Asparaginase (Erwinia chrysanthemi) (recombinant)-rywn

Class: Antineoplastic Agents
Molecular Formula: C₁₅₄₆H₂₅₁₀N₄₃₂O₄₇₆S₉ (monomer)
Brands: Rylaze ([Web])

Medically reviewed by Drugs.com on Feb 17, 2022. Written by ASHP.

Introduction

Antineoplastic agent; biosynthetic (recombinant DNA origin) preparation of an asparagine-specific enzyme. Structurally similar to native asparaginase Erwinia chrysanthemi.

Uses for Asparaginase (Erwinia chrysanthemi) (recombinant)-rywn

Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Component of combination chemotherapy for treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and pediatric patients ≥1 month of age with hypersensitivity to E. coli-derived asparaginase preparations; designated an orphan drug by FDA for treatment of ALL.

Received fast track and priority review from the FDA to alleviate the burden of a global shortage of asparaginase (Erwinia chrysanthemi).

Asparaginase (Erwinia chrysanthemi) (recombinant)-rywn Dosage and Administration

General

Pretreatment Screening

• Pregnancy testing recommended prior to initiating therapy in females of reproductive potential.

Patient Monitoring

• Monitor bilirubin, transaminases, and glucose concentrations, and perform clinical examinations prior to treatment every 2–3 weeks, and if clinically indicated. If results are abnormal, monitor patients until recovery from the cycle of therapy.

Dispensing and Administration Precautions

• Administer the drug in a setting with resuscitation equipment and other agents necessary to treat anaphylactic reactions.

Administration

IM Administration

Administer by IM injection.

Withdraw appropriate volume of drug (based on indicated dose) into a syringe for injection; more than 1 vial may be required for a full dose.

Do not give >2 mL at one injection site. If IM dose >2 mL, divide the dose and administer at separate sites. Rotate injection sites regularly. Do not inject into scar tissue or areas that are reddened, inflamed, or swollen.

Administer IM injection within 4 hours of preparing syringe. If needed, may store the syringe at room temperature (15–25°C) or in the refrigerator at 2–8°C for up to 4 hours. The prepared syringe does not need to be protected from light during storage.

Dosage

Pediatric Patients

ALL or LBL in Patients with Hypersensitivity to E. coli-derived Asparaginase

IM

Children ≥1 month of age: recommended dosage when replacing a long-acting asparaginase product is 25 mg/m² administered every 48 hours for the duration of asparaginase activity expected for that product. Refer to the prescribing information for the long-acting asparaginase product for duration of administration.

Adults

ALL or LBL in Patients with Hypersensitivity to E. coli-derived Asparaginase

IM

Recommended dosage when replacing a long-acting asparaginase product is 25 mg/m² administered every 48 hours for th...