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Brand Name
Rylaze
Generic Name
Asparaginase
View Brand Information FDA approval date: June 30, 2021
Classification: Asparagine-specific Enzyme
Form: Injection
What is Rylaze (Asparaginase)?
RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. RYLAZE is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase.
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Brand Information
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
1INDICATIONS AND USAGE
RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen 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
2DOSAGE FORMS AND STRENGTHS
Injection: 10 mg/0.5 mL clear to opalescent, colorless to slightly yellow solution in a single-dose vial.
3CONTRAINDICATIONS
RYLAZE is contraindicated in patients with:
- History of serious hypersensitivity reactions to
- History of serious pancreatitis during previous asparaginase therapy
- History of serious thrombosis during previous asparaginase therapy
- History of serious hemorrhagic events during previous asparaginase therapy
- Severe hepatic impairment [
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described in greater detail in other sections of the labeling:
- Hypersensitivity Reactions
- Pancreatic Toxicity
- Thrombosis
- Hemorrhage
- Hepatotoxicity, including VOD
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of RYLAZE described in the WARNINGS AND PRECAUTIONS reflect exposure in 167 patients administered RYLAZE intramuscularly at various dosages when used in combination with chemotherapy in study JZP458-201
The safety of RYLAZE described below and in Table 3 was evaluated in study JZP458-201, a multi-cohort study. Patients received RYLAZE administered intramuscularly at dosages of 25 mg/m
A fatal adverse reaction (infection) occurred in 1 patient treated with the RYLAZE 25/25/25 mg/m
All patients treated with the recommended dosages of RYLAZE as a component of multi-agent chemotherapy experienced neutropenia, anemia, or thrombocytopenia. The most common nonhematological adverse reactions (incidence > 20%) in patients were 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. Table 3 shows the common adverse reactions occurring in at least 15% of the patients.
* Includes grouped terms:
*Includes adverse event terms and laboratory abnormalities
a RYLAZE was administered as a component of multi-agent chemotherapy regimens on a Monday, Wednesday, and Friday schedule.
b Does not include the following fatal adverse reactions: infection (N=1).
b Does not include the following fatal adverse reactions: infection (N=1).
Clinically relevant adverse reactions in < 15% of patients who received RYLAZE in combination with chemotherapy included:
Gastrointestinal disorders: Abdominal discomfort, abdominal distension, constipation, gastritis
General disorders and administration site conditions: Infusion site reaction, injection site reaction, pain
Infections and infestations: Viral infection, bacterial infection, fungal infection
Investigations: Antithrombin III decreased, blood cholesterol increased, blood fibrinogen decreased, activated partial thromboplastin time prolonged
Metabolism and nutrition disorders: Acidosis, hyperammonemia, hyperphosphatemia, hypertriglyceridemia, hypoglycemia
Musculoskeletal and connective tissue disorders: Bone pain, muscular weakness, muscle spasms
Nervous system disorders: Paresthesia, dizziness, gait disturbance, hyperammonemic encephalopathy
Psychiatric disorders: Agitation, anxiety, irritability
Respiratory, thoracic, and mediastinal disorders: Acute respiratory distress syndrome, pulmonary edema
Renal and urinary disorders: Acute kidney injury
Skin and subcutaneous disorders: Pruritus
Vascular disorders: Hypertension, hypotension, thrombosis
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of RYLAZE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Hepatic: Veno-occlusive disease (VOD)
5DESCRIPTION
Asparaginase erwinia chrysanthemi (recombinant)-rywn contains an asparagine specific bacterial enzyme (L-asparaginase). L-asparaginase is a tetrameric enzyme that consists of four identical 35 kDa subunits with a combined molecular weight of 140 kDa. The amino acid sequence is identical to native asparaginase
Asparaginase erwinia chrysanthemi (recombinant)-rywn is produced by fermentation of a genetically engineered
RYLAZE (asparaginase erwinia chrysanthemi (recombinant)-rywn) injection is supplied as a sterile, clear to opalescent, colorless to slightly yellow, preservative-free solution for intramuscular injection. Each 0.5 mL contains 10 mg asparaginase erwinia chrysanthemi (recombinant)-rywn and the inactive ingredients: polysorbate 80 (0.1 mg), sodium chloride (1.5 mg), sodium phosphate dibasic anhydrous (0.8 mg), sodium phosphate monobasic monohydrate (0.6 mg), and trehalose dihydrate (32.1 mg). Sodium hydroxide may be added during manufacture to adjust the pH. The pH is approximately 7.
6CLINICAL STUDIES
The efficacy of RYLAZE for the treatment of patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who have developed hypersensitivity to
For the 225 evaluable patients, the median age was 10 years (range: 1-25 years); 61% were male and 39% were female; 69% were White, 11% were Black/African American, 4% were Asian, and 16% were of other or unknown race: 187 (83%) patients had experienced a hypersensitivity reaction (Grade ≥ 3) to pegaspargase, and 15 patients (7%) reported silent inactivation.
The determination of efficacy was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 U/mL by simulation. Table 5 shows the proportion with NSAA ≥ 0.1 U/mL for each approved dosage regimen based on simulation in a virtual population
a Based on 2,000 virtual subjects.
b Based on maximum interval of 58 hours between the Wednesday morning and Friday afternoon doses.
c Based on maximum interval of 67 hours between the Friday afternoon and Monday morning doses.
b Based on maximum interval of 58 hours between the Wednesday morning and Friday afternoon doses.
c Based on maximum interval of 67 hours between the Friday afternoon and Monday morning doses.
7HOW SUPPLIED/STORAGE AND HANDLING
RYLAZE (asparaginase erwinia chrysanthemi (recombinant)-rywn) injection is supplied as a sterile, clear to opalescent, colorless to slightly yellow, preservative-free solution in single-dose vials. Each single-dose vial (NDC 68727-900-01) contains 10 mg/0.5 mL asparaginase erwinia chrysanthemi (recombinant)-rywn. Each carton of RYLAZE (NDC 68727-900-03) contains 3 single-dose vials.
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.
8PATIENT COUNSELING INFORMATION
- HypersensitivityInform patients of the risk of allergic reactions, including anaphylaxis. Instruct the patient on the symptoms of allergic reactions and to seek medical advice immediately if they experience such symptoms [see Warnings and Precautions (.
- PancreatitisInstruct patients on signs and symptoms of pancreatitis and to seek medical attention if they experience severe abdominal pain [see Warnings and Precautions (.
- ThrombosisInstruct patients on the risk of thrombosis and to seek medical advice immediately if they experience headache, arm or leg swelling, shortness of breath, and chest pain [see Warnings and Precautions (.
- HemorrhageAdvise patients to report any unusual bleeding or bruising to their healthcare provider [see Warnings and Precautions (.
- Hepatotoxicity, including Veno-Occlusive Liver DiseaseInform patients that liver problems, including severe, life-threatening, or fatal VOD and abnormalities in liver tests, may develop during RYLAZE treatment. Advise patients to report any jaundice, severe nausea or vomiting, or easy bleeding or bruising to their healthcare provider [see Warnings and Precautions (.
- PregnancyAdvise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (.
- Advise females of reproductive potential to use effective non-hormonal contraception during treatment with RYLAZE and for 3 months after the last dose
- LactationAdvise women not to breastfeed during treatment with RYLAZE and for 1 week after the last dose [see Use in Specific Populations (.
Manufactured by:
Distributed by:
Protected by U.S. Patent nos. 8,288,127 and 10,787,671
RYLAZE
©2024 Jazz Pharmaceuticals
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
10Package/Label Display Panel
3 vials (NDC 68727-900-01)