Reports of fatal and nonfatal intracranial hemorrhage among HIV-1 infected patients taking Aptivus (tipranavir) in combination antiretroviral therapy have prompted the manufacturer to issue new safety information.
Boehringer Ingelheim Pharmaceuticals Inc. has identified 14 reports of intracranial hemorrhage, including eight fatalities, in 6,840 HIV-1 infected individuals receiving Aptivus capsules coadministered with ritonavir (Norvir) (500 mg/200 mg twice daily).
Many of these patients who developed intracranial hemorrhage 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.
The Boxed Warnings, Indications and Usage, Warnings, Precautions, Adverse Reactions, and Animal Pharmacology sections of the label have been changed to reflect concerns about using the drug in patients at increased risk of bleeding.
No pattern of abnormal coagulation parameters has been identified in patients receiving Aptivus in general or preceding the development of intracranial hemorrhage. For this reason, routine measurement of coagulation parameters is not currently indicated for the management of patients taking the drug.
Aptivus/ritonavir therapy should be used cautiously in patients who may be at risk for increased bleeding from trauma, surgery, or other medical conditions, or who are taking other medications known to increase the risk of bleeding.
Of note, patients with advanced HIV-1 disease/AIDS have been observed to have an increased risk of intracranial hemorrhage. Investigations are ongoing to determine the role of Aptivus in the development of intracranial hemorrhage.
For more information or to report adverse reactions, contact Boehringer Ingelheim Pharmaceuticals by calling 800-542-6257 (option 4). Adverse reactions can also be reported to the Food and Drug Administration's MedWatch program by calling 800-332-1088.