Berita Terbaru             -  Good Pharmacovigilance Practice Workshop            -  INFORMASI AWAL UNTUK TENAGA PROFESIONAL KESEHATAN TERKAIT KEAMANAN PRODUK YANG MENGANDUNG BAHAN AKTIF RANITIDIN            -  INFORMASI AWAL UNTUK TENAGA PROFESIONAL KESEHATAN TERKAIT KEAMANAN PRODUK YANG MENGANDUNG BAHAN AKTIF RANITIDIN            -  Tecentriq (Atezolizumab) and New Important Identified Risk of Immune-Related Myositis            -  Actemra┬« (Tocilizumab) and Risk of Hepatotoxicity

Safety Communication

PT Roche Indonesia  would like to inform healthcare professionals related the new safety concern of immune-related myositis associated with Tecentriq® (atezolizumab).

Dermatomyositis and polymyositis are amongst the most common types of myositis. Diagnosis is based on clinical (muscle weakness, muscle pain, skin rash in dermatomyositis), biochemical (serum creatine-kinase increase), and imaging (electromyography/magnetic resonance imaging) features, and is confirmed with a muscle biopsy.  Healthcare professionals are advised to withhold Tecentriq® for moderate or severe (Grade 2 or 3) immune-related myositis and permanently discontinue the drug for recurrent severe or life-threatening myositis (recurrent Grade 3 and Grade 4). Please refer to the attached letter for details information.

 


Download : DHPC Tecentriq- Immune Myostis IDN-Final.pdf
How do you think the content and appearance of this website?




logo dsras Email Rapid Alert System

Selamat email anda telah berlangganan untuk selalu mendapatkan informasi terkini mengenai keamanan obat yang beredar di Indonesia.

 

logo dsras Email Rapid Alert System

Anda ingin berhenti berlangganan untuk selalu mendapatkan informasi terkini mengenai keamanan obat yang beredar di Indonesia?