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Clolar

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Clolar

Indications
Dosage
How Supplied

INDICATIONS

Clolar® (clofarabine) Injection 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 indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Clolar.

DOSAGE AND ADMINISTRATION

Recommended Dosage

Administer the recommended pediatric dose of 52 mg/m² as an intravenous 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.
  • Provide supportive care, such as intravenous fluids, antihyperuricemic treatment, and alkalinize urine throughout the 5 days of Clolar administration to reduce the effects of tumor lysis and other adverse events.
  • Discontinue Clolar if hypotension develops during the 5 days of administration.
  • Monitor renal and hepatic function during the 5 days of Clolar administration [see WARNINGS AND PRECAUTIONS].
  • Monitor patients taking medications known to affect blood pressure. Monitor cardiac function during administration of Clolar.
  • Reduce the dose by 50% in patients with creatinine clearance (CrCL) between 30 and 60 mL/min. There is insufficient information to make a dosage recommendation in patients with CrCL less than 30 mL/min [see Use in Specific Populations].

Supportive Medications and Medications to Avoid

  • Consider prophylactic anti-emetic medications as Clolar is moderately emetogenic.
  • Consider the use of prophylactic steroids to mitigate Systemic Inflammatory
  • Response Syndrome (SIRS) or capillary leak syndrome (e.g., hypotension, tachycardia, tachypnea, and pulmonary edema).
  • Minimize exposure to drugs with known renal toxicity during the 5 days of Clolar administration since the risk of renal toxicity may be increased.
  • Consider avoiding concomitant use of medications known to induce hepatic toxicity.

Dose Modifications and Reinitiation of Therapy

  • Hematologic Toxicity
    • Administer subsequent cycles no sooner than 14 days from the starting day of the previous cycle and provided the patient's ANC is ≥ 0.75 x 109/L.
    • If a patient experiences a Grade 4 neutropenia (ANC < 0.5 x 109/L) lasting ≥ 4 weeks, reduce dose by 25% for the next cycle.
  • Non-hematologic Toxicity
    • Withhold Clolar if a patient develops a clinically significant infection, until the infection is controlled, then restart at the full dose.
    • Withhold Clolar for a Grade 3 non-infectious non-hematologic toxicity (excluding transient elevations in serum transaminases and/or serum bilirubin and/or nausea/vomiting controlled by antiemetic therapy). Re-institute Clolar administration at a 25% dose reduction when resolution or return to baseline.
    • Discontinue Clolar administration for a Grade 4 non-infectious nonhematologic toxicity.
    • Discontinue Clolar administration if a patient shows early signs or symptoms of SIRS or capillary leak (e.g., hypotension, tachycardia, tachypnea, and pulmonary edema) occur and provide appropriate supportive measures.
    • Discontinue Clolar administration if Grade 3 or higher increases in creatinine or bilirubin are noted. Re-institute Clolar with a 25% dose reduction, when the patient is stable and organ function has returned to baseline. If hyperuricemia is anticipated (tumor lysis), initiate measures to control uric acid.

Reconstitution/Preparation

Clolar should be filtered through a sterile 0.2 micron 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. Use within 24 hours of preparation. Store diluted Clolar at room temperature (15-30°C).

Incompatibilities

Do not administer any other medications through the same intravenous line.

HOW SUPPLIED

Dosage Forms And Strengths

20 mg/20 mL (1 mg/mL) single-use vial

Storage And Handling

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 Clolar vials (NDC 58468-0100-2). The 20mL flint vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5.

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.

Procedures for proper handling and disposal should be utilized. Handling and disposal of Clolar should conform to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published. 1

REFERENCES

1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

Manufactured by: Teva Pharmachemie, Swensweg 5, Haarlem, The Netherlands. Manufactured for: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142. Distributed by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142. Revised: January 2013

Last reviewed on RxList: 2/1/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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