Miscellaneous antineoplastics
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Rylaze Dosage

Drug Detail:Rylaze (Asparaginase erwinia chrysanthemi [ as-par-a-jin-ase-er-win-ee-a-kri-san-the-mee ])

Generic Name: ASPARAGINASE 20mg in 1mL

Dosage Form: injection

Drug Class: Miscellaneous antineoplastics

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Recommended Dosage

​There are two RYLAZE regimens that can be used to replace a long-acting asparaginase product. The recommended dosages of RYLAZE are:

​ When administered every 48 hours:

•
​25 mg/m2 administered intramuscularly every 48 hours;

​ When administered on a Monday/Wednesday/Friday schedule:

•
​25 mg/m2 intramuscularly on Monday morning and Wednesday morning, and 50 mg/m2 intramuscularly on Friday afternoon. Administer the Friday afternoon dose 53 to 58 hours after the Wednesday morning dose (e.g., 8:00 am on Monday and Wednesday, and 1:00 pm to 6:00 pm on Friday) [see Clinical Pharmacology (12.3), Clinical Studies (14)].

​Table 1 shows the number of RYLAZE dosages recommended for the intended duration of treatment for replacement of one dose of calaspargase pegol products (3 weeks of asparaginase coverage) or one dose of pegaspargase products (2 weeks of asparaginase coverage). See the full prescribing information for the long-acting asparaginase product to determine the total duration of administration of RYLAZE as replacement therapy.

Table 1: Recommended Duration of RYLAZE Dosing to Replace One Long-Acting Asparaginase Dose

​When RYLAZE is Administered:

​Recommended Duration of RYLAZE to Replace Calaspargase Pegol Products

​Recommended Duration of RYLAZE to Replace Pegaspargase Products

​25 mg/m2 intramuscular every 48 hours

​Replace one dose of calaspargase pegol products with 11 doses of RYLAZE

​Replace one dose of pegaspargase products with 7 doses of RYLAZE

​25 mg/m2 intramuscular on Monday morning and Wednesday morning, and 50 mg/m2 intramuscular on Friday afternoon*

​Replace one dose of calaspargase pegol products with 9 doses of RYLAZE

​Replace one dose of pegaspargase products with 6 doses of RYLAZE

​*See bullet above for timing of 25/25/50 mg/m2 dosing of RYLAZE.

Recommended Premedication

​Premedicate patients with acetaminophen, an H-1 receptor blocker (such as diphenhydramine), and an H-2 receptor blocker (such as famotidine) 30-60 minutes prior to administration of RYLAZE to decrease the risk and severity of hypersensitivity reactions [see Warnings and Precautions (5.1)].

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 2.

Table 2: 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.
** Upper limit of normal

Preparation and Administration Instructions

​Ensure that medical support is available to appropriately manage anaphylactic reactions when administering RYLAZE [see Warnings and Precautions (5.1)].

​Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter, cloudiness, or discoloration are present, discard the vial.

•
​Use aseptic technique.
•
​Determine the dose, total volume of RYLAZE solution required, and the number of RYLAZE vials needed based on the individual patient’s BSA. 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.
o
​Rotate injection sites.
o
​Do not inject RYLAZE into scar tissue or areas that are reddened, inflamed, or swollen.
•
​If the prepared dose is not used immediately, store the syringe(s) at room temperature 15°C to 25°C (59°F to 77°F) for up to 8 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours. The syringe does not need to be protected from light during storage.
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