Asparaginase erwinia chrysanthemi
What is Asparaginase erwinia chrysanthemi?[edit | edit source]
- Asparaginase erwinia chrysanthemi (RYLAZE) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL).
What are the uses of this medicine?[edit | edit source]
This medicine 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]
- An enzyme isolated from the bacterium Erwinia chrysanthemi (E. carotovora).
- 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]
- It was approved for use in the United States in 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.
Administration
- 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.
- Determine the dose, total volume of RYLAZE solution required, and the number of RYLAZE vials needed.
- More than one vial may be needed for a full dose.
- Withdraw the indicated injection volume of RYLAZE into the syringe for injection.
- Do not shake the vial.
- Limit the volume of RYLAZE at a single injection site to 2 mL.
- If the volume to be administered is greater than 2 mL, divide the doses equally into multiple syringes, one for each injection site.
- Discard the remaining unused RYLAZE in the single-dose vial.
- 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 are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As Injection: 10 mg/0.5 mL solution in a single-dose vial.
This medicine is available in fallowing brand namesː
- RYLAZE
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- abnormal liver test
- nausea
- musculoskeletal pain
- fatigue
- infection
- headache
- pyrexia
- drug hypersensitivity
- febrile neutropenia
- decreased appetite
- stomatitis
- bleeding
- hyperglycemia
What special precautions should I follow?[edit | edit source]
- Monitor for signs or symptoms of hypersensitivity. Discontinue RYLAZE for serious reaction.
- Monitor for symptoms of pancreatitis. Discontinue if pancreatitis occurs.
- Discontinue RYLAZE for severe or life-threatening thrombosis. Provide anticoagulation therapy as indicated.
- Discontinue RYLAZE for severe or life-threatening hemorrhage.
- This medicine can cause hepatotoxicity. 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]
- The safety and effectiveness of RYLAZE in the treatment of ALL and LBL have been established in pediatric patients 1 month to < 17 years who have developed hypersensitivity to a long-acting E. coli-derived asparaginase.
- The safety and effectiveness of RYLAZE have not been established in pediatric patients younger than 1 month of age.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredient:
- ASPARAGINASE
Inactive ingredients:
- TREHALOSE DIHYDRATE
- SODIUM CHLORIDE
- SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- POLYSORBATE 80
Who manufactures and distributes this medicine?[edit | edit source]
Packager: Jazz Pharmaceuticals, Inc.
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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