Asparlas Disease Interactions

Cases of pancreatitis have been reported in clinical trials with calaspargase pegol with an incidence as high as 16%. Caution is advised if used in patients with a history of pancreatitis. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to identify early signs of pancreatic inflammation. Discontinue calaspargase pegol if pancreatitis is suspected; if pancreatitis is confirmed, do not resume treatment. Calaspargase pegol is contraindicated in patients with a history of pancreatitis due to any previous asparaginase therapy.

Hemorrhage associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia have been reported in patients receiving calaspargase pegol. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, fibrinogen. Consider appropriate replacement therapy in any patients with severe or symptomatic coagulopathy. The use of calaspargase pegol is contraindicated in patients with any history of serious hemorrhagic events during a previous L-asparaginase therapy.

The use of calaspargase pegol is contraindicated in patients with severe hepatic impairment. Caution and monitoring is advised in patients with liver impairment as hepatotoxicity and abnormal liver function, including elevations of transaminase, bilirubin (direct and indirect), reduced serum albumin, and plasma fibrinogen can occur. Evaluate bilirubin and transaminases at least weekly, during cycles of treatment that include calaspargase pegol, through 6 weeks after the last dose. In the event of serious liver toxicity, discontinue treatment and provide supportive care.