Established Safety and Tolerability Profile

RUCONEST® has by now an established tolerability profile.

Important safety information

  • Adverse reactions: A serious adverse reaction observed in one case during clinical studies was anaphylaxis  in a healthy volunteer with in retrospect, an undisclosed rabbit allergy.
  • Common adverse reaction: The most common adverse reaction was headache.

RUCONEST® should not be used in patients with known or suspected allergy to rabbits. For the full list of restrictions, see the SmPC.

The clinical experience supporting safety of RUCONEST® consists of 300 administrations (83 administrations to healthy subjects or asymptomatic HAE patients and 217 administrations to 119 HAE patients). The table presented lists all adverse reactions occurring within 7 days after treatment with RUCONEST®, as reported in the six treatment studies. 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 administrations.

Adverse reactions

Common Uncommon
Nervous system disorders
Headache
Vertigo
Paraesthesia
Respiratory, thoracic and
mediastinal disorders
Throat irritation
Gastrointestinal disorders
Diarrhoea
Naussea
Abdominal discomfort
Oral paraesthesia
Skin and subcutaneous tissue
disorders
Urticaria
General disorders and administration
site conditions
Swelling

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).