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:

Baxalta US Inc.

INN (International Name):

PEGASPARGASE

Composition:

PEGASPARGASE 750 [iU] in 1 mL

Administration route:

INTRAMUSCULAR

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 There are no available data on the use of ONCASPAR i

Product summary:

ONCASPAR (pegaspargase) Injection is supplied as a sterile, clear, colorless, preservative-free solution in Type I single-dose vials containing 3,750 International Units of pegaspargase per 5 mL (750 International Units per mL) solution (NDC 0944-3810-01). 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
BAXALTA US INC.
----------
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
Dosage and Administration, Recommended Dosage (2.1)
1/2019
Dosage and Administration, Dose Modifications (2.2)
1/2019
Contraindications (4)
1/2019
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
Anaphyl