OLUMIANT® (baricitinib): Laboratory Monitoring

Prescribing Information

See important safety information, including boxed warning, in the attached prescribing information.

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

Reference

1. Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

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