"The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
CLL is a rare blood and bone marrow disease"...
Advise patients to return for regular blood counts and to report any symptoms associated with hematologic toxicity (such as weakness, fatigue, pallor, shortness of breath, easy bruising, petechiae, purpura, fever) to their physician [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Hepatic and Renal Toxicity
Advise patients to avoid medications including over the counter and herbal medications, which may be hepatotoxic or nephrotoxic, during the 5 days of Clolar administration. Also, advise patients of the possibility of developing liver function abnormalities and to immediately report signs or symptoms of jaundice [see WARNINGS AND PRECAUTIONS].
Systemic Inflammatory Response Syndrome (SIRS)/Capillary Leak Syndrome
Pregnancy and Breast-feeding
Advise male and female patients with reproductive potential to use effective contraceptive measures to prevent pregnancy [see WARNINGS AND PRECAUTIONS, Use in Specific Populations]. Advise female patients to avoid breast- feeding during Clolar treatment [see Use In Specific Populations].
Advise patients that they may experience nausea,vomiting, and/or diarrhea with Clolar. If these symptoms are significant, they should seek medical attention.
Advise patients that they may experience skin rash with Clolar. If this symptom is significant, they should seek medical attention.
Last reviewed on RxList: 2/1/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Clolar Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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