Adverse reactions that occurred in at least 5% of patients treated with ONPATTRO® (patisiran) and at least 3% more frequently than in patients treated with placebo1
|Upper respiratory tract infectionsa||29||21|
|Infusion-related reaction (IRR)b||19||9|
aIncludes nasopharyngitis, upper respiratory tract infection, respiratory tract infection, pharyngitis, rhinitis, sinusitis, viral upper respiratory tract infection, upper respiratory tract congestion.
bInfusion-related reactions symptoms include, but are not limited to: arthralgia or pain (including back, neck, or musculoskeletal pain), flushing (including erythema of face or skin warm), nausea, abdominal pain, dyspnea or cough, chest discomfort or chest pain, headache, rash, chills, dizziness, fatigue, increased heart rate or palpitations, hypotension, hypertension, facial edema.
cNot part of an infusion-related reaction.
dIncludes dyspnea and exertional dyspnea.
eIncludes bronchitis, bronchiolitis, bronchiolitis viral, lower respiratory tract infection, lung infection.
- The safety profile of ONPATTRO was generally consistent across all subgroups2,3
- In ONPATTRO-treated patients, all IRRs were either mild (95%) or moderate (5%) in severity4
— One patient in the expanded access program experienced a severe IRR1
- Among ONPATTRO-treated patients who experienced an IRR, 79% experienced the first IRR within
the first 2 infusions and the frequency of IRRs decreased over time1
- IRRs led to treatment discontinuation in <1% of patients1