Pegaspargase (1 brand name, 1 dosage form, 0 routes)
Available dosage forms: VIAL.
Brand Names
- ONCASPAR
Contraindications
ONCASPAR is contraindicated in patients with a: History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients [see Warnings and Precautions (5.1)]. History of serious thrombosis with prior L-asparaginase therapy [see Warnings and Precautions (5.2)]. History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy [see Warnings and Precautions (5.3)]. History of serious hemorrhagic events with prior L-asparaginase therapy [see Warnings and Precautions (5.5)]. Severe hepatic impairment [see Warnings and Precautions (5.6)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and serious hypersensitivity reactions [see Warnings and Precautions (5.1)] Thrombosis [see Warnings and Precautions (5.2)] Pancreatitis [see Warnings and Precautions (5.3)] Glucose intolerance [see Warnings and Precautions (5.4)] Hemorrhage [see Warnings and Precautions (5.5)] Hepatotoxicity, including VOD [see Warnings and Precautions (5.6)]
Mechanism of Action
L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of ONCASPAR is thought to be based on the killing of leukemic cells due to depletion of plasma asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize asparagine, and therefore depend on an exogenous source of asparagine for survival.
Overdosage
Three patients received 10,000 International Units/m2 of ONCASPAR as an intravenous infusion. One patient experienced a slight increase in liver enzymes. A second patient developed a rash 10 minutes after the start of the infusion, which was controlled with the administration of an antihistamine and by slowing down the infusion rate. A third patient did not experience any adverse reactions. There is no specific antidote for ONCASPAR overdosage. In case of overdose, monitor patients closely for signs and symptoms of adverse reactions, and appropriately manage with symptomatic and supportive treatment.