Asparlas FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 26, 2019.
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 timeline for Asparlas
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
