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Elspar (Asparaginase) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Allergic reactions, including skin rashes, urticaria, arthralgia, respiratory distress, and acute anaphylaxis have been reported. (See WARNINGS.) Acute reactions have occurred in the absence of a positive skin test and during continued maintenance of therapeutic serum levels of ELSPAR.

In pediatric patients with advanced leukemia, a lower incidence of anaphylaxis has been reported with intramuscular administration, although there was a higher incidence of milder hypersensitivity reactions than with intravenous administration.

Fatal hyperthermia has been reported.

Pancreatitis, sometimes fulminant and fatal, has occurred during or following therapy with ELSPAR.

Hyperglycemia with glucosuria and polyuria has been reported in low incidence. Serum and urine acetone usually have been absent or negligible in these patients; this syndrome thus resembles hyperosmolar, nonketotic, hyperglycemia induced by a variety of other agents. This complication usually responds to discontinuance of ELSPAR, judicious use of intravenous fluid, and insulin, but may be fatal on occasion.

In addition to hypofibrinogenemia, depression of various other clotting factors has been reported. Most marked has been a decrease in plasma levels of factors V and VIII with a variable decrease in factors VII and IX. A decrease in circulating platelets has occurred in low incidence which, together with the increased levels of fibrin degradation products in the serum, may indicate development of a consumption coagulopathy. Bleeding has been a problem in only a minority of patients with demonstrable coagulopathy. However, intracranial hemorrhage and fatal bleeding associated with low fibrinogen levels have been reported. Increased fibrinolytic activity, apparently compensatory in nature, also has occurred.

Some patients have shown central nervous system effects consisting of depression, somnolence, fatigue, coma, confusion, agitation, and hallucinations varying from mild to severe. Rarely, a Parkinson-like syndrome has occurred, with tremor and a progressive increase in muscular tone. These side effects usually have reversed spontaneously after treatment was stopped. Therapy with ELSPAR is associated with an increase in blood ammonia during the conversion of asparagine to aspartic acid by the enzyme. No clear correlation exists between the degree of elevation of blood ammonia levels and the appearance of CNS changes. Chills, fever, nausea, vomiting, anorexia, abdominal cramps, weight loss, headache, and irritability may occur and usually are mild.

Azotemia, usually pre-renal, occurs frequently. Acute renal shut down and fatal renal insufficiency have been reported during treatment. Proteinuria has occurred infrequently.

A variety of liver function abnormalities have been reported, including elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin (direct and indirect), and depression of serum albumin, cholesterol (total and esters), and plasma fibrinogen. Increases and decreases of total lipids have occurred. Marked hypoalbuminemia associated with peripheral edema has been reported. However, these abnormalities usually are reversible on discontinuance of therapy and some reversal may occur during the course of therapy. Fatty changes in the liver have been documented by biopsy. Malabsorption syndrome has been reported.

Rarely, transient bone marrow depression has been observed, as evidenced by a delay in return of hemoglobin or hematocrit levels to normal in patients undergoing hematologic remission of leukemia. Marked leukopenia has been reported.



REPORTS OF SUSPECTED ELSPAR SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Elspar side effects / adverse reactions in 12 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2011-10-11

Patient: 12 year old female

Reactions: Bronchopulmonary Aspergillosis, White Blood Cell Count Decreased, Electrocardiogram QT Prolonged, Hepatic Lesion, Pyrexia, Hypokalaemia, Respiratory Failure, Hypomagnesaemia, Chest Pain, Neutrophil Count Decreased, Cough

Suspect drug(s):
Voriconazole

Cytarabine
    Indication: Acute Lymphocytic Leukaemia

Elspar
    Indication: Acute Lymphocytic Leukaemia

Prednisolone
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin HCL
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Indication: Acute Lymphocytic Leukaemia

Imatinib Mesylate
    Indication: Acute Lymphocytic Leukaemia

Other drugs received by patient: Potassium; Magnesium; Ciprofloxacin; Lidocaine



Possible Elspar side effects / adverse reactions in 12 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2011-10-12

Patient: 12 year old female

Reactions: Bronchopulmonary Aspergillosis, Electrocardiogram QT Prolonged, White Blood Cell Count Decreased, Hepatic Lesion, Pyrexia, Hypokalaemia, Respiratory Failure, Hypomagnesaemia, Chest Pain, Neutrophil Count Decreased, Cough

Suspect drug(s):
Voriconazole

Doxorubicin HCL
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Indication: Acute Lymphocytic Leukaemia

Elspar
    Indication: Acute Lymphocytic Leukaemia

Imatinib Mesylate
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Indication: Acute Lymphocytic Leukaemia

Prednisolone
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Other drugs received by patient: Magnesium; Ciprofloxacin; Lidocaine; Potassium



Possible Elspar side effects / adverse reactions in 10 year old male

Reported by a physician from United States on 2011-10-20

Patient: 10 year old male

Reactions: Presyncope, Hypotension, Pyrexia, Enterocolitis Infectious, Groin Pain, Blood Test Abnormal

Adverse event resulted in: hospitalization

Suspect drug(s):
Cyclophosphamide
    Dosage: intravenous (not otherwise specified)
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-05-26

Vincristine Sulfate
    Dosage: intravenous (not otherwise specified)
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-05-26

Daunorubicin HCL
    Dosage: intravenous (not otherwise specified)
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-05-26

Hydrocortone
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-05-26

Methotrexate
    Dosage: oral
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-05-26

Elspar
    Dosage: 140000 iu international unit(s), intramuscular
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-05-26

Dexamethasone
    Dosage: oral
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-05-26

Cytarabine
    Dosage: intravenous (not otherwise specified)
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-05-26

Other drugs received by patient: Filgrastim (Filgrastim)



See index of all Elspar side effect reports >>

Drug label data at the top of this Page last updated: 2006-11-11

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