Vertex Pharmaceuticals announced that the INCIVEK label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment. Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified. In Phase 3 clinical trials, less than 1% of people who received INCIVEK combination treatment experienced a serious skin reaction. These serious skin reactions required hospitalization and all patients recovered. The INCIVEK label was also updated to include additional information on the time to onset and management of anemia.
- Vertex Pharmaceuticals