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Admagin 5000/10,000 IU Lyophilized Injection

Generic Name– L-Asparaginase

Drug class- Antineoplastic and immunomodulating agent
Description– L-asparaginase is an enzyme, used for treatment of acute lymphoblastic leukemia and other blood related cancers. It catalyzes the degradation of asparagine, an essential amino acid for leukemic cells into aspartate and ammonia. Degradation of L-asparagine, results in nutritional deficiencies, inhibition of protein synthesis and apoptosis of lymphoblastic cells.1

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Product Description

Admagin 5000/10,000 (L-asparaginase for injection) is a lyophilized powder containing drug concentrate, available in single use glass vial.

Additional Information

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Indications and Usage

• L-asparaginase is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia

Limitations of Use
• L-asparaginase shows limited efficacy in treatment of solid tumors3

Dosage and Administration

• Recommended dose in acute lymphoblastic leukemia: 6,000 IU/m2 intramuscularly (IM) or intravenously (IV) three times a week
• For intramuscular administration: Reconstitute in 2 ml and limit the volume at a single injection site to 2 ml; if greater than 2 ml, use multiple injection sites
• For intravenous administration, reconstitute in 5ml, and give over ≥ 30 min through side arm of an infusion of sodium chloride injection or dextrose Injection 5% (D5W)
• Use reconstituted volume within eight hours.

Dosage Form and Strength
• Supplied as single use vial containing lyophilized powder for intramuscular and intravenous infusion
• Available as 5000IU and 10,000IU for injection

Clinical Efficacy

• Effective and well tolerated in induction, and subsequent phases of various multiagent chemotherapeutic regimens used in acute lymphoblastic leukemia5
• Significantly improves treatment outcomes in children and adults with acute lymphoblastic leukemia6
• Increases percentage of patients who achieved complete remission rate as compared to patients who received vincristine and prednisone7
• Shows greater probability of disease-free survival (DFS) when compared with those receiving treatment without asparaginase.

Adverse Reactions
• The most common adverse events which may occur after administration of L-aspararginase are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia,and elevated transaminases

Contraindications
• It is contraindicated in patients with serious allergic reactions to L-asparaginase r or other Escherichia coli-derived L-asparaginases
• It is not recommended in patients with serious thrombosis, pancreatitis and hemorrhagic events with prior L-asparaginase therapy

Special Precautions

• Patients should be monitored for anaphylaxis and other serious allergic reactions for one hour after administration. If allergic reactions occur, treatment should be discontinued
• Discontinue treatment with L-asparaginase, if serious thrombotic events, including sagittal sinus thrombosis occurs
• Patients should be closely monitored for abdominal pain to evaluate risk of pancreatitis
• Blood serum glucose and hepatic function should be monitored carefully as glucose intolerance and hepatoxicity can occur in some cases
• Do not interchange L-asparaginase with Erwinia asparaginase or pegylated E. coli asparaginase

Admagin 5000/10,000 IU Lyophilized Injection - ADMAC Life Science