"The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved t"...
CeeNU has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in the following:
Brain tumors - both primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures.
Hodgkin's disease - secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
DOSAGE AND ADMINISTRATION
The recommended dose of CeeNU in adult and pediatric patients as a single agent in previously untreated patients is 130 mg/m² as a single oral dose every 6 weeks (see PATIENT INFORMATION and HOW SUPPLIED: Directions to the Pharmacist). In individuals with compromised bone marrow function, the dose should be reduced to 100 mg/m² every 6 weeks. When CeeNU is used in combination with other myelosuppressive drugs, the doses should be adjusted accordingly.
Doses subsequent to the initial dose should be adjusted according to the hematologic response of the patient to the preceding dose. The following schedule is suggested as a guide to dosage adjustment:
|Nadir After Prior Dose||Percentage of Prior Dose to be Given|
|Leukocytes (/mm³)||Platelets (/mm³)|
|≥ 4000||≥ 100,000||100%|
|< 2000||< 25,000||50%|
A repeat course of CeeNU should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm³; leukocytes above 4000/mm³), 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.
CeeNU® (lomustine) Capsules are available in individual bottles of 20 capsules each.
NDC 0015-3032-20 100 mg capsules (Green/Green)
NDC 0015-3031-20 40 mg capsules (White/Green)
NDC 0015-3030-20 10 mg capsules (White/White)
CeeNU 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
The total dose prescribed by the physician can be obtained (to within 10 mg) by determining the appropriate combination of capsule strengths. Only the appropriate number of CeeNU capsules required for a single administration should be dispensed.
The appropriate number of capsules of each size should be placed in a single vial. Each color-coded capsule is imprinted with the dose in milligrams. In order to provide the proper dose of CeeNU, patients should be aware that there may be 2 or more different types and colors of capsules in the container. Patients should be told that CeeNU is taken as a single oral dose and will not be repeated for at least 6 weeks.
Caution should be exercised when handling CeeNU 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 CeeNU Capsules. CeeNU 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.
1. 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.
2. 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
3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. (2nd ed.) Pittsburgh, PA: Oncology Nursing Society.
Manufactured for: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Made in Italy. Revised: October 2010This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/16/2011
Additional CeeNU Information
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