Clolar (Clofarabine) - Indications and Dosage

INDICATIONS AND USAGE

Clolar^® is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.

DOSAGE AND ADMINISTRATION

Recommended Dose

Clolar^® should be filtered through a sterile 0.2 μm syringe filter and then diluted with 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, prior to intravenous (IV) infusion to a final concentration between 0.15 mg/mL and 0.4 mg/mL. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation.

The recommended pediatric dose and schedule is 52 mg/m² administered by intravenous (IV) infusion over 2 hours daily for 5 consecutive days. Treatment cycles are repeated following recovery or return to baseline organ function, approximately every 2 to 6 weeks. The dosage is based on the patient’s body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same intravenous line.

Clolar^® has not been studied in patients with hepatic or renal dysfunction. Its use in such patients should be undertaken only with the greatest caution.

Physicians are encouraged to give continuous IV infusion fluids throughout the 5 days of Clolar^® administration to reduce the effects of tumor lysis and other adverse events. The use of prophylactic steroids (e.g., 100 mg/m² hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak (e.g., hypotension). If patients show early signs or symptoms of SIRS or capillary leak (e.g., hypotension), the physician should immediately discontinue Clolar^® administration and provide appropriate supportive measures. Close monitoring of renal and hepatic function during the 5 days of Clolar^® administration is advised. If substantial increases in creatinine or bilirubin are noted, physicians should immediately discontinue administration of Clolar^®. Clolar^® should be re-instituted when the patient is stable and organ function has returned to baseline, possibly with a 25% dose reduction. If hyperuricemia is anticipated (tumor lysis), patients should prophylactically receive allopurinol.

STORAGE AND HANDLING

Vials containing undiluted Clolar^® should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Diluted admixtures may be stored at room temperature, but must be used within 24 hours of preparation.

HOW SUPPLIED

Clolar^® (clofarabine) injection is supplied in single-use flint vials containing 20 mg of clofarabine in 20 mL of solution. Each box contains one Clolar^® vial (NDC 58468-0100-1) or four (NDC 58468-0100-2). The 20 mL flint vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, is preservative-free, and is free from foreign matter.

Rx only

NAME AND ADDRESS OF MANUFACTURER

Manufactured by:

AAIPharma Inc.

Charleston, SC 29405

Manufactured for:

Genzyme Corporation

4545 Horizon Hill Blvd

San Antonio, TX 78229

Distributed by:

Genzyme Corporation

500 Kendall Street

Cambridge, MA 02142

www.clolar.com

800-RX-CLOLAR

©2008 Genzyme Corporation. All rights reserved.
Clolar is a registered trademark of Genzyme Corporation.