Ruconest – Powder for Solution for Injection

/ Kamada

Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema.
Ruconest should be administered by a healthcare professional.
Patients who have not previously received Ruconest should be tested for the presence of IgE antibodies against rabbit epithelium (dander) prior to initiation of Ruconest.
Adults up to 84 kg body weight: One intravenous injection of 50 U/kg body weight.
Adults of 84 kg body weight or greater: One intravenous injection of 4200 U (two vials).
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 (50 U/kg body weight up to 4200 U) can be administered.
Not more than two doses should be administered within 24 hours.
Dose calculation: Determine the patient’s body weight.
Adults up to 84 kg body weight: For patients up to 84 kg calculate the volume required to be administered according to the formula below:

Adults of 84 kg body weight or greater: For patients of 84 kg or above the volume required to be administered is 28 ml, corresponding to 4200 U (2 vials).
Paediatric population: The safety and efficacy of Ruconest in children (age 0 to 12 years) has not yet been established. Currently available data on adolescents (age 13 to 17 years) are described in section 5.1, but no recommendation on a posology can be made.
Elderly (≥65 years old): Data in patients older than 65 years are limited.
There is no rationale for patients older than 65 years to respond differently to Ruconest.
Renal impairment: No dose adjustment is necessary in patients with renal impairment since conestat alfa does not undergo renal clearance.
Hepatic impairment: There is no clinical experience with Ruconest in patients with hepatic impairment. Hepatic impairment may prolong the plasma half-life of conestat alfa, but this is not thought to be a clinical concern. No recommendation on a dose adjustment can be made.
Method of Administration: For intravenous use.
The required volume of the reconstituted solution should be administered as a slow intravenous injection over approximately 5 minutes.

For treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.

Known or suspected allergy to rabbits.
Hypersensitivity to the active substance or to any of the excipients.

Conestat alfa is derived from milk of transgenic rabbits and contains traces of rabbit protein.
Before initiating treatment with Ruconest, patients should be tested for the presence of IgE antibodies against rabbit allergens using a validated test for IgE antibodies against rabbit epithelium (dander) e.g. ImmunoCap system, Phadia, Sweden. Only patients who have been shown to have negative results for such a test, should be treated with Ruconest. IgE antibody testing should be repeated once a year or after 10 treatments, whichever occurs first.
Hypersensitivity reactions cannot be excluded.
Patients must be closely monitored and carefully observed for any symptoms of hypersensitivity throughout 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.

One case of hypersensitivity was observed in clinical trials with Ruconest. The most common adverse reaction observed after administration of Ruconest is headache.
See prescribing information for full details.

No interaction studies have been performed.
Scientific literature indicates an interaction of tissue-type plasminogen activator (tPA) and C1INH containing medicinal products. Ruconest should not be administered simultaneously with tPA.

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

No clinical information on overdose is available.

Storage: Do not store above 25°C, store in the original package in order to protect from light.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.