COVID-19 - Inpatient
Tofacitinib

Tofacitinib

Background

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

  • No FDA authorization for use in COVID-19; recommended by the NIH when neither tocilizumab nor baricitinib is available
  • In a small randomized-controlled trial (STOP-COVID), tofacitinib showed a lower risk of respiratory failure or death; it was not powered to show a difference in the secondary outcome of mortality
  • Even though no fact sheet exists for tofacitinib, a discussion of the treatment should take place prior to administration, or as soon as feasible if providing information would delay administration and endanger the patient
  • There is no written consent required
  • Age ≥ 18 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
  • 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 < 500 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
  • Currently receiving potent CYP450 inducer (e.g. carbamazepine, phenytoin, rifampin)

Tofacitinib Use

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

Baseline and daily CBC and CMP recommended

Dosing

Tofacitinib

  • GFR ≥50 mL/min: 10 mg PO BID
  • GFR <50 mL/min: 5 mg PO BID
  • Moderate hepatic impairment (AST or ALT > 3 X ULN): 5 mg PO BID
  • Concomitant strong CYP3A4 inhibitor: 5 mg PO BID
  • Concomitant strong CYP2C19 + moderate CYP3A4 inhibitors: 5 mg PO BID

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

Treatment Considerations

  • Anemia
  • Hepatitis
  • Lymphopenia
  • Serious Infections