Pronunciation: O-loo-me-ant
Generic name: baricitinib
Dosage form: tablet (1mg, 2mg, 4mg)
Drug classes: Antirheumatics, Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 19, 2024.

What is Olumiant?

Olumiant (baricitinib) tablets are used to treat rheumatoid arthritis, severe alopecia areata (hair loss) and COVID-19 in certain patients. These conditions may be caused by an overactive immune system causing inflammation. Olumiant works by blocking a specific protein (Janus kinase) that causes inflammation to help relieve the symptoms of these conditions. Olumiant is classified as a Janus kinase inhibitor (JAK inhibitor).

In rheumatoid arthritis, the immune system attacks healthy joint tissues causing the joint to be inflamed. Olumiant reduces inflammation in RA to help relieve pain, swelling, and tenderness of the joints.

In alopecia areata (AA), hair loss is caused by the immune system attacking the hair follicles, causing inflammation that interrupts hair growth. Olumiant blocks inflammation, which allows hair to regrow. Olumiant treats symptoms of alopecia areata, but it is not a cure, and if you stop taking the tablets, then your hair may fall out again.

When used to treat COVID-19, Olumiant is associated with an improvement in COVID-19 symptoms and a reduced need for ventilators. While generally well-tolerated, some patients developed elevated liver enzymes as a side effect.

Olumiant gained FDA approval on May 31, 2018. A generic version of Olumiant was FDA-approved on July 22, 2024, under the name baricitinib.

Who can take Olumiant?

Olumiant may be used to treat rheumatoid arthritis, alopecia areata, and COVID-19 infection.

Rheumatoid arthritis. Olumiant is used for rheumatoid arthritis that is moderately to severely active in adult patients who have had an inadequate response to one or more other medicines called tumor necrosis factor (TNF) blockers. It is NOT recommended for use in combination with other JAK inhibitors, biological disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

Alopecia Areata (hair loss). Olumiant is used for the treatment of adult patients with severe alopecia areata (hair loss). It is NOT recommended for use in combination with biologic immunomodulators, other JAK inhibitors cyclosporine, or other potent immunosuppressants.

Coronavirus Disease 2019 (COVID-19). Olumiant can be used for the treatment of COVID-19 for hospitalized adult patients who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

• It has emergency use authorization for the treatment of children aged 2 and older (see more detailed information below).

Related/similar drugs

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

Olumiant side effects

The most common side effects of Olumiant include:

• cold sores
• shingles
• nausea
• cold symptoms such as stuffy nose, sneezing, or sore throat.

Serious side effects and warnings

Olumiant carries a Boxed Warning for serious infections, an increased risk of death, cancer, major cardiovascular side effects, and blood clots.

Serious infections. Olumiant affects the immune system. Olumiant can lower the ability of your immune system to fight infections. Some people have had serious infections while taking Olumiant, 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 with Olumiant for rheumatoid arthritis or alopecia areata.
• Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with Olumiant.
• You should not start taking Olumiant 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.

After starting Olumiant, call your healthcare provider right away if you have any symptoms of an infection. Olumiant 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 with Olumiant until your infection is controlled.

Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. Olumiant is a JAK inhibitor medicine.

Cancer and immune system problems. Olumiant may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers including skin cancers can happen in people taking Olumiant. People taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. 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 Olumiant.

Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors, 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 Olumiant, including:

• 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

Blood Clots. 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 Olumiant. This may be life-threatening and cause death. Blood clots in the veins of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past. Stop taking Olumiant and tell your healthcare provider or get emergency help right away if you have any signs and symptoms of blood clots during treatment with Olumiant, including swelling, pain or tenderness in the leg, sudden unexplained chest pain, or shortness of breath.

Allergic Reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, which may mean you are having an allergic reaction have been seen in people taking Olumiant. Some of these reactions were serious. If any of these symptoms occur during treatment with Olumiant, stop taking it and get emergency help right away.

Tears (perforation) 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. Some people taking Olumiant can get tears in their stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.

Changes in certain laboratory test results with Olumiant. Your healthcare provider should do laboratory monitoring including blood tests before you start taking Olumiant and while you are taking it to check for the following:

• low neutrophil and lymphocyte counts. Neutrophils and lymphocytes are types of white blood cells that help the body fight off infections
• low red blood cell counts. This may mean that you have anemia, which may make you feel weak and tired
• increased 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 Olumiant, 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.

You should not take Olumiant if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your Olumiant treatment for a period of time if needed because of changes in these blood test results.

Call your doctor at once if you have:

• fever, chills, night sweats, constant tiredness
• wheezing, trouble breathing, severe or worsening cough
• increased urination, pain or burning when you urinate
• unexplained weight loss
• lumps in your neck, armpits, or groin
• signs of shingles - flu-like symptoms, tingly or painful blistering rash on one side of your body
• a hole (perforation) in your digestive tract - fever, severe stomach pain, diarrhea, or changes in bowel habits
• signs of hepatitis - loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Before starting Olumiant, tell your healthcare provider about all your medical conditions, including 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 TB or have been in close contact with someone with TB
• have had shingles (herpes zoster)
• have had liver disease including 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 Olumiant
• think you have an infection or have symptoms of an infection such as:
  • fever, sweating, or chills
  • shortness of breath
  • warm, red, or painful skin or sores on your body
  • feeling tired
  • muscle aches
  • blood in your phlegm
  • diarrhea or stomach pain
  • cough
  • weight loss
  • burning when you urinate or urinating more often than normal

Also, tell your healthcare provider if you have:

• had blood clots in the veins of your legs or lungs
• any type of cancer
• kidney disease
• diverticulitis, an ulcer in your stomach or intestines
• heart problems including a heart attack, stroke, or blood clots
• high cholesterol
• ever smoked
• or are scheduled to receive a vaccine.

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

Also tell your healthcare provider if you are pregnant, intending to become pregnant, or are breastfeeding.

Pregnancy

It is not known if Olumiant will harm an unborn baby. If you become pregnant during treatment call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.

Breastfeeding

It is not known if Olumiant passes into your breast milk. You should not breastfeed during treatment with Olumiant 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 should I take Olumiant?

Take Olumiant exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Olumiant is taken 1 time daily.

• Take it at around the same time every day.
• Olumiant can be taken with or without food.
• 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. 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.

You must remain under the care of a doctor while you are using Olumiant for COVID-19. Use this medicine for the full prescribed length of time (usually for 14 days or until you leave the hospital, whichever comes first).

Your doctor may perform laboratory tests before taking Olumiant to make sure you do not have tuberculosis or other infections.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

If you've ever had shingles (herpes zoster), using this medicine can cause these viruses to become active or get worse.

Olumiant enrollment form

Lilly Cares offers financial assistance for eligible patients. The Lilly Cares Patient Assistance Program provides free Eli Lilly medications to qualifying individuals. An Olumiant enrollment form is available for patients seeking financial support for their prescriptions.

Olumiant Dosing Information

Usual Adult Dose of Olumiant for Rheumatoid Arthritis:

Dose: Olumiant 2 mg once a day
Comments: This drug may be used as monotherapy or in combination with methotrexate or other DMARDs.

Usual Adult Dose of Olumiant for Alopecia Areata:

Dose: Olumiant 2 mg tablet 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.

Usual Olumiant dosage for COVID-19

Olumiant has FDA approval to treat COVID-19 patients who are 18 years and older, who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Dose for adults with COVID-19: Olumiant 4 mg tablet once a day
Duration of therapy: 14 days or until hospital discharge, whichever is first.

Olumiant has an Emergency Use Authorization (EUA) received from the FDA to treat COVID-19 patients aged 2 years to less than 18 years, who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Dose for children with COVID-19 (investigational use only)

• 2 years to less than 9 years: Olumiant 2 mg orally once a day.
• 9 years and older: Olumiant 4 mg orally once a day.
• Olumiant is not authorized for COVID-19 in patients younger than 2 years.

Duration of therapy: 14 days or until hospital discharge, whichever is first.

What strengths is Olumiant available in?

Olumiant is available in film-coated tablets as Olumiant 1 mg tablets, 2 mg tablets, and 4 mg tablets.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Olumiant?

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 Olumiant?

Tell your doctor about all your other medicines, especially:

• methotrexate (sometimes given with Olumiant;
• probenecid;
• steroid medicine such as prednisone or dexamethasone;
• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• other drugs to treat rheumatoid arthritis - abatacept, adalimumab, anakinra, azathioprine, certolizumab, cyclosporine, etanercept, golimumab, infliximab, rituximab, sarilumab, tocilizumab, baricitinib.

This list is not complete. Other drugs may affect Olumiant, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Click the link below to check for interactions with Olumiant.

Storage

• Store Olumiant at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

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.

Who makes Olumiant

Eli Lilly and Company manufacture Olumiant.

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Further information

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