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  1. Medical Information Right
  2. Immunology Right
  3. Olumiant (baricitinib) tablets Right
  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)?

Neutrophil, lymphocyte, and hemoglobin levels should be assessed prior to initiation of baricitinib, and lipids should be assessed 12 weeks after initiation.

US_cFAQ_BAR104_MONITORING_LABORATORY_TESTS_RA_AA
US_cFAQ_BAR104_MONITORING_LABORATORY_TESTS_RA_AA
en-US

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

Laboratory Monitoring With Baricitinib Treatment

Prior to baricitinib initiation, consider evaluating for active and latent tuberculosis (TB), viral hepatitis screening in accordance with clinical guidelines, a complete blood count including absolute lymphocyte count (ALC), absolute neutrophil count (ANC) and hemoglobin, and baseline hepatic and renal function (Guidance for Treatment With Baricitinib).1

Update immunizations in agreement with current immunization guidelines.1

Guidance for Treatment With Baricitinib1

Avoid initiation or interrupt treatment with baricitinib if

  • ALC <500 cells/mm3
  • ANC <1000 cells/mm3
  • Liver enzyme elevations and suspected DILI
  • Hb levels <8 g/dL
  • Active infection

Treatment can be initiated or restarted after

  • levels return above the specified values for ALC, ANC, or Hb
  • drug-induced liver injury diagnosis is excluded, or
  • infection is controlled.

Abbreviations: ALC = absolute lymphocyte count; ANC = absolute neutrophil count; DILI = drug-induced liver injury; Hb = hemoglobin.

Warnings and Precautions Related to Laboratory Abnormalities

Serious Infections

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in rheumatoid arthritis patients receiving baricitinib.1

Avoid use of baricitinib in patients with an active, serious infection, including localized infections.1

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with baricitinib. Interrupt baricitinib if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with baricitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and baricitinib should be interrupted if the patient is not responding to therapy.1

Do not resume baricitinib until the infection is controlled.1

Cytopenias

Neutropenia

Treatment with baricitinib was associated with an increased incidence of neutropenia (ANC <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt baricitinib treatment in patients with an ANC less than 1000 cells/mm3.1

Evaluate at baseline and thereafter according to routine patient management. Adjust dosing based on ANC (see Recommended Dose Adjustments for Cytopenias ).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

Avoid initiation or interrupt baricitinib treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management. Adjust dosing based on ALC (see Recommended Dose Adjustments for Cytopenias ).1

Anemia

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

Avoid initiation or interrupt baricitinib treatment in patients with a hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management. Adjust dosing based on hemoglobin (see Recommended Dose Adjustments for Cytopenias ).1

Recommended Dose Adjustments for Cytopenias

Recommended Dose Adjustments for Cytopenias1 

Cytopenia

Recommendation

Low ANC

ANC ≥1000 cells/m3

Maintain dose

ANC <1000 cells/m3

Interrupt BARI until ANC ≥1000 cells/m3

Low ALC


ALC ≥500 cells/m3

Maintain dose

ALC <500 cells/m3

Interrupt BARI until ALC ≥500 cells/m3

Low Hemoglobin Value

Hemoglobin ≥8 g/dL 

Maintain dose

Hemoglobin <8 g/dL

Interrupt BARI until hemoglobin ≥8 g/dL 

Abbreviations: ALC = absolute lymphocyte count; ANC = absolute neutrophil count; BARI = baricitinib. 

Liver Enzymes

Treatment with baricitinib was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5 times upper limit of normal (ULN) and increases of AST ≥10 times the ULN were observed in patients in baricitinib 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. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt baricitinib until this diagnosis is excluded.1

Lipids

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

  • total cholesterol
  • low-density lipoprotein (LDL), and
  • high-density lipoprotein (HDL).1

Assessment of lipid parameters should be performed approximately 12 weeks following baricitinib 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

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

Date of Last Review: March 08, 2022

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