Olumiant

The active ingredient in Olumiant is baricitinib, which is a JAK inhibitor. JAKs are proteins that play a crucial role in immune signaling. When they are activated, your body becomes more inflamed. By blocking JAKs, Olumiant suppresses the immune system, which reduces joint, skin, and hair follicle inflammation and other symptoms.

Follow all directions provided by your doctor and read all documents carefully, including the full Prescribing Information, FDA-approved Product Labeling, Instructions for Use, and Medication Guide, before using Olumiant. However, the following is a synopsis of the general guidelines for the use of Olumiant:

• Olumiant is taken once a day, around the same time each day.
• Olumiant may be taken with or without food.
• If you are unable to swallow the tablets, place them in a small glass and dissolve them in about 2 teaspoons (10 mL) of room-temperature water.
• Before using Olumiant, your doctor may do laboratory testing to rule out tuberculosis or other illnesses.
• You may be more susceptible to infections, including serious or deadly diseases. You will require frequent medical examinations.
• If you have ever had shingles (herpes zoster), this medication may cause the virus to become active or worsen.

The most common side effects of Olumiant seen in clinical trials as compared to placebo include:

• Upper respiratory tract infection.
• Headaches.
• High cholesterol levels.
• Urinary tract infections.
• Increased liver enzymes.
• Herpes simplex virus infections, including cold sores.
• Nausea.
• Stomach pain.

Some individuals may experience serious side effects while using Olumiant. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Stroke: abrupt weakness in your body, difficulty speaking, confusion, and dizziness.
• Arterial thrombosis (blood clot in the heart) symptoms include chest pain, shortness of breath, pain in the jaw, neck, or back, and a feeling of weakness or lightheadedness.
• Cough, chest pain, difficulty breathing, and a racing heart are symptoms of a pulmonary embolism (a blood clot in the lungs).
• Deep vein thrombosis (blood clot in the leg) causes leg cramping, swelling, pain, and muscle tightness.
• Severe allergic reactions include rash, difficulty breathing, fainting, and swelling of the face or throat.
• Serious infections include fever, trouble breathing, diarrhea, weakness, cough, stomach discomfort, sweating, chills, burning when urinating, and frequent urination.
• Stomach tear (perforation) symptoms include stomach pain, bloating, altered bowel movements, and bloody stools.
• Symptoms of liver disease include nausea, stomach pain, and yellowing of the skin or whites of the eyes, black, tarry stools, and unusual weight loss.

These are not all of the possible side effects of Olumiant. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Olumiant, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether any of the following apply:

• Blood clots in the veins of your legs or lungs.
• Anemia.
• Any type of cancer.
• Kidney disease.
• Diverticulitis is an ulcer in your stomach or intestines.
• Heart problems include a heart attack, stroke, or blood clots.
• High cholesterol.
• Smoke.
• Liver disease, including hepatitis B or C.
• A scheduled live vaccine.
• Have or recently had an infection.
• Diabetes, chronic lung disease, HIV, or a weak immune system.
• TB or have been in close contact with someone with TB.
• Shingles (herpes zoster).
• You should not take Olumiant if your white blood cells (neutropenia) or red blood cell count is too low or your liver tests are too high.

Boxed Warning

Serious infections: Baricitinib may increase the risk of serious, potentially life-threatening infections, especially in patients using other immunosuppressants.

Tuberculosis: Active TB is a contraindication, and latent TB should be screened and treated before starting treatment (except in COVID-19 cases).

Fungal and opportunistic infections: There is a risk of invasive fungal and opportunistic infections that may present as widespread rather than localized disease.

Monitoring for infections: Patients should be monitored closely for signs of infection throughout treatment, even if they initially tested negative for latent TB.

Mortality and cardiovascular risk: Higher all-cause mortality, including sudden cardiovascular death, has been reported with JAK inhibitors in older RA patients with cardiovascular risk factors.

Cardiovascular events: Increased rates of heart attacks, strokes, and other serious cardiovascular events were observed, especially in current or former smokers.

Malignancies: A higher incidence of lymphoma and other cancers (excluding nonmelanoma skin cancer) has been reported in patients using JAK inhibitors.

Thrombosis: Baricitinib is linked to an increased risk of serious blood clots, including DVT, PE, and arterial thrombosis, some of which have been fatal.

There are no other contraindications for this medication.

Some people with rheumatoid arthritis (RA) find improvements in their symptoms within a few weeks, while others may take up to 12 weeks. Alopecia areata can take several months to show substantial changes, with some people experiencing regrowth in as little as a few weeks and others taking several months.

When Olumiant is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Methotrexate (occasionally used with Olumiant).
• Probenecid.
• Steroid medications, such as prednisone or dexamethasone.
• Corticosteroids.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) include aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
• Other treatments for rheumatoid arthritis include abatacept, adalimumab, anakinra, azathioprine, certolizumab, cyclosporine, etanercept, golimumab, infliximab, rituximab, sarilumab, tocilizumab, and baricitinib.
• Not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic DMARDs (disease-modifying antirheumatic drugs), or with potent immunosuppressants (eg, azathioprine, cyclosporine).

Olumiant is available in the following dosage form and strengths: 1 mg, 2 mg, and 4 mg film-coated tablets.

For rheumatoid arthritis, the recommended dose is 2 mg taken orally once daily.

For COVID-19, the normal dose is 4 mg taken orally once a day for two weeks or until hospital discharge, whichever comes first.

For alopecia areata, the typical starting dose is 2 mg taken orally once daily. If necessary, your practitioner may increase your dose to 4 mg daily.

Your doctor may alter your dose based on whether you are taking a drug that interacts with Olumiant, your blood cell count, and whether you have kidney or liver problems.

Store at room temperature and keep out of reach of children.

Eli Lilly and Company is the manufacturer of this medication.

There is no lower-cost generic available.

It is best to speak to your healthcare provider if you wish to stop Olumiant, as stopping it may worsen symptoms.

Based on animal studies, Olumiant may cause fetal harm if taken during pregnancy. You should discuss pregnancy planning and prevention with your healthcare provider if you can become pregnant. You should also call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) if you become pregnant while taking Olumiant.

It is unknown whether Olumiant goes into your breast milk. You should not breastfeed while using Olumiant or for four days after the final dose. Consult your healthcare practitioner about the best manner to feed your infant while taking this medication.