FASENRA▼ benralizumab

FASENRA is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.1

Safety

FASENRA‘s safety profile is being studied in an extensive respiratory Phase III programme5,7,9, 16-19

Safety results from pivotal clinical studies (n = 2,514) of 48 to 56 weeks duration:1

The most commonly reported adverse reactions were headache and pharyngitis.*1

 

Fasenra safety table
Fasenra safety table

 

The frequency of common adverse events is defined as  ≥ 1/100 to <1/101

  • Injection site reactions (e.g. pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.1
  • FASENRA is contraindicated in any patients with known hypersensitivity to the active substance or to any of the excipients.1

 

Fasenra safety table
Fasenra safety table

 

 

Fasenra safety table
Fasenra safety table

 

*Pharyngitis was defined by the following grouped preferred terms: ‘Pharyngitis’, ‘Pharyngitis bacterial’, ‘Viral pharyngitis’, ‘Pharyngitis streptococcal’.

Hypersensitivity reactions were defined by the following grouped preferred terms: ‘Urticaria’, ‘Papular urticaria’, and ‘Rash’.