Baricitinib Oral Tablet (BARICITINIB - ORAL)

Instructions

If unable to swallow whole, dissolve the medicine in a cup with 10 mL of room temperature water. Stir and drink as soon as it is dissolved. After taking dose, add another 10 mL of water to the cup and drink it to make sure you get all the medicine.

This medicine may be taken with or without food.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than once during 24 hours.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Your doctor should check you for tuberculosis (TB) before you start this medicine and while you are using it. Tell your doctor if you are being treated for TB or any other infection.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

This medicine is associated with an increased risk for serious blood clots. Speak with your doctor about the benefits and risks from using this medicine.

Do not use the medication any more than instructed.

Please check with your doctor before drinking alcohol while on this medicine.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 4 days after stopping treatment.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• severe or persistent abdominal pain
• wheezing or difficulty breathing
• chest pain
• cough that does not go away
• fainting
• fever or chills
• fast or irregular heart beats
• sudden leg pain, swelling, warmth or redness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• pale or blue skin, lips or fingernails
• shortness of breath
• skin changes - a darker area with uneven edges or coloring
• darkening of the skin
• change in the size or color of a skin mole
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• sweating at night
• difficulty or discomfort urinating
• unexpected or extreme weight loss
• slow wound healing

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.