Aptivus

Generic Name: tipranavir (tip RA na veer)
Brand Names: Aptivus

What is Aptivus?

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

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

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

Important information

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), flecainide (Tambocor), sildenafil (Revatio for pulmonary arterial hypertension), atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), simvastatin (Zocor, Simcor, Vytorin, Juvisync), propafenone (Rythmol), rifampin (Rifadin, Rifamate, Rimactane), quinidine (Quin-G), pimozide (Orap), midazolam (Versed), triazolam (Halcion), St. John's wort, or an ergot medicine such as Ergomar, Ergotrate, Cafergot, D.H.E. 45, Migranal, or Methergine.

Slideshow: Flashback: FDA Drug Approvals 2013

There are many other medicines that can interact with Aptivus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes prescription, over-the-counter, vitamin, and herbal products.

Aptivus is used in combination with a similar drug called ritonavir (Norvir). Some people taking this combination of medicines 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);

  • problems with walking, breathing, speech, swallowing, or eye movement;

  • sudden severe headache, confusion, severe drowsiness;

  • sudden numbness or weakness on one side of the body; or

  • nausea, upper stomach pain, itching, 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 (Quin-G);

  • 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.

FDA pregnancy category C. 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 Aptivus. 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 Aptivus. 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.

See also: Pregnancy and breastfeeding warnings (in more detail)

How should I take Aptivus?

Take Aptivus exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Aptivus is used in combination with a similar drug called ritonavir (Norvir). Take ritonavir at the same time you take Aptivus unless your doctor has told you otherwise.

Aptivus works best if you take it with food. Swallow the capsule whole. Do not break or chew it.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

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 oral 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.

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?

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

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 Aptivus 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);

  • problems with walking, breathing, speech, swallowing, or eye movement;

  • sudden severe headache, confusion, severe drowsiness;

  • sudden numbness or weakness on one side of the body; or

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

Stop taking Aptivus 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;

  • rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

  • swelling in your neck or throat (enlarged thyroid);

  • muscle weakness, tired feeling, joint or muscle pain, weakness or prickly feeling in your fingers or toes;

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

  • signs of a new infection, such as fever or chills, cough, skin lesions, or flu symptoms.

Less serious Aptivus side effects may include:

  • mild nausea, vomiting, stomach pain;

  • mild headache 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?

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

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • colchicine (Colcrys);

  • 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);

  • rosuvastatin (Crestor);

  • salmeterol (Advair, Serevent);

  • vitamin E (especially at high doses);

  • an antidepressant such as desipramine (Norpramin), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), trazodone (Desyrel), and others;

  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan);

  • 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), and others;

  • medicines to treat erectile dysfunction, such as Viagra, Cialis or Levitra;

  • other HIV /AIDS medicine such as atazanavir (Reyataz), enfuvirtide (Fuzeon), fosamprenavir (Lexiva), lopinavir (Kaletra), raltegravir (Isentress), 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 drugs that can interact with Aptivus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Aptivus.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Aptivus only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 9.01. Revision Date: 2012-04-15, 9:18:05 PM.

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