baricitinib

What is the most important information I should know about baricitinib?

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.

What is baricitinib?

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.

What should I discuss with my healthcare provider before taking baricitinib?

• 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.

How should I take baricitinib?

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 this medicine 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).

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking baricitinib?

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

What are the possible side effects of baricitinib?

• 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.

• 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 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.

What other drugs will affect baricitinib?

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.

Where can I get more information?

Your pharmacist can provide more information about baricitinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 9.01. Revision date: 5/12/2022.