BMS Warns of Liver Damage from Sprycel

Bristol Myers Squibb has added a new subsection to the warnings and precautions section of the Sprycel (dasatinib) label about the risk of hepatotoxicity, or liver damage. Sprycel is a tyrosine kinase inhibitor that treats patients with chronic myeloid leukemia (CML), a slow-growing cancer of the bone marrow. Sprycel, which was first approved in 2006, is indicated for adults and children with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia, which occurs when two chromosomes reverse positions. It was named for the city in which the gene abnormality was discovered.

TKIs are the standard therapy for CML and greatly increase the survival rates. The five-year relative survival rate was 70.4% from 2012 to 2018, according to the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER).

An FDA spokesperson indicated that the Sprycel labeling change was approved after a comprehensive review of all available post-market data based on continuing pharmacovigilance. “FDA continually reassesses safety information and benefit-risk profiles for approved drugs as more data are collected both from clinical trials and the postmarket setting, in order to ensure safe and effective use,” the spokesperson said.

The label also warns that patients who have had liver problems in the past may be at risk of getting liver problems with the use of Sprycel.

The new subsection of Sprycel’s label reads:

“Sprycel may cause hepatotoxicity as measured by elevations in bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase [see Adverse Reactions]. Monitor transaminases at baseline and monthly or as clinically indicated during treatment. Reduce dose, withhold, or permanently discontinue Sprycel based on severity [see Dosage and Administration]. When Sprycel is administered in combination with chemotherapy, liver toxicity in the form of transaminase elevation and hyperbilirubinemia has been observed. Monitor hepatic function when Sprycel is used in combination with chemotherapy.”