DOSAGE AND ADMINISTRATION

Preparation for Administration

ARRANON is not diluted prior to administration. The appropriate dose of ARRANON is transferred into polyvinylchloride (PVC) infusion bags or glass containers and administered as a two-hour infusion in adult patients and as a one-hour infusion in pediatric patients.

Prior to administration, inspect the drug product visually for particulate matter and discoloration.

Adult Dosage

The recommended adult dose of ARRANON is 1,500 mg/m2 administered intravenously over 2 hours on days 1, 3, and 5 repeated every 21 days. ARRANON is administered undiluted.

Pediatric Dosage

The recommended pediatric dose of ARRANON is 650 mg/m2 administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. ARRANON is administered undiluted.

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 continued to benefit from treatment.

Supportive Care

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

Dose Modification

ARRANON 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.

Adjustment of Dose in Special Populations

ARRANON has not been studied in patients with hepatic or renal dysfunction (see PRECAUTIONS). No dose adjustment is recommended for patients with a CLcr≥50 mL/min (see CLINICAL PHARMACOLOGY, Renal Impairment). There are insufficient data to support a dose recommendation for CLcr<50 mL/min.

Precautions

ARRANON 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.

Stability

Nelarabine Injection is stable in polyvinylchloride (PVC) infusion bags and glass containers for up to 8 hours at up to 30° C.

Handling and Disposal

Procedures for proper handling and disposal of anticancer drugs should be used. Several guidelines on this subject have been published.1-9

There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

ARRANON Injection is supplied as a clear, colorless, sterile solution in Type I, clear glass vials with a gray butyl rubber (latex-free) stopper and a red snap-off aluminum seal. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP. Vials are available in the following carton sizes:

NDC 0007-4401-01 (package of 1)

NDC 0007-4401-06 (package of 6)

Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].