New Indication for Sprycel
November 10, 2017 – The U.S. FDA has approved a new indication for Sprycel® (dasatinib) tablets, manufactured by Bristol-Myers Squibb, to treat children and adolescents who weigh at least 10kg (22lbs) and are in the chronic phase of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Recommended dosing for this indication is based on body surface area, at 60mg/m2, and should not exceed 100mg per day. The dosage must be evaluated and adjusted as necessary at least once every three months to account for changes in patient weight.
CML is rare in pediatric patients, but tends to progress rapidly in that patient population. Acute forms of CML can be difficult to treat. The cancer begins with abnormal development of myeloid cells in the bone marrow, leading to the formation of cancerous cells that can then spread into the blood and other organs in the body.
Sprycel has been known to cause growth delays in some patients. As a result, physicians should monitor bone growth in patients being treated with the drug. Use of Sprycel is also associated with blood abnormalities, heart irregularities, bleeding, and pulmonary hypertension.
A kinase inhibitor, Sprycel is also indicated to treat adults with certain types of CML and acute lymphoblastic leukemia (ALL) that are Ph+.
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.