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Safety profile

Adverse reactions were measured in patients receiving RYLAZE1:

  • As a component of multiagent chemotherapy
  • Consistent with other asparaginase therapies

Common adverse reactions (≥15% incidence)1

Adverse ReactionRYLAZE 25/25/25 mg/m2
Intramuscular Dosagea
(n=33)		RYLAZE 25/25/50 mg/m2
Intramuscular Dosagea
(n=51)
All Grades
(%)		Grades 3-4
(%)		All Grades
(%)		Grades 3-4
(%)
Abnormal liver test*#70187527
Musculoskeletal pain*456354
Nausea*459478
Fatigue*36182218
Headache360220
Infection*b36152717
Febrile neutropenia30302727
Pyrexia306200
Hemorrhage*240276
Stomatitis2412274
Abdominal pain*210252
Decreased appetite216276
Drug hypersensitivity*216242
Hyperglycemia213124
Diarrhea*186254
Tachycardia*180162
Cough150140
Dehydration159126
Insomnia15040
Peripheral neuropathy*15060
Pancreatitis*#1202210
Hypokalemia93228
Adverse ReactionRYLAZE 25/25/25 mg/m2
Intramuscular Dosagea
(n=33)
All Grades
(%)		Grades 3-4
(%)
Abnormal liver test*#7018
Musculoskeletal pain*456
Nausea*459
Fatigue*3618
Headache360
Infection*b3615
Febrile neutropenia3030
Pyrexia306
Hemorrhage*240
Stomatitis2412
Abdominal pain*210
Decreased appetite216
Drug hypersensitivity*216
Hyperglycemia213
Diarrhea*186
Tachycardia*180
Cough150
Dehydration159
Insomnia150
Peripheral neuropathy*150
Pancreatitis*#120
Hypokalemia93
Adverse ReactionRYLAZE 25/25/50 mg/m2
Intramuscular Dosagea
(n=51)
All Grades
(%)		Grades 3-4
(%)
Abnormal liver test*#7527
Musculoskeletal pain*354
Nausea*478
Fatigue*2218
Headache220
Infection*b2717
Febrile neutropenia2727
Pyrexia200
Hemorrhage*276
Stomatitis274
Abdominal pain*252
Decreased appetite276
Drug hypersensitivity*242
Hyperglycemia124
Diarrhea*254
Tachycardia*162
Cough140
Dehydration126
Insomnia40
Peripheral neuropathy*60
Pancreatitis*#2210
Hypokalemia228

*Includes grouped terms.

#Includes adverse event terms and laboratory abnormalities.1

 Grading is based on Common Terminology Criteria for Adverse Events version 5.0.1

aRYLAZE was administered as a component of multiagent chemotherapy regimens on a Monday, Wednesday, and Friday schedule.1

bDoes not include the following fatal adverse reactions: infection (n=1).1

Adverse reactions are represented by grouped terms1: 

  • Abnormal liver test includes alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, and transaminases increased
  • Musculoskeletal pain includes arthralgia, back pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, and pain in extremity
  • Nausea includes nausea and vomiting
  • Fatigue includes fatigue and asthenia
  • Infection includes sepsis, upper respiratory tract infection, enterocolitis infectious, skin infection, bacteremia, paronychia, pneumonia, otitis externa, soft tissue infection, abdominal infection, conjunctivitis, device related infection, folliculitis, lymph gland infection, necrotizing fasciitis, perirectal abscess, peritonsillar abscess, sinusitis, subcutaneous abscess, and wound infection
  • Drug hypersensitivity includes drug hypersensitivity, rash, infusion related reaction, lip swelling, periorbital edema, throat irritation, urticaria, dry skin, eczema, erythema, hand dermatitis, rash maculo-papular, and rash papular
  • Hemorrhage includes contusion, epistaxis, catheter site hemorrhage, petechiae, hematochezia, menorrhagia, mouth hemorrhage, increased tendency to bruise, and rectal hemorrhage
  • Abdominal pain includes abdominal pain and abdominal pain upper
  • Diarrhea includes diarrhea and colitis
  • Tachycardia includes sinus tachycardia and tachycardia
  • Peripheral neuropathy includes peripheral motor neuropathy, neuropathy peripheral, and peripheral sensory neuropathy
  • Pancreatitis includes pancreatitis, pancreatitis acute, amylase increased, and lipase increased
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Highly purified biologic2,3

Rely on RYLAZE recombinant manufacturing for uninterrupted therapy1-3

MANUFACTURING PROCESS >

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.

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. 3. Coleman RJ, Bruck T, inventors. Pfenex Inc, assignee. Method for production of recombinant Erwinia asparaginase. US patent 10,787,671. September 29, 2020. 

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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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