Italian Medicines Agency Agenzia Italiana del Farmaco

TECENTRIQ® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) - TECENTRIQ® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)

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TECENTRIQ® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)

TECENTRIQ® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs).

Summary:

  • Severe cutaneous adverse reactions (SCARs), including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with Tecentriq (atezolizumab).
  • Patients should be monitored for suspected severe skin reactions and other causes should be excluded. In case a SCAR is suspected, Tecentriq should be withheld and patients should be referred to a specialist in SCARs for diagnosis and treatment.
  • In case SJS or TEN is confirmed, and for any grade 4 rash/SCAR, treatment with Tecentriq should be permanently discontinued.
  • Caution is recommended when considering the use of Tecentriq in patients with previous history of a severe or life-threatening SCAR with other immune-stimulatory cancer medicines.


Published on: 25 March 2021

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