What is Olumiant?
Olumiant (baricitinib) tablets are used to treat rheumatoid arthritis, severe alopecia areata 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 which 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 loss may return.
Who can take Olumiant?
Olumiant is FDA-approved to be used for:
Rheumatoid arthritis. Olumiant is used for rheumatoid arthritis that is moderate 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, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
Alopecia Areata. Olumiant is used for the treatment of adult patients with severe alopecia areata. 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).
Tell your doctor if you have a weak immune system, diabetes, chronic lung disease, or an infection such as hepatitis, tuberculosis, shingles, or HIV. Also tell your doctor if you've ever had diverticulitis, an ulcer in your stomach or intestines, cancer, heart problems, or a history of smoking, heart attack, stroke, or blood clots.
Call your doctor right away if you have a fever, night sweats, constant tiredness, weight loss, stomach pain, diarrhea or changes in bowel habits, trouble breathing, wheezing, a severe cough, or lumps in your neck, armpits, or groin.
Seek emergency medical help if you have sudden shortness of breath, chest pain spreading to your neck or arms, nausea, severe dizziness, a cold sweat, weakness on one side of your body, slurred speech, or pain, redness, or swelling in an arm or leg.
Before taking this medicine
Taking Olumiant can increase your risk of life-threatening medical problems, including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer. Tell your doctor if you've had:
- a weak immune system or chronic infection (such as tuberculosis, shingles, HIV, or hepatitis);
- any type of cancer;
- kidney disease;
- diverticulitis, an ulcer in your stomach or intestines;
- heart problems;
- a heart attack, stroke, or blood clot;
- high cholesterol; or
- if you've ever smoked.
Tell your doctor if you've been sick with signs of infection, such as fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination.
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.
Also tell your doctor if you have ever had:
- liver disease (especially hepatitis B or C);
- chronic lung disease;
- diabetes; or
- if you are scheduled to receive any vaccine.
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 Olumiant call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
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 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 a tablet to take by mouth once daily. Take it at around the same time every day.
Oluminat 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 tests 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 Dosing Information
Usual Adult Dose of Olumiant for Rheumatoid Arthritis:
Dose: 2 mg tablet once a day
Comments: This drug may be used as monotherapy or in combination with methotrexate or other DMARDs.
Use: For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
Usual Adult Dose of Olumiant for Alopecia Areata:
Dose: 2 mg tablet once daily. Dose maybe 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.
Use: For the treatment of adult patients with severe alopecia areata
Usual Adult Dose of Olumiant for COVID-19:
Dose: 4 mg tablet once a day
Duration of therapy: 14 days or until hospital discharge, whichever is first.
Use: For the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
Usual Pediatric Dose of Olumiant for COVID-19 (For investigational use only)
Dose: 2 years to less than 9 years: 2 mg orally once a day.
9 years and older: 4 mg orally once a day.
Duration of therapy: 14 days or until hospital discharge, whichever is first.
Use: For treatment of COVID-19 in hospitalized pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- In July 2021, the US FDA expanded the Emergency Use Authorization (EUA) for Olumiant 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 optimal duration of therapy is unknown.
- This drug is not authorized for patients younger than 2 years.
What strengths is Olumiant available in?
Olumiant is available in film-coated tablets as1 mg tablet, 2 mg tablet and 4 mg tablet.
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?
Olumiant side effects
Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some people taking Olumiant have developed heart attacks, strokes, or serious blood clots. Stop taking this medicine and seek emergency medical attention if you have:
- sudden shortness of breath;
- chest pain or pressure that may spread to your jaw, shoulder, arms, or back;
- nausea, vomiting, cold sweat;
- a light-headed feeling, like you might pass out;
- weakness on one side of your body;
- slurred speech, drooping on one side of your mouth; or
- pain, swelling, or redness in an arm or a leg.
Olumiant may cause serious side effects. 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; or
- signs of hepatitis - loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects of Olumiant may include:
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.
What other drugs will affect Olumiant?
Tell your doctor about all your other medicines, especially:
- methotrexate (sometimes given with Olumiant;
- 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 for check for interactions with Olumiant.
- Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Active ingredient: baricitinib
Inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.
Olumiant is a registered trademark of Eli Lilly and Company.
Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA.
Janus kinase (JAK) inhibitors are a group of medicines that help block immune system signals in the body that can lead to swelling (inflammation) and pain in conditions like rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis. They work by blocking enzymes that lead to overactivity of the immune system. Continue reading
In studies, about 17% to 35% of adults with severe alopecia areata achieved an 80% or greater scalp hair coverage at 36 weeks, as well as eyebrow and eyelash regrowth, depending upon their Olumiant dose. Some patients using the higher 4 mg dose saw 80% scalp hair regrowth at 24 weeks. Continue reading
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Olumiant only for the indication prescribed.
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