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Baricitinib
Olumiant ® (baricitinib) tablets
1mg, 2mgThis information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Olumiant Prescribing Information
See important safety information, including boxed warning, in the attached prescribing information.
Warnings and Precautions
Monitor for changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.1
BARI initiation is not recommended in patients with an ANC less than 1000 cells/mm3, ALC less than 500 cells/mm3, or hemoglobin level less than 8 g/dL.1
Laboratory Monitoring With Baricitinib Treatment
Neutropenia, lymphopenia, anemia, liver enzyme abnormalities, and lipid parameter changes, observed before or during BARI treatment should be managed as described below.1
Neutropenia
Compared to placebo, treatment with BARI was associated with an increased incidence of neutropenia, defined as ANC <1000 cells/mm3.1
Evaluate ANC at baseline and thereafter according to routine patient management. Maintain BARI dose in patients with an ANC ≥1000 cells/mm3. Avoid initiation or interrupt BARI treatment in patients with an ANC <1000 cells/mm3 until ANC is ≥1000 cells/mm3.1
Lymphopenia
Absolute lymphocyte counts <500 cells/mm3 were reported in BARI clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with BARI, but not placebo.1
Evaluate ALC at baseline and thereafter according to routine patient management. Maintain BARI dose in patients with an ALC ≥500 cells/mm3. Avoid initiation or interrupt BARI treatment in patients with an ALC <500 cells/mm3 until ALC is ≥500 cells/mm3.1
Hemoglobin
Decreases in hemoglobin levels to <8 g/dL were reported in BARI clinical trials.1
Evaluate hemoglobin levels at baseline and thereafter according to routine patient management. Maintain BARI dose in patients with hemoglobin ≥8 g/dL. Avoid initiation or interrupt BARI treatment in patients with hemoglobin <8 g/dL until hemoglobin is ≥8 g/dL.1
Liver Enzymes
Treatment with BARI was associated with increased incidence of liver enzyme elevation compared to placebo. Increases to ≥5 and ≥10 times the upper limit of normal were observed for both ALT and AST in patients in BARI clinical trials.1
Evaluate liver enzymes at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.1
Lipids
Treatment with BARI was associated with increases in lipid parameters, including
total cholesterol
LDL, and
HDL.1
Assess lipid parameters approximately 12 weeks following BARI initiation. Manage patients according to applicable clinical guidelines for the management of hyperlipidemia.1
Enclosed Prescribing Information
OLUMIANT® (baricitinib) tablets, for oral use, Lilly
1. Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.
Glossary
ALC = absolute lymphocyte count
ALT = alanine aminotransferase
ANC = absolute neutrophil count
AST = aspartate aminotransferase
BARI = baricitinib
HDL = high-density lipoprotein
LDL = low-density lipoprotein
Date of Last Review: July 20, 2020
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