fatalities. Extra vigilance is warranted in patients with chronic
hepatitis B or hepatitis C co-infection, as these patients have an
increased risk of hepatotoxicity.
-- Both fatal and non-fatal intracranial hemorrhage (ICH).
The most commonly reported adverse events in patients taking APTIVUS/r are diarrhea, nausea, fever, vomiting, fatigue, headache and abdominal pain. The most common laboratory abnormalities are elevated liver enzymes (AST/ALT) and triglycerides.
"For more than a decade, Boehringer Ingelheim has been at the forefront of developing innovative therapies for HIV patients. The full approval of APTIVUS further demonstrates our commitment to HIV/AIDS," said Dr. Thor Voigt, Senior Vice President, Medicine and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We have developed a robust clinical trial program around APTIVUS. In addition to RESIST, clinical trials for treating HIV are in progress in racially, ethnically and gender diverse patients and hepatitis co-infected patients. A trial comparing the efficacy and safety of APTIVUS/r versus darunavir/r, both as part of combination antiretroviral therapy, is also planned."
Important Safety Information for APTIVUS
-- APTIVUS/r has been associated with reports of clinical hepatitis and
hepatic decompensation, including some fatalities. Extra vigilance is
warranted in patients with chronic hepatitis B or hepatitis C co-
infection, as these patients have an increased risk of hepatotoxicity.
Patients with signs or symptoms of clinical hepatitis should
discontinue APTIVUS/r treatment and seek medical evaluation.
-- APTIVUS/r has been associated with reports of both fatal and non-fatal
intracranial hemorrhage (ICH).
-- All patients should be followed closely with clinical and laboratory
|SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.|
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