Olumiant (baricitinib) for Alopecia Areata and Rheumatoid Arthritis

Olumiant is a once-daily pill prescription medicine that is used to treat:

• adults with severe alopecia areata.
• adults with moderate to severe active rheumatoid arthritis after treatment with 1 or more biologic medicines called tumor necrosis factors (TNF) blockers such as Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) have been used, and did not work well enough or could not be tolerated.

It is also used to treat hospitalized adults with the coronavirus disease 2019 (COVID-19) requiring non-invasive or invasive mechanical ventilation, supplemental oxygen, or extracorporeal membrane oxygenation (ECMO).

Olumiant is a Janus kinase (JAK) inhibitor that works inside the body and helps disrupt how cells respond to some cytokines. Cytokines allow cells to communicate with each other, and too many of these cytokines may cause inflammation.

Limitation of use: Not recommended for use in combination with other biologic immunomodulators, JAK inhibitors cyclosporine, or other potent immunosuppressants.

In a study, some adults taking Olumiant experienced a 20% improvement in the signs and symptoms of their RA in as few as 7 days. Others saw results in 12 weeks.

In clinical studies, some adults taking Olumiant achieved 80% scalp hair coverage at 36 weeks. Some people taking Olumiant 4 mg once daily saw 80% or greater scalp hair coverage as early as 24 weeks.

Some even saw 90% or greater scalp hair coverage at 36 weeks.

In patients with eyelash hair loss and substantial eyebrows, some people taking Olumiant 4 mg once daily saw improvement in eyebrow and eyelash coverage at 36 weeks.

The recommended dosage is 2 mg once daily for most patients, but certain patients may be treated with 4 mg once daily. Your doctor will determine the right dosage for you.

• are being treated for an infection, have an infection that keeps coming back, that won’t go away, or think if you have symptoms of an infection.

• Have TB or have been in close contact with someone with TB.

• Have had herpes zoster (shingles).

• Have had hepatitis B or C, blood clots in the veins of your legs or lungs, or cancer.

• if you live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include Ohio, Mississippi River valleys, and the Southwest.

• Are a past or current smoker.

• Have had other heart problems, heart attacks, or strokes.

• Have other medical conditions, including low blood cell counts, kidney or liver problems, lung disease, diabetes, 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 planning to receive a vaccine. You should not receive live vaccines if you take Olumiant.

• Are pregnant or planning to become pregnant. It is not known if Olumiant can harm your unborn baby.

• Are breastfeeding or planning to breastfeed. You should not breastfeed while taking Olumiant and also for 4 days after the last dose.

• Are taking other medicines, including prescriptions, vitamins, over-the-counter medicines, and herbal supplements. You should also tell your doctor if you take:
  • a medicine called probenecid
  • or medicines that can affect your immune systems, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as cyclosporine or azathioprine) since these may increase your risk of infection.

• Are under age 18. It is not known if Olumiant is safe to use in children.

• Take Olumiant exactly as your doctor says.

• For people with rheumatoid arthritis or alopecia areata, take OLUMIANT 1 time a day by mouth with or without food.

• For people with COVID-19, OLUMIANT will be given to you 1 time a day by mouth with or without food, for up to 14 days or until you are discharged from the hospital (whichever comes first), as instructed by your healthcare provider.

• Take Olumiant once a day by mouth with or without food.

• Talk to your doctor if you cannot swallow tablets whole.

For patients who are unable to swallow whole tablets, an alternative mode of administration may be considered:

• Oral dispersion
• Gastrostomy tube (G tube)
• Nasogastric tube (NG tube) or orogastric tube (OG tube)

Before OLUMIANT treatment initiation, your doctor will perform the following evaluations:

• Active and latent tuberculosis infection evaluation – OLUMIANT shouldn’t be given to patients with active tuberculosis (TB). If the latent infection is positive in patients with rheumatoid arthritis or alopecia areata, consider treatment for TB before OLUMIANT use.

• Viral hepatitis – should also be checked before starting OLUMIANT treatment.

• Complete blood count –
  • In patients with rheumatoid arthritis or alopecia areata, OLUMIANT initiation is not recommended in patients with an absolute neutrophil count (ANC) <1000 cells/μl, absolute lymphocyte count (ALC) <500 cells/μl, or hemoglobin level <8 g/dL.
  • In patients with COVID-19, OLUMIANT initiation is not recommended if the ALC is <200 cells/μl or if the ANC is <500 cells/μl. Your doctor will monitor the complete blood counts during treatment and modify the dosage as recommended.

• Baseline hepatic and renal function – your doctor will assess baseline values and monitor you for any laboratory changes. The dosage will be modified based on hepatic and renal impairment, and laboratory abnormalities.

The recommended dosage of OLUMIANT is 2 mg once daily orally, with or without food. An alternative administration for patients unable to swallow tablets may be used. OLUMIANT may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.

The recommended dosage of OLUMIANT is 2 mg once daily orally, with or without food. Increase 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, with or without food.

Once patients achieve an adequate response to treatment with 4 mg, decrease the dosage to 2 mg once daily.

The recommended dosage of OLUMIANT for adults is 4 mg once daily orally, with or without food, for 14 days or until hospital discharge, whichever occurs first. An alternative administration for patients unable to swallow tablets may be used.

The use of OLUMIANT has not been studied in patients with rheumatoid arthritis or alopecia areata and severe hepatic impairment and is therefore not recommended. It has also not been studied in patients with COVID-19 and severe hepatic impairment. OLUMIANT should only be used in patients with severe hepatic impairment and COVID-19 if the potential benefit outweighs the potential risk.

The renal function would significantly affect baricitinib exposure.

Rheumatoid Arthritis and Alopecia Areata – The recommended dosage of OLUMIANT in patients with moderate renal impairment should be reduced by half the recommended dose. OLUMIANT is not recommended to be used in patients with rheumatoid arthritis or alopecia areata and severe renal impairment.

COVID-19 – The recommended dosage of OLUMIANT in patients with moderate renal impairment or severe renal impairment is 2 mg once daily and 1 mg once daily, respectively. OLUMIANT is not recommended for use in patients who are on dialysis, have an end-stage renal disease (ESRD), or with an estimated GFR of <15 mL/min/1.73 m2.

Note: for more information, you will have to consult your doctor.

Dosage forms and strengths:

OLUMIANT is available as:

• 1 mg tablet
• 2 mg tablet
• 4 mg tablet

None.

• upper respiratory tract infections (cold or sinus infections)

• nausea

• herpes simplex virus infections, including cold sores

• shingles (herpes zoster)

• 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

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

• Cancer and immune system problems: Olumiant may increase your risk of skin cancers and lymphoma. People taking medicine, especially in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lung cancer and lymphoma, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer during treatment with Olumiant.

• There will be a increased risk of heart attack, stroke, or death in people who are 50 years of age and above who have at least 1 heart disease risk factor and taking medicine, especially in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Call your doctor right away if you show symptoms of a heart attack or stroke while taking Olumiant, including:
  • discomfort in the center of your chest
  • severe pain, pressure, tightness, or heaviness in your throat, neck, chest, or jaw
  • pain or discomfort in your back, neck, arms, jaw, or stomach
  • nausea or vomiting
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • feeling lightheaded
  • weakness on one side of your body or in one part
  • slurred speech

• Blood clots: in the veins of your lungs or legs, and arteries. This may even be life-threatening and can cause death. Blood clots in the veins of legs or lungs, and arteries 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 pain, swelling, or tenderness in the sudden chest pain, leg, or shortness of breath, while taking Olumiant.

• Allergic reactions: While taking Olumiant, if you have symptoms, such as swelling of your lips, tongue, or throat, rash, trouble breathing, feeling faint or dizzy stop taking Olumiant and get emergency help right away.

• Tears in the stomach or intestines: This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Call your doctor right away if you have stomach-area pain and fever that does not go away and a change in bowel habits.

• Changes in laboratory test results. Your doctor should also do blood tests before and while taking Olumiant. You should not take Olumiant if your red blood cell or white 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 will also check your cholesterol levels approximately 12 weeks after you start Olumiant and when needed.

• Vaccinations: make sure to avoid the use of live vaccines with OLUMIANT.

Baricitinib exposure is increased when OLUMIANT is used along with strong OAT3 inhibitors (such as probenecid), hence the dosage of baricitinib should be reduced by half the recommended dose.

OLUMIANT has not been studied in combination with Biologic DMARDs or Other JAK Inhibitors.

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

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