Clofarabine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Acute Lymphoblastic Leukemia

Less than 22 years:
Initial Dose: 52 mg/m2 by 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. Subsequent cycles should begin no sooner than 14 days from day 1 of the previous cycle. Subsequent cycles may be administered when the ANC is greater than or equal to 750/mm3.

Greater than 22 years:
Not approved for use by the FDA.

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

Less than 1 year:
Not approved for use by the FDA.

Greater than 1 year:
Initial Dose: 52 mg/m2 by 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. Subsequent cycles should begin no sooner than 14 days from day 1 of the previous cycle. Subsequent cycles may be administered when the ANC is greater than or equal to 750/mm3.

Renal Dose Adjustments

CrCl 30 to 60 mL/min: Reduce the dose by 50%
CrCl less than 30 mL/min: Insufficient information to make a dosage recommendation

Liver Dose Adjustments

Clofarabine has not been studied in patients with liver dysfunction. Therefore, great caution is recommended if clofarabine is to be used in patients with liver dysfunction.

Dose Adjustments

Dosage Adjustments for Toxicity:

Hematologic toxicity:
ANC less than 500/mm3 lasting 4 or more weeks: Reduce clofarabine dose by 25% for next cycle.

Nonhematologic toxicity:
Clinically significant infection: Withhold treatment until infection is under control and then restart clofarabine at full dose.

Grade 3 toxicity excluding infection, nausea, vomiting, and transient elevations in transaminases and bilirubin: Withhold treatment. May reinitiate clofarabine with a 25% dose reduction with resolution or return to baseline.

Grade 3 or 4 increase in creatinine or bilirubin: Discontinue clofarabine. May reinitiate with 25% dosage reduction when creatinine or bilirubin return to baseline and patient is stable. Administer allopurinol for hyperuricemia.

Grade 4 toxicity (noninfectious): Discontinue clofarabine treatment.

Capillary leak or systemic inflammatory response syndrome (SIRS) signs/symptoms (e.g., hypotension, tachycardia, tachypnea, pulmonary edema): Discontinue clofarabine. Institute supportive measures.

Precautions

Clofarabine administration should be stopped if the patient develops hypotension for any reason during the 5 days of administration. If the hypotension is transient and resolves without any pharmacologic intervention, then clofarabine treatment can be reinstituted, generally at a lower dose.

Administration of clofarabine results in a rapid reduction in peripheral leukemia cells. Therefore, patients undergoing treatment with clofarabine should be evaluated and monitored for signs and symptoms of tumor lysis syndrome, as well as signs and symptoms of cytokine release (e.g., tachypnea, tachycardia, hypotension, pulmonary edema) that could develop into systemic inflammatory response syndrome (SIRS)/ capillary leak syndrome, and organ dysfunction. To reduce the effects of tumor lysis syndrome and other adverse effects, physicians are encouraged to give continuous IV fluids throughout the five days of clofarabine administration. Furthermore, allopurinol should be administered if hyperuricemia is expected. Clofarabine should be discontinued immediately if clinically significant signs or symptoms of SIRS or capillary leak syndrome appear. Furthermore, the use of steroids, diuretics, and albumin should be considered. Clofarabine may then be restarted (generally at a lower dose) once the patient is stable.

Dialysis

Data not available

Other Comments

Prior to intravenous infusion, clofarabine should be diluted with 5% dextrose injection, USP or 0.9% sodium chloride injection, USP.

No other medications should be administered through the same intravenous line.

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