calaspargase pegol (Rx)

Brand and Other Names:Asparlas, calaspargase pegol-mknl
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 3750 units/5mL (750 units/mL) in single-dose vials

Acute Lymphoblastic Leukemia

Indicated as part of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years

≤21 years: 2500 units/m² IV no more frequently than every 21 days

Dosage Modifications

Monitor patients at least weekly, with bilirubin, transaminases, glucose, and clinical examinations until recovery from the therapy cycle

Infusion or hypersensitivity reaction

  • Grade 1: Reduce infusion rate by 50%
  • Grade 2: Interrupt infusion and treat symptoms; when symptoms resolve, resume infusion and reduce rate by 50%
  • Grade 3: Discontinue permanently

Hemorrhage

  • Grade 3-4
    • Hold dosing
    • Evaluate for coagulopathy and consider clotting factor replacement
    • Resume dosing with next scheduled dose if bleeding controlled

Pancreatitis

  • Grade 3-4
    • Hold dosing for elevated lipase or amylase >3x ULN until enzymes levels stabilize or are declining
    • Discontinue permanently if clinical pancreatitis confirmed

Thromboembolism

  • Uncomplicated DVT
    • Hold dosing
    • Treat with appropriate antithrombotic therapy
    • Consider resuming upon resolution of symptoms, while continuing antithrombotic therapy
  • Severe or life-threatening thrombosis
    • Discontinue permanently
    • Treat with appropriate antithrombotic therapy

Hepatotoxicity

  • Total bilirubin >3 to ≤10x ULN: Hold dosing until total bilirubin decreases to ≤1.5x ULN
  • Total bilirubin >10x ULN: Discontinue dose and do not make up for missed doses

Dosing Considerations

Conduct pregnancy testing in females of reproductive potential before initiating treatment

Dosage Forms & Strengths

injectable solution

  • 3750 units/5mL (750 units/mL) in single-dose vials

Acute Lymphoblastic Leukemia

Indicated as part of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years

<1 month: Safety and efficacy not established

≥1 month: 2500 units/m² IV no more frequently than every 21 days

Dosage Modifications

Monitor patients at least weekly, with bilirubin, transaminases, glucose, and clinical examinations until recovery from the therapy cycle

Infusion or hypersensitivity reaction

  • Grade 1: Reduce infusion rate by 50%
  • Grade 2: Interrupt infusion and treat symptoms; when symptoms resolve, resume infusion and reduce rate by 50%
  • Grade 3: Discontinue permanently

Hemorrhage

  • Grade 3-4
    • Hold dosing
    • Evaluate for coagulopathy and consider clotting factor replacement
    • Resume dosing with next scheduled dose if bleeding controlled

Pancreatitis

  • Grade 3-4
    • Hold dosing for elevated lipase or amylase >3x ULN until enzymes levels stabilize or are declining
    • Discontinue permanently if clinical pancreatitis confirmed

Thromboembolism

  • Uncomplicated DVT
    • Hold dosing
    • Treat with appropriate antithrombotic therapy
    • Consider resuming upon resolution of symptoms, while continuing antithrombotic therapy
  • Severe or life-threatening thrombosis
    • Discontinue permanently
    • Treat with appropriate antithrombotic therapy

Hepatotoxicity

  • Total bilirubin >3 to ≤10x ULN: Hold dosing until total bilirubin decreases to ≤1.5x ULN
  • Total bilirubin >10x ULN: Discontinue dose and do not make up for missed doses

Dosing Considerations

Conduct pregnancy testing in females of reproductive potential before initiating treatment

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Adverse Effects

>10% All Grades

Pancreatitis (12-16%)

Thrombotic events (9-12%)

>10% Grades 3-4

Elevated transaminase (52%)

Hypersensitivity (7-21%)

Increased bilirubin (20%)

Pancreatitis (18%)

Abnormal clotting studies (14%)

1-10% Grades 3-4

Diarrhea (9%)

Embolic and thrombotic events (8%)

Sepsis (5%)

Dyspnea (4%)

Hemorrhages (4%)

Fungal infection (3%)

Pneumonia (3%)

Arrhythmia (2%)

Cardiac failure (2%)

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Warnings

Contraindications

History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase

History of serious thrombosis, pancreatitis, or hemorrhagic during previous L-asparaginase therapy

Severe hepatic impairment

Cautions

Also see Dosage Modifications

Pancreatitis reported; inform patients of signs and symptoms, which, if untreated, could be fatal; assess serum amylase and/or lipase levels; discontinue if pancreatitis suspected and permanently discontinue if confirmed

Serious thrombotic events, including sagittal sinus thrombosis, reported; discontinue if thrombotic event occurs

Hemorrhage associated in increased PT, PTT, and hypofibrinogenemia reported; consider appropriate replacement therapy with severe or symptomatic coagulopathy

Hypersensitivity

  • Grade 3-4 hypersensitivity, including anaphylaxis, reported
  • Symptoms may include angioedema, lip swelling, eye swelling, erythema, decreased blood pressure, bronchospasm, dyspnea, pruritus, or rash
  • Because of this risk, administer in clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis and observe patients for 1 hr after administration
  • Discontinue with serious hypersensitivity

Hepatoxicity

  • Hepatotoxicity and abnormal liver function, including elevated transaminases, bilirubin, reduced serum albumin, and plasma, can occur
  • Evaluate bilirubin and transaminases at least weekly during treatment cycles and through at least 6 weeks after last dose
  • Discontinue if serious liver toxicity occurs
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Pregnancy

Pregnancy

Based on studies in pregnant animals, calaspargase pegol can cause fetal harm when administered to pregnant women

Conduct pregnancy testing in females of reproductive potential before initiating treatment

Animal studies

  • Published literature studies in pregnant animals suggest asparagine depletion may cause harm to the animal offspring; advise patients of the potential risk to a fetus

Contraception

  • Advise females of reproductive potential to avoid becoming pregnant while receiving calaspargase pegol
  • Effective contraceptive methods, including a barrier method, should be used during treatment and for at least 3 months after the last dose
  • Since there is a potential for an indirect interaction between calaspargase pegol and oral contraceptives, concomitant use is not recommended
  • Another, nonoral contraceptive method should be used in women of childbearing potential

Lactation

There are no data on the presence of calaspargase pegol in human milk, the effects on the breastfed child, or the effects on milk production

Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child, advise lactating women not to breastfeed while receiving calaspargase pegol and for 3 months after the last dose

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Enzyme that catalyzes conversion of the amino acid L-asparagine into aspartic acid and ammonia

The pharmacological effect is thought to be based on selective killing of leukemic cells owing to depletion of plasma L-asparagine; leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize L-asparagine, and therefore depend on an exogenous source of L-asparagine for survival

Absorption

Peak plasma time: 1.17 h

Peak plasma concentration: 1.62 units/mL

AUC, 0-25 days: 16.9 day·unit/mL

AUC 0-infinity: 25.5 day·unit/mL

Distribution

Vd (steady-state): 2.96 L

Elimination

Half-life: 16.1 days

Clearance: 0.147 L/day

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Administration

IV Compatibilities

0.9% NaCl

D5W

IV Preparation

Preservative-free solution should appear clear and colorless

Visually inspect solution for particulate matter, cloudiness, or discoloration; if observed, discard vial

Do not administer if vial has been shaken or vigorously agitated, frozen, or stored at room temperature for >48 hr

Dilute calculated dose in 100 mL of 0.9% NaCl or D5W; discard any unused portion in vial(s)

IV Administration

Administer in clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis and observe patients for 1 hr after administration

After dilution, administer immediately into a running IV infusion of either 0.9% NaCl or D5W

Administer over 1 hr

Do not infuse other drugs through the same IV line during administration

Storage

Unopened vials

  • Refrigerate at 2-8°C (36-46°F) in the original carton to protect from light
  • Do not shake or freeze
  • Store at room temperature (15-25°C [59-77°F]) for up to 48 hr

Diluted solution

  • May be stored up to 4 hr at room temperature (15-25°C [59-77°F]) OR
  • May refrigerate up to 24 hr at 2-8°C (36-46°F)
  • Protect from light
  • Do not shake
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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.