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, allopurinol, 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.
Recommended Concomitant Medications and Medications to Avoid
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Consider prophylactic anti-emetic medications as Clolar® is moderately emetogenic.
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Consider the use of prophylactic steroids to prevent signs or symptoms of Systemic Inflammatory Response Syndrome (SIRS) or capillary leak (e.g., hypotension, tachycardia, tachypnea, and pulmonary edema).
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Consider avoiding drugs with known renal toxicity during the 5 days of Clolar administration.
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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 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 clinically controlled and then restart at the full dose.
Withhold Clolar if a Grade 3 non-infectious non-hematologic toxicity (excluding transient elevations in serum transaminases and/or serum bilirubin and/or nausea/vomiting that was controlled by antiemetic therapy) occurs. Re-institute Clolar® administration at a 25% dose reduction when resolution or return to baseline.
Discontinue Clolar® administration if a Grade 4 non-infectious non-hematologic toxicity occurs.
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® when the patient is stable and organ function has returned to baseline, generally with a 25% dose reduction. If hyperuricemia is anticipated (tumor lysis), prophylactically administer allopurinol.
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 (15-30ºC).
Incompatibilities
Do not administer any other medications through the same intravenous line.
DOSAGE FORMS AND STRENGTHS
20 mg/20 mL (1 mg/mL) single use vial
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HOW SUPPLIED/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.1-4
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