Asparaginase (Erwinia)

(a SPEAR a ji nase er WIN i ah)

• Erwinia chrysanthemi
• Asparaginase Erwinia chrysanthemi
• Crisantaspase
• L-asparaginase (Erwinia)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intramuscular:

Erwinaze: 10,000 units (1 ea)

Concerns related to adverse effects:

• Glucose intolerance: In clinical trials, 5% of patients experienced glucose intolerance; may be irreversible. Monitor glucose levels (baseline and periodic) during treatment. May require insulin administration.

• Hypersensitivity reactions: Serious hypersensitivity reactions (grade 3 and 4), including anaphylaxis, have occurred in 5% of patients in clinical trials. Immediate treatment for hypersensitivity reactions should be available during treatment. Discontinue for serious hypersensitivity reactions (and administer appropriate treatment).

• Pancreatitis: Pancreatitis has been reported in 4% of patients in clinical trials. Promptly evaluate with symptoms suggestive of pancreatitis. For mild pancreatitis, withhold treatment until signs and symptoms subside and amylase levels return to normal; may resume after resolution. Discontinue for severe or hemorrhagic pancreatitis characterized by abdominal pain >72 hours and amylase ≥2 x ULN. Further use is contraindicated if severe pancreatitis is diagnosed.

• Thrombosis and hemorrhage: Serious thrombotic events, including sagittal sinus thrombosis and pulmonary embolism, have been reported with asparaginase formulations. Discontinue for thrombotic event, may resume treatment after resolution. Decreases in fibrinogen, protein C activity, protein S activity, and antithrombin III have been noted following a 2-week treatment course administered intramuscularly. Discontinue for hemorrhagic event; may resume treatment after resolution (contraindicated with history of serious thrombosis or hemorrhagic event with prior asparaginase treatment).

Other warnings/precautions:

• Medication error prevention: Do not interchange Erwinia asparaginase for E. coli asparaginase or pegaspargase; ensure the proper formulation, route of administration, and dose prior to administration.

Adverse events were observed in animal reproduction studies.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, nausea, vomiting, injection site irritation, mouth sores, or abdominal pain. Have patient report immediately to prescriber signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), angina, coughing up blood, shortness of breath, severe headache, bruising, or bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.