NDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylaxis and Serious Allergic Reactions
5.2 Thrombosis
5.3 Pancreatitis
5.4 Glucose Intolerence
5.5 Coagulopathy
5.6 Hepatotoxicity and Abnormal Liver Function
6 ADVERSE REACTIONS
6.1 Clinical Trials and Post-Marketing Experience
6.2 Immunogenicity
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
PRINCIPAL DISPLAY PANEL
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Elspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL).
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
The recommended dose of Elspar is 6,000 International Units/m2 intramuscularly (IM) or intravenously (IV) three times a week.
2.2 Instructions for Administration
When Elspar is administered IM, the volume at a single injection site should be limited to 2 mL. If a volume greater than 2 mL is to be administered, two injection sites should be used. Discard unused portion.
When administered IV, give Elspar over a period of not less than thirty minutes through the side arm of an infusion of Sodium Chloride Injection or Dextrose Injection 5% (D5W). Discard unused portion.
2.3 Preparation and Handling Precautions
For IM administration, reconstitute Elspar by adding 2 mL Sodium Chloride Injection to the 10,000 unit vial. Withdraw volume of reconstituted Elspar containing calculated dose into sterile syringe. The reconstituted solution contains 5,000 international units (IU)/mL.
For IV administration, reconstitute Elspar by adding 5 mL Sterile Water for Injection or Sodium Chloride Injection to the 10,000 unit vial. Withdraw volume of reconstituted Elspar containing calculated dose into sterile syringe. The reconstituted solution contains 2,000 IU/mL.
Use reconstituted Elspar within eight hours.
Parenteral drug products should be inspected visually for particulate matter, cloudiness or discoloration prior to administration, whenever solution and container permit. If any of these are present, discard the solution. However, occasionally, a very small number of gelatinous fiber-like particles may develop on standing. Filtration through a 5.0 micron filter during administration will remove the particles with no resultant loss in potency.
3 DOSAGE FORMS AND STRENGTHS
10,000 International Units as lyophilized powder in single-use vial.
4 CONTRAINDICATIONS
Serious allergic reactions to Elspar or other Escherichia coli-derived L-asparaginases
Serious thrombosis with prior L-asparaginase therapy
Pancreatitis with prior L-asparaginase therapy
Serious hemorrhagic even |
