oncaspar- pegaspargase injection, solution for intramuscular and intravenous use

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

pegaspargase (UNII: 7D96IR0PPM) (pegaspargase - UNII:7D96IR0PPM)

INN (International Name):

pegaspargase

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

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 patients with ALL. Oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase. - History of serious allergic reactions to Oncaspar® - History of serious thrombosis with prior L-asparaginase therapy - History of pancreatitis with prior L‑asparaginase therapy - History of serious hemorrhagic events with prior L-asparaginase therapy Pregnancy Category C . Animal reproduction studies have not been conducted with Oncaspar® . It is also not known whether Oncaspar® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Oncaspar® should be given to a pregnant woman only if clearly needed. It is not known whether Oncaspar® is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reacti

Product summary:

Dosage Form NDC 57665-002-02 3,750 IU/5 mL single-use vial individually packaged in a carton Storage and Handling Keep refrigerated at +2°C to +8ºC (36°F to 46°F). Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration. Do not administer Oncaspar® if the drug:

Summary of Product characteristics

ONCASPAR- PEGASPARGASE INJECTION, SOLUTION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
RECENT MAJOR CHANGES
Indications and Usage, 9/2006
First line acute lymphoblastic leukemia (ALL) (1.1)
Contraindications, 9/2006
History of serious thrombosis with prior L-asparaginase therapy (4)
INDICATIONS AND USAGE
Oncaspar
is indicated as a component of a multi-agent chemotherapeutic regimen
for treatment of patients with:
First line acute lymphoblastic leukemia (1.1)
Acute lymphoblastic leukemia and hypersensitivity to asparaginase
(1.2)
DOSAGE AND ADMINISTRATION
2,500 IU/m intramuscularly (IM) or intravenously (IV) no more
frequently than every 14 days. (2.1)
For IM administration, limit the volume at a single injection site to
2 mL; if greater than 2 mL, use multiple injection
sites. (2.2)
For IV administration, give over a period of 1 to 2 hours in 100 mL of
sodium chloride or dextrose injection 5%, through
an infusion that is already running. (2.2)
Do not administer Oncaspar
if drug has been frozen, stored at room temperature for more than 48
hours, or shaken or
vigorously agitated. (2.3)
DOSAGE FORMS AND STRENGTHS
3,750 IU/5 mL single-use vial. (3)
CONTRAINDICATIONS
History of serious allergic 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)
WARNINGS AND PRECAUTIONS
If the following occur - discontinue Oncaspar
:
Anaphylaxis or serious allergic reactions (5.1)
Thrombosis (5.2)
Pancreatitis (5.3)
Glucose intolerance, in some cases irreversible, can occur (5.4)
Coagulopathy can occur. Perform appropriate monitoring. (5.5)
ADVERSE REACTIONS
Most common adverse reactions (≥ 2%) are allergic reactions
(including anaphylaxis), central nervous system (CNS)
thrombosis, coagulopathy, elevated transaminases, hyperbilirubinemia,
hyperglycemia, and pancreatitis. (6)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2006
FULL PRESCRIBING I