Dosing & Side Effects | Olumiant® (baricitinib) (2022)

Discover a once-daily pill for adults with:

  • Severe alopecia areata or

  • Moderate to severe rheumatoid arthritis

Ask your healthcare provider about Olumiant

Important notes about Olumiant:

(Video) Barinat & Baricitinib Medication Information (dosing, side effects)

  • It is not an injection or a cream
  • It can be taken with or without food
  • It should be taken exactly as prescribed

Most Common Side Effects

When taking Olumiant, some people with alopecia areata may experience any of the following common side effects:

  • Upper respiratory tract infections (cold or sinus infections)
  • Headache
  • Acne
  • Increased cholesterol levels
  • Increased muscle enzyme levels
  • Urinary tract infection
  • Increased liver enzyme levels
  • Inflammation of hair follicles
  • Tiredness
  • Lower respiratory tract infections
  • Nausea
  • Genital yeast infection
  • Low red blood cell count
  • Low white blood cell count
  • Stomach-area pain
  • Shingles
  • Increased weight

When taking Olumiant, some people with rheumatoid arthritis may experience any of the following common side effects:

  • Upper respiratory tract infections (such as a cold or sinus infection)
  • Nausea
  • Cold sores
  • Shingles

There may be other side effects when taking Olumiant.

PURPOSE AND SAFETY SUMMARY WITH WARNINGS

Important Facts About Olumiant® (O-loo-mē·ant). It is also known as baricitinib.

Olumiant is a prescription medicine that is a Janus kinase (JAK) inhibitor used to treat:

  • adults with severe alopecia areata.
  • adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
(Video) Baricitinib for Alopecia | NEJM

Warnings

Olumiant may cause serious side effects, including:

  • Serious infections, including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
    • fever, sweating, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning with urination or urinating more often than normal
    • feeling tired

    If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.

  • Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.
  • Cancer and immune system problems. Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor's advice about having your skin checked for skin cancer while taking 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 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 in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
  • Allergic reactions. While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
  • Tears in the stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
  • Changes in laboratory test results. Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.

Common side effects

The most common side effects of Olumiant in people treated for alopecia areata include:

  • upper respiratory tract infections (cold or sinus infections)
  • headache
  • acne
  • increased cholesterol levels
  • increased muscle enzyme levels
  • urinary tract infection
  • 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 white blood cell count (neutropenia)
  • stomach-area (abdominal) pain
  • shingles (herpes zoster)
  • increased weight

The most common side effects of Olumiant in people treated for rheumatoid arthritis include:

  • herpes simplex virus infections, including cold sores
  • shingles (herpes zoster)
(Video) Baricitinib in Covid 19

These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects. You can report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

(Video) Baricitinib side effects | common side effects of baricitinib | baricitinib tablet side effects

Before using

Before you use Olumiant, tell your doctor if you:

  • Are being treated for an infection, have an infection that won't go away or keeps coming back, or think you have symptoms of an infection.
  • Have TB or have been in close contact with someone with TB.
  • Have had shingles (herpes zoster).
  • Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
  • Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
  • Are a current or past smoker.
  • Have had a heart attack, other heart problems or stroke.
  • Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
  • Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
  • Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
  • Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
  • Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
    • a medicine called probenecid
    • medicines that affect your immune system, such biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
  • Are under age 18. It is not known if Olumiant is safe and effective in children.

How to take

  • Take Olumiant exactly as your doctor says.
  • Take Olumiant once a day by mouth with or without food.
  • Talk to your doctor if you cannot swallow tablets whole.
  • If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

Learn more

For more information, call 1-800-545-5979 or go to www.olumiant.com.

(Video) Barikind review, uses, benefits, dosage, side effects and ingredients

This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.

BA CON BS 13JUN2022

Please see full Prescribing Information, including Boxed Warning, and Medication Guide.

FAQs

What is the most common side effects of baricitinib? ›

More common
  • Body aches or pain.
  • difficulty in breathing.
  • headache.
  • runny or stuffy nose.
  • sore throat.
  • unusual tiredness or weakness.
Jun 1, 2022

Is Olumiant the same as baricitinib? ›

Olumiant (baricitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated ...

How long do you take baricitinib? ›

For treatment of COVID-19 infection, baricitinib is given for 14 days or until discharged from the hospital. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take baricitinib exactly as directed.

What is the use of baricitinib 4 mg? ›

Baricitinib, also known as Olumiant, is used to treat rheumatoid arthritis. It's a type of drug known as a Janus kinase JAK inhibitor. It works by blocking the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of rheumatoid arthritis.

Does Olumiant make you tired? ›

Olumiant affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate.

Does Olumiant cause liver damage? ›

Liver problems, including hepatitis B or C.

Taking Olumiant could also worsen your liver problems, or cause hepatitis to become active again. Your doctor can help determine whether Olumiant is safe for you to take.

Is baricitinib being used for Covid? ›

Bottom line: Baricitinib is FDA approved 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).

What are side effects of Olumiant? ›

When taking Olumiant, some people with alopecia areata may experience any of the following common side effects:
  • Upper respiratory tract infections (cold or sinus infections)
  • Headache.
  • Acne.
  • Increased cholesterol levels.
  • Increased muscle enzyme levels.
  • Urinary tract infection.
  • Increased liver enzyme levels.

Does baricitinib cause hair loss? ›

Recognizing that need, the FDA last year granted breakthrough designation to baricitinib in AA, which can cause patchy hair loss on the scalp, face and other areas of the body.

How long should I take baricitinib for Covid? ›

The recommended total treatment duration of baricitinib is 14 days or until hospital discharge, whichever comes first. For information on clinical trials that are testing the use of baricitinib in COVID-19, please see www.clinicaltrials.gov. Page 2 2 This Fact Sheet may be updated as new data become available.

Can you stop taking Olumiant? ›

You'll need to stop taking Olumiant until the infection has been managed. Talk with your doctor if you're concerned about your risk for infections with Olumiant.

Does baricitinib reduce inflammation? ›

Baricitinib is an oral, selective inhibitor of Janus Kinases (JAK1/2) with potent anti-inflammatory activity approved for treatment of patients with moderate to severe active rheumatoid arthritis (Keystone et al., 2015).

Does baricitinib cause weight gain? ›

No, Olumiant isn't known to cause depression, tiredness, or weight gain. These weren't side effects reported in studies of the drug. Depression, tiredness, and weight gain are all possible symptoms of rheumatoid arthritis (RA), which Olumiant is used to treat. Your doctor can recommend ways to manage these symptoms.

Does Olumiant cause high blood pressure? ›

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects. Check with your doctor as soon as possible if any of the following side effects occur: increased blood pressure.

Is baricitinib an immunosuppressant? ›

However, baricitinib's immunosuppressive effects may be detrimental during acute viral infections by delaying viral clearance and increasing vulnerability to secondary opportunistic infections.

How safe is Olumiant? ›

Among those treated with OLUMIANT, the overall incidence rate of adverse events per 100 patient years of exposure was 22.6, and the incidence rate of serious adverse events was 7.4. Incidence rates remained stable over time across the 14,744 patient years of exposure.

Does Olumiant cause blood clots? ›

Thrombosis, including deep venous thrombosis and pulmonary embolism, has been observed at an increased incidence in patients treated with OLUMIANT compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death.

How long does it take for Olumiant to start working? ›

Olumiant is one of the few therapies for arthritis that is available as an oral tablet. The standard dose is 2-4 mg taken once every day. Olumiant does not work right away. It can take about 2 to 8 weeks before patients start feeling better, and it can take 3 to 6 months to feel the maximum effect of this medication.

Who should not take baricitinib? ›

This medicine may increase your risk of developing blood clots (eg, arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease.

Can baricitinib cause blood clots? ›

clinical trial data show a greater frequency of venous thromboembolism events with baricitinib compared with placebo – deep vein thrombosis and pulmonary embolism events are considered to be uncommon with baricitinib (up to 1 in 100 patients)

Is baricitinib better than tofacitinib? ›

Baricitinib showed higher treatment retention and overall equivalent or better treatment responses compared with bDMARDs. Treatment retention for tofacitinib was lower than for baricitinib, but treatment responses were not significantly different from those of bDMARDs or baricitinib.

How effective is baricitinib? ›

A more recent observational study with propensity score-matched controls showed a lower rate of death or mechanical ventilation associated with baricitinib use, with 86% of patients (71 of 83) receiving concomitant glucocorticoids [14].

Is baricitinib FDA approved? ›

Today, the U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year.

What is the safest drug to take for rheumatoid arthritis? ›

Methotrexate is widely regarded as one of the safest of all arthritis drugs, though it carries some potential downsides. Gastrointestinal symptoms such as nausea and vomiting are its most frequent side effects.

Is Olumiant an anti inflammatory? ›

Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor. It blocks an enzyme that plays a role in inflammation. This blockage calms down your immune system to relieve symptoms of arthritis and prevent worsening arthritis.

Can you live a long life with rheumatoid arthritis? ›

People with RA don't live as long as other people on average. Life expectancy, or how long you may expect to live, is influenced by many things, like your genes, age, medical history, and lifestyle. RA can shorten your life expectancy by an average of 10 years compared to people who don't have the disease.

Is Olumiant approved for alopecia? ›

Olumiant is the first and only FDA-approved once-daily pill for adults with severe alopecia areata.

Is baricitinib covered by insurance? ›

Olumiant (baricitinib) is an expensive drug use to treat rheumatoid arthritis. It is less popular than comparable drugs. It is only available as a brand drug. It is covered by some Medicare and insurance plans, but manufacturer and pharmacy coupons can help offset the cost.

Is baricitinib approved in Canada? ›

Baricitinib is a small molecule that is already approved by Health Canada for treating rheumatoid arthritis (RA), available in tablet form.

Is baricitinib FDA approved for alopecia? ›

The Food and Drug Administration (FDA) originally approved Olumiant (baricitinib) in 2018 to treat rheumatoid arthritis. The approval of Oluminant reportedly marks the first time the FDA approved a “systemic treatment” for this form of alopecia.

How much does baricitinib cost UK? ›

baricitinib is £805.56. Each dose is also available in 84-tablet packs at a pro-rata price. The average cost per patient per year is estimated at £10,501 based on the list price. The company has agreed a patient access scheme with the Department of Health.

What drug class is baricitinib? ›

Baricitinib is a Janus kinase inhibitor used to treat moderate to severe rheumatoid arthritis that has responded poorly to at least one TNF antagonist. Baricitinib is a Janus kinase (JAK) inhibitor.

Does Covid cause rheumatoid arthritis? ›

Multiple studies have reported autoantibodies in patients with COVID-19, particularly anti-cardiolipin, anti-β2-glycoprotein I and antinuclear antibodies. 1 2 Anti-citrullinated protein antibodies (ACPA) and flaring of rheumatoid arthritis (RA) after SARS-Cov-2 infection have also been described.

Should baricitinib be stopped before surgery? ›

treatment with baricitinib will be stopped before surgery. It will be restarted again after the operation at a time determined by your surgeon and rheumatologist.

What is Olumiant 4mg? ›

Olumiant 4mg Tablet is a Janus kinase inhibitor used to treat moderate to severe rheumatoid arthritis. It helps decrease pain, tenderness, and swelling in the joints by reducing inflammation. It also helps slow the progression of bone and joint damage.

Is Olumiant on the PBS? ›

Olumiant and Intivuv are now listed on the Pharmaceutical Benefits Scheme (PBS).

Does baricitinib cause weight gain? ›

No, Olumiant isn't known to cause weight gain, depression, or tiredness. These symptoms weren't reported in people who took Olumiant in clinical studies. However, weight gain, depression, and tiredness are common symptoms in people with rheumatoid arthritis (RA).

Does baricitinib cause hair loss? ›

Recognizing that need, the FDA last year granted breakthrough designation to baricitinib in AA, which can cause patchy hair loss on the scalp, face and other areas of the body.

What is baricitinib used for Covid? ›

Baricitinib has anti-inflammatory properties and it is hoped that it could help against the inflammatory cytokine storm seen in severe cases of COVID-19. Research into baricitinib has also shown that it is also capable of inhibiting NAKs (numb-associated kinases).

Does baricitinib reduce inflammation? ›

Baricitinib is an oral, selective inhibitor of Janus Kinases (JAK1/2) with potent anti-inflammatory activity approved for treatment of patients with moderate to severe active rheumatoid arthritis (Keystone et al., 2015).

Does Olumiant make you immunocompromised? ›

Olumiant can cause your immune system to not work as well as usual. If you have other risk factors for infection, you may have a higher risk of infection with Olumiant. This includes diabetes, lung disease (such as asthma or chronic obstructive pulmonary disease (COPD)), HIV, or a weakened immune system.

What are side effects of Olumiant? ›

When taking Olumiant, some people with alopecia areata may experience any of the following common side effects:
  • Upper respiratory tract infections (cold or sinus infections)
  • Headache.
  • Acne.
  • Increased cholesterol levels.
  • Increased muscle enzyme levels.
  • Urinary tract infection.
  • Increased liver enzyme levels.

Does Olumiant cause blood clots? ›

Thrombosis, including deep venous thrombosis and pulmonary embolism, has been observed at an increased incidence in patients treated with OLUMIANT compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death.

Does Olumiant cause high blood pressure? ›

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects. Check with your doctor as soon as possible if any of the following side effects occur: increased blood pressure.

What is the difference between baricitinib and tofacitinib? ›

Tofacitinib is a first-generation selective oral JAK1/3 inhibitor with less inhibition of JAK2 and TYK2, whereas baricitinib is a selective oral JAK1/2 inhibitor with moderate activity against TYK2 and significantly less inhibition of JAK3.

Is Olumiant a new drug? ›

Olumiant was originally approved in 2018. It is approved as a treatment for certain adult patients with moderately to severely active rheumatoid arthritis. Olumiant is also approved for the treatment of COVID-19 in certain hospitalized adults. The FDA granted the approval of Olumiant to Eli Lilly and Company.

Videos

1. BARICITINIB for the treatment of Alopecia Areata ( FDA approval + trials discussion )
(Fedy)
2. Discussing Rheumatology: Baricitinib Safety and Treatment Interruptions
(The CSF)
3. JAK inhibitors for alopecia areata - challenges and successes
(prof. Lidia Rudnicka)
4. FDA approves landmark drug treatment for Alopecia
(FOX 26 Houston)
5. Baricitinib (OLUMIANT®): Evidence-Based Health Information Related to COVID-19
(The Society of Infectious Diseases Pharmacists)
6. Safety of Baricitinib 4 mg for the Treatment of Rheumatoid Arthritis
(Southern Medical Association)

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