What is it and how is it used?
Ruconest contains conestat alfa as the active substance. Conestat alfa is a recombinant form of human C1 inhibitor ( rhC1INH) and is produced using recombinant DNA technology from the milk of rabbits.
Ruconest is to be used by adults 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 conestat alfa (Ruconest) is to resolve the shortage of C1 inhibitor and will lead to reduction of symptoms of an acute attack of HAE.
What do you have to consider before using it?
Do not use Ruconest
- If you are or think you are allergic (hypersensitive) to rabbits
- If you are allergic (hypersensitive) to conestat alfa or any of the other ingredients of the medicinal product (see section 6).
Only use Ruconest if you have a negative test for rabbit allergy (IgE). Repeat this test every year or after every 10 treatments with Ruconest, whichever occurs first.
Take special care with 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 assistanceso that symptoms of your allergic reaction can be treated urgently.
Children and adolescents
Ruconest is not indicated for use in children and adolescents under 18 years old.
Using other medicines
Please inform your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you are receiving 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.
How is it used?
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 will be worked out based on your weight.
Most of the time a single dose is sufficient, but a second dose may be needed. 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.
What are possible side effects?
Like all medicines, Ruconest 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 (affect 1 to 10 users in 100):
headache
Uncommon (affect 1 to 10 users in 1,000):
sensation of tingling, prickling or numbness in the skin or limb (paraesthesia), dizziness, throat irritation, abdominal pain, diarrhoea, nausea, hives and swelling of the skin.
If any of the side effects gets serious, or if you notice any side effects not listed in the leaflet, please inform your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date 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.
