TECENTRIQ® (atezolizumab): A new important identified risk – immune-related myositis

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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.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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  • Last Modified: Khamis 12 September 2019, 14:20:55.
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