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Rylaze Dosage

Generic name: ASPARAGINASE 20mg in 1mL
Dosage form: injection
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Jun 30, 2021.

Recommended Dosage

When replacing a long-acting asparaginase product, the recommended dosage of RYLAZE is 25 mg/m2 administered intramuscularly every 48 hours.

See the full prescribing information for the long-acting asparaginase product to determine the duration of administration of RYLAZE as replacement therapy.

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.

Table 1: Dosage Modifications

Adverse Reaction

Severity*

Action

Hypersensitivity Reaction [see Warnings and Precautions (5.1)]

Grade 2

Treat the symptoms.

Grade 3 to 4

Discontinue RYLAZE permanently.

Pancreatitis [see Warnings and Precautions (5.2)]

Grade 2 to 4

Hold RYLAZE for elevations in lipase or amylase > 2 times the ULN, or for symptomatic pancreatitis.
Resume treatment when lipase and amylase are < 1.5 times the ULN and symptoms are resolved.
Discontinue RYLAZE permanently if clinical necrotizing or hemorrhagic pancreatitis is confirmed.

Thrombosis [see Warnings and Precautions (5.3)]

Uncomplicated thrombosis

Hold RYLAZE.
Treat with appropriate antithrombotic therapy.
Upon resolution of symptoms, consider resuming RYLAZE, while continuing antithrombotic therapy.

Severe or life-threatening thrombosis

Discontinue RYLAZE permanently.
Treat with appropriate antithrombotic therapy.

Hemorrhage [see Warnings and Precautions (5.4)]

Grade 3 to 4

Hold RYLAZE.
Evaluate for coagulopathy and consider clotting factor replacement as needed.
Resume RYLAZE with the next scheduled dose if bleeding is controlled.

Hepatotoxicity [see Warnings and Precautions (5.5)]

Total bilirubin > 3 times to ≤ 10 times the ULN

Hold RYLAZE until total bilirubin levels decrease to ≤ 1.5 times the ULN.

Total bilirubin > 10 times the ULN

Discontinue RYLAZE and do not make up missed doses.

* 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 [see Warnings and Precautions (5.1)].

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.

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.
o
Do not shake the vial.
o
Limit the volume of RYLAZE at a single injection site to 2 mL.
o
If the volume to be administered is greater than 2 mL, divide the doses equally into multiple syringes, one for each injection site.
o
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).
o
Rotate injection sites.
o
Do not inject RYLAZE into scar tissue or areas that are reddened, inflamed, or swollen.
o
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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.