Asparaginase - Elspar®
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| Summary (Dosage and administration)1:
Note: Preferred route: Intramuscular (IM). 6,000 International Units/m2 intramuscularly (IM) or intravenously (IV) three times a week Reconstitute in volume appropriate for the intended route of administration:
For IM administration, reconstitute in 2 mL
For IV administration, reconstitute in 5 mL For IM administration, limit the volume at a single injection site to 2 mL; if greater than 2 mL, use multiple injection sites. For IV administration, give over ≥ 30 min through side arm of an infusion of Sodium Chloride Injection or Dextrose Injection 5% (D5W). Use reconstituted Elspar within eight hours. Other 2: Avoid IV administration if possible - IV administration greatly increases the risk of allergic reactions. Dilution: Administer in 50-250 mL of D5W or NS over at least 30-60 minutes (never below 30 minutes). The manufacturer recommends a test dose (0.1 mL of a dilute 20 unit/mL solution) prior to initial administration and when given after an interval of 7 days or more. Intradermal skin test: observe the test site for at least 1 hour for a wheal or erythema. Important: a negative skin test does not preclude the possibility of an allergic reaction. During the procedure, a physician should be immediately available as well as epinephrine, diphenhydramine, and hydrocortisone at the bedside for potentially severe allergic reactions. The patient should also have a running I.V. in place.
|Stability / Miscellaneous|
INDICATIONS AND USAGE
Mechanism of Action
In a study in which patients with leukemia and metastatic cancer received intramuscular L-asparaginase, peak plasma levels of asparaginase were reached 14 to 24 hours after dosing. Plasma half-life was 34 to 49 hours.
2.1 Recommended Dose
2.2 Instructions for Administration
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 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
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 events with prior L-asparaginase therapy
HOW SUPPLIED/STORAGE AND HANDLING
10,000 International Units as lyophilized powder in single dose vial individually packaged in a carton.
Storage and Handling
Elspar does not contain a preservative. Store unused, reconstituted solution at 2-8°C (36-46°F) and discard after eight hours, or sooner if it becomes cloudy.
| 1) [PACKAGE INSERT DATA] : Lundbeck Inc., Deerfield, IL 60015, U.S.A. ELSPAR (asparaginase) injection, powder, lyophilized, for solution Package insert. Revised: April 2010.
® Trademark of Lundbeck Inc.
2) Solimando, Dominic A. Drug Information Handbook for Oncology: A Complete Guide to Combination Chemotherapy Regimens, 8th ed. Hudson, OH: Lexi-Comp, Inc.; 2010.