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Oncaspar Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
- loss of appetite
- skin rash or itching
- swelling in your hands/ankles/feet
- weight loss
- stomach cramps
- injection site reactions (pain swelling or redness).
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Oncaspar in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- pain or swelling in one or both legs;
- fever, chills, body aches, flu symptoms;
- easy bruising or bleeding, unusual weakness;
- increased thirst or urination; or
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may be more likely to occur, such as:
- mild skin rash or itching;
- depression, drowsiness;
- swelling in your hands, ankles, or feet;
- nausea, vomiting, loss of appetite, weight loss;
- stomach cramps; or
- headache, feeling tired or irritable.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Oncaspar (Pegaspargase)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Oncaspar Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, signs of an infection (e.g., fever), increased thirst/urination, easy bruising/bleeding, dark urine, yellowing eyes/skin, pain/redness/swelling/numbness/tingling of the arms or legs, change in the amount of urine.
Get medical help right away if any of these rare but very serious side effects occur: sudden shortness of breath, chest pain, severe headache, seizures, slurred speech, confusion, vision changes, weakness on one side of the body.
A very serious allergic reaction to this drug can occur. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Oncaspar (Pegaspargase)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Oncaspar FDA Prescribing 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, hepatotoxicity and elevated transaminases.
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.
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, multi-factorial 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
|Native E. coli L-Asparaginase
|Abnormal Liver Tests||3 (5%)||5 (8%)|
|Elevated Transaminases1||2 (3%)||4 (7%)|
|Hyperbilirubinemia||1 (2%)||1 (2%)|
|Hyperglycemia||3 (5%)||2 (3%)|
|Central Nervous System Thrombosis||2 (3%)||2 (3%)|
|Coagulopathy2||1 (2%)||3 (5%)|
|Pancreatitis||1 (2%)||1 (2%)|
|Clinical Allergic Reactions to Asparaginase||1 (2%)||0|
|1Aspartate aminotransferase, alanine aminotransferase.
2Prolonged 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%).
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 L-asparaginase, 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 (%)||Total|
|Previously Hypersensitive Patients (n=62)||7 (11)||8 (13)||4 (6)||1 (2)||20 (32)|
|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)|
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)
Additional Oncaspar Information
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