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RYLAZE dosing and administration

  • Ready-to-use vial2
    • No reconstitution required2
    • No filtration required1,2
    • Visually inspect RYLAZE for particulate matter, cloudiness, or discoloration prior to administration. If any of these are present, discard the vial1
    • Discard partially used or empty vials of RYLAZE1
    • Do not shake1

Monitor patient’s bilirubin, transaminases, and glucose levels, 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 therapy1
  • If an adverse reaction occurs, modify treatment according to the table shown here1
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

ULN=upper limit of normal.

*Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.1

RYLAZE for injection 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

  • RYLAZE does not contain a preservative1
  • 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 freeze1

To calculate for dose volume:

  • 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 required volume of reconstituted solution as follows:
Volume
(mL)
=
BSA
(m2)
x
Dose
(mg/m2)
÷
Concentration
(20 mg/mL)
BSA (m2)Injection 
volume
based on BSA, mL
Number of vials per 
25 mg/m2 dose
0.40.51
0.50.632
0.60.752
0.70.882
0.812
0.91.133
1.01.253
1.11.383
1.21.53
1.31.634
1.41.754
1.51.884
1.624
1.72.135
1.82.255
1.92.385
2.02.55
2.12.636
2.22.756
2.32.886
2.436
  • 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 25% of patients in clinical trials, and it was severe in 2% of patients. The median time from the first dose of RYLAZE to the onset of the first hypersensitivity event was 27 days (range 1-171 days). The most commonly observed reaction was rash (17%), and no patient experienced a severe rash. The median time from the first dose to the first onset of rash was 33.5 days (range 1-127 days).

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.

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 was reported in 14% of patients in clinical trials of RYLAZE and was severe in 6%. Clinical pancreatitis occurred in 5% of patients, and it was severe in 4% of patients. Elevated amylase or lipase without clinical diagnosis of pancreatitis was observed in 9% of patients, and it was severe in 2% 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 following treatment with L-asparaginase class products. 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 17% of patients treated with RYLAZE, and it was severe in 1%. Most commonly observed reactions were bruising (8%) (contusion, increased tendency to bruise and injection site bruising) and nose bleeding (6%), which was severe in 1% of patients. Other observed bleeding reactions included hematuria (2%), disseminated intravascular coagulopathy (1%), rectal bleeding (1%) and gingival bleeding (1%).

In patients treated with 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 62% of patients treated with RYLAZE in clinical trials, and 12% 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

Serious adverse reactions occurred in 55% of patients who received RYLAZE. The most frequent serious adverse reactions (in ≥5% of patients) were febrile neutropenia, dehydration, pyrexia, stomatitis, diarrhea, drug hypersensitivity, infection, nausea, and viral infection.

The most common adverse reactions (incidence >20%) with RYLAZE are abnormal liver test (70%), nausea (46%), musculoskeletal pain (39%), fatigue (36%), infection (30%), headache (30%), pyrexia (27%), drug hypersensitivity (24%), febrile neutropenia (24%), decreased appetite (21%), stomatitis (21%), bleeding (21%), and hyperglycemia (21%).

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/intramuscularly.

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