Asparlas FDA 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.
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.
The most common (incidence ≥10%) adverse reactions were elevated transaminase, bilirubin increased, pancreatitis and abnormal clotting studies.
Development Timeline for Asparlas
|Dec 20, 2018||FDA Approves Asparlas (calaspargase pegol-mknl) for Acute Lymphoblastic Leukemia (ALL)|
|Feb 28, 2018||U.S. FDA Accepts Shire's Biologics License Application for Calaspargase Pegol (Cal-PEG) for Acute Lymphoblastic Leukemia (ALL)|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.