WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS See full prescribing information for completeboxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with OLUMIANT if serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB tests., Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients., Malignancies have occurred in patients treated with OLUMIANT. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients., Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients., Thrombosis has occurred in patients treated with OLUMIANT. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Tell your doctor if you have tuberculosis or if you have any other active infections or an infection that keeps coming back. Olumiant may increase the risk for serious infections and opportunistic infections, especially in those taking medications that suppress the immune system. Once you are prescribed and buy Olumiant, immediately tell your doctor if you develop a fever, cough, shortness of breath, muscle aches, diarrhea, stomach pain, tiredness, bloody phlegm, skin problems, sores on your body, weight loss, burning with urination, or the need to urinate more frequently. The risk of all-cause death is increased in patients who are at least 50 years old who have one or more risk factors for cardiovascular disease and are taking a JAK inhibitor. Olumiant may increase your risk of developing certain cancers such as skin cancer, lung cancer, and lymphoma. Tell your doctor if you have heart problems or if you've ever had a stroke or heart attack. It is important to tell your doctor if you smoke. The risk of major cardiovascular events is increased in patients who are at least 50 years old who have one or more risk factors for cardiovascular disease and are taking a JAK inhibitor. Seek medical care immediately if you feel chest discomfort, nausea, vomiting, lightheadedness, shortness of breath, slurred speech, weakness in one part or on one side of your body, cold sweat, pain or discomfort in your arms, back, jaw, neck, or stomach, or tightness, heaviness, pain, or pressure in your chest, throat, neck, or jaw. Tell your doctor if you have had blood clots in your legs or lungs.Thrombosishas been reported with the use of Olumiant. Immediately tell your doctor if you experience leg pain, tenderness, or swelling, chest pain, or shortness of breath. Tell your doctor if you have stomach or intestinal problems. Tears in the stomach and intestines have occurred with Olumiant treatment. Immediately tell your doctor if you develop a fever, persistent stomach pain, and bowel changes. Abnormal blood counts may occur with Olumiant treatment. You should not receive live vaccines while being treated with Olumiant. Olumiant may cause hypersensitivity reactions such as itching, swelling, or a rash. Some reactions may be more severe. Discuss yourallergieswith your doctor. Tell your doctor if you are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. Olumiant may interact with certain medications that can lead to serious reactions. So, tell your doctor about all the medications that you take.
