, 13] 4 (6)
[2, 14]
PR, n (%)
[95% Confidence Interval] 27 (28)
[19, 38] 21 (30)
[20, 43]
Duration of Response (months)
N 33 25
Median (range) 15 (1, 20*) 11 (1, 66*)
*denotes censored value
15 REFERENCES
NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
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
American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J Health-Syst Pharm. 2006;63:1172-1193.
Polovich M., White JM, Kelleher LO (eds). Chemotherapy and biotherapy guidelines and recommendations for practice (2nd ed.) 2005. Pittsburgh, PA: Oncology Nursing Society.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
ISTODAX is supplied as a kit including a sterile, lyophilized powder in a single-use vial containing 10 mg of romidepsin and 20 mg of the bulking agent, povidone, USP. In addition, each kit includes one sterile Diluent vial containing 2 mL (deliverable volume) of 80% propylene glycol, USP, and 20% dehydrated alcohol, USP.
NDC 59572-983-01: ISTODAX® KIT containing 1 vial of romidepsin, 10 mg and 1 vial of diluent for romidepsin, 2 mL per carton
Storage
ISTODAX (romidepsin) for injection is supplied as a kit containing two vials in a single carton. The carton must be stored at 20° to 25°C, excursions permitted between 15° to 30°C. (See USP Controlled Room Temperature.)
Keep out of reach of children.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published [See References (15)].
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling.
17.1 Instructions
Patients should be instructed to report excessive nausea or vomiting, abnormal heartbeat, chest pain, or shortness of breath to their physician. Patients receiving ISTODAX® should seek immediate medical attention if unusual bleeding occurs.
ISTODAX binds to estrogen receptors. Advise women of childbearing potential that ISTODAX may reduce the effectiveness of estrogen-containing contraceptives [See Warnings and Precautions (5.5)].
Patients should be instructed to read the patient insert carefully.
Manufactured for:
Celgene Corporation
Summit, NJ 07901
Manufactured by:
Ben Venue Laboratories, Inc.
Bedford, OH 44146
ISTODAX® is a registered trademark of Astellas Pharma, Inc.
U.S. Patents: 4,977,138; 7,608,280; 7,611,724
ISTBVPI.001/PPI.001 03/10
oved Patient Labeling
ISTODAX (ISS toe dax) (romidepsin) for injection
Read the patient information that comes with ISTODAX before you receive your first treatment and each time before you are treated. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What is ISTODAX?
ISTODAX is a prescription medicine used to treat people with a type of cancer called cutaneous T |
