Agenzia Italiana del Farmaco
TECENTRIQ® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) - TECENTRIQ® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)
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