Clofarabine (clofarabine)

Dosage of clofarabine is based on the patient's body surface area and is calculated using the actual body weight and height of the patient before starting each cycle.

For the treatment of acute lymphocytic leukemia (ALL) in patients 1-21 years of age, the recommended dosage of clofarabine is 52 mg/m2 administered by IV infusion over 2 hours daily for 5 consecutive days. The treatment cycle is repeated following recovery or return to baseline organ function, approximately every 2-6 weeks.

If early manifestations of cytokine release or capillary leak syndrome occur, administration of clofarabine should be discontinued immediately and appropriate supportive measures initiated. Reinstitution of clofarabine therapy, generally at a lower dosage, may be considered once the patient is stable and organ function has returned to baseline levels.

If substantial increases in serum creatinine or bilirubin concentrations occur, clofarabine should be discontinued immediately. The drug may be reinstituted, possibly at a lower dosage, once the patient is stable and organ function has returned to baseline levels.

If hypotension develops during administration of clofarabine, administration of the drug should be discontinued. Reinstitution of clofarabine therapy at a lower dosage may be considered if hypotension was transient and resolved without pharmacologic intervention.

Clofarabine is administered by IV infusion over 2 hours.

The patient's respiratory status and blood pressure should be monitored during infusion of clofarabine. Patients receiving drugs that affect blood pressure or cardiac function should be monitored especially closely. (See Systemic Inflammatory Response Syndrome/Capillary Leak Syndrome under Warnings/Precautions: Warnings, in Cautions.)

Commercially available clofarabine for IV infusion containing 1 mg of the drug per mL should be diluted prior to administration. The appropriate dose should be filtered through a sterile 0.2 mcm filter and then further diluted with 5% dextrose injection or 0.9% sodium chloride injection. When diluted as directed, clofarabine solutions may be stored at room temperature and must be used within 24 hours of preparation.

The manufacturer states that other drugs should not be infused through the same IV line. Parenteral clofarabine solutions should be inspected visually for particulate matter and discolorations prior to administration.

Continuous administration of IV fluids throughout the 5 days of clofarabine administration is advised to reduce the effects of tumor lysis and other adverse effects. If tumor lysis is expected, allopurinol should be administered to prevent hyperuricemia. (See Tumor Lysis Syndrome under Warnings/Precautions: Warnings, in Cautions.)

Administration of corticosteroids (e.g., hydrocortisone 100 mg/m2 on days 1-3) may prevent signs and symptoms of cytokine release or capillary leak syndrome. (See Systemic Inflammatory Response Syndrome/Capillary Leak Syndrome under Warnings/Precautions: Warnings, in Cautions.)

The usual precautions for handling and preparing solutions of cytotoxic drugs should be observed when preparing or administering clofarabine.

No dosing information is available for this tab.

No dosing information is available for this tab.

Drug interaction studies have not been conducted to date.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

The manufacturer states that there are no contraindications to use of clofarabine. However, clofarabine should be used with caution in patients with known hypersensitivity to the drug or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Most common adverse effects include nausea, vomiting, diarrhea, anemia, leukopenia, thrombocytopenia, neutropenia (including febrile neutropenia), and infections.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy for treatment of relapsed or refractory acute lymphocytic leukemia (ALL) has been established in patients 1-21 years of age.

Clofarabine has been evaluated in a limited number of children with refractory acute myeloid leukemia (AML)+.

Category D. (See Users Guide.) (See Warnings: Fetal/Neonatal Morbidity and Mortality, in Cautions.)

Not known whether clofarabine or its metabolites are distributed into human milk. Because of the potential for serious adverse reactions to clofarabine in nursing infants, women should discontinue nursing while receiving clofarabine therapy.

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