Upadacitinib

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

Brand Name(s): Rinvoq®, Rinvoq® LQ

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.

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 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.

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 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 ( https://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). 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. https://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 https://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.

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