Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Gastrointestinal Disorders: tooth hypoplasia
PATIENT COUNSELING INFORMATION
- 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.
- 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.
- Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy.
- Advise females and males of reproductive potential to use effective contraception during and after treatment with BUSULFEX.
- Advise females to discontinue breastfeeding during treatment with BUSULFEX.
- Advise females and males of reproductive potential that BUSULFEX may cause temporary or permanent infertility.
- The following adverse reactions (reported as MedRA terms) have been identified during post-approval use of Busulfex (busulfan) Injection: febrile neutropenia; tumor lysis syndrome; thrombotic micro-angiopathy (TMA); severe bacterial, viral (e.g., cytomegalovirus viraemia) and fungal infections; and sepsis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure.