenol, others); cholesterol lowering medications (statins) such as atorvastatin (Lipitor), lovastatin (Mevacor) and simvastatin (Zocor); iron products; isoniazid (INH, Nydrazid);methotrexate (Rheumatrex); niacin (nicotinic acid);rifampin (Rifadin, Rimactane); and salicylate pain relievers (aspirin, others). If you experience any of the following symptoms, stop taking tipranavir and call your doctor immediately: tiredness; flu-like symptoms; loss of appetite; upset stomach; pain, ache, swelling, or sensitivity on your right side below your ribs; yellowing of the skin or eyes; dark (tea-colored) urine; or pale bowel movements.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to tipranavir.

Talk to your doctor about the risks of taking tipranavir.

Why is this medication prescribed

Tipranavir is used with ritonavir (Norvir) and at least two other medications to treat human immunodeficiency virus (HIV). Tipranavir is in a class of medications called protease inhibitors. It works by slowing the spread of HIV in the body. Tipranavir does not cure HIV infection and may not prevent you from developing HIV-related illnesses. Tipranavir does not prevent you from spreading HIV to other people.

How should this medicine be used

Tipranavir comes as a capsule to take by mouth. It is usually taken with food and with ritonavir twice a day. Take tipranavir and ritonavir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tipranavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not take tipranavir without ritonavir.

Swallow the capsules whole; do not chew them.

Tipranavir controls HIV but does not cure it. Continue to take tipranavir even if you feel well. Do not stop taking tipranavir without talking to your doctor. If you stop taking tipranavir or skip doses, your condition may become more difficult to treat. When your supply of tipranavir starts to run low, get more from your doctor or pharmacist.

Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient. Read this information carefully and ask your doctor or pharmacist if you have any questions.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking tipranavir

• tell your doctor and pharmacist if you are allergic to tipranavir, ritonavir (Norvir), sulfa medications, any other medications, or any of the ingredients in tipranavir. Ask your pharmacist if you are unsure if a medication you are allergic to is a sulfa medication.
• do not take tipranavir if you are taking astemizole (Hismanal) (no longer available in the United States); cisapride (Propulsid) (no longer available in the United States); ergot medications for migraines such as dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylate (Hydergine), ergotamine (Bellamine, Cafergot, Ergomar, others), or methylergonovine (Methergine); certain medications for irregular heartbeat including amiodarone (Pacerone), bepridil (Vascor) (no longer available in the United States), flecainide (Tambocor), propafenone (Rythmol), or quinidine (Quinaglute); midazolam (Versed); pimozide (Orap); terfenadine (Seldane) (no longer available in the United States); and triazolam (Halcion).
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend); calcium-channel blockers such as diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Lexxel, Plendil), nicardipine (Cardene), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan, others); clarithromycin (Biaxin, in Prevpac); desipramine (Norpramin); disulfiram (Antabuse); immunosuppressants such as cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf); medications for diabetes such as glimepiride (Amaryl), glipizide (Glucotrol, in Metaglip), glyburide (Diabeta, Glycron, Glynase, Micronase, others), pioglitazone (Actos, in Actoplus), repaglinide (Prandin), or tolbutamide; certain medications for erectile dysfunction including sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra); other medications for HIV including amprenavir (Agenerase), lopinavir (in Kaletra), and saquinavir (Invirase); meperidine (Demerol, in Mepergan); methadone (Dolophine, Methadose); metronidazole (Flagyl); rifabutin (Mycobutin); and selective-serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem, in Symbyax), paroxetine (Paxil), or sertraline (Zoloft). Many other medications may also interact with tipranavir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Be sure to talk to your doctor or pharmacist before you begin taking any new medications during your treatment with tipranavir. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• If you are taking didanosine, take it 2 hours before or 2 hours after you take tipranavir.
• If you are taking antacids, take them 2 hours before or 4 hours after you take tipranavir.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had diabetes or high blood sugar; high blood cholesterol or triglycerides (blood fats); or an infection that comes and goes such as tuberculosis (TB), cytomegalovirus (CMV), herpes, shingles, or pneumonia.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tipranavir, call your doctor. Do not breastfeed if you are infected with HIV or are taking tipranavir.
• you should know that tipranavir may decrease the effectiveness of hormonal contraceptives (birth control pills, rings, patches, and injections). Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tipranavir.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Tipranavir may make your skin sensitive to sunlight.
• you should know that your body fat may increase or move to different areas of your body such as your breasts and upper back.

What special dietary instructions should I follow

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

Minor Side Effects

Tipranavir may cause hyperglycemia (high blood sugar). Call your doctor if you have any of the following symptoms of hyperglycemia:

• extreme thirst
• frequent urination
• extreme hunger
• weakness
• blurred vision

Severe Side Effects

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:

• dry mouth
• upset stomach and vomiting
• shortness of breath
• breath that smells fruity
• decreased consciousness

Tipranavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• vomiting
• headache
• difficulty falling asleep or staying asleep
• depression

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• fever, chills, cough, or other signs of infection
• rash
• itching
• throat tightness
• difficulty breathing or swallowing
• joint pain or stiffness

Tipranavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store unopened bottles of tipranavir capsules in the refrigerator. Store opened bottles of tipranavir at room temperature, and away from excess heat and moisture (not in the bathroom). Throw away any unused tipranavir capsules 60 days after you open the bottle Mark the date you open the bottle of tipranavir on the label so you will know when it is time to throw the remaining medication away. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Aptivus®