Asparaginase erwinia chrysanthemi (recombinant)-rywn
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Asparaginase erwinia chrysanthemi (recombinant)-rywn is an asparagine specific enzyme that is FDA approved for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products, as a component of a chemotherapy regimen. Common adverse reactions include musculoskeletal pain, febrile neutropenia, hypokalemia, abnormal liver test, abdominal pain, hypersensitivity, pyrexia, fatigue, nausea, infection, decreased appetite, stomatitis, hemorrhage, diarrhea, drug hypersensitivity, pancreatitis, and hyperglycemia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Treatment Options of Rylaze to replace a long-acting asparaginase product
- Option 1 is 25 mg/m2 administered intramuscularly every 48 hours
- Option 2 is 25 mg/m2 intramuscularly in the mornings of Monday and Wednesday, and 50 mg/m2 intramuscularly in the afternoon on Friday. Friday dosage should be administered 53 to 58 hours after the Wednesday dose.
Table 1 summarizes Recommended Duration of Rylaze Dosing to Replace One Long-Acting Asparaginase Dose.
Insert Table 1
Recommended Pre-medication
- 30-60 minutes prior to Rylaze treatment, consider administering an H-1 receptor blocker, acetaminophen, and an H-2 receptor blocker to reduce severity and risk of hypersensitivity reactions.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in pediatric patients.
Contraindications
- Serious hypersensitivity reactions to Erwinia asparaginase
- If a patient experienced, during previous asparaginase therapy, serious pancreatitis
- If a patient experienced, during previous asparaginase therapy, serious thrombosis
- If a patient experienced, during previous asparaginase therapy, serious hemorrhagic events
Warnings
Hypersensitivity Reactions
- 29% of patients experienced hypersensitivity reactions in clinical trials when given Rylaze
- 6% of patients experienced severe hypersensitivity reactions in clinical trials when given Rylaze
- 2% of patients in clinical trials experienced anaphylaxis after intramuscular administration
- 5% of patients in clinical trials had to discontinue treatment due to hypersensitivity reactions
- 12 doses was the median number to the first recorded experience of a hypersensitivity reaction from a patient receiving Rylaze.
- Rash was the most common observed reaction
- Blood pressure decrease, pruritus, eye swelling, angioedema, rash or erythema, dyspnea, lip swelling, bronchospasm, and urticaria are some of the many hypersensitivity reactions observed with L-asparaginase class products
- If severe hypersensitivity reaction is observed, patients are advised to discontinue Rylaze treatment.
Pancreatitis
- 20% of patients experienced pancreatitis in clinical trials when given Rylaze
- 8% of patients experienced severe pancreatitis in clinical trials when given Rylaze
- 7% of patients experienced symptomatic pancreatitis in clinical trials when given Rylaze
- 6% of patients experienced severe symptomatic pancreatitis in clinical trials when given Rylaze
- 13% of patients had signs of elevated lipase or amylase without symptomatic pancreatitis.
- Necrotizing pancreatitis and hemorrhagic pancreatitis are observed with L-asparaginase class products
- Advise patients about signs and symptoms associated with pancreatitis
- Monitor patients lipase levels and serum amylase levels during Rylaze treatment
- Advise patients with severe or hemorrhagic pancreatitis to discontinue Rylaze treatment
- Withhold treatment of Rylaze in patients who experience mild pancreatitis till the signs/symptoms are gone as well as the return of amylase/lipase levels to 1.5 times the ULN
Thrombosis
- 1% of patients experienced serious thrombotic events in clinical trials when given Rylaze
- Advise patients who experience signs/symptoms associated with a thrombotic event to discontinue Rylaze treatment
- If the patient experienced an uncomplicated thrombosis, the patient should be considered for Rylaze treatment
Hemorrhage
- 25% of patients experienced bleeding in clinical trials when treated with Rylaze
- 2% of patients experienced severe bleeding in clinical trials when treated with Rylaze
- Nose bleed and bruising were most common observed reaction
- For patients with severe or symptomatic coagulopathy, replacement therapy should be considered
Hepatotoxicity
- 75% of patients experienced elevated bilirubin and/or transaminases in clinical trials when treated with Rylaze
- 26% had Grade ≥ 3 elevations of bilirubin and/or transaminases in clinical trials when treated with Rylaze
- 28% of patients experienced elevated bilirubin in clinical trials when treated with Rylaze
- 2% had Grade ≥ 3 elevations of bilirubin in clinical trials when treated with Rylaze
- 73% of patients experienced elevated transaminases in clinical trials when treated with Rylaze
- 25% had Grade ≥ 3 elevations of transaminases in clinical trials when treated with Rylaze
- Monitor bilirubin and transaminases levels in patients treated with Rylaze
- Patients who experience serious liver toxicity should discontinue Rylaze treatment
Adverse Reactions
Clinical Trials Experience
Clinical Trials Experience
Postmarketing Experience
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Asparaginase erwinia chrysanthemi (recombinant)-rywn in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Asparaginase erwinia chrysanthemi (recombinant)-rywn in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Asparaginase erwinia chrysanthemi (recombinant)-rywn during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in geriatric settings.
Gender
There is no FDA guidance on the use of Asparaginase erwinia chrysanthemi (recombinant)-rywn with respect to specific gender populations.
Race
There is no FDA guidance on the use of Asparaginase erwinia chrysanthemi (recombinant)-rywn with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Asparaginase erwinia chrysanthemi (recombinant)-rywn in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Administration in the drug label.
Monitoring
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Asparaginase erwinia chrysanthemi (recombinant)-rywn and IV administrations.
Overdosage
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Mechanism of Action in the drug label.
Structure
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Structure in the drug label.
Pharmacodynamics
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Clinical Studies in the drug label.
How Supplied
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn How Supplied in the drug label.
Storage
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Asparaginase erwinia chrysanthemi (recombinant)-rywn |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Asparaginase erwinia chrysanthemi (recombinant)-rywn |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Asparaginase erwinia chrysanthemi (recombinant)-rywn interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Asparaginase erwinia chrysanthemi (recombinant)-rywn Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.