Leukemias, lymphomas, and other hematologic cancers:

Indications for: RYLAZE

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.

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:

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

RYLAZE 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 Classification:

Asparagine-specific enzyme.

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.

Generic Drug Availability:

NO

How Supplied:

Single-dose vials (0.5mL)—3

Pricing for RYLAZE

0.5ml of 10mg/0.5ml vial (Qty: 1)
Appx. price $4494
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