for: Rheumatoid Arthritis
Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis. How Supplied
OLUMIANT for oral administration is available as debossed, film-coated, immediate-release tablets. Each tablet contains a recessed area on each face of the tablet surface.
OLUMIANT Tablets 1 mg 2 mg
Color Very Light Pink Light Pink
Shape Round Oblong
Identification Lilly Lilly
1 2
NDC Codes:
Bottle of 30 0002-4732-30 0002-4182-30
16.2 Storage and Handling
Store at 20� to 25�C (68� to 77�F); excursions permitted to 15� to 30�C (59� to 86�F) [see USP Controlled Room Temperature].
Keep out of reach of children. These highlights do not include all the information needed to use OLUMIANT safely and effectively. See full prescribing information for OLUMIANT.
OLUMIANT (baricitinib) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS
See full prescribing information for complete boxed warning.
Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving OLUMIANT. (5.1)
If a serious infection develops, interrupt OLUMIANT until the infection is controlled. (5.1)
Prior to starting OLUMIANT, perform a test for latent tuberculosis; if it is positive, start treatment for tuberculosis prior to starting OLUMIANT. (5.1)
Monitor all patients for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative. (5.1)
Lymphoma and other malignancies have been observed in patients treated with OLUMIANT. (5.2)
Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with OLUMIANT. Patients with symptoms of thrombosis should be evaluated promptly. (5.3)
RECENT MAJOR CHANGES
Dosage and Administration:
Dose Modifications in Patients with Renal or Hepatic Impairment (2.4) 10/2019
Dose Modifications Due to Drug Interactions (2.5) 10/2019
INDICATIONS AND USAGE
OLUMIANT� is a Janus kinase (JAK) inhibitor 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 antagonist therapies. (1.1)
Limitation of Use: Use of OLUMIANT in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1)
DOSAGE AND ADMINISTRATION
The recommended dose of OLUMIANT is 2 mg once daily. (2.1)
OLUMIANT may be used as monotherapy or in combination with methotrexate or other DMARDs. (2.1)
Anemia: Avoid initiation or interrupt OLUMIANT in patients with hemoglobin less than 8 g/dL. (2.2, 2.3, 5.5)
Lymphopenia: Avoid initiation or interrupt OLUMIANT in patients with an Absolute Lymphocyte Count less than 500 cells/mm3. (2.2, 2.3, 5.5)
Neutropenia: Avoid initiation or interrupt OLUMIANT in patients with an Absolute Neutrophil Count less than 1000 cells/mm3. (2.2, 2.3, 5.5)
Moderate Renal Impairment: Reduce dose to 1 mg once daily. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets (not scored): 2 mg, 1 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Serious Infections: Avoid use of OLUMIANT in patients with active, serious infection, including localized infections. If a serious infection develops, interrupt OLUMIANT therapy until the infection is controlled. Do not give OLUMIANT to patients with active tuberculosis. (5.1)
Thrombosis: Use with caution in patients who may be at increased risk. (5.3)
Gastrointestinal Perforations: Use with caution in patients who may be at increased risk. (5.4)
Laboratory Assessment: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids. (5.5)
Vaccinations: Avoid use of OLUMIANT with live vaccines. (5.6)
ADVERSE REACTIONS
Adverse reactions (greater than or equal to 1%) include: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
The recommended dose of OLUMIANT in patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors (e.g., probenecid) is 1 mg once daily. (2.5, 7.1)
USE IN SPECIFIC POPULATIONS
Hepatic Impairment: OLUMIANT is not recommended in patients with severe hepatic impairment. (2.4, 8.6)
Renal Impairment: OLUMIANT is not recommended in patients with severe renal impairment. (2.4, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2019
