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Baricitinib (Olumiant)

Baricitinib Photo

Photo source: Olumaint.com

Information about this drug is likely to change. Note that this page was last updated May 2021 and may be rendered inaccurate as more data emerges. This page focuses on baricitinb for COVID-19.

KEY POINTS

  • Baricitinib (Olumiant) a Janus kinase (JAK) inhibitor
    • Mechanism of action as per package insert: JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Baricitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs… JAK enzymes transmit cytokine signaling through their pairing (e.g., JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, JAK2/JAK2, JAK2/TYK2). In cell-free isolated enzyme assays, baricitinib had greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3. In human leukocytes, baricitinib inhibited cytokine induced STAT phosphorylation mediated by JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, or JAK2/TYK2 with comparable potencies. However, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.
  • Baricitinib was FDA-approved in 2018  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
  • An FDA Emergency Use Authorization (EUA) was issued on 19 November 2020 to permit use in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). It was then revoked when an FDA approval was granted.
    • May 10th, 2022 baricitinib was approved for treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
  • The NIH COVID Guidelines were updated 5/27/2021 regarding the role of baricitinib for COVID-19, read it all here. Baricitinib remains in the NIH guideline recommendations.
  • Baricitinib holds multiple boxed warnings:
    • Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections
      • Per the package insert, test for latent tuberculosis prior to initiation as per the package insert and start treatment for tuberculosis prior to starting baricitinib
      • Monitor patients for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative
    • Lymphoma and other malignancies
    • Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis
      • Some cases occurring during baricitinib therapy have been fatal
  • Dosing varies depending on age, for adults it is 4 mg once daily for 14 days or until hospital discharge
    • Baricitinib requires dose adjustment for renal function
    • Baricitinib capsules may be prepared for administration via feeding tube or dispersed tablets in water, details are provided in the Provider Fact Sheet
      • Not considered hazardous in dosage form provided, but precautions may be warranted if preparing in a solution/ suspension
    • Can give with or without food
  • If engaged in the prescribing, dispensing, or administration of baricitinib for COVID-19, folks should familiarize themselves with the Provider Fact Sheet
    • A Patient Fact Sheet must be given to the patient or caregiver as per the FDA EUA, it is available here.
    • Serious adverse events occurring under EUA use must be reported to FDA Medwatch and Eli Lilly within 7 days of the event
    • The EUA recommends patients should be on VTE prophylaxis unless contraindicated
    • Consider avoiding if lymphocyte count is below 200 cells/microliter
    • Consider avoiding use if ANC is below 500 cells/mL
    • Avoid if increases in ALT or AST are observed or drug-induced liver diseases is suspected
    • Beware drug-drug interactions (e.g., with OAT3 inhibitors)
    • eGFR, liver enzymes, and CBC should be assessed prior to initiation and periodically on therapy as per clinician judgement
  • Baricitinib is expensive and not widely available
    • Historically has been an outpatient drug not commonly carried by hospital pharmacies

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