After more than 93% of patients maintained nadir serum asparaginase activity in the therapy’s clinical trials, on June 30, 2021, the U.S. Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)–rywn (RylazeTM) for use as a component of a multiagent chemotherapeutic regimen for treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients who have developed hypersensitivity to E. coli-derived asparaginase.
Mechanism of Action
Catalyzes the conversion of L-asparagine into aspartic acid and ammonia, leading to leukemia cell death
Adult and pediatric patients aged one month or older with ALL or LBL who have developed a hypersensitivity to E. coli-derived asparaginase
25 mg/m2 via intramuscular injection every 48 hours (use the full prescribing information to determine administration duration)
Administer via intramuscular injection within four hours after drawing the injectate into the syringe. Limit the volume at each injection site to 2 ml. If the dose volume is greater than 2 ml, divide it equally into multiple syringes, one for each injection site. Rotate the injection sites. Do not inject into areas of inflammation, redness, swelling, or scar tissue.
More than 25% of patients in clinical trials experienced a hypersensitivity reaction that was severe in 2% of patients. Hypersensitivity reactions may present as anaphylaxis, angioedema, urticaria, swelling of the lips or eyes, rash, decreased blood pressure, bronchospasm, dyspnea, or pruritis. Other adverse reactions included pancreatitis, thrombosis, hemorrhage, hepatotoxicity, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, febrile neutropenia, decreased appetite, stomatitis, and hyperglycemia.
Because of the risk for life-threatening anaphylaxis, administer in a setting with resuscitation equipment and agents to treat anaphylaxis. Observe patients for signs of pancreatitis, thrombosis, and hemorrhage. Monitor patients for hepatotoxicity (i.e., bilirubin, transaminases, glucose, and clinical examinations prior to treatment initiation, every two to three weeks throughout treatment, and as clinically indicated). Confirm a patient’s pregnancy status prior to starting treatment.
Watch for signs and symptoms of bleeding, thrombosis, pancreatitis, and fever. Because of the risk of fetal harm, patients with a uterus of reproductive potential must use effective nonhormonal contraception during treatment and for three months after last dose and should not breastfeed during treatment and for one week after last dose.
Clinical studies did not include enough patients older than age 65 to determine whether they respond differently than younger patients, and safety and effectiveness have not been established in pediatric patients younger than one month. Black and Asian patients had a 29% lower drug clearance, which may increase serum asparaginase activity. Researchers did not observe any clinically significant differences in clearance between Hispanic and non-Hispanic patients.
Asparaginase erwinia chrysanthemi (recombinant)-rywn is a hazardous drug because of its reproductive risk. Follow safe handling and disposal procedures.
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