Medication Monitor

Generic Name (Trade Name—Company)
May 29, 2019


(Jakafi—Incyte Corporation)
FDA approves ruxolitinib for acute graft versus host disease

FDA approved ruxolitinib (Jakafi—Incyte Corporation) for steroid-refractory acute graft versus host disease (GVHD) in adult and pediatric patients aged 12 years and older.

In acute GVHD, the most common hematologic adverse reactions (incidence > 50%) are anemia, thrombocytopenia, and neutropenia. The most common nonhematologic adverse reactions (incidence > 50%) are infections and edema.

The recommended starting dose of ruxolitinib for GVHD is 5 mg given orally twice daily.

Approval was based on Study INCB 18424-271 (NCT02953678), an open-label, single-arm, multicenter study of ruxolitinib that enrolled 49 patients with steroid-refractory acute GVHD Grades 2 to 4 (Mount Sinai Acute GVHD International Consortium criteria) occurring after allogeneic hematopoietic stem cell transplantation. Ruxolitinib was administered at 5 mg twice daily, and the dose could be increased to 10 mg twice daily after 3 days in the absence of toxicity.