Olumiant

The U.S. Food and Drug Administration (FDA) has approved Olumiant (baricitinib) 2 mg, a once-daily, oral, Janus kinase (JAK) inhibitor for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies.

Read this Medication Guide carefully before you start treatment. This information does not take the place of talking with your doctor about your medical condition or your treatment.

• Take Olumiant exactly as your healthcare provider tells you to take it.
• Take Olumiant one time each day with or without food.

Olumiant can cause serious side effects including:

• See Important information.

Common side effects include (these are not all of the possible side effects):

• upper respiratory tract infections (common cold, sinus infections)
• nausea
• cold sores
• shingles

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

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

Keep all medicines out of the reach of children and pets.

Advise the patient to read the FDA-approved patient labeling (Medication Guide). 1

Patient Counseling

Advise patients of the potential benefits and risks of baricitinib. 1

Infections

Inform patients that they may be more likely to develop infections when taking baricitinib. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection. 1

Advise patients that the risk of herpes zoster is increased in patients treated with baricitinib and some cases can be serious. 1

Malignancies and Lymphoproliferative Disorders

Inform patients that baricitinib may increase their risk of certain cancers, and that lymphoma and other cancers have been observed in patients taking baricitinib. Instruct patients to inform their healthcare provider if they have ever had any type of cancer. 1

Thrombosis

Advise patients that events of DVT and PE have been reported in clinical studies with baricitinib. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of a DVT or PE. 1

Laboratory Abnormalities

Inform patients that baricitinib may affect certain lab tests, and that blood tests are required before and during baricitinib treatment. 1

Lactation

Advise a woman not to breastfeed during treatment with baricitinib. 1

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.