Baricitinib

Pronunciation: bar-ee-sit-tin-nib
Generic name: baricitinib
Brand name: Olumiant
Dosage form: oral tablets
Drug classes: Antirheumatics, Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on May 7, 2024.

What is baricitinib?

Baricitinib (Olumiant) is an oral Janus kinase (JAK) inhibitor that may be used to treat adults with:

• moderately to severely active rheumatoid arthritis (RA) who have not had a good response to one or more TNF blockers
• COVID-19 in hospitalized patients requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
• severe alopecia areata.

Baricitinib works by blocking a specific group of enzymes called Janus kinases, that transmit signals from other immune system cells and influence processes such as blood cell production and immune cell function. Baricitinib reduces inflammation caused by an overactive immune system.

Baricitinib was FDA-approved on May 31, 2018, under the brand name Olumiant. There is no generic Olumiant available.

Baricitinib side effects

Baricitinib may cause serious side effects including serious infections, an increased risk of death in people over the age of 50 with cardiovascular risk factors, cancer, immune system problems, an increased risk of major cardiovascular events, blood clots, allergic reactions, gastrointestinal tears (perforations), and changes in laboratory test results. See warnings below.

The most common side effects of baricitinib affecting 1% or more people treated for rheumatoid arthritis include:

• upper respiratory tract infections (common cold, sinus infections)
• nausea
• herpes simplex virus infections, including cold sores
• shingles (herpes zoster).

The most common side effects of baricitinib affecting 1% or more people treated for COVID-19 include:

• increased liver enzyme levels
• increased platelets in your blood (thrombocytosis)
• increased blood creatine phosphokinase
• low white blood cell count (neutropenia)
• blood clots in the veins of your legs (DVT)
• blood clot in your lungs (pulmonary embolism)
• urinary tract infections.

The most common side effects of baricitinib affecting 1% or more people treated for alopecia areata include:

• upper respiratory tract infections (common cold, sinus infections)
• headache
• acne
• increased blood cholesterol
• increased blood creatine phosphokinase
• urinary tract infections
• increased liver enzyme levels
• inflammation of hair follicles (folliculitis)
• tiredness
• lower respiratory tract infections
• nausea
• genital yeast infection
• low red blood cell count (anemia)
• low numbers of certain types of white blood cells (neutropenia)
• stomach-area (abdominal) pain
• shingles (herpes zoster)
• increased weight.

These are not all of the possible side effects of baricitinib. Call your doctor for medical advice about side effects. You may report side effects to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Related/similar drugs

Cimzia, triamcinolone, hydroxychloroquine, Humira, Paxlovid, minoxidil topical, Enbrel

Warnings

Baricitinib (Olumiant) may cause the following serious side effects.

Serious infections. Baricitinib can lower the ability of your immune system to fight infections. Some people have had serious infections while taking baricitinib, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting treatment for RA or alopecia areata and monitor you throughout treatment. Do not start treatment with baricitinib for these conditions if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles.

JAK inhibitors, such as baricitinib have been associated with an increased risk of death in people aged 50 years and older with at least 1 heart disease (cardiovascular) risk factor when compared to people of the same age taking a TNF inhibitor, especially if you are a current or past smoker. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking baricitinib, such as:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
• weakness in one part or on one side of your body
• slurred speech.

Cancer and immune system problems. Baricitinib may increase your risk of certain cancers, such as lymphoma, lung cancer, or skin cancer, especially if you are a current or past smoker, by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer. Follow your healthcare provider’s advice about having your skin checked for skin cancer during treatment with baricitinib.

Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) and arteries (arterial thrombosis) can happen in some people taking baricitinib. This may be life-threatening and cause death. People aged 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor are more at risk. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past. Stop taking baricitinib and tell your healthcare provider or get emergency help right away if you have any signs and symptoms of blood clots during treatment including swelling, pain or tenderness in the leg, sudden unexplained chest pain, or shortness of breath.

Allergic reactions, including anaphylaxis. Tell your doctor if you develop any hypersensitivity symptoms such as a rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat.

Tears (perforations) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. People who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate are more at risk. Tell your healthcare provider right away if you have a fever, stomach-area pain that does not go away, and a change in your bowel habits.

Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking baricitinib and while you are taking it, including measuring counts of red and white blood cells. Tell your doctor if you develop signs of an infection, or feel weak and tired.

High cholesterol levels. If you are being treated for rheumatoid arthritis or alopecia areata, your healthcare provider should do blood tests to check your cholesterol levels approximately 12 weeks after you start taking baricitinib, and as needed.

Elevated liver enzymes. Liver enzymes help to tell if your liver is functioning normally. Elevated liver enzymes may indicate that your healthcare provider needs to do additional tests on your liver.

It is not known if baricitinib is safe and effective in children.

Before taking

Before starting baricitinib, tell your healthcare provider if you:

• are being treated for an infection
• have an infection that does not go away or that keeps coming back
• have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance of infections
• have or have had blood clots
• have diverticulitis
• have TB or have been in close contact with someone with TB
• have had shingles (herpes zoster)
• have had hepatitis B or C
• live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain kinds of fungal infections. These infections may happen or become more severe if you use baricitinib. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common
• think you have an infection or have symptoms of an infection such as fever, sweating, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinating more often than normal; or feeling tired
• are pregnant or intend to become pregnant
• are breastfeeding.

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.

Using this medicine may increase your risk of developing certain cancers, such as lymphoma or lung cancer. Ask your doctor about this risk.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm an unborn baby. If you become pregnant during treatment with baricitinib call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You should not breastfeed during treatment with baricitinib and for 4 days after the last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.

How is baricitinib administered?

Baricitinib is an oral tablet that is usually administered once daily by mouth. Try to take it around the same time each day.

• It may be taken with or without food.
• Take it exactly as your healthcare provider tells you to take it.

For people with COVID-19, the usual course of baricitinib treatment is 14 days or until you are discharged from the hospital (whichever comes first), as instructed by your healthcare provider. You must remain under the care of a doctor while you are using baricitinib for COVID-19.

For people with RA or alopecia areata, baricitinib is usually taken long-term but your healthcare provider may consider stopping treatment if there is no improvement in your symptoms after 6 months.   

If you are unable to swallow baricitinib tablets whole, you may put them into a small glass and dissolve them in approximately 2 teaspoonfuls (10 mL) of room-temperature water. You should 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. Dispersed tablets are stable in water for up to 4 hours.

After starting baricitinib, call your healthcare provider right away if you have any symptoms of an infection. Baricitinib can make you more likely to get infections or, make worse any infection that you have. If you get a serious infection, your healthcare provider may stop your treatment until your infection is controlled.

Recommended baricitinib dosage

Your healthcare provider will decide the right dose for you. The usual baricitinib dosage for adults is as follows:

• Rheumatoid Arthritis: 2 mg once a day
  • May be used as monotherapy or in combination with methotrexate or other DMARDs.
• Alopecia Areata: Initially, 2 mg once daily. The dose may be increased to 4 mg once daily if the response to treatment is not adequate.
  • For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg once daily. Reduce the dose to 2 mg once daily when an adequate response has been achieved.
• COVID-19: 4 mg tablet once a day
  • Duration of therapy: 14 days or until hospital discharge, whichever is first.

Pediatric use of baricitinib for COVID-19

In July 2021, the US FDA expanded the Emergency Use Authorization (EUA) for Olumiant (baricitinib) to allow the emergency use of this drug, with or without remdesivir, for treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or ECMO.

• The pediatric dose is 2 mg once daily (2 years to less than 9 years) or 4mg once daily (9 years and older).
• Duration of therapy: 14 days or until hospital discharge, whichever is 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?

If you take too much baricitinib, call your healthcare provider or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

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 other drugs will affect baricitinib?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Baricitinib and other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

• probenecid
• methotrexate
• steroid medicines such as prednisone or dexamethasone;
• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others
• medicines that affect your immune system such as biologic medications, other JAK inhibitors, and strong immunosuppressants (such as azathioprine and cyclosporine) as these medicines may increase your risk of infection.

For RA or alopecia areata, baricitinib should not be used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Ask your healthcare provider or pharmacist if you are not sure if you are taking one of these medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the baricitinib package insert for more information.

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C).

Keep out of reach of children.

Olumiant Ingredients

Active ingredient: baricitinib.

Inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

Olumiant tablets are available in 1 mg, 2 mg, and 4 mg strength.

Manufacturer

Olumiant: Eli Lilly and Company.

Frequently asked questions

• What are the new drugs for rheumatoid arthritis (RA)?
• Is baricitinib (Olumiant) being used to treat COVID-19?
• What type of drug is Olumiant (baricitinib)?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer