Label Changes for:

Elspar (asparaginase)

July 2013

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

July 2013

WARNINGS AND PRECAUTIONS

Glucose Intolerence
  • Glucose intolerance can occur in patients receiving Elspar. In some cases, glucose intolerance is irreversible. Cases of diabetic ketoacidosis have been reported. Monitor serum glucose.
Neurotoxicity
  • Patients treated with Elspar, in a combination with other chemotherapeutic agents, have been reported to develop posterior reversible encephalopathy syndrome (PRES). PRES is a neurological disorder with clinical symptoms of headache, seizures, visual disturbances, altered mental status, and hypertension. Symptoms can be nonspecific, and diagnosis requires confirmation by radiological procedures. Interrupt use of Elspar if PRES is suspected or diagnosed. Control blood pressure promptly and monitor closely for seizure activity.
Risk of Medication Errors
  • Medication errors involving Elspar have occurred. In particular, different formulations and routes of administration (intramuscular and intravenous) of asparaginase have been interchanged inappropriately, which may result in subtherapeutic blood levels of asparaginase or additional toxicity related to an overdose. Confirm the formulation of asparaginase prior to administration. Do not interchange Elspar with Erwini

ADVERSE REACTIONS

Posterior Reversible Encephalopathy Syndrome (PRES)
  • Risk of Medication Errors
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