Asparaginase Erwinia Chrysanthemi Recombinant

Asparaginase Erwinia Chrysanthemi Recombinant is an enzyme used as part of a chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients who have developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.

• Asparaginase Erwinia Chrysanthemi Recombinant is available under the following different brand names: Rylaze

Common side effects of Asparaginase Erwinia Chrysanthemi Recombinant include:

• serious allergic reactions (anaphylaxis)
• inflammation of the pancreas (pancreatitis)
• high blood levels of liver enzymes (abnormal transaminases and bilirubin)
• blood clotting
• bleeding (hemorrhage)
• nausea
• vomiting
• diarrhea
• stomach pain, and
• high blood sugar (hyperglycemia)

Serious side effects of Asparaginase Erwinia Chrysanthemi Recombinant include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• pancreatitis,
• glucose intolerance
• thrombosis and hemorrhage

Rare side effects of Asparaginase Erwinia Chrysanthemi Recombinant include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, solution

• 10 mg/0.5mL

Acute Lymphoblastic Leukemia & Lymphoma

Adult dosage

• 25 mg/m2 IM every 48 hours; duration-dependent regimen, OR
• Administer on a Monday/Wednesday/Friday schedule
• 25 mg/m2 IM every Monday and Wednesday mornings, AND
• 50 mg/m2 IM on Friday afternoon
• Administer Friday afternoon dose 53-58 hr after Wednesday morning dose (eg, 8:00 am on Monday and Wednesday and 1:00-6:00 pm on Friday)

Pediatric dosage

• Aged younger than 1 month: Safety and efficacy not established
• 25 mg/m2 IM every 48 hours; duration-dependent regimen, OR
• Administer on a Monday/Wednesday/Friday schedule
• 25 mg/m2 IM every Monday and Wednesday mornings, AND
• 50 mg/m2 IM on Friday afternoon
• Administer Friday afternoon dose 53-58 hr after Wednesday morning dose (eg, 8:00 am on Monday and Wednesday and 1:00-6:00 pm on Friday)

Lymphoblastic Lymphoma

Adult dosage

• 25 mg/m2 IM every 48 hours; duration-dependent regimen, OR
• Administer on a Monday/Wednesday/Friday schedule
• 25 mg/m2 IM every Monday and Wednesday mornings, AND
• 50 mg/m2 IM on Friday afternoon
• Administer Friday afternoon dose 53-58 hr after Wednesday morning dose (eg, 8:00 am on Monday and Wednesday and 1:00-6:00 pm on Friday)

Pediatric dosage

• Aged younger than 1 month: Safety and efficacy not established
• 25 mg/m2 IM every 48 hours; duration-dependent regimen, OR
• Administer on a Monday/Wednesday/Friday schedule
• 25 mg/m2 IM every Monday and Wednesday mornings, AND
• 50 mg/m2 IM on Friday afternoon
• Administer Friday afternoon dose 53-58 hr after Wednesday morning dose (eg, 8:00 am on Monday and Wednesday and 1:00-6:00 pm on Friday)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Asparaginase Erwinia Chrysanthemi Recombinant has no noted severe interactions with any other drugs
• Asparaginase Erwinia Chrysanthemi Recombinant has no noted serious interactions with any other drugs
• Asparaginase Erwinia Chrysanthemi Recombinant has no noted moderate interactions with any other drugs
• Asparaginase Erwinia Chrysanthemi Recombinant has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity reactions to E asparaginase, including anaphylaxis
• Serious pancreatitis during previous asparaginase therapy
• Serious thrombosis during previous asparaginase therapy
• Serious hemorrhagic events during previous asparaginase therapy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Asparaginase Erwinia Chrysanthemi Recombinant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Asparaginase Erwinia Chrysanthemi Recombinant?”

Cautions

• Pancreatitis, including elevated amylase or lipase, reported; monitor for signs and symptoms; withhold or discontinue depending on severity
• Serious thrombotic events reported, including sagittal sinus thrombosis and pulmonary embolism; discontinue if a thrombotic event occurs and administer antithrombotic therapy; consider resumption only if the event was an uncomplicated thrombosis
• Bleeding reported; monitor for bruising, nose bleeds, hematuria, rectal bleeding, and gingival bleeding; monitor PT, PTT, and hypofibrinogenemia
• Hepatotoxicity reported; evaluate bilirubin and transaminases before initiating and every 2 to 3 weeks as clinically indicated during treatment
• Hypersensitivity
  • 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 before administration of therapy as recommended
  • Owing to the risk for serious allergic reactions (eg, life-threatening anaphylaxis), administered in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis

Pregnancy and Lactation

• Based on findings from animal reproduction studies, it can cause fetal harm when administered to pregnant females
• Advise pregnant females of potential fetal risk
• Contraception
  • Females of reproductive potential: Use effective nonhormonal contraceptive methods during treatment and for 3 months after the last dose
• Lactation
  • Data are unavailable regarding the presence of the drug in human milk, its effects on breastfed children, or milk production
  • Advise women not to breastfeed during treatment and for 1 week after the last dose