Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ruconest 2100 U powder for solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Conestat alfa may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Ruconest contains conestat alfa as the active substance. Conestat alfa is a recombinant (not blood-derived) form of human C1 inhibitor (rhC1-INH). Ruconest is to be used by adults, adolescents, and children (aged 2 years and above) with a rare inherited blood disorder, called Hereditary Angioedema (HAE). These patients have a shortage of the C1 inhibitor protein in their blood. This can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. The administration of Ruconest is to resolve the shortage of C1 inhibitor and will lead to reduction of symptoms of an acute attack of HAE.
2.
What you need to know before you take it
e Ruconest
Do not use Ruconest • If you are or think you are allergic to rabbits. • If you are allergic to conestat alfa or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor before using Ruconest. If you experience allergic reactions e.g. hives, rash, itching, dizziness, wheezing, difficulty breathing or your tongue swells up following the administration of Ruconest, you should seek emergency medical assistance so that symptoms of your allergic reaction can be treated urgently. Before you start treatment with Ruconest, it is important that you tell your doctor if you have, or have had, problems with your blood clotting (thrombotic events). You will be carefully monitored if this is the case. Hypersensitivity reactions cannot be excluded and may have symptoms similar to angioedema attacks.
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Children and adolescents Do not give this medicine to children under 2 years old. Ruconest has not been studied in children younger than 5 years of age. Your doctor will determine whether treatment of your child with Ruconest is appropriate. Additional monitoring of your child for symptoms of allergic reactions during and after administration is needed. Other medicines and Ruconest Tell your doctor if you are taking, have recently taken or might take any other medicines. If you are receiving tissue type plasminogen activator as acute treatment for blood clots, you should not be treated with Ruconest at the same time. Pregnancy and breast-feeding It is not recommended to use Ruconest during pregnancy or breast-feeding. If you plan becoming pregnant, discuss with your doctor before starting to use Ruconest. Driving and using machines Do not drive or use machinery if you feel dizzy or suffer from headache after using Ruconest. Ruconest contains sodium (19.5 mg per vial) This should be taken into consideration by patients on a controlled sodium diet.
3.
How to take it
Ruconest
Ruconest will be initiated by a doctor who is specialised in the diagnosis and treatment of hereditary angioedema. Ruconest will be given to you directly into a vein over a period of approximately 5 minutes by your doctor or by a nurse. Your dose, up to 2 vials, will be worked out based on your weight. Most of the time a single dose is sufficient. Your doctor may decide that an additional dose should be administered if your symptoms do not improve after 120 minutes (for adults and adolescents) or 60 minutes (for children). No more than 2 doses should be given within 24 hours. The instructions for use are clearly described in the doctor's information leaflet and are attached. If you have any further questions on the use of this medicine, ask your doctor or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If your symptoms get worse and/or you develop a rash, tingling, difficulty breathing or your face or tongue swells up, get medical attention immediately. This may indicate that you have developed an allergy to Ruconest. Some side effects may occur during treatment with Ruconest: Common: may affect up to 1 in 10 people • Nausea Uncommon: may affect up to 1 in 100 people • Abdominal pain, 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 3
• •
Swelling of the ears or the area around the ears Allergic shock
Not known: the frequency is not known • Hypersensitivity reactions Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in the leaflet. You can also report side effects directly via: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store For any patients who do not have online access to report a suspected side effect to the Yellow Card scheme, call 0800 731 6789 for free, Monday to Friday between 10am and 2pm. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Ruconest
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original package in order to protect from light. Before Ruconest can be administered, it needs to be dissolved in water for injections, by a healthcare professional. Once reconstituted, the product should be used immediately. Do not use this medicine if you notice particles in the solution or if the solution is discoloured.
6.
Contents of the pack and other information
What Ruconest contains The active substance is conestat alfa. Each vial contains 2100 units of conestat alfa, corresponding to 2100 units per 14 ml after reconstitution, or a concentration of 150 units/ml. The other ingredients are sucrose, sodium citrate (E331) and citric acid. What Ruconest looks like and contents of the pack Ruconest is presented as a single glass vial containing a white to off-white powder for solution for injection. After dissolving the powder in water for injections, the solution is clear and colourless. Ruconest is supplied in a carton box containing one vial.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Pharming Group N.V. 4
Darwinweg 24 2333 CR Leiden The Netherlands Manufacturer: Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands This leaflet was last revised in July 2023.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
The following information is intended for healthcare professionals only:
POSOLOGY AND METHOD OF ADMINISTRATION Posology Body weight up to 84 kg
- One intravenous injection of 50 U/kg body weight. Body weight of 84 kg 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. Body weight up to 84 kg
- For patients up to 84 kg calculate the volume required to be administered according to the formula below: Volume to be administered (ml)
=
body weight (kg) times 50 (U/kg) 150 (U/ml)
=
body weight (kg) 3
Body weight of 84 kg or greater
- For patients of 84 kg or above the volume required to be administered is 28 ml, corresponding to 4200 U (2 vials). Reconstitute each vial with 14 ml water for injections (see section on Reconstitution below). The reconstituted solution in each vial contains 2100 U conestat alfa at 150 U/ml. The required volume of the reconstituted solution should be administered as a slow intravenous injection over approximately 5 minutes. SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING 5
Each vial of Ruconest is for single use only. An aseptic technique should be used for reconstitution, combining and mixing the solutions. Reconstitution Each vial of Ruconest (2100 U) should be reconstituted with 14 ml water for injections. Water for injections should be added slowly to avoid forceful impact on the powder and mixed gently to minimise foaming of the solution. The reconstituted solution in each vial contains 2100 U conestat alfa at 150 U/ml and appears as a clear colourless solution. The reconstituted solution in each vial should be inspected for particulate matter and discoloration. A solution exhibiting particulates or discoloration should not be used. The medicinal product should be used immediately. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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Frequently asked questions about Ruconest 2100 U powder for solution for injection
How do I take Ruconest 2100 U powder for solution for injection?
Ruconest 2100 U powder for solution for injection comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ruconest 2100 U powder for solution for injection?
The active substance in Ruconest 2100 U powder for solution for injection is conestat alfa.
Are there equivalent medicines to Ruconest 2100 U powder for solution for injection?
Medicines with the same active substance, strength and form include: Ruconest 2100 U powder and solvent for solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ruconest 2100 U powder for solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ruconest 2100 U powder for solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: conestat alfa
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic 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.
4.2. Posology and method of administration
Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema.
Posology in adults, adolescents and children aged 2 years and above
Body weight up to 84 kg
- One intravenous injection of 50 U/kg body weight.
Body weight of 84 kg or greater
- One intravenous injection of 4200 U (2 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 at the discretion of the physician (see section 5.1).
- 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.
Dose calculation
Determine the patient's body weight.
Body weight up to 84 kg
- For patients up to 84 kg calculate the volume required to be administered according to the formula below:
Body weight of 84 kg 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
Ruconest may be used in paediatric patients (2 years and older) at the same dose as in adults (50 U/kg body weight).
The safety and efficacy of Ruconest in children less than 2 years old have not been established. No clinical data are available.
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.
Ruconest should be administered by a healthcare professional.
For instructions on reconstitution of Ruconest before administration, see section 6.6.
The required volume of the reconstituted solution should be administered as a slow intravenous injection over approximately 5 minutes.
4.3. Contraindications
• Known or suspected allergy to rabbits (see section 4.4)
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
4.4. Special warnings and precautions for use
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 and may have symptoms similar to angioedema attacks.
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 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 patient should be observed for signs and symptoms of hypersensitivity following Ruconest administration.
Thromboembolic events
Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with known risk factors (e.g., indwelling catheters, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, immobility). Patients with known risk factors should be monitored closely.
Sodium
Each vial of Ruconest contains 19.5 mg of sodium. To be taken into consideration by patients on a controlled sodium diet.
4.5. Interaction with other medicinal products and other forms of interaction
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.
4.6. Fertility, pregnancy and lactation
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.
4.7. Effects on ability to drive and use machines
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.
4.8. Undesirable effects
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 reported with Ruconest in the treatment of acute HAE attacks obtained from clinical trials and post-marketing surveillance are tabulated below. In clinical trials, the incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administrations.
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).
System Organ Class
Adverse reaction
Frequency
Nervous system disorders
Headache
Uncommon
Vertigo
Uncommon
Hypoaesthesia
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
Hypersensitivity reactions*
Not known
*Further information is found in section 4.4
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:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
No clinical information on overdose is available.
💬 Ask about this leaflet
Ask anything about Ruconest 2100 U powder for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.