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

Generic Availability

NO

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.

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 bilirubin, transaminases, glucose, clinical examinations prior to treatment every 2–3 weeks and as clinically indicated. Discontinue if serious liver toxicity occurs; treat appropriately. 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

See Literature

Rylaze Interactions

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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