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Safety profile in APOLLO

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

Adverse Reaction ONPATTRO
N=148
%
Placebo
N=77
%
Upper respiratory tract infectionsa 29 21
Infusion-related reaction (IRR)b 19 9
Dyspepsia 8 4
Dyspneac,d 8 0
Muscle spasmsc 8 1
Arthralgiac 7 0
Erythemac 7 3
Bronchitise 7 3
Vertigo 5 1

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
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References:

  1. ONPATTRO [package insert]. Cambridge, MA: Alnylam Pharmaceuticals, Inc; 2018.
  2. Coelho T, Adams D, Gonzalez-Duarte A, et al. Slides presented at: European Academy of Neurology; June 16, 2018; Lisbon, Portugal. 
  3. Coelho T, Adams D, Gonzalez-Duarte A, et al. Poster presented at: XVIth International Symposium on Amyloidosis (ISA) Meeting; March 26-29, 2018; Kumamoto, Japan. Poster PC040. 
  4. Polydefkis M, Adams D, Kristen A, et al. Poster presented at: Peripheral Nerve Society (PNS) Annual Meeting; July 22-25, 2018; Baltimore, MD. Poster 126.