Other safety alerts
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| Canada: TECENTRIQ (atezolizumab) - Risk of Immune-related myositis |
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Health Canada announces that cases of immune-related myositis, some with a fatal outcome, have been reported in patients receiving TECENTRIQ (atezolizumab).
Myositis or inflammatory myopathies are a group of disorders sharing the common feature of inflammatory muscle injury. Dermatomyositis and polymyositis are among the most common disorders. Diagnosis is based on clinical (muscle weakness, muscle pain, skin rash in dermatomyositis), biochemical (serum creatine-kinase increase), and imaging (electromyography/MRI) features, and is confirmed with a muscle-biopsy.
As of 4 Feb 2019, a comprehensive analysis was performed across the TECENTRIQ program and identified 51 serious and 14 non-serious cases of immune-related myositis. Of the identified serious and non-serious cases, 53 were from clinical trials and 12 from post-marketing. Of the 53 clinical trial cases, 5 were identified as category A confirmed with a muscle biopsy. There were no Canadian cases reported. Approximately 19,323 clinical trial patients and 28,975 post-marketing patients have been exposed to TECENTRIQ as of 17 Nov 2018. The incidence of myositis (including related terms of dermatomyositis, polymyositis, rhabdomyolysis) observed across the atezolizumab monotherapy clinical program was <0.1%. Based on the assessment of all available data, immune-related myositis is considered an important identified risk for TECENTRIQ.
Healthcare professionals are advised to:
- Hold TECENTRIQ treatment in patients with moderate or severe (Grade 2 or 3) immune-related myositis until symptoms resolve.
- Permanently discontinue TECENTRIQ treatment in patients with recurrent, severe, or life-threatening myositis (recurrent Grade 3 and Grade 4).
- Administer corticosteroids (1-2 mg/kg intravenous methylprednisolone or equivalent per day) to patients who develop severe signs of myositis, such as weakness limiting mobility, respiratory function, or dysphagia.
- For patients with severe or life-threatening myositis (Grade 3 and Grade 4) who do not improve following corticosteroid therapy, consider administration of other immunosuppressive agents as described in the American Society of Clinical Oncology Clinical Practice Guideline.
Health Canada is working with the manufacturer to include the risk of immune-related myositis in the Canadian Product Monograph for TECENTRIQ.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../69274a-eng.php
In Hong Kong, Tecentriq Concentrate For Solution For Infusion 1200mg/20ml (HK-65567) is a registered pharmaceutical product containing atezolizumab. The product is registered by Roche Hong Kong Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received 24 cases of adverse drug reaction related to atezolizumab, but these cases are not related to myositis. Related news was previously issued by Singapore Health Sciences Authority, and was posted on the Drug Office website on 26 Feb 2019. Letters to inform local healthcare professionals were issued by the DH on the same day. In light of the above Health Canada’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Mar 15, 2019
Issued at HKT 16:00
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