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

User Rating: 4 / 5

Star ActiveStar ActiveStar ActiveStar ActiveStar Inactive
 

 

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

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Newsletter Subsription

Site Last Modified

  • Last Modified: Wednesday 17 July 2019, 16:23:30.
© Copyright 2019 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Main Menu English

Choose Your Language