Aptivus

Generic Name: tipranavir (tip RA na veer)

What is Aptivus?

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

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

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

Important information about Aptivus

Do not use Aptivus if you are allergic to tipranavir or ritonavir (Norvir), 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: amiodarone (Cordarone, Pacerone), bepridil (Vascor), cisapride (Propulsid), flecainide (Tambocor), lovastatin (Mevacor), simvastatin (Zocor, Vytorin), propafenone (Rythmol), rifampin (Rifadin, Rifamate, Rimactane), quinidine (Quinaglute, Quinidex), 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.

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 vitamins, minerals, herbal products, and drugs prescribed by other doctors.

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);

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).

Before taking Aptivus

Do not use Aptivus 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 Aptivus.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using Aptivus, 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 Aptivus 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. 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. You should not breast-feed while you are using Aptivus. 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.

How should I take Aptivus?

Take Aptivus exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you also take ritonavir, take it 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 Aptivus is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using Aptivus.

It is important to use Aptivus regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. 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 for the first time, you may store the capsules at room temperature. Throw away any capsules 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. 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 to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Aptivus?

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

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking Aptivus 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.

Aptivus 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 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);

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).

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 Aptivus 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.

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);

disulfiram (Antabuse);

enfuvirtide (Fuseon);

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) and others;

medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

other HIV /AIDS medicine such as 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 Aptivus. 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.