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Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
Date:10/5/2007

propionate, inhaled or intranasally administered, unless the potential

benefit to the patient outweighs the risk.

-- Caution should be used when prescribing sildenafil, tadalafil, and

vardenafil with APTIVUS/r because concentrations of these drugs may

increase.

-- Caution should be used when prescribing carbamazepine, phenobarbital

and/or phenytoin. APTIVUS may be less effective due to decreased

tipranavir plasma concentrations.

-- Caution should be used when prescribing valproic acid. Valproic acid

may be less effective due to decreased valproic acid plasma

concentrations.

-- Use caution when prescribing APTIVUS/r in patients who may be at risk

of increased bleeding from trauma, surgery or other medical conditions,

or who are receiving medications known to increase the risk of bleeding

such as antiplatelet agents and anticoagulants, or who are taking

supplemental high doses of vitamin E. In in vitro experiments,

tipranavir was observed to inhibit human platelet aggregation at levels

consistent with exposures observed in patients receiving APTIVUS/r. In

rats, co-administration with vitamin E increased the bleeding effects

of tipranavir.

-- Rash, including urticarial rash, maculopapular rash, and possible

photosensitivity, has been reported in patients receiving APTIVUS/r. In

some, rash was accompanied by joint pain or stiffness, throat

tightness, or generalized pruritus. In controlled clinical trials, rash

(all grades, all causality) was observed in 10% of females and in 8% of

males receiving APTIVUS/r through 48 weeks of treatment. The median

time to onset of rash was 53 days and the median duration of rash was

22 days. The discontinuation rate for rash in clinical trials was

0.5%. In an uncontrolled compassionate use progra
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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