Baricitinib

Baricitinib, sold under the brand name Olumiant^®, is an oral treatment for severe alopecia areata, an autoimmune condition that causes significant hair loss due to the immune system attacking hair follicles. Olumiant was the first systemic treatment for adults approved by the United States Food and Drug Administration for this condition.

It belongs to a class of medications called janus kinase (JAK) inhibitors, which reduce immune system overactivity. By blocking certain pathways involved in the inflammatory process, baricitinib helps decrease inflammation and prevent further hair follicle damage, allowing for potential hair regrowth in people with extensive scalp hair loss. 

While generally well-tolerated, common side effects of baricitinib include mild upper respiratory infections, headaches, and nausea. More serious effects include an increased risk of infections, blood clots, liver enzyme elevations, and changes in cholesterol levels. Due to these risks, patients should be monitored with regular blood tests before and during treatment.

Baricitinib is indicated for:

• The treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers

• The treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO

• The treatment of adult patients with severe alopecia areata

Janus kinase (JAK) inhibitor

Adverse reactions reported in clinical trials (≥1%) are:

Rheumatoid Arthritis:

• Upper respiratory tract infections (URTIs)

• Nausea

• Herpes simplex

• Herpes zoster

COVID-19:

• Increases of liver enzymes

• Thrombocytosis

• Creatine phosphokinase increases

• Neutropenia

• Deep vein thrombosis

• Pulmonary embolism

• Urinary tract infection (UTI)

Alopecia areata:

• URTIs

• Headache

• Acne

• Hyperlipidemia

• Creatine phosphokinase increase

• UTI

• Liver enzyme elevations

• Folliculitis

• Fatigue

• Lower respiratory tract infections

• Nausea

• Genital Candida infections

• Anemia

• Neutropenia

• Abdominal pain

• Herpes zoster

• Weight increase

The cost of Olumiant (baricitinib) may vary depending on factors such as your insurance plan, the quantity and dosage, and where you buy it. Olumiant is a limited distribution drug, which means it’s only available at specialty pharmacies. In other words, you won’t be able to fill a prescription for baricitinib at your local CVS.

According to Eli Lilly and Company, the drug’s manufacturer, the cost of Olumiant without insurance is $2,767.39 for a 30-day supply of 2-milligram (mg) tablets or $5,534.78 for a 30-day supply of 4-mg tablets. But the company offers a savings support program for eligible people that may bring down the cost as low as $5 per month. And a separate nonprofit organization called Lilly Cares helps qualified people receive medicines like Olumiant at no cost.

There is currently no generic version of Olumiant available in the US.

You can get a prescription for baricitinib after being evaluated by your primary care provider or a specialist who can determine if the medicine is right for you based on factors like your symptoms and medical history.

• Drug interactions: Strong organic anion transporter 3 (OAT3) inhibitors (e.g., probenecid)

• Hypersensitivity

• Gastrointestinal perforations

• Laboratory abnormalities: Monitor for changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids

• Vaccinations: Avoid use with live vaccines

• Pregnancy: Based on animal data, may cause fetal harm

• Breastfeeding: Advise not to breastfeed

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS

Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.

Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients.

Malignancies have occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.

Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients.

Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers.

There are other medications prescribed to treat the symptoms of alopecia areata, many of which are prescribed off-label at the discretion of a healthcare provider. Some of these drugs may be better suited to you than others. If you’re interested in finding an alternative to baricitinib, talk with your provider to learn more about other medications that may work well for you.

Alternative medication options to baricitinib:

• Corticosteroids, including steroid shots

• Dupixent^® (dupilumab), for folks who also have or are at risk for eczema

• Immunotherapy drugs, including dibutyl squarate and diphencyprone

• Oral and topical minoxidil 

• Other JAK inhibitors, including Leqselvi^® (deuruxolitinib), Litfulo^® (ritlecitinib), and Xeljanz^® (tofacitinib)

*This information is from the label for brand name Olumiant^®. See the Full Prescribing Information for more complete information. Baricitinib, the active ingredient in Olumiant, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient baricitinib.