Olumiant (Baricitinib) - Oral

What Is Olumiant?

Olumiant (baricitinib) is a treatment option for moderate to severe rheumatoid arthritis (RA). It's considered a disease-modifying antirheumatic drug (DMARD).

This medication, however, isn't a first-choice option. It's typically used after trying at least one tumor necrosis factor (TNF) inhibitor which hasn't produced good results. TNF inhibitors work by blocking TNF which then decreases inflammation (swelling) in the body.

Olumiant, on the other hand, is a Janus kinase (JAK) inhibitor that works by suppressing the body's immune system. Olumiant is available as a prescription tablet.

What Is Olumiant Used For?

Olumiant (baricitinib) is used to treat moderate to severe rheumatoid arthritis (RA).

Millions of U.S. adults receive a diagnosis of arthritis—including RA—every year. In RA, the body's immune system mistakenly attacks the synovium and damages this soft tissue that lines the joints. As a result, people with RA tend to experience joint pain, swelling, and stiffness.

How to Take Olumiant

Olumiant (baricitinib) is taken by mouth with or without food. It can be used by itself or in combination with a non-biologic DMARD, such a methotrexate. A non-biologic DMARD is a chemical based medication. A biologic DMARD is made from naturally occurring sources, like proteins and tissues. Biologic DMARDS, however, should not be used in combination with Olumiant as it can cause additive immunosuppression and risk of infection.

It's not typically recommended to use Olumiant with other Janus kinase (JAK) inhibitors.

Storage

Once you receive Olumiant from the pharmacist, store the medication at room temperature between 68 to 77 degrees Fahrenheit (F)—with a safety range between 59 to 86 degrees F.

If you're going to travel with Olumiant, become familiar with the regulations of your final destination. In general, however, consider making a copy of your Olumiant prescription and have the medicine in the original container from your pharmacy, with your name on it.

Off-Label Uses

Olumiant received an emergency use authorization (EUA) from the Food and Drug Administration (FDA) to treat COVID-19 in people who are hospitalized with certain oxygen requirements.

Additionally, the Infectious Diseases Society of America (IDSA) and National Institutes of Health (NIH) guidelines currently support Olumiant for COVID-19 in people who are hospitalized with certain oxygen requirements plus other factors. The IDSA and NIH, however, recommend using Olumiant with one of the following:

• Steroid (dexamethasone)
• Steroid and Veklury (remdesivir)

What Are the Side Effects of Olumiant?

Side effects are possible with Olumiant.

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Common side effects with Olumiant include:

• Cold sores
• Nausea
• Shingles
• Upper respiratory tract infections (e.g., common colds, sinus infections)
  

Severe Side Effects

Severe side effects are possible with Olumiant. Get medical help right away if you experience the following serious side effects:

• Severe allergic reaction: If you have a severe allergic reaction to Olumiant or any of its ingredients, you might experience breathing difficulties, swelling, and rash.
• Serious infections: Olumiant might raise your risk for serious infections. If you have an infection, symptoms may include fever, chills, cough, muscle aches, and tiredness.
• Abnormal labs: Olumiant is linked to low amounts of red blood cells (RBCs), which can make you feel weak or tired. Olumiant is also connected to abnormal white blood cell (WBC) levels, which can affect your body's ability to fight off infections. Abnormal WBCs can also be a symptom of cancer—especially blood cancers, and cancer is also a possible serious side effect of Olumiant.
• Heart-related effects: Olumiant is linked to a higher risk of heart-related effects, such as a heart attack. If you're experiencing a heart attack, symptoms may include chest pain and breathing problems.
• Stroke: Olumiant may also raise your chance of getting a stroke. If you're having a stroke, some symptoms may include slurred speech and one-sided body weakness.
• Blood clots: Blood clots are possible side effects with Olumiant. If you have a blood clot, you might notice pain or swelling in your legs. You may also experience chest pain or breathing problems.
• Tears in your stomach or intestines: If you're experiencing tears in your stomach or intestines, symptoms may include fever, changes in bowel movements, or stomach pain that doesn't go away.
  

Long-Term Side Effects

The above serious side effects are also possible long-term side effects with Olumiant. Some people may also experience other abnormal lab results relating to cholesterol levels and liver injury. If you're experiencing liver problems, symptoms may include dark-colored urine, upper right-sided stomach pain and jaundice (yellowing of the eyes and skin). Contact your healthcare provider if you have any of these side effects.

Dosage: How Much Olumiant Should I Take?

Modifications

Your healthcare provider might change your Olumiant treatment with the following situations:

People with trouble swallowing tablets: If you're having trouble swallowing Olumiant tablets, you can place up to 4 milligrams (mg) of Olumiant in a container with 5 milliliters to 10 milliliters (mL) of water. To mix, gently swirl the tablets in the room temperature water. After you take this mixture, add another 5 milliliters to 10 milliliters of water into the container to rinse and take any remaining mixture.

People with a gastrostomy feeding tube (G-tube): If you have a G-tube, you can place up to four milligrams of Olumiant in a container with 10 milliliters to 15 milliliters of room temperature water. To mix, gently swirl the tablets in the water. Then, use a syringe to transfer the mixture through the G-tube. Afterward, add another 10 milliliters to 15 milliliters of water into the container to rinse before using a syringe to transfer the remaining mixture through the G-tube again.

People with a nasogastric feeding tube (NG-tube): If you have an NG-tube, you can place up to four milligrams of Olumiant in a container with 30 milliliters of room temperature water. To mix, gently swirl the tablets in the water. Then, use a syringe to transfer the mixture through the NG-tube. Afterward, add another 15 milliliters of water into the container to rinse before using a syringe to transfer the remaining mixture through the NG-tube again.

People with severe kidney problems: If you have severe kidney impairment, avoid taking Olumiant.

People with severe liver problems: If you have severe liver impairment, Olumiant isn't recommended.

Pregnant or nursing parents: There is limited safety and effectiveness data about Olumiant's use in pregnant people. As for nursing, there is no available safety and effectiveness information about Olumiant in nursing babies.

Missed Dose

If you accidentally forgot your Olumiant dose, take it as soon as you remember. If it's already close to your next scheduled dose, however, then skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.

Try to find ways to help yourself remember to regularly take your medication, like setting up a reminder on your phone or calendar. Missing too many Olumiant doses may lead to further joint damage.

Overdose: What Happens If I Take Too Much Olumiant?

In clinical trials, a one-time high dose of 40 milligrams and daily high doses of 20 milligrams of Olumiant for 10 days didn't result in dose-related side effects. If you think that you're experiencing life-threatening side effects, however, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn't Take Olumiant?

Before taking Olumiant, talk with your healthcare provider if any of the following apply to you:

• Severe allergic reaction: If you're severely allergic to Olumiant or any of its parts or ingredients (components), then Olumiant isn't an ideal treatment option for you.
• Pregnant or nursing: There is little safety and effectiveness data about Olumiant in pregnant or nursing individuals. Therefore, talking with your healthcare provider may help you weigh the benefits and risks of taking Olumiant while pregnant or nursing.
• Children: There is no safety or effectiveness information for Olumiant in children.
• Older adults: Based on currently available safety and effectiveness data, there are no differences in effects of Olumiant between younger adults and older adults—people over 65 years of age. Older adults, however, may have changes in the way their kidneys work that may raise the likelihood of side effects.
• Cancer: Olumiant is linked to a higher risk of cancer. So, notify your healthcare provider if you are at increased risk for cancer, or have ever had any type of cancer.
• Current infection: If you have a currently active infection, your healthcare provider may want to wait until you feel better to start Olumiant.
• Kidney or liver problems: If you have severe kidney or liver problems, Olumiant isn't recommended for you.
• Medical conditions of the stomach or intestines: Olumiant is linked to a risk of tears to your stomach or intestines. Talk with your healthcare provider if you have any medical condition relating to your stomach or intestines.
• Past or current smokers: Past or current smokers might have a higher risk for the following serious side effects: cancer, heart-related effects (e.g., heart attack), and stroke.

What Other Medications Interact with Olumiant?

Use caution when taking organic anion transporter 3 (OAT3)-inhibiting medications, such as probenecid—a gout medication that's typically used with Zyloprim (allopurinol). OAT3 is a protein that helps move medications—like Olumiant—around in your body. Taking an OAT3-inhibiting medication raises the amount of Olumiant in the body. High Olumiant levels also raise the likelihood of side effects.

Olumiant hasn't been studied with biologic DMARDs (made from naturally occurring sources—like proteins and tissues)—like Humira (adalimumab)—or other JAK inhibitors—like Xeljanz (tofacitinib). As a result, combining these types of medications with Olumiant isn't recommended.

What Medications Are Similar?

There are several different non-biologic (chemical-based) disease-modifying antirheumatic drugs (DMARDS) that are used to treat rheumatoid arthritis (RA). Some DMARDs are biologics (made from naturally occurring sources—like proteins and tissues), and others are non-biologics (chemical-based). Since Olumiant is a chemical-based DMARD and also a JAK inhibitor, the following medications are most similar to Olumiant.

• Rinvoq (Upadacitinib)
• Xeljanz (tofacitnib)

Clinical trials suggest that the following combinations are more effective than Humira with methotrexate:

• Olumiant with methotrexate
• Rinvoq with methotrexate

Olumiant with methotrexate, however, has a higher potential for side effects. Although studies suggest that Olumiant has a greater risk of side effects, this medication might be the least costly JAK inhibitor.

How Can I Stay Healthy While Taking Olumiant?

If you're taking Olumiant, you've probably tried a few different treatment options for rheumatoid arthritis (RA). While living with RA can understandably feel difficult and isolating, there are ways to help improve your quality of life. Refer to the following general tips:

• Improve your knowledge about RA and its treatments to become actively involved in discussions with your healthcare provider.
• Balance exercise and rest to achieve a healthy weight, build strong muscles, and maintain flexibility—while lessening joint pain and swelling.
• Having a well-balanced diet may help you achieve a healthy weight, which might relieve some of your RA symptoms.
• Consider physical or occupational therapy to protect your joints through self-help devices or tools, etc.
• Manage your stress and mental health—Support groups or a mental health professional may help you find coping strategies to change the way you think, feel, react or respond to living with RA.