Description
TECENTRIQ® (atezolizumab) has been associated with the risk of immune-related myositis.
In a comprehensive analysis that was performed across the TECENTRIQ® programme, cases of immune-related myositis including biopsy-confirmed cases have been identified in patients who received atezolizumab.
It is recommended that:
- TECENTRIQ® should be withheld in patients who developed moderate or severe immune-related myositis (Grade 2 or 3).
- TECENTRIQ® should be permanently discontinued in patients with recurrent severe or life-threatening myositis (recurrent Grade 3 and Grade 4).
- Patients should be referred to a rheumatologist and/or neurologist.
- Muscle biopsy and supportive measures with corticosteroids and/or additional immunosuppressive agents should be considered as clinically indicated.
NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Roche (M) Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.
