RYLAZE Solution for injection Ref.[109542] Active ingredients: Asparaginase

2.1 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:

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

2.2 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)].

2.3 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:

^* Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
^** Upper limit of normal

2.4 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.
  • 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.
  • Rotate injection sites.
  • 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.

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.