Aptivus

DRUG DESCRIPTION

APTIVUS (tipranavir) is a protease inhibitor of HIV-1 belonging to the class of 4-hydroxy-5,6-dihydro-2-pyrone sulfonamides. 12

The chemical name of tipranavir is 2-Pyridinesulfonamide, N-[3-[(1R)-1-[(6R)-5,6-dihydro-4-hydroxy-2-oxo-6-(2-phenylethyl)-6-propyl-2H-pyran-3yl]propyl]phenyl]-5-(trifluoromethyl). It has a molecular formula of C31H33F3N2O5S and a molecular weight of 602.7. Tipranavir has the following structural formula and is a single stereoisomer with the 1R, 6R configuration.

APTIVUS® (tipranavir) Structural Formula Illustration

Tipranavir is a white to off-white to slightly yellow solid. It is freely soluble in dehydrated alcohol and propylene glycol, and insoluble in aqueous buffer at pH 7.5.

APTIVUS (tipranavir) soft gelatin capsules are for oral administration. Each capsule contains 250 mg tipranavir. The major inactive ingredients in the capsule are dehydrated alcohol (7% w/w or 0.1 g per capsule), polyoxyl 35 castor oil, propylene glycol, mono/diglycerides of caprylic/capric acid and gelatin.

APTIVUS (tipranavir) oral solution is available in a strength of 100 mg/mL of tipranavir. APTIVUS (tipranavir) oral solution is a yellow, viscous clear liquid with a buttermint-butter toffee flavor. The major inactive ingredients in the oral solution are polyethylene glycol 400, vitamin E polyethylene glycol succinate (TPGS), purified water, and propylene glycol. Each milliliter of APTIVUS (tipranavir) oral solution contains 116 IU of vitamin E, and when taken at the recommended maximum dose of 500 mg/200 mg tipranavir/ritonavir BID results in a daily dose of 1160 IU.

What are the possible side effects of tipranavir (Aptivus)?

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 tipranavir 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,...

Read All Potential Side Effects and See Pictures of Aptivus »

What are the precautions when taking tipranavir (Aptivus)?

Before taking tipranavir, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (coronary artery disease, heart attack), blood or bleeding disorders (e.g., hemophilia), other conditions causing an increased risk of bleeding (e.g., injury, surgery), high blood fat levels (cholesterol/triglyceride), other viral infections (chronic hepatitis B or hepatitis C), liver disease (including abnormal liver function tests).

This drug may make you dizzy or drowsy....

Read All Potential Precautions of Aptivus »


Aptivus Consumer (continued)

SIDE EFFECTS: See also Warning and Drug Interactions sections.

Diarrhea, nausea, drowsiness, dizziness, headache or vomiting may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: depression, tingling of hands/feet, increased thirst, signs of infection (e.g., fever, persistent sore throat), change in the amount of urine.

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Tipranavir can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop a rash. Taking estrogen (in birth control or hormone therapy) may increase your risk of developing this rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking tipranavir, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (coronary artery disease, heart attack), blood or bleeding disorders (e.g., hemophilia), other conditions causing an increased risk of bleeding (e.g., injury, surgery), high blood fat levels (cholesterol/triglyceride), other viral infections (chronic hepatitis B or hepatitis C), liver disease (including abnormal liver function tests).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug may infrequently make your blood sugar rise, an effect that can cause or worsen diabetes. High blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar such as unusual increased thirst/urination. If you already have diabetes, check your blood sugar regularly, and tell your doctor if you notice unusually high blood sugar levels.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Aptivus Patient Information Including Side Effects

Brand Names: Aptivus

Generic Name: tipranavir (Pronunciation: tip RA na veer)

  • What is tipranavir (Aptivus)?
  • What are the possible side effects of tipranavir (Aptivus)?
  • What is the most important information I should know about tipranavir (Aptivus)?
  • What should I discuss with my health care provider before taking tipranavir (Aptivus)?
  • How should I take tipranavir (Aptivus)?
  • What happens if I miss a dose (Aptivus)?
  • What happens if I overdose (Aptivus)?
  • What should I avoid while taking tipranavir (Aptivus)?
  • What other drugs will affect tipranavir (Aptivus)?
  • Where can I get more information?

What is tipranavir (Aptivus)?

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

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

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

What are the possible side effects of tipranavir (Aptivus)?

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 tipranavir 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).

Stop taking tipranavir 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;
  • easy bruising or bleeding; or
  • signs of a new infection, such as fever or chills, cough, skin lesions, or flu symptoms.

Less serious 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 is the most important information I should know about tipranavir (Aptivus)?

Do not use this medication 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 tipranavir 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 tipranavir. 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.

Tipranavir 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).
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