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Aspaveli gives patients the assurance of a well-tolerated treatment1

AEs reported in ≥5% of patients treated with Aspaveli1

AEs reported in ≥5% of patients treated with Aspaveli

*The following terms were combined: abdominal pain includes: abdominal pain upper, abdominal discomfort, abdominal pain, abdominal pain lower, abdominal tenderness, epigastric discomfort; back pain includes: back pain, sciatica; chest pain includes: chest discomfort, non-cardiac chest pain, musculoskeletal chest pain, chest pain; fatigue includes: asthenia, lethargy, fatigue; infections include: oral herpes, bacterial infection, fungal infection, gastrointestinal infection, gastrointestinal viral infection, influenza-like illness, nasopharyngitis, pulpitis dental, rhinitis, tonsillitis, tonsillitis bacterial, vulvovaginal mycotic infection, hordeolum, sepsis, furuncle, otitis externa, viral respiratory tract infection, gastroenteritis, upper respiratory tract infection, bronchitis, ear infection, respiratory tract infection, rhinovirus infection, sinusitis, urinary tract infection; Injection-site reaction includes: injection-site erythema, injection-site reaction, injection-site swelling, injection-site induration, injectionsite bruising, injection-site pain, injection-site pruritus, vaccination-site reaction, administration-site swelling, injection-site hemorrhage, injection-site edema, injection-site warmth, administration-site pain, application-site pain, injection-site mass, injection-site rash, vaccination-site pain; Respiratory tract infection includes: influenza-like illness, nasopharyngitis, rhinitis, tonsillitis, viral upper respiratory tract infection, upper respiratory tract infection, respiratory tract infection, sinusitis; systemic hypertension includes: hypertension; viral infection includes: oral herpes, gastrointestinal viral infection, viral upper respiratory tract infection, rhinovirus infection.1


Serious infections caused by encapsulated bacteria

The use of Aspaveli may predispose individuals to serious infections caused by encapsulated bacteria including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae. To reduce the risk of infection, all patients must be vaccinated against these bacteria according to applicable local guidelines at least 2 weeks prior to receiving Aspaveli, unless the risk of delaying therapy outweighs the risk of developing an infection 


Aspaveli must not be initiated in patients:

  • with unresolved infection caused by encapsulated bacteria including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae
  • who are not currently vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination


Patients with PNH receiving Aspaveli should be monitored regularly for signs and symptoms of haemolysis, including measuring LDH levels, and may require dose adjustment within the recommended dosing schedule

Please refer to the Aspaveli Summary of Product Characteristics for further information.

AE=adverse event; LDH=lactate dehydrogenase; PNH=paroxysmal nocturnal haemoglobinuria.

Reference: 1. Hillmen P, Szer J, Weitz I, et al. Pegcetacoplan versus eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2021;384:1028–1037. 2. Aspaveli (pegcetacoplan) Summary of Product Characteristics. 2021.