Asparaginase erwinia chrysanthemi

What is Asparaginase erwinia chrysanthemi?

• 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?

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?

• 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 ?

This medicine cannot be used in patients with:

1. Serious hypersensitivity reactions to Erwinia asparaginase, including anaphylaxis
2. Serious pancreatitis during previous asparaginase therapy
3. Serious thrombosis during previous asparaginase therapy
4. Serious hemorrhagic events during previous asparaginase therapy

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

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?

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?

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?

• 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?

• 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?

• 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?

• 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?

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?

Packager: Jazz Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Asparaginase erwinia chrysanthemi
• FDA Asparaginase erwinia chrysanthemi

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