Kimmtrak

Cytokine Release Syndrome (CRS) 

Moderate defined as temperature ≥38°C with hypotension that responds to fluids (does not require vasopressors); or hypoxia requiring low flow nasal canula (≤6L/min) or blow-by oxygen.

• If hypotension and hypoxia do not improve within 3 hours or CRS worsens, escalate care and manage according to next higher level of severity.
• For moderate CRS that is persistent (lasting 2-3 hours) or recurrent, administer corticosteroid premedication (eg, dexamethasone 4mg or equivalent) at least 30 minutes prior to next dose.

Severe defined as temperature ≥38°C with hemodynamic instability requiring vasopressor (with or without vasopressin); or worsening hypoxia or respiratory distress requiring high flow nasal canula (>6L/min oxygen) or face mask.

• Withold Kimmtrak until CRS and sequelae resolved.
• Administer IV corticosteroid (eg, 2mg/kg/day methylprednisolone or equivalent).
• Resume Kimmtrak at same dose level (ie, do not escalate if severe CRS occurred during initial dose escalation; resume escalation once dosage is tolerated).
• For severe CRS, administer corticosteroid premedication (eg, dexamethasone 4mg or equivalent) at least 30 minutes prior to next dose.

Life threatening defined as temperature ≥38°C with hemodynamic instability requiring multiple vasopressors (excluding vasopressin) and worsening hypoxia or respiratory distress despite oxygen administration requiring positive pressure.

• Permanently discontinue Kimmtrak.
• Administer IV corticosteroid (eg, 2mg/kg/day methylprednisolone or equivalent).

Skin Reactions

Grade 2 or 3: Withhold Kimmtrak until ≤Grade 1 or baseline. Resume at same dose level (ie, do not escalate if Grade 3 skin reactions occurred during initial dose escalation; resume escalation once dosage is tolerated). For persistent reactions not responding to oral steroids, consider IV corticosteroid.

Grade 4: Permanently discontinue Kimmtrak. Administer IV corticosteroid.

Elevated Liver Enzymes

Grade 3 or 4: Withhold Kimmtrak until ≤Grade 1 or baseline. Resume at same dose level if the elevated liver enzymes occur in the setting of Grade 3 CRS; resume escalation if next administration is tolerated. If the elevated liver enzymes occur outside the setting of Grade 3 CRS; resume escalation if the current dose is less than 68 mcg, or resume at same dose level if dose escalation has completed. Administer IV corticosteroids if no improvement within 24 hours.

Other Adverse Reactions

Grade 3: Withhold Kimmtrak until ≤Grade 1 or baseline. Resume at same dose level (ie, do not escalate if other Grade 3 adverse reaction occurred during initial dose escalation; resume escalation once dosage is tolerated).

Grade 4: Permanently discontinue Kimmtrak.