ONCASPAR- pegaspargase injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PEGASPARGASE (UNII: 7D96IR0PPM) (PEGASPARGASE - UNII:7D96IR0PPM)

Available from:

Servier Pharmaceuticals LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ONCASPAR® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase. ONCASPAR is contraindicated in patients with a: - History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients [see Warnings and Precautions (5.1)] . - History of serious thrombosis with prior L-asparaginase therapy [see Warnings and Precautions (5.2)] . - History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy [see Warnings and Precautions (5.3)] . - History of serious hemorrhagic events with prior L-asparaginase therapy [see Warnings and Precautions (5.5)] . - Severe hepatic impairment [see Warnings and Precautions (5.6)] . Risk summary Based on published literature studies with L-asparaginase in pregnant animals, ONCASPAR can cause fetal harm when administered to a pregnant woman. There are no available data on ONCASPAR use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published literature studies in pregnant animals suggest asparagine depletion may cause harm to the animal offspring (see Data) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with ONCASPAR to evaluate its effect on reproduction and fetal development. Published literature studies in which pregnant rabbits were administered L-asparaginase or pregnant rats were deprived of dietary asparagine suggested harm to the animal offspring. Risk summary There are no data on the presence of pegaspargase in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with ONCASPAR and for 1 month after the last dose. ONCASPAR can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Pregnancy Pregnancy testing is recommended in females of reproductive potential prior to initiating ONCASPAR. Contraception Advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with ONCASPAR and for 3 months after the last dose. The safety and effectiveness of ONCASPAR in the treatment of ALL have been established in pediatric patients. Use of ONCASPAR in these age groups is supported by evidence of efficacy as first-line treatment from one adequate and well-controlled trial, and evidence of efficacy for treatment of patients with hypersensitivity to asparaginase from four adequate and well-controlled trials [see Clinical Studies (14.1)] , and safety data from 7 total trials. The pediatric patients treated with ONCASPAR 2,500 International Units/m2 on these trials included 26 infants (1 month to <2 years old), 165 children (2 years to <12 years old), and 39 adolescents (12 to 17 years old). Clinical studies of ONCASPAR did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.

Product summary:

ONCASPAR (pegaspargase) injection is supplied as a sterile, clear, colorless, preservative-free solution in Type I single-dose vial containing 3,750 International Units of pegaspargase per 5 mL (750 International Units per mL) solution (NDC 72694-954-01). Store ONCASPAR refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake or freeze product . Unopened vials may be stored at room temperature (15°C to 25°C [59°F to 77°F]) for no more than 48 hours.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ONCASPAR- PEGASPARGASE INJECTION, SOLUTION
SERVIER PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONCASPAR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONCASPAR.
ONCASPAR (PEGASPARGASE) INJECTION, FOR INTRAMUSCULAR OR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1994
RECENT MAJOR CHANGES
Warnings and Precautions (5.6)
3/2024
INDICATIONS AND USAGE
ONCASPAR is an asparagine specific enzyme indicated as a component of
a multi-agent
chemotherapeutic regimen for treatment of pediatric and adult patients
with:
First-line acute lymphoblastic leukemia (1.1)
Acute lymphoblastic leukemia and hypersensitivity to asparaginase
(1.2)
DOSAGE AND ADMINISTRATION
Administered intramuscularly or intravenously no more frequently than
every 14 days. (2.1)
Patients ages 21 years and younger: 2,500 International Units/m .
(2.1)
Patients ages over 21 years: 2,000 International Units/m . (2.1)
For intramuscular administration, limit the volume at a single
injection site to 2 mL; if greater than 2
mL, use multiple injection sites. (2.3)
For intravenous administration, give over a period of 1 to 2 hours in
100 mL of 0.9% Sodium Chloride
Injection, USP or 5% Dextrose Injection, USP through an infusion that
is already running. (2.3)
Do not administer ONCASPAR if drug has been frozen, stored at room
temperature for more than 48
hours, or shaken or vigorously agitated. (16)
DOSAGE FORMS AND STRENGTHS
Injection: 3,750 International Units/5 mL (750 International Units/mL)
solution in a single-dose vial. (3)
CONTRAINDICATIONS
History of serious hypersensitivity reactions to ONCASPAR. (4)
History of serious thrombosis with prior L-asparaginase therapy. (4)
History of pancreatitis with prior L-asparaginase therapy. (4)
History of serious hemorrhagic events with prior L-asparaginase
therapy. (4)
Severe hepatic impairment. (4)
WARNINGS AND PRECAUTIONS
Anaphylaxis or serious hypersensitivity reactions: Observe patients
for 1 hour after administration.
Dis