Nelarabine Dosage

Medically reviewed by Drugs.com. Last updated on May 5, 2025.

Usual Adult Dose for Acute Lymphoblastic Leukemia

1500 mg/m2 IV over 2 hours on days 1, 3, and 5 repeated every 21 days

Comments:

• Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
• The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for hematopoietic stem cell transplantation (HSCT).

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.

Usual Adult Dose for Lymphoma

1500 mg/m2 IV over 2 hours on days 1, 3, and 5 repeated every 21 days

Comments:

• Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
• The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for hematopoietic stem cell transplantation (HSCT).

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

1 year and older:
650 mg/m2 IV over 1 hour daily for 5 consecutive days repeated every 21 days

Comments:

• Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
• The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for hematopoietic stem cell transplantation (HSCT).

Uses: For the treatment of patients 1 year and older with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.

Usual Pediatric Dose for Lymphoma

1 year and older:
650 mg/m2 IV over 1 hour daily for 5 consecutive days repeated every 21 days

Comments:

• Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
• The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for hematopoietic stem cell transplantation (HSCT).

Uses: For the treatment of patients 1 year and older with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.

Renal Dose Adjustments

• This drug has not been studied in patients with renal dysfunction.
• CrCl 50 mL/min or greater: No adjustment recommended.
• CrCl less than 50 mL/min: Data not available. Monitor closely for toxicities if used.

Liver Dose Adjustments

• This drug has not been studied in patients with liver dysfunction.
• Mild and Moderate liver dysfunction: No adjustment recommended.
• Severe liver dysfunction (total bilirubin greater than 3 times upper limit of normal): Monitor closely for toxicities.

Dose Adjustments

• Discontinue treatment if the patient develops neurologic adverse reactions of National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) grade 2 or greater.
• Dosage may be delayed for other toxicities, including hematologic toxicity.

Precautions

US BOXED WARNINGS: NEUROLOGICAL ADVERSE REACTIONS:

• Severe neurologic adverse reactions have been reported (e.g., altered mental states including severe somnolence, central nervous system effects including convulsions, peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis). There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barre syndrome.
• Full recovery from these adverse reactions has not always occurred with cessation of therapy. Patients should be monitored for neurologic adverse reactions, and therapy should be discontinued for neurologic adverse reactions of NCI (CTCAE) Grade 2 or greater.

CONTRAINDICATIONS:

• None

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IV use only; administer undiluted.
• This drug should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
• Prior to administration, inspect the drug product visually for particulate matter and discoloration.
• Administer this drug as a 2-hour infusion in adult patients and as a 1-hour infusion in pediatric patients.

Storage requirements:

• This drug should be stored between 20C and 25C (68F and 77F). Excursions are permitted to 15C to 30C (59F to 86F).
• This drug is stable in polyvinylchloride (PVC) infusion bags and glass containers for up to 8 hours at up to 30 degrees Celsius.

Reconstitution/preparation techniques:

• Consult the manufacturer product information for further preparation of diluent solution and administration instructions.
• This drug is a cytotoxic agent. Caution should be used during handling and preparation.
• Use of gloves and other protective clothing to prevent skin contact is recommended. ---Proper aseptic technique should be used.
• Consult the guidelines for proper handling and disposal of anticancer drugs.
• Do not dilute this drug product prior to administration.

General:

• Health care providers should report adverse reactions to Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Monitoring:

• Hematologic: Monitor regularly complete blood counts (including platelets).
• Hepatic: Closely monitor patients with severe hepatic impairment for toxicities.
• Neurologic: Monitor for signs and symptoms of neurological toxicity.
• Renal: Closely monitor patients with moderate or severe renal impairment for toxicities.

Patient advice:

• Read the FDA-approved patient labeling (Patient Information).
• Do not breastfeed during therapy with this drug.
• Do not receive live vaccines during therapy with this drug.
• This drug causes somnolence. Do not drive or engage in hazardous occupations or activities until somnolence has resolved.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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