Oncaspar

Pegaspargase

Component of antineoplastic combination therapy in acute lymphoblastic leukaemia in paed patients from birth to 18 yr, & adults.

IM/IV Adult >21 yr 2,000 u/m² every 14 days. Paed patient & adult ≤21 yr w/ BSA ≥0.6 m² 2,500 u/m² every 14 days. Childn w/ BSA <0.6 m² 82.5 u/kg every 14 days.

Hypersensitivity. Severe hepatic impairment (bilirubin >3 times ULN; transaminases >10 times ULN). History of serious thrombosis w/ prior L-asparaginase therapy. History of pancreatitis, including pancreatitis related to previous L-asparaginase therapy. History of serious haemorrhagic events w/ prior L-asparaginase therapy.

Premedicate w/ paracetamol, an H₁ receptor blocker (eg, diphenhydramine), & an H₂ receptor blocker (eg, famotidine) 30-60 min prior to Oncaspar administration. Presence of anti-asparaginase Ab. Risk of hypersensitivity reactions; pancreatitis including haemorrhagic or necrotising pancreatitis; serious thrombotic events, including sagittal sinus thrombosis; increased prothrombin time, increased partial thromboplastin time, & hypofibrinogenaemia; hyperbilirubinaemia; CNS signs & symptoms manifesting as somnolence, confusion, convulsions; myelosuppression. Increased risk of infection due to myelosuppression. Risk of osteonecrosis in the presence of glucocorticoids. Risk of severe hepatic toxicity w/ other hepatotoxic products. Combination therapy w/ Oncaspar can result in CNS toxicity. Risk of hyperammonaemia following IV administration of asparaginase. Major influence on the ability to drive & use machines. Effective non-oral method of contraception must be used during treatment & for at least 6 mth after Oncaspar discontinuation. Should not be used during pregnancy unless required by clinical conditions of the woman. Discontinue breast-feeding during treatment & do not restart until after treatment discontinuation. Limited data available in elderly >65 yr.

Febrile neutropenia; hypersensitivity, urticaria, anaphylactic reaction; decreased appetite, hyperglycaemia; embolism; pancreatitis, diarrhoea, abdominal pain, nausea; rash; decreased wt, hypoalbuminaemia, increased ALT/AST, hypertriglyceridaemia, decreased blood fibrinogen, increased lipase, increased amylase, prolonged aPTT, increased blood bilirubin. Infections, sepsis; anaemia, coagulopathy; hyperlipidaemia, hypercholesterolaemia; seizure, peripheral motor neuropathy, syncope; thrombosis; hypoxia; vomiting, stomatitis, ascites; hepatotoxicity, fatty liver; pain in extremities; prolonged prothrombin time, increased INR, hypokalaemia, increased blood cholesterol, hypofibrinogenaemia, increased γ-glutamyl transferase.

Increased toxicity of other medicinal products that are protein-bound. Can disturb the mechanism of action of other substances which require cell division for effect eg, MTX. Prior administration of MTX & cytarabine can increase the action of pegaspargase synergistically. If MTX & cytarabine are given subsequently, effect of pegaspargase can be weakened antagonistically. Can interfere w/ metabolism & clearance of other medicinal products. Caution when co-administered w/ anticoagulants eg, coumarin, heparin, dipyridamole, ASA or NSAIDs; chemotherapy regimen including MTX, daunorubicin & corticosteroids. More pronounced alteration in coagulation parameters when given at the same time w/ glucocorticoids (eg, prednisone). Potential increase in exposure of glucocorticoids, resulting to increased risk of osteonecrosis in childn & adolescents. Immediately preceding or simultaneous treatment w/ vincristine can increase the toxicity of pegaspargase. Administration of Oncaspar before vincristine may increase the neurotoxicity of vincristine. An indirect interaction cannot be ruled out between pegaspargase & OCs. Increased risk of severe infections w/ simultaneous vaccination w/ live vaccines.

Cytotoxic Chemotherapy

L01XX24 - pegaspargase ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.

P₁S₁S₃