Rylaze Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Rylaze Indications
Indications
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.
Elimination
Half-life: 15.9 hours. Clearance: 0.17 L/hour/m2.
Rylaze Interactions
Not Applicable
Rylaze Adverse Reactions
Adverse Reactions
Rylaze Clinical Trials
See Literature
Rylaze Note
Not Applicable
Rylaze Patient Counseling
See Literature
Images
