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Oncaspar (Pegaspargase) - Side Effects and Adverse Reactions

 
 



ONCASPAR® ADVERSE REACTIONS

Adverse reactions have been reported in adults and pediatric patients. Overall, the adult patients treated with ONCASPAR® had a somewhat higher incidence of known L-asparaginase toxicities, except for hypersensitivity reactions, than the pediatric patients treated with ONCASPAR®.

Excluding hypersensitivity reactions, the most frequently occurring known L-asparaginase related toxicities and adverse experiences reported for the 174 patients in clinical studies were chemical hepatotoxicities and coagulopathies, the majority of which did not result in any significant clinical events. The incidence of significant clinical events included clinical pancreatitis (1%), hyperglycemia requiring insulin therapy (3%), and thrombosis (4%).

The following adverse reactions related to ONCASPAR® were reported for 174 patients in five clinical studies.

The adverse reactions reported most frequently (greater than 5%) were allergic reactions (which may have included rash, erythema, edema, pain, fever chills, urticaria, dyspnea, or bronchospasm), SGT increase, nausea and/or vomiting, fever, and malaise.

The adverse reactions reported occasionally (greater than 1% but less than 5%) were anaphylactic reactions, dyspnea, injection site hypersensitivity, lip edema, rash, urticaria, abdominal pain, chills, pain in the extremities, hypotension, tachycardia, thrombosis, anorexia, diarrhea, jaundice, abnormal liver function test, decreased anticoagulant effect, disseminated intravascular coagulation, decreased fibrinogen, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, increased thromboplastin, injection site pain, injection site reaction, bilirubinemia, hyperglycemia, hyperuricemia, hypoglycemia, hypoproteinemia, peripheral edema, increased SGOT, arthralgia, myalgia, convulsion, headache, night sweats, and paresthesia.

The adverse reactions reported rarely (less than 1%) were bronchospasm, petechial rash, face edema, lesional edema, sepsis, septic shock, chest pain, endocarditis, hypertension, constipation, flatulence, gastrointestinal pain, hepatomegaly, increased appetite, liver fatty deposits, coagulation disorder, increased coagulation time, decreased platelet count, purpura, increased amylase, edema, excessive thirst, hyperammonemia, hyponatremia, weight loss, bone pain, joint disorder, confusion, dizziness, emotional lability, somnolence, increased cough, epistaxis, upper respiratory infection, erythema simplex, pruritus, hematuria, increased urinary frequency, and abnormal kidney function.

The following ONCASPAR® related reactions have been observed in patients with hematologic malignancies, primarily acute lymphoblastic leukemia (approximately 75%), non-Hodgkins lymphoma (approximately 13%), acute myelogenous leukemia (approximately 3%), and a variety of solid tumors (approximately 9%):

HYPERSENSITIVITY REACTIONS: a variety of hypersensitivity reactions have occurred. These reactions may be acute or delayed, and include acute anaphylaxis, bronchospasm, dyspnea, urticaria, arthralgia, erythema, induration, edema, pain, tenderness, hives, swelling, lip edema, chills, fever, and skin rashes (SEE WARNINGS AND CONTRAINDICATIONS).

PANCREATIC FUNCTION: pancreatitis, sometimes fulminant and fatal, has occurred. Increased serum amylase and lipase have also occurred.

LIVER FUNCTION: a variety of liver function abnormalities have been observed, including elevations of SGOT, SGPT, and bilirubin (direct and indirect). Jaundice, ascites, and hypoalbuminemia, which may be associated with peripheral edema, have been observed. These abnormalities usually are reversible on discontinuance of therapy, and some reversal may occur during the course of therapy. Fatty changes in the liver and liver failure have occurred.

HEMATOLOGIC: hypofibrinogenemia, prolonged prothrombin times, prolonged partial thromboplastin times, and decreased antithrombin III have been observed. Superficial and deep venous, thrombosis, sagittal sinus thrombosis, venous catheter thrombosis, and atrial thrombosis have occurred. Leukopenia, agranulocytosis, pancytopenia, thrombocytopenia, disseminated intravascular coagulation, severe hemolytic anemia, and anemia have been observed. Clinical hemorrhage, which may be fatal; easy bruisability, and ecchymosis have also been observed.

METABOLIC: mild to severe hyperglycemia has been observed in low incidence, and usually responds to discontinuation of ONCASPAR® and the judicious use of intravenous fluid and insulin. Hypoglycemia, increased thirst and hyponatremia, uric acid nephropathy, hyperuricemia, hypoproteinemia, and peripheral edema have also been observed. Hypoalbuminemia, proteinuria, weight loss, and metabolic acidosis have occurred. Therapy with ONCASPAR® is associated with an increase in blood ammonia during the conversion of L-asparagine to aspartic acid by the enzyme.

NEUROLOGIC: status epilepticus and temporal lobe seizures, somnolence, coma, malaise, mental status changes, dizziness, emotional lability, headache, lip numbness, finger paresthesia, mood changes, night sweats, and a Parkinson-like syndrome have occurred. Mild to severe confusion disorientation, and paresthesia have also occurred. These side effects usually have reversed spontaneously after treatment was stopped.

RENAL: increased BUN, increased creatinine, urinary frequency, hematuria due to thrombopenia, severe hemorrhagic cystitis, renal dysfunction, and renal failure have been observed.

CARDIOVASCULAR: chest pain, subacute bacterial endocarditis, hypertension, severe hypotension, and tachycardia have occurred.

DIGESTIVE: anorexia, constipation, decreased appetite, diarrhea, indigestion, flatulence, gas, gastrointestinal pain, mucositis, hepatomegaly, elevated gamma-glutamyltranspeptidase, increased appetite, mouth tenderness, severe colitis, and nausea and/or vomiting have been observed.

MUSCULOSKELETAL: diffuse and local musculoskeletal pain, arthralgia, joint stiffness, and cramps have occurred.

RESPIRATORY: cough, epistaxis, severe bronchospasm, and upper respiratory infection have been observed.

SKIN/APPENDAGES: itching, alopecia, fever blister, purpura, hand whiteness and fungal changes, nail whiteness and ridging, erythema simplex, jaundice, and petechial rash have occurred.

GENERAL: localized edema, injection site reactions (including pain, swelling, or redness), malaise, infection, sepsis, fatigue, and septic shock may occur.



REPORTS OF SUSPECTED ONCASPAR SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Oncaspar. The information is not vetted and should not be considered as verified clinical evidence.

Possible Oncaspar side effects / adverse reactions in 29 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2011-10-20

Patient: 29 year old female

Reactions: Mucosal Inflammation, Hyperbilirubinaemia, Oral Pain, Pyrexia

Suspect drug(s):
Oncaspar
    Dosage: (1725 iu, d4+18) intravenous
    Start date: 2011-03-21
    End date: 2011-04-04

Palifermin (Palifermin)
    Dosage: (4.3 mg, per protocol) intravenous
    Indication: Stomatitis
    Start date: 2011-07-17
    End date: 2011-07-30

Palifermin (Palifermin)
    Dosage: (4.3 mg, per protocol) intravenous
    Indication: Prophylaxis
    Start date: 2011-07-17
    End date: 2011-07-30

Other drugs received by patient: Itraconazole; Allopurinol; Norethindrone; Difflan (Benzydamine Hydrochloride); Tazocin (Tazocin); Acyclovir; Enoxaparin Sodium; Acyclovir; Benzocaine + Codeine Mouthwash (Benzocaine, Codein); Cyclicine (Cyclicine); Acetaminophen; Codeine Sulfate; Piperacillin and Tazobactam; Chlorhexidine Gluconate; Cyclosporine; Nystatin; Itraconazole; Morphine Sulphate (Morphine Sulphate); Teicoplanin (Teicoplanin); Ondansetron



Possible Oncaspar side effects / adverse reactions in 11 year old female

Reported by a pharmacist from United States on 2011-12-07

Patient: 11 year old female weighing 48.4 kg (106.5 pounds)

Reactions: Ear Discomfort, Pruritus, Dyspnoea, Tachycardia, Rash, Oral Discomfort, Diarrhoea, Hypotonia, Infusion Related Reaction

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Oncaspar

Other drugs received by patient: Vincristine



Possible Oncaspar side effects / adverse reactions in 9 year old female

Reported by a pharmacist from United States on 2011-12-07

Patient: 9 year old female weighing 39.5 kg (86.9 pounds)

Reactions: Flushing, Vomiting, Hypersensitivity, Dyspnoea, Chest Discomfort, Cyanosis, Hypotonia, Infusion Related Reaction

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Oncaspar

Other drugs received by patient: Vincristine; Methotrexate; Ketamine HCL; Midazolam



See index of all Oncaspar side effect reports >>

Drug label data at the top of this Page last updated: 2006-09-25

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