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Guidelines
Baricitinib

Baricitinib

Background

JAK inhibitors for treatment of COVID-19 require approval from Critical Care or Infectious Diseases service

Emergency Use Authorization (EUA)
  • Baricitinib is approved via Emergency Use Authorization (EUA) from the FDA for treatment of COVID-19
  • The NIH recommends as an alternative to tocilizumab in patients requiring high-flow oxygen or non-invasive ventilation (NIV)
  • A non-peer-reviewed randomized-controlled trial (COV-BARRIER) showed a mortality reduction most pronounced in patients requiring high-flow oxygen or NIV, although not initially designed to detect this outcome

Consent
  • Per the baricitinib EUA, must provide the Fact Sheet for Patients, Parents, and Caregivers and communicate the information contained within the document prior to administration, or as soon as feasible if providing information would delay administration and endanger the patient
  • There is no written consent required

Inclusion Criteria
  • Age ≥ 2 years
  • Hospitalized with confirmed COVID-19 with radiographic evidence of COVID-19 pneumonia
  • Severe pneumonia requiring respiratory support of high-flow nasal oxygen (at least 40 LPM/60% FiO₂), non-invasive mechanical ventilation, or invasive mechanical ventilation
  • Respiratory function is acutely deteriorating leading to increased respiratory support in the last 24 hours

Exclusion Criteria
  • Mechanically ventilated for ≥ 12 hours
  • Hospital stay > 14 days with symptoms of an acute illness due to COVID-19 infection
  • Strongly suspected or known concomitant infection (exceptions: chronic, stable viral infections such as hepatitis B or HIV)
  • History of or current venous thromboembolism (DVT/PE)
  • AST/ALT > 5 x ULN or Child Pugh C score
  • Neutropenia: ANC < 1,000 cell/mm³
  • Lymphopenia: absolute lymphocyte count < 200 cell/mm³
  • Hemoglobin < 8 g/dL
  • Cytotoxic or long-term anti-rejection or immunomodulatory medications (e.g. TNF inhibitors, anti-IL-1 or IL-6, rituximab, interferon, chronic prednisone equivalent of 20 mg/day)
    • CAUTION using with concomitant high dose corticosteroids (e.g. dexamethasone ≥10 mg daily) as risk is unknown
  • Pregnancy
  • Receipt of any live vaccine within 4 weeks (inactive okay)
  • Known hypersensitivity to JAK inhibitors or excipients

Baricitinib Use

Order Process

Ensure patient meets criteria, then contact pharmacist to enter order (availability of either JAK inhibitor will determine ability to provide this treatment option)

Monitoring

Baseline and daily CBC and CMP recommended

Dosing

Baricitinib
  • GFR ≥60 mL/min: 4 mg PO once daily
  • GFR 30-59 mL/min: 2 mg PO once daily
  • GFR 15-29 mL/min: 1 mg PO once daily
  • GFR <15 mL/min: use not recommended

Duration: up to 14 days OR until hospital discharge (whichever is sooner)

Treatment Considerations

Serious Adverse Events
  • Anemia
  • Hepatitis
  • Lymphopenia
  • Serious Infections