Brand Name
Oncaspar
Generic Name
Pegaspargase
View Brand Information FDA approval date: January 02, 2020
Classification: Asparagine-specific Enzyme
Form: Injection
What is Oncaspar (Pegaspargase)?
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.
Approved To Treat
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Brand Information
ONCASPAR (Pegaspargase)
1DOSAGE FORMS AND STRENGTHS
Injection: 3,750 International Units/5 mL (750 International Units/mL) clear, colorless solution in a single-dose vial.
2CONTRAINDICATIONS
ONCASPAR is contraindicated in patients with a:
- History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients
- History of serious thrombosis with prior L-asparaginase therapy
- History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy
- History of serious hemorrhagic events with prior L-asparaginase therapy
- Severe hepatic impairment
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Anaphylaxis and serious hypersensitivity reactions
- Thrombosis
- Pancreatitis
- Glucose intolerance
- Hemorrhage
- Hepatotoxicity, including VOD
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
The most common grade 3 and 4 adverse reactions (>5%) included: hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections.
3.2Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other asparaginase products may be misleading.
In Study CCG-1962, ONCASPAR treated patients were assessed for evidence of binding antibodies using an enzyme-linked immunosorbent assay (ELISA) method. The incidence of protocol-specified "high-titer" antibody formation was 2% in Induction (n=48), 10% in Delayed Intensification 1 (n=50), and 11% in Delayed Intensification 2 (n=44). In study CCG-1962, there is insufficient information to determine whether the development of antibodies is associated with an increased risk of clinical allergic reactions or altered pharmacokinetics (i.e., loss of asparaginase activity).
In Study DFCI 11-001, of the 100 evaluable patients treated with ONCASPAR, 19 (19%) patients developed anti-drug antibodies (ADA) during treatment; 18 of these 19 patients were positive for anti-PEG antibodies. The presence of ADA correlated with the occurrence of hypersensitivity reactions. There is insufficient information to determine whether the development of antibodies is associated with altered pharmacokinetics (i.e., loss of asparaginase activity).
3.3Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ONCASPAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: Coagulopathy.
Gastrointestinal disorders: Hepatic impairment, pancreatic cyst, pancreatitis.
Hepatic: Veno-occlusive disease.
Immune system disorders: Anaphylactic shock, hypersensitivity reaction.
Investigations: Blood cholesterol increased.
Metabolism and nutrition disorders: Hyperglycemia, hyperammonemia.
Musculoskeletal and connective tissue disorders: Osteonecrosis.
Vascular disorders: Hemorrhage including central nervous system hemorrhage, thrombosis including superior sagittal sinus thrombosis.
4OVERDOSAGE
Three patients received 10,000 International Units/m
There is no specific antidote for ONCASPAR overdosage. In case of overdose, monitor patients closely for signs and symptoms of adverse reactions, and appropriately manage with symptomatic and supportive treatment.
5DESCRIPTION
Pegaspargase is a conjugate of monomethoxypolyethylene glycol (mPEG) and L-asparaginase (L-asparagine amidohydrolase), an asparagine specific enzyme. L-asparaginase is a tetrameric enzyme that is produced endogenously by
ONCASPAR (pegaspargase) injection is supplied as a clear, colorless, preservative-free, isotonic sterile solution in phosphate-buffered saline, pH 7.3, for intramuscular use or for dilution prior to intravenous infusion. Each vial of ONCASPAR contains 3,750 International Units of pegaspargase in 5 mL of solution. Each milliliter contains 750 International Units of pegaspargase, dibasic sodium phosphate, USP (5.58 mg), monobasic sodium phosphate, USP (1.20 mg), and Sodium Chloride, USP (8.50 mg) in Water for Injection, USP.
6HOW SUPPLIED/STORAGE AND HANDLING
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).
7PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton
NDC 72694-954-01
ONCASPAR
3750 International
For intravenous or intramuscular use.
Single-use vial.
Discard unused portion.
Rx ONLY
