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

m (n=3,920), cases of

rash, some of which were severe, accompanied by myalgia, fever,

erythema, desquamation, and mucosal erosions were reported.

Discontinue and initiate appropriate treatment if severe skin rash

develops.

-- APTIVUS should be used with caution in patients with a known

sulfonamide allergy.

-- New onset diabetes mellitus, exacerbation of pre-existing diabetes

mellitus, hyperglycemia and increased bleeding (in patients with

hemophilia) have been reported in patients taking protease inhibitors.

A causal relationship between protease inhibitors and these events has

not been established.

-- Immune reconstitution syndrome has been reported in patients treated

with combination antiretroviral therapy, including APTIVUS/r.

-- Redistribution and/or accumulation of body fat have been observed in

patients receiving antiretroviral therapy. A causal relationship has

not been established.

-- Treatment with APTIVUS/r has resulted in large increases in total

cholesterol and triglycerides, which should be monitored prior to and

during APTIVUS/r therapy.

-- Because the potential for HIV cross-resistance among protease

inhibitors has not been fully explored in APTIVUS/r-treated patients,

it is unknown what effect therapy with APTIVUS will have on the

activity of subsequently administered protease inhibitors.

-- APTIVUS must be co-administered with 200 mg of ritonavir to exert its

therapeutic effect. Failure to correctly co-administer APTIVUS with

ritonavir will result in reduced plasma levels of tipranavir that will

be insufficient to achieve the desired antiviral effect and will alter

some drug interactions.

-- Please refer to the complete ritonavir prescribing information for a

description of ritonavir contraindications and
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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