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U.S. Department of Health and Human Services

Safety

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Aptivus (tipranavir)

Audience: Infectious disease specialists, pharmacists, and other healthcare professionals
[Posted 06/30/2006] Boehringer Ingelheim and FDA informed healthcare professionals of important new safety information for Aptivus (tipranavir) capsules, co-administered with ritonavir (500mg/200mg), that includes an addition to the drug's Black Box Warning regarding reports of both fatal and non-fatal intracranial hemorrhage (ICH). Boehringer Ingelheim identified 14 reports of intracranial hemorrhage events, including 8 fatalities, in 6,840 HIV-1 infected individuals receiving Aptivus capsules in combination antiretroviral therapy in clinical trials.

Many of the patients experiencing ICH in the Aptivus clinical development program had other medical conditions (CNS lesions, head trauma, recent neurosurgery, coagulopathy, hypertension or alcohol abuse) or were receiving concomitant medications, including anticoagulants and antiplatelet agents, that may have caused or contributed to these events.

No pattern of abnormal coagulation parameters were observed in patients receiving Aptivus in general, or preceding the development of ICH. Routine measurement of coagulation parameters is not currently indicated in the management of patients on Aptivus. An increased risk of ICH was previously observed in patients with advanced HIV-1 disease/AIDS. Further investigations are ongoing to assess the role of Aptivus in ICH.

[June 30, 2006 – Revised Prescribing Information – Boehringer Ingelheim]
[June 30, 2006 – Dear Healthcare Provider Letter – Boehringer Ingelheim]