THE ONLY FDA-APPROVED ERWINIA ASPARAGINASE FOR THE TREATMENT OF ALL/LBL1
RELY ON RYLAZE
Meeting supply needs with modern, recombinant manufacturing
RYLAZE (NDC 68727-900-01) is available through our specialty distribution partners
Specialty Distributors
RYLAZE (asparaginase erwinia chrysanthemi (recombinant)-rywn) is available for purchase from the authorized Specialty Distributors listed below. Verify that your facility has an account with their Specialty Distributor before ordering. If not, they should contact their Specialty Distributor. The facility should also contact their Specialty Distributor with questions regarding product returns.
ASD Healthcare
RYLAZE Item #: 10259717
Phone: 1-800-746-6273
Fax: 1-800-547-9413
asd.customerservice@asdhealthcare.com
- Orders can be placed Monday-Thursday, 7 AM-6:30 PM CT; Friday, 7 AM-6 PM CT
- For emergency orders after hours of service, call 1-800-746-6273
Oncology Supply
RYLAZE Item #: 10259764
Phone: 1-800-633-7555
Fax: 1-800-248-8205
custserv@oncologysupply.com
- Orders can be placed Monday-Friday, 9 AM-8 PM CT
- Orders placed after hours via Oncology Supply’s email address are processed the next business day
Cardinal Specialty Pharmaceutical Distribution
RYLAZE Item #: 5731948
Phone: 1-877-453-3972
Fax: 1-877-274-9897
SPDOncologyTeam@cardinalhealth.com
- Orders can be placed Monday-Friday, 8 AM-7 PM CT
- For emergency orders after hours of service, call 1-877-453-3972
McKesson Plasma and Biologics
RYLAZE Item #: 2338747
Phone: 1-877-625-2566
Fax: 1-888-752-7626
MPBOrders@mckesson.com
- Orders can be placed Monday-Friday, 9 AM-7:30 PM ET
- Email for all other information requests: MPB@mckesson.com
- For emergency orders after hours of service, call 1-877-625-2566
RYLAZE Coding Information
| Permanent J Code |
|---|
| J9021 |
Effective January 1, 2022
| NDC | ||
|---|---|---|
| 10-digit | 11-digit | Carton containing 3 vials of RYLAZE |
| 68727-900-03 | 68727-0900-03 | |
Payers may require a 10-digit or 11-digit NDC. Both are provided for your convenience. These are sample codes based on publicly available information and are informational only and not a guarantee or promise of coverage. Appropriate codes can vary by patient, setting of care, and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements.
Press Releases
See the exciting announcements and more information about RYLAZE in these press releases.
NCCN ANNOUNCEMENTLABEL ANNOUNCEMENT
LATEST DATA RELEASE
Patient Access and Resources
JazzCares® supports healthcare providers and office staff with coverage and reimbursement supporta so appropriate patients can get access to RYLAZE and reduce their out-of-pocket costs.b
JazzCares
Assists you with benefits investigations, prior authorizations and appeals,a and referrals to other financial assistance options for eligible patients.
Savings Card
Eligible, commercially insured patients can pay as little as $10 for their RYLAZE medication, subject to an annual maximum (restrictions apply).a
Free Drug Program
Uninsured or underinsured patients who meet certain financial criteria may be eligible to receive RYLAZE at no cost.b
Learn more about JazzCares support offerings by calling 1-833-533-JAZZ (5299) Monday-Friday, 8 am - 8 pm ET, or visiting the JazzCares site.
- Insurance coverage and plans may vary. JazzCares provides general information only and is not a guarantee of any coverage or reimbursement outcome. All treatment decisions rest solely with the treating physician or qualified healthcare professional.
- Subject to eligibility requirements and terms and conditions.
Leighton's story—completing treatment with RYLAZE
Dosing and Administration
When replacing a long-acting asparaginase product, the recommended dosage of RYLAZE is:
- 25 mg/m2 administered intramuscularly (IM) every 48 hours1
See the full prescribing information for the long-acting asparaginase product to determine the duration of administration of RYLAZE as replacement therapy.1
RYLAZE is administered by intramuscular injection.1
- Limit the volume of RYLAZE at a single injection site to 2 mL1
- If the volume to be administered is greater than 2 mL, divide the dose equally into multiple syringes, 1 for each injection site1
- Administer RYLAZE by intramuscular injection within 4 hours after drawing the dose into the syringe(s)1
- Rotate injection sites
- Do not inject RYLAZE into scar tissue or areas that are reddened, inflamed, or swollen
- If needed, store the syringe(s) at room temperature 59°F to 77°F or refrigerated at 36°F to 46°F for up to 4 hours. The syringe does not need to be protected from light during storage
- Ensure that medical support is available to appropriately manage anaphylactic reactions when administering RYLAZE1
Monitor patient’s bilirubin, transaminase, 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 below1
| Adverse Reaction | Severity* | Action |
|---|---|---|
| Hypersensitivity Reaction | Grade 2 |
|
| Grade 3 to 4 |
| |
| Pancreatitis | Grade 2 to 4 |
|
| Thrombosis | Uncomplicated thrombosis |
|
| Severe or life-threatening thrombosis |
| |
| Hemorrhage | Grade 3 to 4 |
|
| Hepatotoxicity | Total bilirubin >3 times to ≤10 times the ULN |
|
| Total bilirubin >10 times the ULN |
|
*Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
To calculate 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 total volume of RYLAZE solution required for each dose:Volume(mL)=BSA(m2)xDose(25 mg/m2)÷Concentration(20 mg/mL)
- Calculate the total volume of RYLAZE solution required for each dose:
| BSA (m2) | Injection volume based on BSA, mL | Number of vials per 25 mg/m2 dose |
|---|---|---|
| 0.4 | 0.5 | 1 |
| 0.5 | 0.63 | 2 |
| 0.6 | 0.75 | 2 |
| 0.7 | 0.88 | 2 |
| 0.8 | 1 | 2 |
| 0.9 | 1.13 | 3 |
| 1.0 | 1.25 | 3 |
| 1.1 | 1.38 | 3 |
| 1.2 | 1.5 | 3 |
| 1.3 | 1.63 | 4 |
| 1.4 | 1.75 | 4 |
| 1.5 | 1.88 | 4 |
| 1.6 | 2 | 4 |
| 1.7 | 2.13 | 5 |
| 1.8 | 2.25 | 5 |
| 1.9 | 2.38 | 5 |
| 2.0 | 2.5 | 5 |
| 2.1 | 2.63 | 6 |
| 2.2 | 2.75 | 6 |
| 2.3 | 2.88 | 6 |
| 2.4 | 3 | 6 |
- 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
RYLAZE Dosing and Ordering Guide—dosing, ordering, and patient support information on the go.
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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.
ALL=acute lymphoblastic leukemia; FDA=Food and Drug Administration; LBL=lymphoblastic lymphoma; NCCN=National Comprehensive Cancer Network; NDC=National Drug Code; ULN=upper limit of normal.
Reference: 1. RYLAZE [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.