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RYLAZE recommended dosing options1

There are two RYLAZE regimens that can be used to replace a long-acting asparaginase product. The recommended dosages of RYLAZE are1:

MWF Dosing Graphic MWF Dosing Graphic

OR

Dosing Every 48 Hours Graphic Dosing Every 48 Hours Graphic

RYLAZE dosing examples for 25/25/50 mg/m2 IM schedule1:

  • 8 am on Monday and Wednesday, and 1 pm to 6 pm on Friday OR
  • 9 am on Monday and Wednesday, and 2 pm to 7 pm on Friday OR
  • 10 am on Monday and Wednesday, and 3 pm to 8 pm on Friday

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.1

Recommended Duration Of Rylaze Dosing 
To Replace One Long-Acting Asparaginase Dose1

When RYLAZE is AdministeredRecommended Duration of RYLAZE to Replace 3 Weeks of Asparaginase Coverage (Calaspargase Products)Recommended Duration of RYLAZE to Replace 2 Weeks of Asparaginase Coverage (Pegaspargase Products)
25 mg/m2 intramuscular every 48 hoursReplace 1 dose of calaspargase pegol products with 11 doses of RYLAZEReplace 1 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 1 dose of calaspargase pegol products with 9 doses of RYLAZEReplace 1 dose of pegaspargase products with 6 doses of RYLAZE
When RYLAZE is Administered
25 mg/m2 intramuscular every 48 hours
25 mg/m2 intramuscular on Monday morning and Wednesday morning, and 50 mg/m2 intramuscular on Friday afternoon*
Recommended Duration of RYLAZE to Replace 3 Weeks of Asparaginase Coverage (Calaspargase Products)
Replace 1 dose of calaspargase pegol products with 11 doses of RYLAZE
Replace 1 dose of calaspargase pegol products with 9 doses of RYLAZE
When RYLAZE is Administered
25 mg/m2 intramuscular every 48 hours
25 mg/m2 intramuscular on Monday morning and Wednesday morning, and 50 mg/m2 intramuscular on Friday afternoon*
Recommended Duration of RYLAZE to Replace 2 Weeks of Asparaginase Coverage (Pegaspargase Products)
Replace 1 dose of pegaspargase products with 7 doses of RYLAZE
Replace 1 dose of pegaspargase products with 6 doses of RYLAZE

*Administer the Friday afternoon dose 53 to 58 hours after the Wednesday morning dose.1

The above table shows the number of RYLAZE dosages recommended for the intended duration of treatment for replacement of1:

  • 3 weeks of asparaginase coverage (1 dose of calaspargase pegol products) or
  • 2 weeks of asparaginase coverage (1 dose of pegaspargase products)

See the full Prescribing Information for the long-acting asparaginase product to determine the total duration of administration of RYLAZE as replacement therapy.1

  • Ready-to-use vial2
  • No reconstitution required2
  • No filtration required1,2
  • Use aseptic technique1
  • Determine the dose, total volume of RYLAZE solution required, and the number of RYLAZE vials needed based on the individual patient's body surface area (BSA). More than one vial may be needed for a full dose1
  • Withdraw the indicated injection volume of RYLAZE into the syringe for injection1
    • 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 IM injection1
    • 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 59°F to 77°F for up to 8 hours or refrigerated at 36°F to 46°F for up to 24 hours. The syringe does not need to be protected from light during storage1
  • Ensure that medical support is available to appropriately manage anaphylactic reactions when administering RYLAZE1

Ensure that medical support is available to appropriately manage anaphylactic reactions when administering RYLAZE.1

  • Ready-to-use vial2
    • No reconstitution required2
    • No filtration required1,2
    • RYLAZE 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 vial1
    • Discard the remaining unused RYLAZE in the single-dose vial1
    • Do not shake or freeze1

Monitor patient’s bilirubin, transaminases, glucose, and clinical examinations prior to treatment every 2-3 weeks and as indicated clinically.1

  • If results are abnormal, monitor patients until recovery from the cycle of therapy
  • If an adverse reaction occurs, modify treatment according to the table shown here
Adverse ReactionSeverity*Action
Hypersensitivity
Reaction		Grade 2
  • Treat the symptoms
Grade 3 to 4
  • Discontinue RYLAZE permanently
PancreatitisGrade 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
ThrombosisUncomplicated 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
HemorrhageGrade 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
HepatotoxicityTotal 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 5.0.1

RYLAZE is supplied as a clear to opalescent, colorless to slightly yellow, preservative-free sterile solution in single-dose vials. Each single-dose vial contains 10 mg/0.5 mL.1

  • Each carton of RYLAZE contains 3 single-dose vials1
  • Store RYLAZE refrigerated at 36°F to 46°F in the original carton to protect from light1
  • Do not shake or freeze1

To calculate for dose volume for 25 mg/m2 on Monday and Wednesday, and 50 mg/m2 on Friday:

  • Each single-dose vial of RYLAZE contains 10 mg/0.5 mL1
  • Use the chart to determine the injection volume based on patient’s body surface area (BSA)
    • Calculate the total volume of RYLAZE solution required for each dose:
Volume
(mL)
=
BSA
(m2)
x
Individual dose
(mg/m2)
÷
Concentration
(20 mg/mL)
BSA (m2)Monday/Wednesday OR Q48 dose 
25 mg/m2		Friday dose
50 mg/m2
Volume (mL)Number of VialsVolume (mL)Number of Vials
0.40.5011.002
0.50.6321.253
0.60.7521.503
0.70.8821.754
0.81.0022.004
0.91.1332.255
1.01.2532.505
1.11.3832.756
1.21.5033.006
1.31.6343.257
1.41.7543.507
1.51.8843.758
1.62.0044.008
1.72.1354.259
1.82.2554.509
1.92.3854.7510
2.02.5055.0010
2.12.6365.2511
2.22.7565.5011
2.32.8865.7512
2.43.0066.0012
BSA (m2)Monday/Wednesday OR Q48 dose 
25 mg/m2
Volume (mL)Number of Vials
0.40.501
0.50.632
0.60.752
0.70.882
0.81.002
0.91.133
1.01.253
1.11.383
1.21.503
1.31.634
1.41.754
1.51.884
1.62.004
1.72.135
1.82.255
1.92.385
2.02.505
2.12.636
2.22.756
2.32.886
2.43.006
BSA (m2)Friday dose
50 mg/m2
Volume (mL)Number of Vials
0.41.002
0.51.253
0.61.503
0.71.754
0.82.004
0.92.255
1.02.505
1.12.756
1.23.006
1.33.257
1.43.507
1.53.758
1.64.008
1.74.259
1.84.509
1.94.7510
2.05.0010
2.15.2511
2.25.5011
2.35.7512
2.46.0012
  • Injection volume should be rounded based on institutional standard of care
  • It is solely the responsibility of the treating healthcare professional and/or institution to determine the appropriate dosage for each patient and to appropriately account for any unused drug or wastage in accordance with any applicable law, regulation, or policy
  • Healthcare professionals should calculate all doses before administration. This vial usage chart is merely a guide and is not a substitute for, nor intended to influence, the independent judgment of healthcare professionals. Neither Jazz Pharmaceuticals nor its contractors accept any responsibility for the applicability of the information provided to any particular clinical situation or for any actions or decisions taken in calculating or administering the dose
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Indication

RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection 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.

IMPORTANT SAFETY INFORMATION

Contraindications

RYLAZE is contraindicated in patients with a history of:

  • 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

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions after the use of RYLAZE occurred in 29% of patients in clinical trials, and it was severe in 6% of patients. Anaphylaxis was observed in 2% of patients after intramuscular administration. Discontinuation of RYLAZE due to hypersensitivity reactions occurred in 5% of patients. Hypersensitivity reactions were higher in patients who received intravenous asparaginase erwinia chrysanthemi (recombinant)-rywn. The intravenous route of administration is not approved.

In patients administered RYLAZE intramuscularly in clinical trials, the median number of doses of RYLAZE that patients received prior to the onset of the first hypersensitivity reaction was 12 doses (range: 1-64 doses). The most commonly observed reaction was rash (19%), and 1 patient (1%) experienced a severe rash.

Hypersensitivity reactions observed with L-asparaginase class products include angioedema, urticaria, lip swelling, eye swelling, rash or erythema, blood pressure decreased, bronchospasm, dyspnea, and pruritus.

Premedicate patients prior to administration of RYLAZE as recommended. Because of the risk of serious allergic reactions (e.g., life-threatening anaphylaxis), administer RYLAZE in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, oxygen, intravenous steroids, antihistamines). Discontinue RYLAZE in patients with serious hypersensitivity reactions.

Pancreatitis

Pancreatitis, including elevated amylase or lipase, was reported in 20% of patients in clinical trials of RYLAZE and was severe in 8%. Symptomatic pancreatitis occurred in 7% of patients, and it was severe in 6% of patients. Elevated amylase or lipase without symptomatic pancreatitis was observed in 13% of patients treated with RYLAZE. Hemorrhagic or necrotizing pancreatitis have been reported with L-asparaginase class products.

Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Evaluate patients with symptoms compatible with pancreatitis to establish a diagnosis. Assess serum amylase and lipase levels in patients with any signs or symptoms of pancreatitis. Discontinue RYLAZE in patients with severe or hemorrhagic pancreatitis. In the case of mild pancreatitis, withhold RYLAZE until the signs and symptoms subside and amylase and/or lipase levels return to 1.5 times the ULN. After resolution of mild pancreatitis, treatment with RYLAZE may be resumed.

Thrombosis

Serious thrombotic events, including sagittal sinus thrombosis and pulmonary embolism, have been reported in 1% of patients following treatment with RYLAZE. Discontinue RYLAZE for a thrombotic event, and administer appropriate antithrombotic therapy. Consider resumption of treatment with RYLAZE only if the patient had an uncomplicated thrombosis.

Hemorrhage

Bleeding was reported in 25% of patients treated with RYLAZE, and it was severe in 2%. Most commonly observed reactions were bruising (12%) and nose bleed (9%).

In patients treated with L-asparaginase class products, hemorrhage may be associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.

Hepatotoxicity

Elevated bilirubin and/or transaminases occurred in 75% of patients treated with RYLAZE in clinical trials, and 26% had Grade ≥3 elevations. Elevated bilirubin occurred in 28% of patients treated with RYLAZE in clinical trials, and 2% had Grade ≥3 elevations. Elevated transaminases occurred in 73% of patients treated with RYLAZE in clinical trials, and 25% had Grade ≥3 elevations.

Inform patients of the signs and symptoms of hepatotoxicity. Evaluate bilirubin and transaminases prior to treatment every 2-3 weeks and as indicated clinically during treatment with RYLAZE. In the event of serious liver toxicity, discontinue treatment with RYLAZE and provide supportive care.

Adverse Reactions

The most common adverse reactions (incidence >20%) with RYLAZE are abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea, pancreatitis, and hypokalemia.

Use in Specific Populations

Pregnancy and Lactation

RYLAZE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with RYLAZE and for 3 months after the last dose. Advise women not to breastfeed during treatment with RYLAZE and for 1 week after the last dose.

Please see full Prescribing Information.

IM=intramuscular; Q48=every 48; U=unit; ULN=upper limit of normal.

References: 1. RYLAZE [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2. Maese L, Rizzari C, Coleman R, et al. Can recombinant technology address asparaginase Erwinia chrysanthemi shortages? Pediatr Blood Cancer. 2021;68(10):e29169.

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Indication

RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection 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.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY 
INFORMATION AND INDICATION

Contraindications

RYLAZE is contraindicated in patients with a history of:

  • 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
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