No | Prevention and Management |
---|---|
1. Hypersensitivity reactions | |
 | It is advisable to pre-medicate every administration of Peg-ASP to reduce incidence and/or severity of hypersensitivity reactions |
In case of known grade 3–4 allergic reaction, further administrations of Peg-ASP are contraindicated and substitution with the Erwinia chrysanthemi formulation is indicated | |
In case of a clinically manifested hypersensitivity reaction, ASP activity should be measured to promptly identify any possible inactivation of the medication | |
2. Hepatic toxicity | |
 | BMI > 30 and pre-existing hepatic steatosis require a reduction in the dosage of Peg-ASP |
Development of grade 3–4 toxicity does not contraindicate subsequent administrations of Peg-ASP when grade toxicity ≤2 | |
L-carnitine is suggested in the event of hyperbilirubinemia | |
Concomitant therapy (chemotherapy, antibiotics, antifungals, steroids, other) plays a decisive role in increasing the risk of hepatotoxicity during Peg-ASP therapy | |
3. Metabolic toxicity | |
 | Hyperglycaemia should be corrected with insulin therapy and it is not an indication to discontinue or delay subsequent PegAsp administrations |
Hypoalbuminemia should be corrected | |
4. Hemorrhagic/thrombotic toxicity | |
 | Laboratory alterations of the hemocoagulative parameters in the absence of clinical signs of thrombosis or bleeding do not necessitate discontinuation or delay of Peg-ASP |
It is advisable to correct hypofibrinogenemia with cryoprecipitate | |
Replenishment of AT is advisable to maintain levels consistently above 60% | |
5. Peg asparaginase-associated pancreatitis | |
 | CTCAE grade 2 asymptomatic pancreatitis, once resolved, does not contraindicate subsequent administration of Peg-ASP |
Development of symptomatic pancreatitis or asymptomatic with CTCAE grade 3–4 amylase/lipase elevation contraindicates subsequent administrations even with a different ASP formulation |