"The U.S. Food and Drug Administration today approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
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ARRANON® is indicated 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 two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.
DOSAGE AND ADMINISTRATION
This product is for intravenous use only.
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.
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.
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.
ARRANON administration should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria grade 2 or greater. Dosage may be delayed for other toxicity including hematologic toxicity. [See BOXED WARNING and WARNINGS AND PRECAUTIONS]
Adjustment of Dose in Special Populations
ARRANON has not been studied in patients with renal or hepatic dysfunction [see Use inSpecific Populations]. No dose adjustment is recommended for patients with a creatinine clearance (CLcr) > 50 mL/min [see CLINICAL PHARMACOLOGY]. There are insufficient data to support a dose recommendation for patients with a CLcr < 50 mL/min.
Prevention of Hyperuricemia
Instructions for Handling, Preparation, and Administration
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.1-4
Preparation and Administration
Do not dilute ARRANON 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.
Stability: ARRANON Injection is stable in polyvinylchloride (PVC) infusion bags and glass containers for up to 8 hours at up to 30° C.
Dosage Forms And Strengths
250 mg/50 mL (5 mg/mL) vial
Storage And Handling
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 size:
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].
1. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm vi/otm vi 2.html
3. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs. Am JHealth-Syst Pharm. 2006;63:1172-1193.
4. Polovich M, White JM, Kelleher LO (eds.) 2005. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. (2nded) Pittsburgh, PA: Oncology Nursing Society.
GlaxoSmithKline, Research Triangle Park, NC 27709. December 2011This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/15/2012
Additional Arranon Information
Report Problems to the Food and Drug Administration
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