Rylaze

— THERAPEUTIC CATEGORIES —
  • Leukemias, lymphomas, and other hematologic cancers

Rylaze Generic Name & Formulations

General Description

Asparaginase erwinia chrysanthemi (recombinant)-rywn 10mg; per vial; soln for IM inj; preservative-free.

Pharmacological Class

Asparagine-specific enzyme.

How Supplied

Single-dose vials (0.5mL)—3

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake or freeze.

Generic Availability

NO

Mechanism of Action

Asparaginase erwinia chrysanthemi (recombinant)-rywn is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of Rylaze is based on the killing of leukemic cells due to depletion of plasma asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize asparagine, and therefore depend on an exogenous source of asparagine for survival.

Rylaze Indications

Indications

As a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity to E. coli-derived asparaginase.

Rylaze Dosage and Administration

Adults and Children

<1month: not established. Premedicate with APAP, an H1 receptor blocker (eg, diphenhydramine), and H2 receptor blocker (eg, famotidine) 30–60mins prior to administration. ≥1month: Give by IM inj (max 2mL/inj site); rotate inj sites. To replace a long-acting asparaginase product (48hr schedule): 25mg/m2 every 48hrs; or (MWF schedule): 25mg/m2 on Monday AM and Wednesday AM, and 50mg/m2 on Friday afternoon 53–58hrs after the Wednesday AM dose. To determine the duration of Rylaze administration as replacement therapy: see full labeling for the long-acting asparaginase product. Dose modifications for adverse reactions: see full labeling.

Rylaze Contraindications

Contraindications

History of serious pancreatitis, thrombosis, hemorrhagic events during previous L-asparaginase therapy. Severe hepatic impairment.

Rylaze Boxed Warnings

Not Applicable

Rylaze Warnings/Precautions

Warnings/Precautions

Have resuscitation equipment and other agents available. Discontinue if serious hypersensitivity reactions occur. Monitor for pancreatitis; assess serum amylase and lipase levels if signs/symptoms develop. Discontinue if severe or hemorrhagic pancreatitis occurs. Withhold if mild pancreatitis until symptoms subside and amylase and/or lipase levels return to 1.5×ULN; may resume after resolution. Discontinue if a thrombotic event occurs and treat appropriately; consider resuming only if uncomplicated thrombosis. Hemorrhage. Consider appropriate replacement therapy if severe or symptomatic coagulopathy occurs. Monitor glucose, clinical examinations prior to treatment every 2–3 weeks and as clinically indicated. Evaluate bilirubin, transaminases prior to each cycle, at least weekly during therapy, and through 4 weeks after the last dose; monitor more frequently if abnormal liver tests develop. Monitor for signs/symptoms of hepatic veno-occlusive disease (VOD). Discontinue if serious liver toxicity, including VOD occurs. Advise females of reproductive potential to use effective non-hormonal contraception during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Rylaze Pharmacokinetics

Absorption

Median time to maximum concentration: 12 hours. Mean absolute bioavailability: 37%.

Distribution

Volume of distribution: 1.37 L/m2.

Metabolism

Catabolic pathways.

Elimination

Half-life: 15.9 hours. Clearance: 0.17 L/hour/m2.

Rylaze Interactions

Not Applicable

Rylaze Adverse Reactions

Adverse Reactions

Abnormal liver test, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding, hyperglycemia; hypersensitivity reactions, pancreatitis, thrombosis, hepatotoxicity.

Rylaze Clinical Trials

See Literature

Rylaze Note

Not Applicable

Rylaze Patient Counseling

See Literature

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