Wednesday, June 18, 2008

Increased risk of marked hepatic enzyme elevations in patients taking SOMAVERT® (pegvisomant) in combination with a somatostatin analogue

From Health Canada:
In a global post-marketing combination study with a somatostatin analogue, one out of 25 patients in the pegvisomant group and 1 out of 27 in the octreotide acetate group had transaminases greater than three or more times the upper limit of normal (ULN). Three patients out of 26 treated with the combination were found to have serum concentrations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ranging from 13 to 45 times the ULN within 3 months of starting this treatment. Two of these patients received supratherapeutic doses of octreotide acetate (30 mg every 2 weeks) combined with a normal dose of SOMAVERT (10 mg daily). All three patients completely recovered after discontinuation of treatment.
For Health Professionals
For the Public

No comments: