Rylaze

Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) — as a component of a multi-agent chemotherapeutic regimen in adult and pediatric patients 1 month of age and older who have developed hypersensitivity to E. coli-derived asparaginase.

Monday/Wednesday/Friday schedule (replacing pegaspargase): 25 mg/m² IM, 3 times per week for 6 doses per pegaspargase dose
Monday/Wednesday/Friday schedule (replacing native E. coli asparaginase): 25 mg/m² IM, 3 times per week for each scheduled dose
IM injection only; do not administer IV
Volume: Maximum 1 mL per injection site; use multiple sites for doses >1 mL

Injection: 10 mg/0.5 mL in single-dose vial (for IM injection)

History of serious hypersensitivity reactions (including anaphylaxis) to Rylaze. History of serious thrombosis with prior L-asparaginase therapy. History of serious pancreatitis with prior L-asparaginase therapy. History of serious hemorrhagic events with prior L-asparaginase therapy.

• Hypersensitivity Reactions: Including anaphylaxis (1%). Observe for 1 hour after administration. Discontinue for serious reactions.
• Pancreatitis: In 6%. Including fatal pancreatitis. Monitor lipase and amylase. Discontinue for Grade ≥3 pancreatitis.
• Thrombosis: In 4%. Includes sagittal sinus thrombosis, DVT, PE. Consider anticoagulation.
• Hemorrhage: In 3%. Due to decreased production of coagulation factors (fibrinogen, antithrombin). Monitor fibrinogen and replace as needed.
• Hepatotoxicity: Elevated bilirubin and transaminases in 27%. Monitor LFTs.

Abnormal liver tests (27%), nausea (16%), musculoskeletal pain (12%), infection (11%), fatigue (10%), febrile neutropenia (9%), headache (8%), pancreatitis (6%), pyrexia (5%), hypersensitivity (4%), thrombosis (4%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Rylaze contains recombinant L-asparaginase derived from Erwinia chrysanthemi (now classified as Dickeya chrysanthemi). L-asparaginase catalyzes the hydrolysis of the amino acid L-asparagine to aspartic acid and ammonia. Leukemic lymphoblasts lack asparagine synthetase and are dependent on exogenous L-asparagine for protein synthesis and survival. Depletion of circulating L-asparagine by the enzyme results in inhibition of protein synthesis, cell cycle arrest, and apoptosis of leukemic cells while normal cells (which express asparagine synthetase) are relatively spared.

Target serum asparaginase activity (SAA) level: ≥0.1 IU/mL (nadir 48-hour). Tmax: ~12-16 hours after IM injection. Half-life: approximately 16-18 hours. Serum asparagine depletion maintained with MWF dosing schedule.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• JZP458-201 — Recombinant erwinia asparaginase as substitute in ALL/LBL with hypersensitivity. Phase II/III.
  🔬 NCT04145531 ↗ 📄 Primary Publication ↗

Rylaze has FDA-approved indications across the following cancer types covered on PipelineEvidence: