Upadacitinib

Taking upadacitinib may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe fungal, bacterial, or viral infections that spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B (a viral infection that affects the liver), hepatitis C virus infection (HCV: an ongoing liver infection), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), a lung disease, or any other condition that affects your immune system. You should also tell your doctor if you live or have ever lived in areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you are not sure if these infections are common in your area. Tell your doctor if you are taking medications that decrease the activity of the immune system. Make sure you have discussed any medications you are currently taking or plan to take with your doctor and pharmacist before starting upadacitinib.

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: fever; sweating; chills; muscle aches; cough; shortness of breath; weight loss; warm, red, or painful skin; sores on the skin; frequent, painful, or burning feeling during urination; diarrhea; or excessive tiredness.

You may already be infected with tuberculosis (TB; a serious lung infection) or hepatitis B (a virus that affects the liver) but not have any symptoms of the disease. In this case, taking upadacitinib may make your infection more serious and cause you to develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order a blood test to see if you have an inactive hepatitis B infection before you begin your treatment with upadacitinib. If necessary, your doctor will give you medication to treat this infection before you start using upadacitinib. Tell your doctor if you have or have ever had TB, if you have lived in or visited a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up bloody mucus, weight loss, loss of muscle tone, or fever.

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Taking upadacitinib may increase the risk that you will develop a lymphoma (cancer that begins in the cells that fight infection) or other types of cancers such as skin cancer or lung cancer. Tell your doctor if you have or have ever had any type of cancer. Plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing and sunscreen. Also tell your doctor if you smoke or if you have ever smoked.

Taking upadacitinib may cause serious or life-threatening heart problems, such as a heart attack or stroke, or serious or life-threatening blood clots in the lungs or legs. Tell your doctor if you smoke or if you have ever smoked. Also tell your doctor if have or have ever had a heart attack or other heart problems; a stroke; a blood clot in your legs, arms, or lungs, or in the arteries; high cholesterol; high blood pressure; or diabetes. If you experience any of the following symptoms during your treatment, call your doctor immediately or get emergency medical treatment: pain in the chest, arms, back, neck, jaw, or stomach; breaking out in cold sweat; feeling light-headed; dizziness; numbness or weakness in face, arm, or legs; slow or difficult speech; sudden shortness of breath or difficulty breathing; swelling of a leg or arm; leg pain; redness, discoloration, or warmth in the legs or arms.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before, during, and after your treatment to check your body’s response to upadacitinib.

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Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with upadacitinib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of taking upadacitinib.

🔔 Why is this medication prescribed?

Upadacitinib is used alone or with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in people who are unable to take or have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s). It is also used to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults who are unable to take or did not respond to or tolerate one or more TNF inhibitor medication(s). Upadacitinib is also used to treat symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children 12 years and older who cannot use other medications for their condition or whose eczema has not responded to other medications. It is also used to treat ulcerative colitis (a condition that causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s). Upadacitinib is also used to treat Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s). Upadacitinib is used to treat ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain, swelling, and joint damage) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s). It is also used to treat active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas, causing pain and signs of swelling), but without changes seen on X-ray, in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s). Upadacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.

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🔔 How should this medicine be used?

Upadacitinib comes as an extended-release (long-acting) tablet. It is usually taken with or without food once daily. Take upadacitinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take upadacitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not split, chew, or crush them.

Your doctor may need to temporarily or permanently stop treatment if you experience certain severe side effects. Be sure to tell your doctor how you are feeling during your treatment.