Rylaze 20 mg/mL
asparaginase erwinia chrysanthemi (recombinant)-rywn · INJECTION · Jazz Pharmaceuticals, Inc.
Rylaze is a injection containing asparaginase erwinia chrysanthemi (recombinant)-rywn at 20 mg/mL, taken intramuscular. Manufactured by Jazz Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Rylaze
- Generic Name
- asparaginase erwinia chrysanthemi (recombinant)-rywn
- NDC Code (Product)
68727-900- Manufacturer
- Jazz Pharmaceuticals, Inc.
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- BLA761179
- Drug Class
- Asparagine-specific Enzyme [EPC]
- Marketing Start
- 06/30/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS 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 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 (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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/m 2 intramuscularly every 48 hours; When administered Monday/Wednesday/Friday • 25 mg/m 2 intramuscularly on Monday morning and Wednesday morning and 50 mg/m 2 intramuscularly on Friday afternoon. ( 2.1 ) 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/m 2 administered intramuscularly every 48 hours; When administered on a Monday/Wednesday/Friday schedule: • 25 mg/m 2 intramuscularly on Monday morning and Wednesday morning, and 50 mg/m 2 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 pr…
Contraindications
4 CONTRAINDICATIONS RYLAZE is contraindicated in patients with: • History of serious hypersensitivity reactions to Erwinia asparaginase , including anaphylaxis [see Warnings and Precautions ( 5.1 )] ; • History of serious pancreatitis during previous asparaginase therapy [see Warnings and Precautions ( 5.2 )] ; • History of serious thrombosis during previous asparaginase therapy [see Warnings and Precautions ( 5.3 )] ; • History of serious hemorrhagic events during previous asparaginase therapy [see Warnings and Precautions ( 5.4 )] ; • Severe hepatic impairment [ see Warnings and Precautions ( 5.5 ) ]. RYLAZE is contraindicated in patients with: • History of serious hypersensitivity reactions to RYLAZE, including anaphylaxis. ( 4 ) • History of serious pancreatitis during previous L-asparaginase therapy. ( 4 ) • History of serious thrombosis during previous L-asparaginase therapy. ( 4 ) • History of serious hemorrhagic events during previous L-asparaginase therapy. ( 4 ) • Severe hepatic impairment. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Pancreatic Toxicity [see Warnings and Precautions ( 5.2 )] • Thrombosis [see Warnings and Precautions ( 5.3 )] • Hemorrhage [see Warnings and Precautions ( 5.4 )] • Hepatotoxicity, including VOD [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence > 20%) 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals Ireland Limited at 1-800-520-5568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 practic…
Frequently Asked Questions
What is Rylaze used for?
Rylaze contains asparaginase erwinia chrysanthemi (recombinant)-rywn. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Rylaze a controlled substance?
Rylaze is not classified as a controlled substance by the DEA.
What is the generic name for Rylaze?
The generic name for Rylaze is asparaginase erwinia chrysanthemi (recombinant)-rywn. There are no other listed brand versions of asparaginase erwinia chrysanthemi (recombinant)-rywn.
What is the NDC code for Rylaze 20 mg/mL?
The NDC (National Drug Code) for Rylaze 20 mg/mL is 68727-900, listed by Jazz Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)