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RUC-INT-2023-0020 (v2) November 2023

RUCONEST® EU PRESCRIBING INFORMATION

Consult full Summary of Product Characteristics before prescribing.
Name of the product: RUCONEST® 2100 Units powder for solution for injection. Indications: RUCONEST® is indicated for treatment of acute angioedema attacks in adults, adolescents, and children (aged 2 years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. Dosage and administration: Each vial of RUCONEST® (2100 U) should be reconstituted with 14ml water for injections to obtain a solution of 150U/ml. RUCONEST® should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema until the patient (or caregiver) is competent to administer after having been properly trained.

RUCONEST® should be administered based on patient body weight:

Body weight

RUCONEST® dose for Intravenous infusion

Volume (ml) of reconstituted solution (150 U/ml) to be administered

<84 kg

50 U/kg

Body weight in kg divided by 3

≥84 kg

4200 U (2 vials)

28 ml

The reconstituted solution should be administered at room temperature as a slow intravenous injection over approximately 5 minutes. In the majority of cases, a single dose of RUCONEST® is sufficient to treat an acute angioedema attack. In case of an insufficient clinical response, an additional dose can be administered.

– In adults and adolescents an additional dose may be administered if the patient has not responded adequately after 120 minutes.
– In children an additional dose may be administered if the patient has not responded adequately after 60 minutes. Not more than two doses should be administered within 24 hours.

Contraindications: Known or suspected allergy to rabbits. Known hypersensitivity to any of the components of the product. Warnings and precautions: RUCONEST® is derived from the milk of transgenic rabbits and contains traces of rabbit protein. Before initiating treatment, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction. Serious arterial and venous thromboembolic events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with known risk factors. Patients with known risk factors should be monitored closely. Hypersensitivity reactions cannot be excluded and may have signs and symptoms similar to angioedema attacks. All patients must be closely monitored and carefully observed for any signs and symptoms of hypersensitivity during and after the administration period. Patients should be informed of the early signs of hypersensitivity reactions, e.g., 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 patien should be observed for signs and symptoms of hypersensitivity following RUCONEST® administration. Patients on a controlled sodium diet should be aware that each vial of RUCONEST® contains 19.5 mg sodium. Interactions: Although no interaction studies have been performed, RUCONEST® should not be administered simultaneously with tissue-type plasminogen activator (tPA). Pregnancy and lactation: There is no experience of using RUCONEST® in pregnant or breast-feeding women. RUCONEST® is not recommended for use during pregnancy or breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks. Ability to drive and use machines: Patients should be advised not to drive or use machines if they experience headache, vertigo or dizziness following RUCONEST® treatment. Undesirable effects: Common: Nausea. Uncommon: Abdominal pain, anaphylaxis, diarrhoea, sensation of tingling, prickling or numbness in the mouth, headache, dizziness, reduced sense of touch or sensation in skin or limbs, throat irritation, hives, swelling of the ears or the area around the ears. Frequency not known: Hypersensitivity. Please consult the full Summary of Product Characteristics for a detailed listing of all adverse events before prescribing. Legal classification: POM. Presentation & Basic price: Powder for solution for injection: €750, Powder and solvent for solution for injection: €750. Marketing Authorisation Numbers: EU/1/10/641/001, EU/1/10/641/002. Marketing Authorisation Holder: Pharming Group N.V., Darwinweg 24, 2333 CR Leiden, the Netherlands. Date text last revised: October 2023.

Adverse events should be reported to Pharming
Pharmacovigilance at
safety@pharming.com

RUC-INT-2023-0021 October 2023

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