RUCONEST^®
Safety

Clinical trials and real-world evidence

RUCONEST® is generally well tolerated in patients with acute HAE attacks^1-6

Adverse reactions reported with RUCONEST® in the treatment of acute HAE attacks obtained from clinical trials and post-marketing surveillance¹

System organ class	Adverse reaction	Frequency
Nervous system disorders	Headache	Uncommon
	Vertigo	Uncommon
	Hypoesthesia	Uncommon
	Dizziness	Uncommon
Ear and labyrinth disorders	Auricular swelling	Uncommon
Respiratory, thoracic and mediastinal disorders	Throat irritation	Uncommon
Gastrointestinal disorders	Nausea	Common
	Diarrhoea	Uncommon
	Abdominal discomfort	Uncommon
	Oral paraesthesia	Uncommon
Skin and subcutaneous tissue disorders	Urticaria	Uncommon
Immune system disorders	Anaphylaxis	Uncommon
Immune system disorders	Hypersensitivity reactions	Not known

A total of 205 patients with HAE participated in the RUCONEST^® clinical development program for acute attack treatment⁷
Patients with known risk factors for serious arterial and venous thromboembolic events should be monitored closely, as these have been reported at the recommended dose of plasma-derived C1 esterase inhibitor products in such patients¹
In clinical trials, the incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administration¹

For a complete list of side effects, please refer to the RUCONEST^® Summary of Product Characteristics.

References

RUCONEST^® SmPC. July 2023.
Zuraw B, et al. J Allergy Clin Immunol 2010 Oct;126(4):821-827.
Moldovan D, et al. Clin Exp Allergy 2012 Jun;42(6):929-935.
Riedl M, et al. Ann Allergy Asthma Immunol 2013;112(2):163-169.
Li H, et al. J Allergy Clin Immunol Pract 2015;3(3):417-423.
Valerieva A, et al. World Allergy Organ J 2021;14(4):100535.
CHMP Group of variations including an extension of indication assessment report. EMA/193472/2020.

This website is intended for HCPs only and has been compiled by Pharming Group N.V.
You will receive a warning message if you use any of the external links on this page.

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

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.

Necessary

Always Enabled

Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.

Cookie	Duration	Description
cookielawinfo-checkbox-analytics	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional	11 months	The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy	11 months	The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.

Functional

Performance

Analytics

Others

RUCONEST® Safety

Clinical trials and real-world evidence

RUCONEST^®
Safety