Baricitinib

Taking baricitinib may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe fungal, bacterial, or viral infections that spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B virus infection (HBV; an ongoing liver infection), hepatitis C virus infection (HCV: an ongoing liver infection), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), a lung disease, or any other condition that affects your immune system. You should also tell your doctor if you live or have ever lived in areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Tell your doctor if you are taking medications that decrease the activity of the immune system.

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: fever; sweating; chills; muscle aches; cough; shortness of breath; weight loss; warm, red, or painful skin; sores on the skin; frequent, painful, or burning feeling during urination; diarrhea, or excessive tiredness.

You may already be infected with tuberculosis (TB; a serious lung infection) but not have any symptoms of the disease. In this case, taking baricitinib may make your infection more serious and cause you to develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection before and during your treatment with baricitinib. If necessary, your doctor will give you medication to treat this infection before you start taking baricitinib. Tell your doctor if you have or have ever had TB, if you have lived in or visited a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up bloody mucus, weight loss, loss of muscle tone, or fever.

Taking baricitinib may increase the risk that you will develop a lymphoma (cancer that begins in the cells that fight infection) or other types of cancers, including lung cancer and skin cancer. Tell your doctor if you have or have ever had any type of cancer. Also tell your doctor if you smoke or if you have ever smoked.

Taking baricitinib may cause serious or life-threatening heart problems, such as a heart attack or stroke, or serious or life-threatening blood clot in the lungs or legs. Tell your doctor if you smoke or if you have ever smoked. Also tell your doctor if have or have ever had a heart attack or other heart problems; a stroke; a blood clot in your legs, arms, or lungs, or in the arteries; high cholesterol; high blood pressure; or diabetes. If you experience any of the following side effects during your treatment, call your doctor immediately or get emergency medical treatment: crushing chest pain or chest heaviness; pain in the arms, back, neck, jaw, or stomach; breaking out in cold sweat; feeling light-headed; numbness or weakness in face, arm, or legs; slow or difficult speech; shortness of breath or difficulty breathing; cough; or pain, warmth, redness, swelling, or leg tenderness.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to baricitinib.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with baricitinib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of taking baricitinib.

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.

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.

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

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.

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

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.

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).

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

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.

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.

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