pronounced as (ue pad" a sye' ti nib)

Brand Name(s): Rinvoq®

Why is this medicine 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.

Are there other uses for this medicine?

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

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.

What special precautions should I follow?

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. 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.

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 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 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.

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 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).

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. http://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 ( http://goo.gl/c4Rm4p ) for more information if you do not have access to a take-back program.

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.

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.

subscribe section background