Established Safety and Tolerability Profile

RUCONEST® has by now an established tolerability profile.*

Important safety information

  • Adverse reactions: One case of hypersensitivity was observed in clinical trials with RUCONEST®.
  • Common adverse reaction: The most common adverse reaction observed after administration of RUCONEST® is nausea.

RUCONEST® should not be used in patients with:

  • Known or suspected allergy to rabbits.
  • Hypersensitivity to the active substance or to any of the excipients.

The table presented lists all adverse reactions obtained from clinical trials in patients with HAE following acute attack treatment with RUCONEST®. Adverse reactions were usually mild to moderate in severity. The incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administration.

* Only for adults and adolescents patients.

Paediatric population
In the clinical development program, 37 children and adolescents (aged 5 to 17 years) with HAE were treated for 124 acute angioedema attacks. Frequency, type and severity of adverse reactions in children and adolescents were similar to those in adults.

Adverse reactions

System organ class Common Uncommon
Nervous system disorders
Headache
Vertigo
Hypoaesthesia
Dizziness
Respiratory, thoracic and
mediastinal disorders
Throat irritation
Ear and labyrinth disorders
Auricular swelling
Gastrointestinal disorders
Nausea
Diarrhoea
Abdominal discomfort
Oral paraesthesia
Skin and subcutaneous tissue
disorders
Urticaria

The frequency of adverse reactions listed below is defined using the following convention:
Very common (≥1/10),
Common (≥1/100 to <1/10),
Uncommon (≥1/1,000 to <1/100),
Rare (≥1/10,000 to <1/1,000),
Very rare (<1/10,000),
Not known (cannot be estimated from the available data).