positive [18:<30 mL/minute) renal impairment. 1 Effect of end-stage renal disease on romidepsin pharmacokinetics not studied. 1 Age, gender, or race did not appear to affect the pharmacokinetics of romidepsin in a population pharmacokinetic analysis. 1 In a limited number of pediatric patients (aged from 2 21 years), pharmacokinetics of romidepsin were similar to those reported in adults in a phase I trial. 14 Stability Storage Parenteral Powder for Injection Store commercially available kit containing romidepsin vial and diluent vial in the original carton at 20 25 C (may be exposed to 15 30 C). 1 Reconstituted solutions with concentrations of 5 mg/mL are stable at room temperature for up to 8 hours. 1 Diluted solutions are stable at room temperature for up to 24 hours, but should be administered as soon after dilution as possible. 1 Diluted romidepsin solution is compatible in polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), and polyethylene (PE) infusion bags and glass bottles. 1 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Solution Compatibility 1 Compatible Sodium chloride 0.9% Actions Histone deacetylase (HDAC) inhibitor; antineoplastic agent. 1 10 11 Bicyclic depsipeptide isolated from the bacterium Chromobacterium violaceum . 1 10 11 Precise mechanism of antineoplastic effect not fully characterized. 1 However, HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in modulation of gene expression. 1 11 HDACs also deacetylate non-histone proteins, such as transcription factors. 1 11 13 In vitro, romidepsin restores the acetylation of histones, resulting in accumulation of acetylated histones, and induces cell cycle arrest and apoptosis in some cancer cell lines with IC 50 (concentration of the drug required to inhibit cell growth by 50%) values in the nanomolar range. 1 11 Advice to Patients Importance of instructing patients to read the patient information carefully before starting therapy and before each treatment. 1 Importance of instructing patients to report excessive nausea or vomiting. 1 Risk of low blood cell counts. 1 Importance of informing patient that regular blood tests will be performed during therapy and of notifying a clinician if unusual bleeding or bruising, tiredness, pallor, shortness of breath, infection, fever, cough, flu-like symptoms, burning on urination, muscle aches, and/or worsening of skin problems occurs. 1 Risk of ECG changes; importance of informing patient that an ECG test may be performed as needed to check for possible changes. 1 Importance of notifying clinician immediately if abnormal heartbeat, chest pain, or shortness of breath occurs. 1 Importance of informing women of childbearing potential that romidepsin may reduce effectiveness of estrogen-containing contraceptives (e.g., birth control pills, patches, implants, IUDs). 1 15 Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Advise pregnant women of potential risk to the fetus. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., anticoagulants, estrogen-containing contraceptives) and OTC drugs and herbal supplements, as well as any concomitant illnesses. 1 Importance of informing patients of other important precautionary information. 1 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. romiDEPsin Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection, for IV infusion only 10 mg Istodax (available as kit with single-use vial of romiDEPsin and a vial of diluent [containing 80% propylene glycol and 20% dehydrated alcohol]) Celgene AHFS DI Essentials. Copyright 2017, Selected Revisions February 1, 2011. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Celgene Corporation. Istodax (romidepsin) for injection prescribing information. Summit, NJ; 2009 Nov. 2. Food and Drug Administration. Orphan designation pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act. (P.L. 97-414). Rockville, MD. From FDA website; accessed 2010 Jul 1. 3. Piekarz RL, Frye R, Turner M et al. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol . 2009; 27:5410-7. [PubMed 19826128] 4. Kim Y, Whittaker S, Demierre MF et al. Clinically significant responses achieved with romidepsin in treatment-refractory cutaneous T-cell lymphoma: final results from a phase 2B international, multicenter, registration study. Blood 2008;112: Abstr. No. 263. Presented at the 50th Annual ASH Meeting. San Francisco, CA: 2008 Dec 6-9. 5. Kim Y, Demierre MF, Kim EJ et al. Clinically significant responses achieved with romidepsin in 37 patients with cutaneous T-cell lymphoma (CTCL) with blood involvement. Blood 2009; 114: Abstr. No. 2683. Presented at the 51st Annual ASH Meeting. New Orleans, LA: 2009 Dec 5-8. 6. Piekarz RL, Frye AR, Wright JJ et al. Cardiac studies in patients treated with depsipeptide, FK228, in a phase II trial for T-cell lymphoma. Clin Cancer Res . 2006; 12:3762-73. [PubMed 16778104] 7. Cabell C, Bates S, Piekarz R et al. Systematic assessment of potential cardiac effects of the novel histone deacetylase (HDAC) inhibitor romidepsin. Blood 2009; Abstr. No. 3709. Presented at the 51st Annual ASH Meeting. New Orleans, LA: 2009 Dec 5-8. 8. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry. E14 Clinical Evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. 2005 Oct. Accessed at FDA website. 9. Morgan M, Maloney D, Duvic M. Hypomagnesemia and hypocalcemia in mycosis fungoides: a retrospective case series. Leuk Lymphoma . 2002; 43:1297-302. [PubMed 12152999] 10. Lech-Maranda E, Robak E, Korycka A et al. Depsipeptide (FK228) as a novel histone deacetylase inhibitor: mechanism of action and anticancer activity. Mini Rev Med Chem . 2007; 7:1062-9. [PubMed 17979809] 11. Konstantinopoulos PA, Vandoros GP, Papavassiliou AG. FK228 (depsipeptide): a HDAC inhibitor with pleiotropic antitumor activities. Cancer Chemother Pharmacol . 2006; 58:711-5. [PubMed 16435156] 12. Blagosklonny MV, Robey R, Sackett DL et al. Histone deacetylase inhibitors all induce p21 but differentially cause tubulin acetylation, mitotic arrest, and cytotoxicity. Mol Cancer Ther . 2002; 1:937-41. [PubMed 12481415] 13. Lane AA, Chabner BA. Histone deacetylase inhibitors in cancer therapy. J Clin Oncol . 2009; 27:5459-68. [PubMed 19826124] 14. Fouladi M, Furman WL, Chin T et al. Phase I study of depsipeptide in pediatric patients with refractory solid tumors: a Children's Oncology Group report. J Clin Oncol . 2006; 24:3678-85. [PubMed 16877737] 15. Anon. Romidepsin (Istodax) for cutaneous T-cell lymphoma. Med Lett Drugs Ther . 2010; 52:42-3. [PubMed 20508581] 16. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Zolinza (vorinostat) capsules prescribing information. Whitehouse Station, NJ; 2010 Feb. 17. Schering-Plough. Saphris (asenapine maleate) sublingual tablets prescribing information. Kenilworth, NJ; 2010 Jun. 18. Ortho-McNeil-Janssen Pharmaceuticals. Invega (paliperidone) extended-release tablets prescribing information. Titusville, NJ; 2010 Jan. 19. Stöllberger C, Huber JO, Finsterer J. Antipsychotic drugs and QT prolongation. Int Clin Psychopharmacol . 2005; 20:243-51. [PubMed 16096514] 20. Lundbeck Inc. Xenazine (tetrabenazine) tablets prescribing information. Deerfield, IL; 2009 Sep. 21. Klimek VM, Fircanis S, Maslak P et al. Tolerability, pharmacodynamics, and pharmacokinetic studies of depsipepide (Romidepsin) in patients with acute myelogenous leukemia or advanced myelodysplastic syndromes. Clin Cancer Res . 2008; 14:826-32. [PubMed 18245545] 22. Woo S, Gardner ER, Chen X et al. Population pharmacokinetics of romidepsin in patients with cutaneous T-cell lymphomas and relapsed peripheral T-cell lymphoma. Clin Cancer Res . 2009; 15:1496-503. [PubMed 19228751] 23. Celgene Corporation. Summit, NJ: Personal communication. Next Interactions Print this page Add to My Med List More about romidepsin Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 1 Review Add your own review/rating Drug class: histone deacetylase inhibitors Consumer resources Romidepsin Romidepsin Intravenous (Advanced Reading) Professional resources RomiDEPsin (Wolters Kluwer) Other brands: Istodax Related treatment guides Cutaneous T-cell Lymphoma Peripheral T-cell Lymphoma> ]} 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 Histone deacetylase inhibitors Related Drugs Peripheral T-cell Lymphoma Folotyn , Istodax , belinostat , Beleodaq , pralatrexate , More... Cutaneous T-cell Lymphoma bexarotene , Targretin , methoxsalen , Zolinza , Uvadex , Actimmune , vorinostat , Targretin Gel , Istodax , interferon gamma-1b , More... Romidepsin Rating 1 User Review 1.0 /10 1 User Review 1.0 Rate it!} } different
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