INDICATIONS AND IMPORTANT SAFETY INFORMATION for Jakafi® (ruxolitinib) скачать в хорошем качестве

INDICATIONS AND IMPORTANT SAFETY INFORMATION for Jakafi® (ruxolitinib)

Indications and Usage Jakafi is a prescription medicine used to treat adults with polycythemia vera who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it. Jakafi is used to treat adults with certain types of myelofibrosis. Jakafi is used 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. Jakafi is also used to treat adults and children 12 years of age and older with chronic GVHD who have taken one or two types of treatments and they did not work well enough. Selected Safety Information Jakafi can cause serious side effects including low blood counts and infection. Some people who take Jakafi have developed certain types of non‐melanoma skin cancers. Increases in blood cholesterol levels can also occur. In patients who took another JAK inhibitor to treat rheumatoid arthritis, there was an increased risk of potentially fatal cardiovascular events like heart attack or stroke in patients with risk factors for these events who smoke now or smoked in the past, as well as an increased risk of blood clots in legs or lungs and new (secondary) cancers like lymphoma, especially in patients who smoke now or smoked in the past. The most common side effects of Jakafi for certain types of MF and polycythemia vera include: low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea. The most common side effects of Jakafi for acute GVHD include: low platelet counts, low red or white blood cell counts, infections, and swelling and for chronic GVHD: low red blood cell or platelet counts and infections including viral infections. Call your doctor for medical advice about side effects. To learn more about these and other risks, please read the Important Safety Information at https://www.jakafi.com/. Please see the Full Prescribing Information (http://www.jakafi.com/pdf/prescribing..., which includes a more complete discussion of the risks associated with Jakafi. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Incyte Medical Information at 1-855-463-3463. Register now for information, support, and resources about Jakafi. Visit https://www.jakafi.com/register.aspx. Sponsored by Incyte Corporation. Jakafi and the Jakafi logo are registered trademarks of Incyte. © 2020, Incyte Corporation. MAT-JAK-03783 02/22