Class Name(s):

• 90:24.12.92 Janus Kinase Inhibitors, Miscellaneous

Pronunciation:

• (ue pad" a sye' ti nib)

Brand Name(s):

• Rinvoq^®
• Rinvoq^® LQ

IMPORTANT WARNING:

Upadacitinib may make it harder for you to fight infections and increase the chance that you will get a serious infection. 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 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, 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. If necessary, your doctor will give you medication to treat this infection before you start taking 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.

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 or anyone in your family 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.

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 you 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.

You will be given the 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 http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of taking upadacitinib.

WHY is this medicine prescribed?

Upadacitinib is used alone or with other medications to treat:

• rheumatoid arthritis (a condition in which the body attacks its own joints causing pain, swelling, and loss of function)
• psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin)
• eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes)
• ulcerative colitis (a condition that causes swelling and sores in the lining of the colon [large intestine] and rectum)
• Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever)
• ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain, swelling, and joint damage)
• axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas, causing pain and signs of swelling)
• 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)
• giant cell arteritis (a condition that causes swelling of blood vessels, especially in the scalp and head)

Upadacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.

HOW should this medicine be used?

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

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. Use the bottle adapter and syringe provided by the manufacturer to measure and give each dose. Read the written instructions that come with the medication. Ask your doctor or pharmacist if you have any questions about preparing or giving a 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.

Are there OTHER USES for this medication?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking upadacitinib,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• 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 ileostomy 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 before beginning your treatment. 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.

What SPECIAL DIETARY instructions should I follow?

Avoid drinking grapefruit juice or eating grapefruit while taking upadacitinib.

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://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.

What should I know about STORAGE and DISPOSAL of this medication?

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.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 15, 2025.