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Asparlas Approval History

Reviewed by J.Stewart BPharm. Last updated on Dec 30, 2018.

FDA Approved: Yes (First approved December 20, 2018)
Brand name: Asparlas
Generic name: calaspargase pegol-mknl
Dosage form: Injection
Company: Servier Pharmaceuticals LLC
Treatment for: Acute Lymphoblastic Leukemia

Asparlas (calaspargase pegol-mknl) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia.

Warnings and Precautions
Patients and caregivers should be advised of the following risks of Asparlas:

  • Hypersensitivity Patients should be aware of the possibility of serious allergic reactions, including anaphylaxis, and must remain under observation for one hour after the administration of each dose.
  • Pancreatitis Patients should seek immediate medical attention if they experience severe abdominal pain.
  • Thrombosis Patients should seek immediate medical attention if they experience severe headache, arm or leg swelling, shortness of breath, or chest pain.
  • Hemorrhage Patients should report any unusual bleeding or bruising to their physician.
  • Hepatotoxicity Patients should immediately report jaundice, severe nausea or vomiting, or easy bruising or bleeding to their physician.
  • Pregnancy and Lactation Female patients of reproductive potential should use effective contraception during treatment, and for at least 3 months after the last dose. The use of oral contraceptives is not recommended since there is a potential for an indirect interaction with Asparlas. Patients should notify their healthcare provider immediately in the event of a pregnancy or suspected pregnancy. Lactating women should not breastfeed during treatment, and for at least 3 months after the last dose.

Administration
Asparlas is administered intravenously, no more frequently than every 21 days. This provides for a longer interval between doses compared to other available pegaspargase products.

Adverse Reactions
The most common (incidence ≥10%) adverse reactions were elevated transaminase, bilirubin increased, pancreatitis and abnormal clotting studies.

Development History and FDA Approval Process for Asparlas

DateArticle
Dec 20, 2018Approval FDA Approves Asparlas (calaspargase pegol-mknl) for Acute Lymphoblastic Leukemia (ALL)
Feb 28, 2018U.S. FDA Accepts Shire's Biologics License Application for Calaspargase Pegol (Cal-PEG) for Acute Lymphoblastic Leukemia (ALL)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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