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
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