f the second dose interruption was 21 days (mean, 26 days; range, 2-148 days).
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
Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or crushed. If a powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.
Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.1-4
White opaque capsules imprinted “REV” on one half and “5 mg” on the other half in black ink:
5 mg bottles of 28(NDC 59572-405-28)
5 mg bottles of 100(NDC 59572-405-00)
Blue/green and pale yellow opaque capsules imprinted “REV” on one half and “10 mg” on the other half in black ink:
10 mg bottles of 28(NDC 59572-410-28)
10 mg bottles of 100(NDC 59572-410-00)
Powder blue and white opaque capsules imprinted “REV” on one half and “15 mg” on the other half in black ink:
15 mg bottles of 21(NDC 59572-415-21)
15 mg bottles of 100 (NDC 59572-415-00)
White opaque capsules imprinted “REV” on one half and “25 mg” on the other half in black ink:
25 mg bottles of 21(NDC 59572-425-21)
25 mg bottles of 100(NDC 59572-425-00)
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].
Dispense no more than a 28-day supply.
17. PATIENT COUNSELING INFORMATION
See Medication Guide (17.4)
17.1 Importance of Preventing Pregnancy
Females of Childbearing Potential
Patients must be counseled on lenalidomide’s potential risk of teratogenicity due to its structural similarity to thalidomide and data from an embryofetal development study showing treatment with lenalidomide produced malformations in the offspring of female monkeys who received the drug during pregnancy.
REVLIMID treatment should only be initiated in females of childbearing potential following a negative pregnancy test. Females of childbearing potential must be informed of the importance of monthly pregnancy tests and the need to use two different forms of contraception including at least one highly effective form simultaneously during REVLIMID therapy, during therapy interruption and for 4 weeks after she has completely finished taking REVLIMID. Highly effective forms of contraception other than tubal ligation include IUD and hormonal (birth contro