Baricitinib is used to reduce pain, stiffness, and swelling in adults with rheumatoid arthritis after other treatments have failed. Baricitinib also helps slow the progression of bone and joint damage.

Baricitinib is also used in adults who are hospitalized with COVID-19 requiring oxygen or assistance with breathing.

Baricitinib may also be used for purposes not listed in this medication guide.

Taking baricitinib may increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer.

Tell your doctor if you have a weak immune system, diabetes, chronic lung disease, or an infection such as hepatitis, tuberculosis, shingles, or HIV. Also tell your doctor if you've ever had diverticulitis, an ulcer in your stomach or intestines, cancer, heart problems, or a history of smoking, heart attack, stroke, or blood clots.

Call your doctor right away if you have a fever, night sweats, constant tiredness, weight loss, stomach pain, diarrhea or changes in bowel habits, trouble breathing, wheezing, a severe cough, or lumps in your neck, armpits, or groin.

Seek emergency medical help if you have sudden shortness of breath, chest pain spreading to your neck or arms, nausea, severe dizziness, a cold sweat, weakness on one side of your body, slurred speech, or pain, redness, or swelling in an arm or leg.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Talk to your doctor if you cannot swallow whole tablets. You may use baricitinib in a different administration route if you are not able to swallow the tablets.

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

You may take baricitinib with or without food.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

If you've ever had shingles (herpes zoster), using baricitinib can cause these viruses to become active or get worse.

You must remain under the care of a doctor while you are using baricitinib for COVID-19. Use this medicine for the full prescribed length of time (usually for 14 days or until you leave the hospital, whichever comes first).

Store at room temperature away from moisture and heat.

Taking baricitinib can increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer. Tell your doctor if you've had:

• a weak immune system or chronic infection (such as tuberculosis, shingles, HIV, or hepatitis);

• any type of cancer;

• kidney disease;

• diverticulitis, an ulcer in your stomach or intestines;

• heart problems;

• a heart attack, stroke, or blood clot;

• high cholesterol; or

• if you've ever smoked.

Tell your doctor if you've been sick with signs of infection, such as fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Also tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• chronic lung disease;

• diabetes; or

• if you are scheduled to receive any vaccine.

Using baricitinib may increase your risk of developing certain cancers, such as lymphoma or lung cancer. Ask your doctor about this risk.

Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

Not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

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.

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

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Stop taking baricitinib and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking baricitinib have developed heart attacks, strokes, or serious blood clots. Stop taking baricitinib and seek emergency medical attention if you have:

• sudden shortness of breath;

• chest pain or pressure that may spread to your jaw, shoulder, arms, or back;

• nausea, vomiting, cold sweat;

• a light-headed feeling, like you might pass out;

• weakness on one side of your body;

• slurred speech, drooping on one side of your mouth; or

• pain, swelling, or redness in an arm or a leg.

Baricitinib may cause serious side effects. Call your doctor at once if you have:

• fever, chills, night sweats, constant tiredness;

• wheezing, trouble breathing, severe or worsening cough;

• increased urination, pain or burning when you urinate;

• unexplained weight loss;

• lumps in your neck, armpits, or groin;

• signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body;

• a hole (perforation) in your digestive tract--fever, severe stomach pain, diarrhea or changes in bowel habits; or

• signs of hepatitis--loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of baricitinib may include:

• cold sores, shingles;

• nausea; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• methotrexate (sometimes given with baricitinib);

• probenecid;

• steroid medicine such as prednisone or dexamethasone;

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• other drugs to treat rheumatoid arthritis--abatacept, adalimumab, anakinra, azathioprine, certolizumab, cyclosporine, etanercept, golimumab, infliximab, rituximab, sarilumab, tocilizumab, baricitinib.

This list is not complete. Other drugs may affect baricitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.

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.