Baricitinib (bar-i-SYE-ti-nib)

Treats rheumatoid arthritis, coronavirus disease 2019 (COVID-19), and alopecia areata (patchy hair loss).

Brand Name(s):

Olumiant

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• For COVID-19:
  • A nurse or other trained health professional will give you this medicine.
  • This medicine comes with a Fact Sheet for Patients, Parents, and Caregivers. Read and follow the information in the Fact Sheet carefully. Ask your doctor if you have any questions.
• For rheumatoid arthritis: Your doctor will tell you how much medicine to use. Do not use more than directed.
• For alopecia areata: Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Tell your doctor if you cannot swallow the tablet whole. The tablet can be mixed it in water and swallowed right away. It may also be given through a gastrostomy tube, nasogastric tube, or orogastric tube.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how baricitinib works. Tell your doctor if you are using any of the following:
  • Diclofenac, ibuprofen, probenecid
  • Medicines that weaken your immune system (including azathioprine, cyclosporine, methotrexate)
  • Steroid medicine
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease (including hepatitis B or C), blood problems, cancer or a history of cancer, diabetes, lung disease, HIV, stomach or bowel problem (including blockage, diverticulitis, ulcers), or a history of tuberculosis. Tell your doctor if you have a current infection or an infection that keeps coming back, or if you are a current or past smoker.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Increased risk of serious infections (bacterial, fungal, viral), including herpes infection or shingles
  • Increased risk of cancer (including lymphoma, lung cancer, skin cancer)
  • Increased risk of serious heart or blood vessel disease (including heart attack, stroke)
  • Increased risk of blood clots (including arterial thrombosis, deep vein thrombosis, pulmonary embolism)
  • Stomach or bowel perforation (tear or hole)
  • High cholesterol in the blood
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blemishes on the skin, pimples
• Bloody or cloudy urine, change in how much or how often you urinate, difficult or painful urination, lower back or side pain
• Burning, itching, and pain in hairy areas, pus at root of the hair
• Chest pain that may spread, trouble breathing, coughing up blood, nausea, unusual sweating, fainting
• Fever, chills, cough, runny or stuffy nose, sore throat, night sweats, body aches
• Itching of the vagina or genitals
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Pain, redness, swelling, or tenderness in the arms or legs
• Skin or mole changes, sores that do not heal
• Stomach pain, cramping, bloody stools
• Sudden or severe headache, problems with vision, speech, or walking
• Swollen glands in your neck, armpits, or groin
• Unusual bleeding, bruising, or weakness
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088