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U.S. Department of Health and Human Services

Safety

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CeeNu (lomustine) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Brand (Generic) Name

Sections Modified

CeeNu (lomustine) Capsules

 

PRECAUTIONS

  • Information for Patients
    • Patients should be told that CeeNU is an anticancer drug and belongs to the group of medicines known as alkylating agents.
    • In order to provide the proper dose of CeeNU, patients should be aware that there may be two or more different types and colors of capsules in the container dispensed by the pharmacist.
    • Patients should be told that CeeNU is given as a single oral dose and will not be repeated for at least 6 weeks.
    • Patients should be told that nausea and vomiting usually last less than 24 hours, although loss of appetite may last for several days.
    • If any of the following reactions occur, notify the physician: fever, chills, sore throat, unusual bleeding or bruising, shortness of breath, dry cough, swelling of feet or lower legs, mental confusion, or yellowing of eyes and skin.
    • Patients should be told to wear gloves when handling CeeNU Capsules.