Jakafi FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 27, 2021.
FDA Approved: Yes (First approved November 16, 2011)
Brand name: Jakafi
Generic name: ruxolitinib
Dosage form: Tablets
Company: Incyte Corporation
Treatment for: Myelofibrosis, Polycythemia Vera, Graft-versus-host disease
Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor used for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.
- Jakafi is indicated for treatment of:
- intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults.
- polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
- steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.
- chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
- Jakafi tablets are administered orally, twice daily.
- Jakafi can cause serious adverse reactions including thrombocytopenia, anemia and neutropenia; increased risk of infection; increased risk of non-melanoma skin cancer; elevated lipids; major adverse cardiovascular events; thrombosis; and secondary malignancies.
- Common side effects of Jakafi:
- In myelofibrosis and polycythemia vera, the most common side effects include thrombocytopenia, anemia, bruising, dizziness, headache, and diarrhea.
- In acute graft-versus-host disease, the most common side effects include anemia, thrombocytopenia, neutropenia, infections, and edema.
- In chronic graft-versus-host disease, the most common side effects include anemia, thrombocytopenia, and infections.
Development timeline for Jakafi
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
