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Oncaspar

Last reviewed on RxList: 1/11/2019
Oncaspar Side Effects Center

Last reviewed on RxList 1/11/2019

Oncaspar (pegaspargase) is a cancer (antineoplastic) medication used to treat acute lymphoblastic leukemia. Common side effects of Oncaspar include:

  • nausea
  • vomiting
  • weakness
  • loss of appetite
  • diarrhea
  • dizziness
  • skin rash or itching
  • depression
  • drowsiness
  • swelling in your hands/ankles/feet
  • weight loss
  • stomach cramps
  • headache
  • tiredness
  • irritability
  • injection site reactions (pain swelling or redness).
The recommended dose of Oncaspar is 2,500 IU/m2 intramuscularly (IM) or intravenously (IV). It should be administered no more frequently than every 14 days. Oncaspar may interact with vincristine, prednisone, or methotrexate. Tell your doctor all medications and supplements you use. During pregnancy, Oncaspar should be used only when prescribed. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Oncaspar Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Oncaspar (Pegaspargase)

Oncaspar Professional Information

SIDE EFFECTS

The following serious adverse reactions are described in greater detail in other sections of the label:

  • Anaphylaxis and serious allergic reactions [see WARNINGS AND PRECAUTIONS]
  • Serious thrombosis [see WARNINGS AND PRECAUTIONS]
  • Pancreatitis [see WARNINGS AND PRECAUTIONS]
  • Glucose intolerance [see WARNINGS AND PRECAUTIONS]
  • Coagulopathy [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity and abnormal liver function [see WARNINGS AND PRECAUTIONS]
    The most common adverse reactions with ONCASPAR are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases.

Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to ONCASPAR.

Clinical 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.

First-Line ALL

The data presented below are derived from 2 studies in patients with standard-risk ALL who received ONCASPAR as a component of first-line multi-agent chemotherapy. Study 1 was a randomized (1:1), active-controlled study that enrolled 118 patients, with a median age of 4.7 years (1.1-9.9 years), of whom 54% were males and 65% White, 14% Hispanic, 8% Black, 8% Asian, and 6% other. Of the 59 patients in Study 1 who were randomized to ONCASPAR, 48 patients (81%) received all 3 planned doses of ONCASPAR, 6 (10%) received 2 doses, 4 (7%) received 1 dose, and 1 patient (2%) did not receive the assigned treatment. Study 2 is an ongoing, multifactorial design study in which all patients received ONCASPAR as a component of various multi-agent chemotherapy regimens; interim safety data are available for 2,770 patients. Study participants had a median age of 4 years (1-10 years), and were 55% male, 68% White, 18% Hispanic, 4% Black, 3% Asian, and 7% other. Per protocol, the schedule of ONCASPAR varied by treatment arm, with intermittent doses of ONCASPAR for up to 10 months.

In Study 1, detailed safety information was collected for pre-specified adverse reactions identified as asparaginase-induced adverse reactions and for grade 3 and 4 non-hematologic adverse reactions according to the Children's Cancer Group (CCG) Toxicity and Complication Criteria. The per-patient incidence, by treatment arm, for these selected adverse reactions occurring at a severity of grade 3 or 4 are presented in Table 1 below:

TABLE 1 : STUDY 1: PER-PATIENT INCIDENCE OF SELECTED GRADE 3 AND 4 ADVERSE REACTIONS

  ONCASPAR
(n=58)
Native E. coli L-Asparaginase
(n=59)
Abnormal Liver Tests 3 (5%) 5 (8%)
Elevated Transaminases* 2 (3%) 4 (7%)
Hyperbilirubinemia 1 (2%) 1 (2%)
Hyperglycemia 3 (5%) 2 (3%)
Central Nervous System Thrombosis 2 (3%) 2 (3%)
Coagulopathy† 1 (2%) 3 (5%)
Pancreatitis 1 (2%) 1 (2%)
Clinical Allergic Reactions to Asparaginase 1 (2%) 0
*1Aspartate aminotransferase, alanine 1 aminotransferase.
† Prolonged prothrombin time or partial thromboplastin time; or hypofibrinogenemia.

Safety data were collected in Study 2 only for National Cancer Institute Common Toxicity Criteria (NCI CTC) version 2.0, grade 3 and 4 non-hematologic toxicities. In this study, the per-patient incidence for the following adverse reactions occurring during treatment courses in which patients received ONCASPAR were: elevated transaminases, 11%; coagulopathy, 7%; hyperglycemia, 5%; CNS thrombosis/hemorrhage, 2%; pancreatitis, 2%; clinical allergic reaction, 1%; and hyperbilirubinemia, 1%. There were 3 deaths due to pancreatitis.

Previously Treated ALL

Adverse reaction information was obtained from 5 clinical trials that enrolled a total of 174 patients with relapsed ALL who received ONCASPAR as a single agent or in combination with multi-agent chemotherapy. The toxicity profile of ONCASPAR in patients with previously treated relapsed ALL is similar to that reported above with the exception of clinical allergic reactions (see Table 2). The most common adverse reactions of ONCASPAR were clinical allergic reactions, elevated transaminases, hyperbilirubinemia, and coagulopathies. The most common serious adverse events due to ONCASPAR treatment were thrombosis (4%), hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).

Allergic Reactions

Allergic reactions include the following: bronchospasm, hypotension, laryngeal edema, local erythema or swelling, systemic rash, and urticaria.

First-Line ALL

Among 58 ONCASPAR-treated patients enrolled in Study 1, clinical allergic reactions were reported in 2 patients (3%). One patient experienced a grade 1 allergic reaction and the other grade 3 hives; both occurred during the first delayed intensification phase of the study (see Table 2).

Previously Treated ALL

Among 62 patients with relapsed ALL and prior hypersensitivity reactions to asparaginase, 35 patients (56%) had a history of clinical allergic reactions to native Escherichia (E.) coli Lasparaginase, and 27 patients (44%) had a history of clinical allergic reactions to both native E. coli and native Erwinia L-asparaginase. Twenty (32%) of these 62 patients experienced clinical allergic reactions to ONCASPAR (see Table 2).

Among 112 patients with relapsed ALL with no prior hypersensitivity reactions to asparaginase, 11 patients (10%) experienced clinical allergic reactions to ONCASPAR (see Table 2).

TABLE 2 : INCIDENCE OF CLINICAL ALLERGIC REACTIONS, OVERALL AND BY SEVERITY GRADE

Patient Status Toxicity Grade, n (%)
1 2 3 4 Total
Previously Hypersensitive 7 (11) 8 (13) 4 (6) 1 (2) 20 (32)
Patients (n=62)
Non-Hypersensitive Patients (n=112)
5 (4) 4 (4) 1 (1) 1 (1) 11 (10)
First Line (n=58) 1 (2) 0 1 (2) 0 2 (3)

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity, defined as development of binding and/or neutralizing antibodies to the product.

In Study 1, 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). There is insufficient information to determine whether the development of antibodies is associated with an increased risk of clinical allergic reactions, altered pharmacokinetics, or loss of anti-leukemic efficacy.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. Therefore, comparison of the incidence of antibodies to ONCASPAR with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Oncaspar (Pegaspargase)

Related Resources for Oncaspar

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© Oncaspar Patient Information is supplied by Cerner Multum, Inc. and Oncaspar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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