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Ruconest
ruconest



Be Free. Break Free!

The only plasma-free human C1 inhibitor for treatment of acute HAE attacks*

In HAE patients, one dose** of Ruconest®:

96%

Succesfully treated 96% of attacks>1

93%

Stopped 93% of attacks for at least 3 days*2

94%

Raised C1-INH levels back to normal*** in 94% of patients3

* Ruconest® is indicated for treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. 

** Dosing of Ruconest® is body weight dependent and one dose is, therefore, based on patient weight as follows; <42kg = up to 1 vial, 42-84 kg = 50 U/kg (up to 2 vials), >84kg = 2 vials. 

*** Above the lower limit of the normal range as observed in healthy individuals (0.7-1.3 U/ml).4

What is HAE?

HAE is the result of a genetic mutation caused by a deficiency of the blood protein functional C1 esterase inhibitor (C1-INH). Patients with HAE suffer from repeated episodes of spontaneous swelling that can occur at any time and in almost any part of the body but more predominantly in the hands, feet, face, airway (throat) and internal organs. HAE is not an allergy or allergic reaction.

How does Ruconest® work

Ruconest® works by increasing functional C1-INH levels in the blood into the normal range. Ruconest® also helps stop the production of kallikrein, an enzyme that activates bradykinin, which causes blood vessels to leak and certain parts of the body to swell.

For more detailed information please check
EMA’s EPAR summary.

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Ruconest®:
Recombinant Technology Produces Human C1-INH5

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Ruconest

99% 
purity5,6

Ruconest

Safety
no risk of human
blood-borne viruses7

Ruconest

4-year shelf life
when stored at room
temperature8

Just One Dose

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** Dosing of Ruconest® is body weight dependent and one dose is, therefore, based on patient weight as follows; <42kg = up to 1 vial, 42-84 kg = 50 U/kg (up to 2 vials), >84kg = 2 vials.


Raffi Tachdjian, MD, UCLA School of Medicine, Los Angeles, CA

Ruconest

One Dose** of Ruconest®
stopped 93% of attacks
for at least 3 days
n=68 (259 of a total of
280 attacks)*2

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Established Safety and Tolerability Profile***

Ruconest

One Dose** of Ruconest®
50 U/kg raised C1-INH
back to normal
**** in
94%
of patients3

* Ruconest® is indicated for treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.

**Dosing of Ruconest® is weight dependent and one dose is, therefore, based on patient weight as follows; <42kg = up to 1 vial, 42-84 kg = 50 U/kg (up to 2 vials), >84kg = 2 vials. 

*** For information on potential undesirable effects, please refer to the Ruconest® SmPC. 

**** Above the lower limit of the normal range as observed in healthy individuals (0.7-1.3 U/ml).4

Phase II/III combined analysis of time to onset of relief

HAE


Symptom Relief

WAO guidelines state that HAE patients experienced earlier relief of symptoms when treated early in the course of an attack.

A single dose of Ruconest® worked rapidly to help patients get relief of their symptoms fast compared to placebo.*

Adapted from Zuraw B, Cicardi M, Levy RJ, et al. Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema. J Allergy Clin Immunol. 2010;126(4):821-827.

Established Safety and Tolerability Profile

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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.

Dosing

Dosing of Ruconest® is weight dependent and one dose is, therefore, based on patient weight as follows; <42kg = up to 1 vial, 42-84kg = 50 U/kg (up to 2 vials), >84kg = 2 vials

The clinical efficacy of C1-INH replacement therapy in the treatment of acute attacks is dose dependent10:

• Beginning of relief of symptoms
• Time to resolution of symptoms
• Response rate within 4 hours

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ADMIN kit ruconest

Administration

• Ruconest® is administered by slow intravenous (IV) injection over approximately 5 minutes

• Patients may self-administer Ruconest® after receiving appropriate training by a qualified healthcare professional

• Ruconest® should be administered immediately upon recognition of an HAE attack

For information on reconstitution and administration please consult the SmPC.

Ruconest