d tests to monitor your blood fat (triglycerides and cholesterol) during treatment with APTIVUS. Some patients taking APTIVUS have large increases in triglycerides and cholesterol. The long-term chance of having a heart attack or stroke due to increases in blood fats caused by APTIVUS is not known at this time.
changes in body fat. These changes have happened in patients taking APTIVUS and other anti-HIV medicines. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.
The most common side effects of APTIVUS include diarrhea, nausea, fever, vomiting, tiredness, headache, and stomach pain. Rash was seen more frequently in children.
It may be hard to tell the difference between side effects caused by APTIVUS, by the other medicines you are also taking, or by the complications of HIV infection. For this reason it is very important that you tell your healthcare professional about any changes in your health. You should report any new or continuing symptoms to your healthcare professional right away. Your healthcare professional may be able to help you manage these side effects.
The list of side effects is not complete. Ask your healthcare professional or pharmacist for more information.
How should I store APTIVUS?
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Store APTIVUS capsules in a refrigerator at approximately 36°F to 46°F (2°C to 8°C). Once the bottle is opened, the contents must be used within 60 days. Patients may take the bottle with them for use away from home so long as the bottle remains at a temperature of approximately 59°F to 86°F (15°C to 30°C). You can write the date of opening the bottle on the label. Do not use after the expiration date written on the bottle.
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Store APTIVUS oral solution at approximately 59°F to 86°F (15°C to 30°C). Do not refrigerate or freeze. The solution must be used within 60 days after first opening the bottle.
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Keep APTIVUS and all medicines out of the reach of children.
General advice about APTIVUS
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use APTIVUS for a condition for which it was not prescribed. Do not give APTIVUS to other people, even if they have the same condition you have. It may harm them.
This leaflet summarizes the most important information about APTIVUS. If you would like more information, talk with your healthcare professional. You can ask your pharmacist or healthcare professional for information about APTIVUS that is written for health professionals.
For additional information, you may also call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or 1-800-459-9906 TTY.
What are the ingredients in APTIVUS?
Capsules:
Active Ingredient: tipranavir
Major Inactive Ingredients: dehydrated alcohol, polyoxyl 35 castor oil, propylene glycol, mono/diglycerides of caprylic/capric acid and gelatin.
Oral Solution:
Active Ingredient: tipranavir
Major Inactive Ingredients: polyethylene glycol 400, vitamin E polyethylene glycol succinate, purified water, and propylene glycol.
Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
APTIVUS® is a regist
