most leeway [0.05:<2000> <25,000 50% A repeat course of CCNSB should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm 3 ; leukocytes above 4000/mm 3 ), and this is usually in 6 weeks. Adequate number of neutrophils should be present on a peripheral blood smear. Blood counts should be monitored weekly and repeat courses should not be given before 6 weeks because the hematologic toxicity is delayed and cumulative. HOW SUPPLIED CCNSB TM (lomustine) Capsules are available in individual bottles of 5 capsules each. NDC 58181-3032-5 100 mg capsules (Green/Green) NDC 58181-3031-5 40 mg capsules (White/Green) NDC 58181-3030-5 10 mg capsules (White/White) Stability CCNSB Capsules are stable for the lot life indicated on package labeling when stored in well-closed containers at 25 C (77 F); excursions permitted to 15 C 30 C (59 F 86 F) [see USP Controlled Room Temperature]. Avoid excessive heat (over 40 C, 104 F). Directions to the Pharmacist Confirm the total dose prescribed by the physician can be obtained by determining the appropriate combination of capsule strengths. Only the appropriate number of CCNSB Capsules required for the administration of a single dose should be dispensed. In order to provide the proper dose of CCNSB, patients should be aware that the prescribed dose may be made up of 2 or more different strengths and colors of capsules and that each strength must be dispensed separately. Inform patients that CCNSB is taken as a single oral dose and will not be repeated for at least 6 weeks. Daily use of the recommended dose may lead to toxicities and fatal outcomes. Caution should be exercised when handling CCNSB Capsules. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published. 1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing CCNSB Capsules. CCNSB Capsules should not be broken. Personnel should avoid exposure to broken capsules. If contact occurs, wash immediately and thoroughly. More information is available in the references listed below. 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. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society. NEXTSOURCE Biotechnology Manufactured by Corden Pharma Latina S.p.A. for: NextSource Biotechnolgy, LLC Miami, FL 33155 USA Made in Italy Rev May 2013 Principal Display Panel - 10 mg Bottle Label NDC 58181-3030-5 5 CAPSULES NEXTSOURCE Biotechnology CCNSB (lomustine) Capsules Rx only 10 mg per capsule Caution: DO NOT DISPENSE ENTIRE CONTAINER. Dispense only enough capsules for one dose. Principal Display Panel - 40 mg Bottle Label NDC 58181-3031-5 5 CAPSULES NEXTSOURCE Biotechnology CCNSB (lomustine) Capsules Rx only 40 mg per capsule Caution: DO NOT DISPENSE ENTIRE CONTAINER. Dispense only enough capsules for one dose. CCNSB lomustine capsule, gelatin coated Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58181-3031 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength lomustine (lomustine) lomustine 40 mg Product Characteristics Color green (green) , white ( white) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code Bristol;3031;40;mg Contains Packaging # Item Code Package Description 1 NDC:58181-3031-5 5 CAPSULE, GELATIN COATED in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug for use in drug shortage 05/15/2013 05/24/2013 CCNSB lomustine capsule, gelatin coated Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58181-3030 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength lomustine (lomustine) lomustine 10 mg Product Characteristics Color white (white) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code Bristol;3030;10;mg Contains Packaging # Item Code Package Description 1 NDC:58181-3030-5 5 CAPSULE, GELATIN COATED in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug for use in drug shortage 05/15/2013 05/24/2013 Labeler - NextSource Biotechnology, LLC (078779322) Revised: 05/2013 NextSource Biotechnology, LLC Next Interactions Print this page Add to My Med List More about CCNSB Capsules (lomustine) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: alkylating agents Consumer resources Professional resources Lomustine (AHFS Monograph) Lomustine (FDA) Other brands: Gleostine , CeeNU> ] 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 Drug Class Alkylating agents Related Drugs alkylating agents carboplatin , cisplatin , cyclophosphamide , oxaliplatin , Cytoxan , Temodar CCNSB Capsules Rating No Reviews - Be the first! 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