Tipranavir, Oral

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KEY POINTS

• This medicine is taken by mouth, along with other medicines, to treat HIV-1 infection. Take all medicines exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• You may develop diabetes when you take this medicine. If you already have diabetes, it may get worse. This medicine may cause serious or life-threatening side effects, including liver damage or bleeding into the brain, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking this medicine with certain other medicines may be life-threatening. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: protease inhibitor (anti-HIV)

Generic and brand names: tipranavir, oral; Aptivus

What is this medicine used for?

This medicine is taken by mouth to treat HIV-1 infection. It must be taken along with ritonavir (Norvir). It may also be taken with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Hemophilia or bleeding problems
• High cholesterol or high triglycerides
• Liver disease, including hepatitis B or hepatitis C
• Problems with alcohol abuse

Tell your provider if you have recently had a head injury or brain surgery. You may be at higher risk for bleeding in the brain.

Taking this medicine with certain other medicines may be life-threatening. Tell your provider about ALL of the medicines and natural remedies you take, especially antibiotics, sedatives, St. John's Wort, and medicines to treat cholesterol, prostate problems, migraines, mental disorders, or heart rhythm problems.

Males: If you take avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) while you are taking this medicine, you may be at increased risk of side effects such as low blood pressure, vision changes or priapism (prolonged and painful erections).

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine.

Hormonal birth control may be less effective while you are taking this medicine. Talk to your healthcare provider if you need birth control.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not change your dosage on your own. Do not stop taking this medicine without your healthcare provider's approval. If you are not sure of how much and how often to take this medicine, ask your healthcare provider or pharmacist to explain.

Do not run out of this medicine. The amount of HIV-1 in your blood may increase and become harder to treat if the medicine is stopped for even a short time.

Take this medicine with other medicines your healthcare provider prescribes. Follow your healthcare provider's instructions exactly.

Check with your healthcare provider before using this medicine in children under 2 years old.

This medicine comes in capsule form and liquid form. Swallow the capsules whole. Do not open the capsules. Take this medicine at the same time that you take ritonavir.

If you take tipranavir with ritonavir capsules or oral solution, this medicine may be taken with or without food. If you take tipranavir with ritonavir tablets, this medicine must be taken with meals.

If you take the liquid form of this medicine, use the measuring device given to you by the pharmacist to make sure you get the right dose. The average household teaspoon may not hold the right amount of liquid.

Ask your healthcare provider or pharmacist about anything you do not understand.

What if I miss a dose?

Do not miss any doses. If you do miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Taking ritonavir with this medicine may cause serious or life-threatening side effects, including liver damage or bleeding into the brain. Contact your healthcare provider right away if you have:

• Any unusual bruising or bleeding
• A sudden or severe headache
• Confusion
• Problems with vision, speech, or walking
• Unusual tiredness or weakness
• Unexplained loss of appetite, nausea or vomiting
• Dark urine
• Light-colored bowel movements
• Yellowing of your eyes or skin

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Your immune system may get stronger and start to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting this medicine.

This medicine is not a cure for HIV infection. You may continue to get illnesses associated with advanced HIV infection, including other infections. There is no evidence that this medicine will reduce the risk of spreading HIV through sexual contact or blood contamination.

Do not give this medicine to other people, even if they have the same symptoms you have.

Your body fat may change as a result of taking this medicine. Talk with your healthcare provider about this.

Some forms of this medicine contain alcohol. Do not drink alcohol unless your healthcare provider approves.

This medicine may make your skin more sensitive to the sun and may cause you to sunburn more easily. While you are taking this medicine, avoid long exposure to the sun. While you are in the sun, wear protective clothing and sunscreen lotion until you know how you will react to the sun. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

This medicine may increase the total cholesterol and triglyceride levels in your blood. You will need tests to check these levels regularly. Keep all appointments for tests.

You may bleed more easily when taking this medicine. Be careful when shaving or brushing your teeth. Report any unusual bruising or bleeding to your healthcare provider.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

You may develop diabetes when you take this medicine. Talk with your healthcare provider about this.

If you have diabetes: Your dosage of insulin or medicines taken by mouth for diabetes may need to be changed. If you are controlling your diabetes with diet and exercise, you may need to start taking medicine. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider about any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Severe nausea, vomiting, and stomach pain; unusual bruising or bleeding; severe diarrhea; yellowing of eyes or skin; tingling or numbness in the hands or feet; loss of appetite; light-colored bowel movements; dark urine; increased hunger, thirst, or urination; confusion; joint pain or stiffness; severe itching; muscle aches; fever; redness, blisters, or peeling of the skin; unusual tiredness or weakness.

Other: Mild nausea, vomiting, diarrhea, weight loss, stomach pain, cough, mild headache, tiredness, mild skin rash, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Allergy, cold, or cough medicines that contain dextromethorphan (Delsym, Mucinex, Robitussin DM)
• Alpha blockers such as alfuzosin (Uroxatral), silodosin (Rapaflo), and tamsulosin (Flomax)
• Alprazolam (Xanax)
• Anagrelide (Agrylin)
• Antacids (Take antacids at least 1 hour before or 2 hours after you take this medicine.)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, lidocaine (Lidoderm, Xylocaine), mexiletine, procainamide, propafenone (Rythmol), and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), metronidazole, rifabutin (Mycobutin), rifampin (Rifadin), and rifapentine (Priftin)
• Antidepressants such as amitriptyline, desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), protriptyline, sertraline (Zoloft), trazodone, trimipramine (Surmontil), venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), cariprazine (Vraylar), clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clonazepam (Klonopin), ethosuximide (Zarontin), fosphenytoin (Cerebyx), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and valproic acid (Depacon, Depakene, Depakote)
• Beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol), nebivolol (Bystolic), and timolol
• Bladder control medicines such as fesoterodine (Toviaz) and tolterodine (Detrol)
• Bromocriptine (Cycloset, Parlodel)
• Buprenorphine (Buprenex, Butrans) and buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv)
• Calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as crizotinib (Xalkori), docetaxel (Docefrez, Taxotere), doxorubicin (Doxil), enzalutamide (Xtandi), imatinib (Gleevec), irinotecan (Camptosar), paclitaxel (Abraxane, Taxol), tamoxifen, vinblastine, and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Colchicine (Colcrys)
• Corticosteroids such as dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), and prednisone (Prednisone Intensol)
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as exenatide (Bydureon, Byetta), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), saxagliptin (Onglyza), and tolbutamide
• Didanosine (Videx) (Take didanosine at least 2 hours before or 2 hours after you take this medicine.)
• Digoxin (Lanoxin)
• Disulfiram (Antabuse)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Hepatitis C medicines such as elbasvir/grazoprevir (Zepatier), ledipasvir/sofosbuvir (Harvoni), simeprevir (Olysio), and sofosbuvir (Sovaldi)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Liraglutide (Saxenda, Victoza)
• Malaria medicines such as chloroquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), dexlansoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (AcipHex), and ranitidine (Zantac)
• Medicines to treat breathing or lung problems such as budesonide (Entocort, Rhinocort, Uceris), fluticasone (Flonase, Flovent, Veramyst), fluticasone/salmeterol (Advair), mometasone (Asmanex, Nasonex), salmeterol (Serevent), and theophylline
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), aspirin, clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), vorapaxar (Zontivity), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer), sildenafil (Revatio), and tadalafil (Adcirca)
• Methylergonovine
• Midazolam (Versed)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• Naloxegol (Movantik)
• Natural remedies such as alfalfa, anise, bilberry, bladderwrack, bromelain, cat's claw, celery, chamomile, cranberry, dong quai, evening primrose, fenugreek, feverfew, fish oil, garlic, ginger, ginkgo biloba, ginseng, green tea, horse chestnut, licorice, red clover, red yeast rice, and St. John's wort
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), ondansetron (Zofran), and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other HIV medicines such as abacavir (Ziagen), atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), enfuvirtide (Fuzeon), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), raltegravir (Isentress), ritonavir (Norvir), saquinavir (Invirase), tenofovir (Viread), and zidovudine (Retrovir)
• Pain medicines such as codeine, meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Ranolazine (Ranexa)
• Stimulants such as atomoxetine (Strattera), methamphetamine (Desoxyn), and modafinil (Provigil)
• Tetrabenazine (Xenazine)
• Triazolam (Halcion)
• Vitamin E

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store capsules in the refrigerator. After opening the container, you may keep the capsules at room temperature. Store the oral solution at room temperature. Do not refrigerate or freeze the oral solution. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

Use the medicine within 60 days after opening the container.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.