Recommended Topic Related To:


"The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.




Inform patients of the possibility of developing low blood cell counts and the need for hematopoietic progenitor cell infusion. Instruct patients to immediately report to their healthcare provider if fever develops [see WARNINGS AND PRECAUTIONS].

Inform patients of the risks associated with the use of BUSULFEX as well as the plan for regular blood monitoring during therapy. Specifically inform patients of the following: The risk of veno-occlusive liver disease [see WARNINGS AND PRECAUTIONS].

Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Advise females and males of reproductive potential to use effective contraception during and after treatment with BUSULFEX [see Use in Specific Populations]

Advise females to discontinue breastfeeding during treatment with BUSULFEX [see Use in Specific Populations].

Advise females and males of reproductive potential that BUSULFEX may cause temporary or permanent infertility [see Use In Specific Populations].

Last reviewed on RxList: 1/28/2015
This monograph has been modified to include the generic and brand name in many instances.


Report Problems to the Food and Drug Administration


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.

Women's Health

Find out what women really need.