Usual Adult Dose for Acute Lymphoblastic Leukemia

There are two recommended regimens that can be used to replace a long-acting asparaginase product dose:

When administered every 48 hours: 25 mg/m2 IM every 48 hours
Recommended duration:

• To replace one dose of Calaspargase Pegol product: 11 doses of this drug
• To replace one dose of Pegaspargase products: 7 doses of this drug

When administered on a Monday/Wednesday/Friday schedule: 25 mg/m2 IM on Monday and Wednesday mornings, and 50 mg/m2 IM on Friday afternoon (53 to 58 hours after Wednesday morning dose)
Recommended duration:

• To replace one dose of Calaspargase Pegol product: 9 doses of this drug
• To replace one dose of Pegaspargase products: 6 doses of this drug

Comments:

• Premedicate patients as recommended (see Administration advice)

Uses:

• Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults who have developed hypersensitivity to E. coli-derived asparaginase.

Usual Adult Dose for Lymphoma

There are two recommended regimens that can be used to replace a long-acting asparaginase product dose:

When administered every 48 hours: 25 mg/m2 IM every 48 hours
Recommended duration:

• To replace one dose of Calaspargase Pegol product: 11 doses of this drug
• To replace one dose of Pegaspargase products: 7 doses of this drug

When administered on a Monday/Wednesday/Friday schedule: 25 mg/m2 IM on Monday and Wednesday mornings, and 50 mg/m2 IM on Friday afternoon (53 to 58 hours after Wednesday morning dose)
Recommended duration:

• To replace one dose of Calaspargase Pegol product: 9 doses of this drug
• To replace one dose of Pegaspargase products: 6 doses of this drug

Comments:

• Premedicate patients as recommended (see Administration advice)

Uses:

• Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults who have developed hypersensitivity to E. coli-derived asparaginase.

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

There are two recommended regimens that can be used to replace a long-acting asparaginase product dose:

When administered every 48 hours: 25 mg/m2 IM every 48 hours
Recommended duration:

• To replace one dose of Calaspargase Pegol product: 11 doses of this drug
• To replace one dose of Pegaspargase products: 7 doses of this drug

When administered on a Monday/Wednesday/Friday schedule: 25 mg/m2 IM on Monday and Wednesday mornings, and 50 mg/m2 IM on Friday afternoon (53 to 58 hours after Wednesday morning dose)
Recommended duration:

• To replace one dose of Calaspargase Pegol product: 9 doses of this drug
• To replace one dose of Pegaspargase products: 6 doses of this drug

Comments:

• Premedicate patients as recommended (see Administration advice)

Uses:

• Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric patients one month old or older, with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed hypersensitivity to E. coli-derived asparaginase.

Usual Pediatric Dose for Lymphoma

There are two recommended regimens that can be used to replace a long-acting asparaginase product dose:

When administered every 48 hours: 25 mg/m2 IM every 48 hours
Recommended duration:

• To replace one dose of Calaspargase Pegol product: 11 doses of this drug
• To replace one dose of Pegaspargase products: 7 doses of this drug

When administered on a Monday/Wednesday/Friday schedule: 25 mg/m2 IM on Monday and Wednesday mornings, and 50 mg/m2 IM on Friday afternoon (53 to 58 hours after Wednesday morning dose)
Recommended duration:

• To replace one dose of Calaspargase Pegol product: 9 doses of this drug
• To replace one dose of Pegaspargase products: 6 doses of this drug

Comments:

• Premedicate patients as recommended (see Administration advice)

Uses:

• Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric patients one month old or older, with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed hypersensitivity to E. coli-derived asparaginase.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dose modifications for adverse reactions:

HYPERSENSITIVITY REACTIONS:

• Grade 2: Treat symptoms
• Grade 3 to 4: Discontinue permanently

PANCREATITIS:

• Grade 2 to 4:
• Withhold treatment for lipase or amylase elevations greater than 2 times the upper limit of normal (ULN), or for symptomatic pancreatitis.
• Resume treatment when lipase and amylase are less than 1.5 times the ULN, and symptoms resolve.
• Discontinue permanently if clinical necrotizing or hemorrhagic pancreatitis is confirmed.

THROMBOSIS:
Uncomplicated thrombosis:

• Withhold treatment, treat with appropriate antithrombotic therapy.
• Consider resuming treatment upon resolution of symptoms and continue antithrombotic therapy.

Severe or life-threatening thrombosis:

• Discontinue permanently and treat with appropriate antithrombotic therapy.

HEMORRHAGE:
Grade 3 to 4:

• Withhold treatment, evaluate coagulopathy, and consider clotting factor replacement as needed.
• Resume treatment with the next scheduled dose if the bleeding is controlled.

HEPATOTOXICITY:
Total bilirubin greater than 3 times to lower than 10 times ULN:

• Withhold treatment until total bilirubin levels decrease to 1.5 times the ULN or lower.

Total bilirubin greater than 10 times the ULN:

• Discontinue treatment (do not make up missed doses).

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS:

• History of serious hypersensitivity to Erwinia asparaginase, including anaphylaxis
• Serious pancreatitis with previous L-asparaginase therapy
• Serious thrombosis with previous L-asparaginase therapy
• Serious hemorrhagic events with previous L-asparaginase therapy

Safety and efficacy have not been established in patients younger than 1 month old.
Safety and efficacy have not been established in patients 65 years or older.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Premedicate patients with acetaminophen, an H-1 receptor blocker, and an H-2 receptor blocker 30 to 60 minutes before administration to decrease the risk of hypersensitivity reactions.
• Ensure that medical support is available to appropriately manage anaphylactic reactions.
• Administer by intramuscular (IM) injection only.
• Do not inject in scar tissue or red, swollen areas.
• Rotate injection sites.

Storage requirements:

• Store unused or unopened vials and cartons at 2C to 8C (36F to 46F).
• Store in original carton to protect from light.
• Do not shake or freeze.
• If prepared dose is not used immediately, store the syringe at room temperature 15C to 25C (59F to 77F) for up to 8 hours or refrigerate at 2C to 8C (36F to 46F) for up to 24 hours. The syringe does not need to be protected from light during storage.

Preparation techniques: The manufacturer product information should be consulted.

Monitoring:

• Monitor bilirubin, transaminases, glucose levels at baseline and periodically every 2 to 3 weeks during treatment.

Patient advice:

• Read the Patient Information and Instructions for Use.