Elspar Side Effects
Generic Name: asparaginase
Please note - some side effects for Elspar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Elspar - for the Consumer
Elspar
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Elspar:
Seek medical attention right away if any of these SEVERE side effects occur when using Elspar:Agitation; chills; confusion; depression; drowsiness; fatigue; fever; headache; hives; irritability; joint pain; loss of appetite; muscle pain; nausea; rash; vomiting; weight loss.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; change in the amount of urine; coma; confusion; dark urine; hallucinations; high fever; joint pain; pain, redness, or swelling at the injection site; seizures; stomach pain; tremor; unusual bruising or bleeding; unusual tiredness or weakness.
Elspar Side Effects - for the Professional
Elspar
Most common adverse reactions are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Ovation Pharmaceuticals at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION
Revised: 05/2007
| FULL PRESCRIBING INFORMATION: CONTENTS* | |
|---|---|
|
|
|
2.2 Instructions for Administration 2.3 Preparation and Handling Precautions 5.1 Anaphylaxis and Serious Allergic Reactions 6.1 Clinical Trials and Post-Marketing Experience 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION |
|
FULL PRESCRIBING INFORMATION Top
Side Effects by Body System
Hematologic
Hematologic side effects have included a marked decrease in circulating lymphoblasts, with normal or below normal leukocyte counts, within the first days after initiating therapy. This is sometimes accompanied by a marked rise in serum uric acid. Pre-renal azotemia has also been reported.
Hypofibrinogenemia has been reported. Depression of other clotting factors including factors V and VIII (marked decreases) and factors VII and IX (variable decreases) have also been reported. A low incidence of decrease in circulating platelets has been reported. Bleeding has been reported in a minority of patients with a demonstrable coagulopathy. Intracranial hemorrhage and fatal bleeding associated with low fibrinogen levels have been reported. Compensatory increased fibrinolytic activity has also been reported.
Transient bone marrow depression has rarely 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 also been reported.
Hypertriglyceridemia has been reported.
Gastrointestinal
Gastrointestinal side effects have included nausea, vomiting, and anorexia. Acute hemorrhagic pancreatitis (sometimes fatal) has also been reported.
General
General side effects include chills, fever, abdominal cramps, weight loss, and headache. Fatal hyperthermia has also been reported.
Hepatic
Hepatic side effects have included elevations of SGOT, SGPT, alkaline phosphatase, bilirubin, and depression of serum albumin, cholesterol, and plasma fibrinogen. Both increases and decreases in total blood lipids have been reported. Marked hypoalbuminemia associated with peripheral edema has been reported. Fatty changes in the liver have been documented by biopsy. Malabsorption syndrome has also been reported.
Most hepatic abnormalities are usually reversible upon discontinuation of therapy and some reversal has been reported during the course of therapy.
Nervous system
Nervous system side effects have included somnolence, fatigue, seizures, coma, and confusion. A Parkinson-like syndrome with tremor and a progressive increase in muscle tone has been reported rarely.
Nervous system side effects have usually reversed spontaneously upon discontinuation of asparaginase.
Cardiovascular
Cardiovascular side effects have included one reported case of acute myocardial infarction.
Dermatologic
Dermatologic side effects have included skin rashes and urticaria.
Musculoskeletal
Musculoskeletal side effects have included arthralgia.
Respiratory
Respiratory side effects have included respiratory distress.
Metabolic
The syndrome resembles hyperosmolar nonketonic hyperglycemia. While the syndrome usually responds to discontinuation of asparaginase, judicious use of IV fluid, and insulin, it has occasionally been fatal.
Metabolic side effects have included a low incidence of hyperglycemia with glycosuria and polyuria.
Psychiatric
Psychiatric side effects have included depression, agitation, confusion, paranoia, and hallucinations.
Renal
Renal side effects include acute renal shut down and fatal renal insufficiency. Proteinuria has been reported infrequently.
Other
Other side effects have included interference with the interpretation of thyroid function tests by production of a rapid and marked reduction in serum concentrations of thyroxine-binding globulin within days after the first dose.
Serum concentrations of thyroxine-binding globulin have been reported to return to pretreatment values within four weeks of the last dose.
Oncologic
Oncologic side effects have included reports of small increases in pulmonary adenomas in animal studies..
Immunologic
Immunosuppressive activity has been reported in animal experiments.
Top
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
