Conestat alfa

Scientific literature indicates an interaction of tissue-type plasminogen activator (tPA) and C1-INH containing medicinal products. Conestat alfa should not be administered simultaneously with tPA.

There is no experience with the use of conestat alfa in pregnant women. In one animal study reproductive toxicity was observed. Conestat alfa is not recommended for use during pregnancy, unless the treating physician judges the benefits to outweigh the possible risks.

There is no experience with the use of conestat alfa in breast-feeding women. In one animal study reproductive toxicity was observed. Conestat alfa is not recommended for use during breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks.

Fertility

There are no data on the effects of conestat alfa on male or female fertility.

Based on the known pharmacology and adverse reaction profile of conestat alfa, effects on the ability to drive and use machines are not expected. However, headache, vertigo and dizziness have been reported following the use of conestat alfa, but may also occur as a result of an attack of HAE. Patients should be advised not to drive and use machines if they experience headache, vertigo or dizziness.

Summary of the safety profile

One case of hypersensitivity was observed in clinical trials with conestat alfa. The most common adverse reaction observed after administration of conestat alfa is nausea.

Lists of adverse reactions

Adverse reactions obtained from clinical trials in patients with HAE following acute attack treatment with conestat alfa are listed below. 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.

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).

Nervous system disorders

Uncommon: Headache

Uncommon: Vertigo

Uncommon: Hypoaesthesia

Uncommon: Dizziness

Ear and labyrinth disorders

Uncommon: Auricular swelling

Respiratory, thoracic and mediastinal disorders

Uncommon: Throat irritation

Gastrointestinal disorders

Common: Nausea

Uncommon: Diarrhoea

Uncommon: Abdominal discomfort

Uncommon: Oral paraesthesia

Skin and subcutaneous tissue disorders

Uncommon: Urticaria

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.