Baricitinib

pronounced as (bar" i sye' ti nib)

Brand Name(s): Olumiant®

Why is this medicine prescribed?

Baricitinib 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 adults who have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s). It is also used for the treatment of coronavirus disease 2019 (COVID-19 infection) in hospitalized adults who require supplemental oxygen, a ventilator, or who need extracorporeal membrane oxygenation (ECMO; a device that adds oxygen to the blood). Baricitinib is also used to treat alopecia areata (a condition in which the body attacks hair follicles and causes hair loss) in adults. Baricitinib 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?

Baricitinib comes as a tablet to take by mouth. It is usually taken with or without food once daily. Take baricitinib 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 baricitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are unable to swallow the tablets, you may put them into a small glass and dissolve them in approximately 2 teaspoonfuls (10 mL) of room temperature water. Swirl the contents a few times and swallow the mixture immediately. After drinking the mixture, add another 10 mL of water to the glass. Swirl the contents a few times and swallow the mixture.

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 baricitinib,

  • tell your doctor and pharmacist if you are allergic to baricitinib, any other medications, or any of the ingredients in baricitinib tablets. Ask your pharmacist 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have stomach pain that has not been diagnosed or if you have or have 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), liver disease, or kidney disease.
  • tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking baricitinib, call your doctor.
  • tell your doctor if you are breastfeeding. You should not breastfeed while taking baricitinib and for 4 days after your final dose.
  • tell your doctor if you have recently received or are scheduled to receive any vaccinations. Do not have any vaccinations during your treatment without talking to your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

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?

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

  • nausea
  • headache
  • acne
  • 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:

  • hives; swelling of face, eyes, lips, or throat; difficulty swallowing or breathing
  • stomach pain, especially if it comes along with fever and diarrhea or constipation
  • shortness of breath, tiredness, or pale skin

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

Baricitinib 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 at room temperature and away from excess heat and moisture (not in the bathroom).

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.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking baricitinib.

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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