New Indication for Bosulif
December 19, 2017 – The U.S. FDA has approved a new indication for Bosulif® (bosutinib) tablets, manufactured by Pfizer, as a first-line treatment for adults with chronic phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML).
A tyrosine kinase inhibitor (TKI), Bosulif works by binding to two different receptors in cancer cells and impeding cell division. It was originally approved in 2012 to treat chronic, accelerated, or blast phase Ph+ CML that was resistant to prior therapy, or in patients who had intolerance to prior therapy. Recommended dosing under the new indication is 400 mg by mouth once daily with food. Dosage can be increased up to 600mg daily if needed.
Bosulif is available in 100mg, 400mg, and 500mg tablets.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.