What is Jakafi used to treat?
This medication is used to treat certain bone marrow disorders (myelofibrosis, polycythemia vera). It works by blocking your body from producing substances called growth factors. Growth factors cause cells to grow and divide, and cause the blood cell and spleen problems found in these disorders.
What is ruxolitinib approved for?
On May 24, 2019, the Food and Drug Administration approved ruxolitinib (JAKAFI, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
Does Jakafi treat GVHD?
Jakafi is FDA-approved to treat adults and children 12 years of age and older with acute graft-versus-host disease (GVHD) who have taken corticosteroids and they did not work well enough.
Is Jakafi chemotherapy?
Jakafi is not chemotherapy. It is a targeted treatment that works to help keep the production of blood cells under control. Discover what may be possible with Jakafi for the treatment of polycythemia vera in patients who did not benefit from HU.
How long do you take Jakafi?
Jakafi is a long-term treatment. Your Healthcare Professional may allow up to 6 months to see if Jakafi is working for you. If you do not see an improvement after 6 months of treatment, your Healthcare Professional may have you stop taking Jakafi.
Does Jakafi lower red blood cells?
Jakafi can cause serious side effects, including low blood counts. Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered.
How do you wean off jakafi?
Taper Jakafi by one dose level approximately every 8 weeks (10 mg twice daily to 5 mg twice daily to 5 mg once daily). If acute GVHD signs or symptoms recur during or after the taper of Jakafi, consider retreatment.
When do you hold jakafi?
Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
How long can you take jakafi?
How does ruxolitinib work in GVHD?
Ruxolitinib, a targeted therapy that patients take as a pill, inhibits two proteins, JAK1 and JAK2, that are thought to play a role in GVHD. Blocking these proteins may lead to a reduction in inflammation that is associated with the disease, according to the researchers.
Does Jakafi prolong life?
Jakafi Prolongs Survival in Primary Myelofibrosis Jakafi® (ruxolitinib) prolongs survival in patients with intermediate- or high-risk primary myelofibrosis compared with patients who receive conventional therapy, according to the results of a study published in the journal Blood.
Does Jakafi cause fatigue?
Jakafi can cause anemia (low red blood cell counts). When you start taking Jakafi, you should watch for the symptoms of anemia and discuss them with your Healthcare Professional. They include: Fatigue (extreme tiredness) or a lack of energy.
What are the side effects of Jakafi in adults?
Jakafi is used in adults to treat myelofibrosis or polycythemia vera, which are bone marrow disorders that that affect your body’s ability to produce blood cells. Jakafi is also used to treat acute graft versus host disease (GVHD) in adults and children 12 years of age and older who have taken corticosteroids and they did not work well enough.
How old do you have to be to take Jakafi?
Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. 2. DOSAGE AND ADMINISTRATION
How is Jakafi used in the treatment of myelofibrosis?
Jakafi is a kinase inhibitor indicated for treatment of patients with: • intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. (1.1) • bruising, dizziness and headache.
What was the FDA priority review for Jakafi?
View full prescribing information for JAKAFI. FDA granted this application priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.