Brand Name

Asparlas

Generic Name
Calaspargase Pegol
View Brand Information
FDA approval date: September 27, 2019
Classification: Asparagine-specific Enzyme
Form: Injection

What is Asparlas (Calaspargase Pegol)?

ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
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Brand Information

asparlas (calaspargase pegol)
1DOSAGE FORMS AND STRENGTHS
Injection: 3,750 units/5 mL (750 units/mL) clear, colorless solution in a single-dose vial.
2CONTRAINDICATIONS
ASPARLAS is contraindicated in patients with:
  • History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy
  • History of serious pancreatitis during previous L-asparaginase therapy
  • History of serious thrombosis during previous L-asparaginase therapy
  • History of serious hemorrhagic events during previous L-asparaginase therapy
  • Severe hepatic impairment
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Hypersensitivity
  • Pancreatitis
  • Thrombosis
  • Hemorrhage
  • Hepatotoxicity, including VOD
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of ASPARLAS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hepatic: Veno-occlusive disease
4DESCRIPTION
Calaspargase pegol-mknl contains an asparagine specific enzyme derived from
L-asparaginase is a tetrameric enzyme that is produced endogenously by
ASPARLAS injection is supplied as a clear, colorless, preservative-free, isotonic sterile solution in phosphate-buffered saline, pH 7.3 that requires dilution prior to intravenous infusion. Each vial of ASPARLAS contains 3,750 units in 5 mL of solution. Each milliliter contains 750 units of calaspargase pegol-mknl; dibasic sodium phosphate, USP (5.58 mg); monobasic sodium phosphate, USP (1.20 mg); and sodium chloride, USP (8.50 mg) in water for injection, USP.
5HOW SUPPLIED/STORAGE AND HANDLING
ASPARLAS (calaspargase pegol-mknl) injection is supplied as a clear, colorless, preservative-free sterile solution in a single-dose vial containing 3,750 units of calaspargase pegol-mknl per 5 mL solution (NDC 72694-515-01).
6PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton
NDC 72694-515-01
ASPARLAS
Injection
3750 units/5 mL
For Intravenous Infusion
One single-dose vial.
Must dilute before use.
Rx ONLY
SERVIER
PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton