Baricitinib Oral Tablets

What is this medication?

BARICITINIB (BAR i SYE it nib) treats rheumatoid arthritis. It may be used to treat severe hair loss. It can also be used to treat COVID-19. This medication works on the immune system.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): OLUMIANT

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• blood clots
• cancer
• diabetes (high blood sugar)
• heart disease
• high blood pressure
• high cholesterol
• immune system problems
• infection especially a virus infection such as chickenpox, cold sores, hepatitis B or herpes
• infection such as tuberculosis (TB) or other bacterial, fungal or viral infections
• kidney disease
• liver disease
• lung or breathing disease (asthma, COPD)
• low blood counts (white cells, platelets, or red blood cells)
• organ transplant
• smoke tobacco cigarettes
• stomach or intestine problems
• stroke
• an unusual or allergic reaction to baricitinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• azathioprine
• biologic medicines such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, ofatumumab, rituximab, sarilumab, secukinumab, tocilizumab, ustekinumab
• cyclosporine
• live vaccines
• medicines that lower your chance of fighting infection
• probenecid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work while taking this medication.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects.

Do not breast-feed an infant while taking this medication or 4 days after stopping it.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired; yellowing of the eyes or skin)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• tears in the stomach or intestines (fever; stomach pain; sudden change in bowel habits)

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• nasal congestion (runny or stuffy nose)
• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.