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 or hepatitis C (viral infection that affects the liver) but not have any symptoms of these diseases. 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 or hepatitis C 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.

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.

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 https://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.

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) in adults and children 2 years of age and older. 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 also used to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children 2 years of age or older 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.

Upadacitinib comes as an extended-release (long-acting) tablet and solution (liquid) to take by mouth. The extended-release tablet is usually taken with or without food once daily. The oral solution is usually taken without or without food twice a day. Take upadacitinib at around the same time(s) 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.

If you are taking the liquid, do not use a household spoon to measure your dose. Always use the bottle adapter and measuring syringe provided by the manufacturer to measure each dose of the liquid.

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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking upadacitinib,

• tell your doctor and pharmacist if you are allergic to upadacitinib, any other medications, or any of the ingredients in upadacitinib extended-release tablets or solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while you are taking upadacitinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or ever had ulcers (sores in the lining of your stomach or intestine), diverticulitis (swelling of the lining of the large intestine), a low number of white blood cells, anemia (a lower than normal number of red blood cells), or kidney or liver problems. Also, tell your doctor if you ever had any kind of surgery on your stomach or intestines, if you have had an iliostomy or colostomy (surgery to create an opening for waste to leave the body through the abdomen), or any other gastrointestinal problem.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you start treatment with upadacitinib. You should use birth control to prevent pregnancy during your treatment and for at least 4 weeks after your final dose. Talk to your doctor about birth control methods that you can use. If you become pregnant, call your doctor immediately. Upadacitinib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with upadacitinib and for 6 days after your final dose.
• tell your doctor if you have recently received or are scheduled to receive any vaccinations. If you need any vaccinations, you may have to receive the vaccinations and then wait some time before beginning your treatment with upadacitinib. Do not have any vaccinations during your treatment without talking to your doctor.
• you should know that some people may see something that looks like a tablet (whole tablet or tablet pieces) in their stool. If this happens, it could mean that you did not get your complete dose of medication. Call your doctor if you see a whole tablet or tablet pieces in your stool.

Avoid drinking grapefruit juice or eating grapefruit while taking upadacitinib.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Upadacitinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stuffy or runny nose
• nausea
• acne
• headache
• increased weight
• muscle pain
• red bumps or pimples around hair follicles

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• rash, hives, swelling of face, eyes, lips, or throat, difficulty swallowing or breathing
• stomach pain, especially if it comes along with fever, chills, nausea, and vomiting
• shortness of breath, tiredness, or pale skin
• sudden changes in vision

Upadacitinib may cause an increase in your blood cholesterol levels. Your doctor will order tests to monitor your cholesterol levels during your treatment with upadacitinib. Talk to your doctor about the risks of taking this medication.

Upadacitinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it either in the refrigerator or at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of any unused oral solution 60 days after first opening the bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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