Recommended Dosage

This product is for intravenous use only.

Adult Dosage: The recommended adult dose of ARRANON is 1500 mg/m2 administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. Administer ARRANON 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. Administer ARRANON 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 hematopoietic stem cell transplantation (HSCT), or the patient no longer continued to benefit from treatment.

Dosage Modification

Discontinue ARRANON if the patient develops a neurologic adverse reaction of NCI CTCAE Grade 2 or greater. Dosage may be delayed for other toxicity, including hematologic toxicity [see Boxed Warning, Warnings and Precautions (5.1, 5.2)].

Dosage in Special Populations

ARRANON has not been studied in patients with renal or hepatic dysfunction [see Use in Specific Populations (8.6, 8.7)]. No dose adjustment is recommended for patients with a creatinine clearance (CLCr) greater than or equal to 50 mL/min [see Clinical Pharmacology (12.3)]. There are insufficient data to support a dose recommendation for patients with a CLCr less than 50 mL/min.

Prevention of Hyperuricemia

Take precautions against hyperuricemia (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol) [see Warnings and Precautions (5.4)].

Instructions for Handling, Preparation, and Administration

Handling: 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. Guidelines for proper handling and disposal of anticancer drugs have been published.1

Preparation and Administration: Administer ARRANON undiluted. Transfer the appropriate dose of ARRANON into polyvinylchloride (PVC) infusion bags or glass containers and administer as a 2-hour infusion in adult patients and as a 1-hour infusion in pediatric patients.

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

Stability: ARRANON Injection is stable in PVC infusion bags and glass containers for up to 8 hours at up to 30ºC.