Asparaginase erwinia chrysanthemi (recombinant)-rywn
What is Asparaginase erwinia chrysanthemi-rywn?[edit | edit source]
- Asparaginase erwinia chrysanthemi-rywn (Rylaze) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen used to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products, as a component of a chemotherapy regimen.
What are the uses of this medicine?[edit | edit source]
- Asparaginase erwinia chrysanthemi-rywn (Rylaze) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.
How does this medicine work?[edit | edit source]
- Asparaginase erwinia chrysanthemi (recombinant)-rywn is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia.
- The pharmacological effect of RYLAZE is based on the killing of leukemic cells due to depletion of plasma asparagine.
- Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize asparagine, and therefore depend on an exogenous source of asparagine for survival.
Who Should Not Use this medicine?[edit | edit source]
This medicine cannot be used in patients with:
- Serious hypersensitivity reactions to Erwinia asparaginase, including anaphylaxis.
- Serious pancreatitis during previous asparaginase therapy.
- Serious thrombosis during previous asparaginase therapy.
- Serious hemorrhagic events during previous asparaginase therapy.
Is this medicine FDA approved?[edit | edit source]
- Asparaginase erwinia chrysanthemi-rywn is FDA approved in the year of 2021.
How should this medicine be used?[edit | edit source]
Recommended Dosage
- When replacing a long-acting asparaginase product, the recommended dosage of RYLAZE is 25 mg/m2 administered intramuscularly every 48 hours.
Recommended Monitoring and Dosage Modifications for Adverse Reactions
- Monitor patient’s bilirubin, transaminases, glucose, and clinical examinations prior to treatment every 2-3 weeks and as indicated clinically.
- If results are abnormal, monitor patients until recovery from the cycle of therapy. If an adverse reaction occurs, modify treatment according to Table
1.
Adverse Reaction | Severity* | Action |
Hypersensitivity Reaction | Grade 2 |
|
Grade 3 to 4 |
| |
Pancreatitis | Grade 2 to 4 |
|
Thrombosis | Uncomplicated thrombosis |
|
Severe or life-threatening thrombosis |
| |
Hemorrhage | Grade 3 to 4 |
|
Hepatotoxicity | Total bilirubin > 3 times to ≤ 10 times the ULN |
|
Total bilirubin > 10 times the ULN |
|
* Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Preparation and Administration Instructions
- Ensure that medical support is available to appropriately manage anaphylactic reactions when administering RYLAZE
- Visually inspect parenteral drug products for particulate matter, cloudiness, or discoloration prior to administration. If any of these are present, discard the vial. RYLAZE does not contain a preservative.
- Use aseptic technique.
- Administer RYLAZE by intramuscular injection within 4 hours after drawing the dose into the syringe(s).
- Rotate injection sites.
- Do not inject RYLAZE into scar tissue or areas that are reddened, inflamed, or swollen.
- If needed, store the syringe(s) at room temperature (15°C to 25°C [59°F to 77°F]) or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours. The syringe does not need to be protected from light during storage.
What side effects can this medication cause?[edit | edit source]
The following clinically significant adverse reactions are described in greater detail in other sections of the labeling:
- Hypersensitivity Reactions
- Pancreatic Toxicity
- Thrombosis
- Hemorrhage
- Hepatotoxicity
What special precautions should I follow?[edit | edit source]
- Hypersensitivity reactions observed with L-asparaginase class products include angioedema, urticaria, lip swelling, eye swelling, rash or erythema, blood pressure decreased, bronchospasm, dyspnea, and pruritus. Monitor for signs or symptoms. Discontinue RYLAZE for serious reaction.
- Pancreatitis was reported in 14% of patients in clinical trials of RYLAZE. Monitor for symptoms. Discontinue if pancreatitis occurs.
- Serious thrombotic events, including sagittal sinus thrombosis and pulmonary embolism, have been reported following treatment with L-asparaginase class products. Discontinue RYLAZE for severe or life-threatening thrombosis. Provide anticoagulation therapy as indicated.
- Bleeding was reported in 17% of patients treated with RYLAZE. Discontinue RYLAZE for severe or life-threatening hemorrhage.
- Elevated bilirubin and/or transaminases occurred in 62% of patients treated with RYLAZE. Discontinue RYLAZE for grade 4 increases of bilirubin.
What to do in case of emergency/overdose?[edit | edit source]
- In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.
- Overdose related information is also available online at poisonhelp.org/help.
- In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
Can this medicine be used in pregnancy?[edit | edit source]
- Based on findings from animal reproduction studies, RYLAZE can cause fetal harm when administered to a pregnant woman.
- There are no available data on RYLAZE use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Can this medicine be used in children?[edit | edit source]
- Pediatric patient one month and older can use this drug.
What should I know about storage and disposal of this medication?[edit | edit source]
- Store RYLAZE vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake or freeze.
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