Olumiant is an oral prescription medication used to treat adults with moderate to severe rheumatoid arthritis (RA).

Olumiant belongs to a group of drugs called Janus kinase (JAK) inhibitors.

This medication comes in tablet form and is taken typically once daily with or without food. 

Common side effects of Olumiant include upper respiratory tract infections (common cold, sinus infections), nausea, cold sores and shingles.

Olumiant is a prescription medication used to treat adults with moderate to severe rheumatoid arthritis (RA) who have no responded well enough to or could not tolerate at least one medicine called a tumor necrosis factor (TNF) antagonist.

It is not known if Olumiant is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Olumiant. See the “Olumiant Precautions” section.

Common side effects of Olumiant include the following:

• Upper respiratory tract infections (common cold, sinus infections)
• Nausea
• Cold sores
• Shingles

This is not a complete list of Olumiant side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• a medication called probenecid
• any other medicines to treat your rheumatoid arthritis. For example, you should not take tocilizumab (Actemra), etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab pegol (Cimzia), golimumab (Simponi), tofacitinib (Xeljanz, Xeljanz XR), sarilumab (Kevzara), azathioprine or cyclosporine while you are taking Olumiant. Taking Olumiant with these medicines may increase your risk of infection.

This is not a complete list of Olumiant drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Olumiant including the following:

• Serious infections. Tell your healthcare provider right away if you have some or all of the following symptoms of serious infections:
  • Fever, sweating, or chills
  • Shortness of breath
  • Pain or burning on urination
  • Feeling tired
  • Diarrhea or stomach pain
  • Muscle aches
  • Cough
• Skin cancer. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Signs and symptoms include:
  • Open sore that remains open for several weeks
  • Reddish, raised patch
  • Wart-like growth
  • Elevated pink growth
• Blood clots that can form in your leg or elsewhere in your body. Symptoms include:
  • Swelling, pain or tenderness in the leg
  • Shortness of breath
  • Pain with deep breathing
  • Coughing up blood.
• Gastrointestinal perforations (GP). GP occurs when a hole forms through the stomach, large bowel, or small intestine. Symptoms include:
  • Severe abdominal pain intensified by movement
  • Nausea
  • Vomiting
  • Vomiting of blood
• Laboratory abnormalities. Patients should undergo routine laboratory management. Possible abnormalities include:
  • Low white blood cell count
  • Low red blood cell count
  • Increase in liver enzymes
  • Increase in blood cholesterol levels

Avoid use of live vaccines with Olumiant.

Do not take Olumiant if you:

• Have an active, serious infection, including localized infections
• Have a chronic or recurrent infection
• Have been exposed to tuberculosis
• Hav a history of a serious or an opportunistic infection
• Have resided or traveled in areas of endemic tuberculosis or endemic mycoses
• Have underlying conditions that make you more susceptible to infection

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Olumiant, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Olumiant, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Olumiant or to any of its ingredients
• have kidney problems
• have liver problems
• have stomach ulcers or diverticulitis
• have an infection
• have diabetes, chronic lung disease, HIV, or a weak immune system
• have TB or have been in close contact with someone with TB
• have had hepatitis B or C
• live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting fungal infections
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Olumiant crosses into human milk. However, in animal studies, Olumiant crossed into the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a choice should be made whether to stop nursing or stop the use of this medication.

Take Olumiant exactly as prescribed.

Olumiant comes in tablet form and is taken once a day.

Take with or without food.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose of Olumiant for the treatment of moderate to severe RA is 2 mg once daily.

If you take too much Olumiant, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Olumiant at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep this and all medicines out of the reach of children.

WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

SERIOUS INFECTIONS

Patients treated with OLUMIANT are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt OLUMIANT until the infection is controlled.

Reported infections include:

• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before initiating OLUMIANT and during therapy. Treatment for latent infection should be considered prior to OLUMIANT use.
• Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral, and other infections due to opportunistic pathogens.

The risks and benefits of treatment with OLUMIANT should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OLUMIANT including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with OLUMIANT.

THROMBOSIS

Thrombosis, including deep venous thrombosis and pulmonary embolism, has been observed at an increased incidence in patients treated with OLUMIANT compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.