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  1. Medical Information Right
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  4. What labs should be monitored when initiating and continuing treatment with OLUMIANT® (baricitinib)?
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Baricitinib

Olumiant® (baricitinib) tablets

1mg, 2mg, 4mg
Full Prescribing Information

baricitinib

1mg, 2mg, 4mg

HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter

This 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.

What labs should be monitored when initiating and continuing treatment with OLUMIANT® (baricitinib)?

Monitor for changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.

US_cFAQ_BAR104_MONITORING_LABORATORY_TESTS_RA_AA
US_cFAQ_BAR104_MONITORING_LABORATORY_TESTS_RA_AAen-US

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

Laboratory Monitoring With Baricitinib Treatment

An overview of laboratory considerations when treating a patient with baricitinib can be seen in Laboratory Measures for the Treatment With Baricitinib, and further detail is provided in the sections below.

Laboratory Measures for the Treatment With Baricitinib1

 

Before Treatment Initiation

During Routine Patient Management

Monitoring at Week 12

Tuberculosis screeninga

Yes

 

 

Hepatitis screening
in accordance with clinical guidelines

Yesb

 

 

Complete blood count w/differentialc

ANCd


Yes


Yes

 
 
 

ALCe

Hbf

Hepatic transaminases (ALT, AST)g

Yes

Yesh

 

Lipids

 

 

Yesi

Glomerular filtration rate

Yesj

 

 

Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; ALC = absolute lymphocyte count; AST = aspartate transaminase; eGFR = estimated glomerular filtration rate; Hb = hemoglobin; HBV = hepatitis B virus; N/A= not applicable; TB = tuberculosis.

aBaricitinib should not be given to patients with active TB. Treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.

bShould HBV DNA be detected, consult with a hepatologist.

cEvaluate at baseline and thereafter monitor complete blood counts during treatment and modify dosage based on ANC, ALC, and Hb as recommended

dAvoid initiation or interrupt baricitinib treatment in patients with an ANC less than 1000 cells/mm3.

eAvoid initiation or interrupt baricitinib treatment in patients with an ALC <500 cells/mm3.

fAvoid initiation or interrupt baricitinib treatment in patients with a hemoglobin <8 g/dL.

gEvaluate 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. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt baricitinib until this diagnosis is excluded.

hBaricitinib is not recommended for use in patients with severe hepatic impairment.

iManage patients according to applicable clinical guidelines for the management of hyperlipidemia.

jBaricitinib is not recommended for use in patients with eGFR <30 mL/min/1.73 m2. The recommended dose in patients with moderate renal impairment (eGFR between 30 and 60mL/min/1.73m2) is 1 mg once daily.

Warnings and Precautions Related to Laboratory Measures

Tuberculosis

Evaluate patients for active infection prior to administration of Olumiant. Olumiant should not be given to patients with active tuberculosis (TB).1

  • Test patients with rheumatoid arthritis or alopecia areata for latent tuberculosis. Patients with rheumatoid arthritis or alopecia areata and latent TB should be treated with standard antimycobacterial therapy before initiating Olumiant.
  • Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
  • Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient.1

During Olumiant use, monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.1

Cytopenias

Neutropenia

Treatment with baricitinib was associated with an increased incidence of neutropenia (absolute neutrophil count <1000 cells/mm3) compared to placebo.1

Lymphopenia

Absolute lymphocyte counts <500 cells/mm3 were reported in baricitinib clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with baricitinib, but not placebo.1

Hemoglobin

Decreases in hemoglobin levels to <8 g/dL were reported in baricitinib clinical trials.1

Liver Enzymes

Treatment with baricitinib was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine aminotransferase ≥5 times upper limit of normal (ULN) and increases of aspartate transaminase ≥10 times the ULN were observed in patients in baricitinib clinical trials.1

Lipids

Treatment with baricitinib was associated with increases in lipid parameters, including

  • total cholesterol
  • low-density lipoprotein, and
  • high-density lipoprotein.1

Enclosed Prescribing Information

OLUMIANT® (baricitinib) tablets, for oral use, Lilly

Reference

1Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.

Date of Last Review: December 19, 2024

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