RUCONEST Powder for solution for injection Ref.[10970] Active ingredients: Conestat alfa

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered products should be clearly recorded.

Conestat alfa is derived from milk of transgenic rabbits and contains traces of rabbit protein. Before initiating treatment with Ruconest, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction.

Hypersensitivity reactions cannot be excluded.

All patients must be closely monitored and carefully observed for any symptoms of hypersensitivity during and after the administration period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur after administration, they should alert their physician.

In case of anaphylactic reactions or shock, emergency medical treatment should be administered. Although cross-reactivity between cow milk and rabbit milk is considered unlikely, the possibility of such a cross-reactivity in a patient who has evidence of clinical allergy to cow milk cannot be excluded and the patient should be observed for signs and symptoms of hypersensitivity following Ruconest administration.

Sodium

Each vial of Ruconest contains 19.5 mg of sodium. To be taken into consideration by patients on a controlled sodium diet.

No interaction studies have been performed.

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

Pregnancy and breast-feeding

There is no experience with the use of Ruconest in pregnant and breast-feeding women. In one animal study reproductive toxicity was observed (see section 5.3). Ruconest is not recommended for use during pregnancy or breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks.

Fertility

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

Based on the known pharmacology and adverse reaction profile of Ruconest, effects on the ability to drive and use machines are not expected. However, headache, vertigo and dizziness have been reported following the use of Ruconest, 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 Ruconest. The most common adverse reaction observed after administration of Ruconest is nausea.

Tabulated lists of adverse reactions

Adverse reactions obtained from clinical trials in patients with HAE following acute attack treatment with Ruconest are tabulated 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.