Nelarabine Dosage

Usual Adult Dose for Acute Lymphoblastic Leukemia

Initial dose: 1,500 mg/m2 administered intravenously over 2 hours on days 1, 3, and 5 repeated every 21 days

The dose is administered as a two-hour infusion in adult patients.

Usual Adult Dose for Lymphoma

Initial dose: 1,500 mg/m2 administered intravenously over 2 hours on days 1, 3, and 5 repeated every 21 days

The dose is administered as a two-hour infusion in adult patients.

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

Initial dose: 650 mg/m2 administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.

The dose is administered as a one-hour infusion in pediatric patients.

Usual Pediatric Dose for Lymphoma

Initial dose: 650 mg/m2 administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.

The dose is administered as a one-hour infusion in pediatric patients.

Renal Dose Adjustments

There is insufficient data to support a dose recommendation for CRCL <50 mL/min.

Liver Dose Adjustments

Data not available

Precautions

Appropriate measures (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol) must be taken to prevent hyperuricemia of tumor lysis syndrome.

Nelarabine should be discontinued for neurologic events of NCI common toxicity criteria grade 2 or greater. Dosage may be delayed for other toxicity including hematologic toxicity.

The influence of hepatic impairment on the pharmacokinetics of nelarabine has not been evaluated. Because the risk of adverse reactions to this drug may be greater in patients with severe hepatic impairment (bilirubin >3.0 mg/dL), these patients should be closely monitored for toxicities.

Dialysis

There are insufficient data to support a dose recommendation for CRCL <50 mL/min.

Other Comments

Nelarabine is not diluted prior to administration.

The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for bone marrow transplant, or the patient no longer benefited from treatment.