for example [460:<5 years of age. 1 Used in 7 children 5 16 years of age with APL in one study and in 13 children and young adults 4 21 years of age with refractory or relapsed APL in another study; 5 and 11 achieved complete responses, respectively. 1 11 26 Hepatic Impairment Not studied in patients with hepatic impairment. 1 Renal Impairment Not studied in patients with renal impairment. 1 Potential for prolonged elimination. 1 Use with caution in patients with renal failure. 1 Common Adverse Effects Leukocytosis, GI effects (nausea, vomiting, diarrhea, abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, dizziness. 1 Interactions for Arsenic Trioxide Extensively metabolized in the liver. 1 Methyltransferases involved in metabolism of arsenic trioxide are not CYP isoenzymes. 1 Has no inhibitory effects on metabolism of substrates of major CYP isoenzymes (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11). 1 No formal drug interaction studies to date. 1 Drugs that Prolong the QT Interval Potential pharmacologic interaction (additive effects on prolongation of the QT interval). 14 15 Drugs that May be Associated with Electrolyte Abnormalities Potential pharmacologic interaction (additive effects on prolongation of the QT interval). 1 Specific Drugs Drug Interaction Comments Amphotericin B Additive effects on prolongation of QT interval 1 Use with caution 1 Antiarrhythmics producing QT-interval prolongation Additive effects on prolongation of QT interval 1 Use with caution 1 Diuretics (potassium-wasting) Additive effects on prolongation of QT interval 1 Use with caution 1 Pimozide Additive effects on prolongation of QT interval 14 15 Concomitant use not recommended 14 15 Thioridazine Additive effects on prolongation of QT interval 1 Use with caution 1 Ziprasidone Additive effects on prolongation of QT interval 14 15 Concomitant use not recommended 14 15 Arsenic Trioxide Pharmacokinetics Pharmacokinetics of trivalent arsenic have not been characterized. 1 Distribution Extent Arsenic is stored mainly in liver, kidney, heart, lung, hair, and nails. 1 Inorganic arsenical preparations cross the placenta in animals. 1 Elimination Metabolism Arsenic trioxide is extensively metabolized via reduction by arsenate reductase and methylation (mainly in the liver) by methyltransferases. 1 Elimination Route Trivalent arsenic is excreted in urine. 1 Stability Storage Parenteral Solution 25 C (may be exposed to 15 30 C). 1 Do not freeze. 1 Chemically and physically stable after dilution for 24 hours at room temperature and 48 hours when refrigerated. 1 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Solution Compatibility HID Compatible 1 Dextrose 5% in water Sodium chloride 0.9% Actions Mechanism of action not fully elucidated. 1 5 Believed to induce apoptosis (programmed cell death) of promyelocytic leukemia cells. 1 5 Advice to Patients Importance of informing clinicians if unexplained fever, dyspnea, or weight gain occurs. 1 Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 1 Importance of informing patients of other important precautionary information. 1 (See Boxed Warning and see Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Arsenic Trioxide Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection, for IV use only 1 mg/mL (10 mg) Trisenox Cephalon AHFS DI Essentials. Copyright 2017, Selected Revisions January 1, 2010. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References Only references cited for selected revisions after 1984 are available electronically. 1. Cephalon. Trisenox (arsenic trioxide) injection prescribing information. Frazer, PA; 2006 Jul. 2. Food and Drug Administration. Labeling and prescription drug advertising; content and format for labeling for human prescription drugs. 21 CFR Parts 201 and 202. Final Rule. [Docket No. 75N-0066] Fed Regist . 1979; 44:37434-67. 3. Department of Health and Human Services, Food and Drug Administration. Subpart B Labeling requirements for prescription drugs and/or insulin. (21 CFR Ch. 1 (4-1-87 ed.). 1987:18-24. 4. Anon. FDA approves arsenic trioxide for leukemia treatment in record time for a cancer drug development program. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2000 Sep 26. 5. Soignet SL, Maslak P, Wang ZG et al. Complete remission after treatment of acute promyelocytic leukemia with arsenic trioxide. N Engl J Med . 1998; 339:1341-8. [PubMed 9801394] 6. Food and Drug Administration. Torsades de pointes arrhythmia and sudden death associated with the use of arsenic trioxide. Medwatch safety information summaries 2001. Rockville, MD; March 2001. From FDA website. 7. Food and Drug Administration: Healthcare providers reminded to closely monitor patients on arsenic trioxide. Medwatch safety information summaries 2001. Rockville, MD; March 2001. From FDA website. Correction. 8. Dear health care provider letter regarding the importance of close monitoring of patients on arsenic trioxide. Seattle, WA: Cell Therapeutics; 2001 March. 9. Unnikrishnan D, Dutcher JP, Varshneya N et al. Torsades de pointes in 3 patients with leukemia treated with arsenic trioxide. Blood . 2001; 97:1514-6. [PubMed 11222403] 10. Ohnishi K, Yoshida H, Shigeno K et al. Prolongation of the QT interval and ventricular tachycardia in patients treated with arsenic trioxide for acute promyelocytic leukemia. Ann Intern Med . 2000; 133:881-5. [PubMed 11103058] 11. Cell Therapeutics, Seattle, WA: Personal communication. 12. Westervelt P, Brown RA, Adkins DR et al. Sudden death among patients with acute promyelocytic leukemia treated with arsenic trioxide. Blood . 2001; 98:266-71. [PubMed 11435292] 13. Dear doctor letter commenting on the report of sudden death in 3 patients receiving arsenic trioxide. Seattle, WA: Cell Therapeutics; 2001 Jul 24. 14. Food and Drug Administration. MedWatch Safety-related drug labeling changes: Geodon (ziprasidone) capsules [February 15, 2002]. From FDA web site. 15. Food and Drug Administration. MedWatch Safety-related drug labeling changes: Orap (pimozide) [November 14, 2002]. From FDA web site. 16. Anon. Drugs of choice for cancer. Treat Guidel Med Lett . 2003; 1:41-52. [PubMed 15529105] 17. Adult acute myeloid leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 Aug 8. 18. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97[[030]]414). Rockville, MD; [May 5, 2003]. From FDA web site. 19. Soignet SL, Frankel SR, Douer D et al. United States multicenter study of arsenic trioxide in relapsed acute promyelocytic leukemia. J Clin Oncol . 2001; 19:3852-60. [PubMed 11559723] 20. Childhood acute myeloid leukemia/other myeloid malignancies. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 Aug 18. 21. Shen ZX, Shi ZZ, Fang J et al. All-trans retinoic acid/As2O3 combination yields a high quality remission and survival in newly diagnosed acute promyelocytic leukemia. Proc Natl Acad Sci U S A . 2004; 101:5328-35. [PubMed 15044693] 22. Hussein MA, Saleh M, Ravandi F et al. Phase 2 study of arsenic trioxide in patients with relapsed or refractory multiple myeloma. Br J Haematol . 2004; 125:470-6. [PubMed 15142117] 23. Munshi NC, Tricot G, Desikan R et al. Clinical activity of arsenic trioxide for the treatment of multiple myeloma. Leukemia . 2002; 16:1835-7. [PubMed 12200700] 24. Sekeres MA. Arsenic trioxide as a treatment for myelodysplastic syndrome. Curr Hematol Rep . 2005; 4:59-63. [PubMed 15610661] 25. Powell BL, Moser B, Stock W et al. Effect of consolidation with arsenic trioxide (As 2 O 3 ) on event-free survival (EFS) and overall survival (OS) among patients with newly diagnosed acute promyelocytic leukemia (APL): North American Intergroup Protocol C9710. Proc ASCO . 2007; Abstract No. 2.. 26. Fox E, Razzouk BI, Widemann BC et al. Phase I trial and pharmacokinetic study of arsenic trioxide in children and adolescents with refractory or relapsed acute leukemia, including acute promyelocytic leukemia or lymphoma. Blood . 2008; 111:566-73. [PubMed 17959855] 27. Estey E, Garcia-Manero G, Ferrajoli A et al. Use of all-trans retinoic acid plus arsenic trioxide as an alternative to chemotherapy in untreated acute promyelocytic leukemia. Blood . 2006; 107:3469-73. [PubMed 16373661] 28. Mathews V, George B, Lakshmi KM et al. Single-agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: durable remissions with minimal toxicity. Blood . 2006; 107:2627-32. [PubMed 16352810] 29. Douer D. ATO: the forefront of APL treatment? Blood . 2006; 107:2588-2589. HID. Trissel LA. Handbook on injectable drugs. 14th ed; Bethesda, MD: American Society of Health-System Pharmacists; 2007:171. Next Interactions Print this page Add to My Med List More about arsenic trioxide Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 1 Review Add your own review/rating Drug class: miscellaneous antineoplastics Consumer resources Arsenic trioxide Arsenic trioxide Intravenous (Advanced Reading) Professional resources Arsenic Trioxide (Wolters Kluwer) Other brands: Trisenox Related treatment guides Acute Promyelocytic Leukemia> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Miscellaneous antineoplastics Related Drugs Acute Promyelocytic Leukemia tretinoin , Trisenox , Vesanoid , More... Arsenic trioxide Rating 1 User Review 9.0 /10 1 User Review 9.0 Rate it!} } vast
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