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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 06934/0251.
Icatibant 30 mg solution for injection in pre-filled syringe
Icatibant 30 mg solution for injection pre-filled syringe
Icatibant
1. What Icatibant 30 mg is and what it is used for
2. What you need to know before you use Icatibant 30 mg
3. How to use Icatibant 30 mg
4. Possible side effects
5. How to store Icatibant 30 mg
6. Contents of the pack and other information
Icatibant 30 mg contains the active substance icatibant.
Icatibant 30 mg is used for treating the symptoms of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older.
In HAE levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea.
Icatibant 30 mg blocks the activity of bradykinin and therefore ends the further progression of the symptoms.
Talk to your doctor before taking Icatibant 30 mg:
Some of the side effects connected with Icatibant 30 mg are similar to the symptoms of your disease.
Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received Icatibant 30 mg.
In addition:
Icatibant 30 mg is not recommended for use in children under 2 years of age or weighing less than 12 kg because it has not been studied in these patients.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Icatibant 30 mg is not known to interact with other medicines. If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) which is used to lower your blood pressure or for any other reason, you should inform your doctor before receiving Icatibant 30 mg.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before starting to use Icatibant 30 mg.
If you are breast-feeding you should not breast-feed for 12 hours after you have last received Icatibant 30 mg.
Do not drive or use machines if you feel tired or dizzy as a result of your HAE attack or after using Icatibant 30 mg.
The injection solution contains less than 1 mmol (23 milligrams) of sodium per syringe, so it is essentially ‘sodium-free’.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
If you have never received Icatibant 30 mg previously, your first dose of Icatibant 30 mg will always be injected by your doctor or nurse. Your doctor will tell you when it is safe for you to go home. After discussion with your doctor or nurse and after training in subcutaneous (under the skin) injection technique, you may be able to inject yourself with Icatibant 30 mg or your caregiver may inject Icatibant for you when you have an HAE attack. It is important that Icatibant is injected subcutaneously (under the skin) as soon as you notice an attack of angioedema. Your healthcare provider will teach you and your caregiver how to safely inject Icatibant 30 mg by following the instructions in the Package Leaflet.
Your doctor has determined the exact dose of Icatibant 30 mg and will tell you how often it should be used.
Icatibant 30 mg is intended for subcutaneous injection (under the skin). Each syringe should only be used once.
Icatibant 30 mg is injected with a short needle into the fatty tissue under the skin in the abdomen (tummy). If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
The instructions include the following main steps:
1) General Information
2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less
2b) Preparing the syringe and needle for injection (all patients)
3) Preparing the injection site
4) Injecting the solution
5) Disposal of the injection material
1) General Information
2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less:
Important information for healthcare professionals and caregivers:
Where the dose is less than 30 mg (3 ml), the following equipment is required to extract the appropriate dose (see below):
a) Icatibant 30 mg pre-filled syringe (containing icatibant solution)
b) Connector (female luer lock adapter)
c) 3 ml graduated syringe
The required injection volume in ml should be drawn up in an empty 3 ml graduated syringe as instructed below.
Table 1: Dosage regimen for children and adolescents
Body Weight Injection Volume
12 kg to 25 kg 1.0 ml
26 kg to 40 kg 1.5 ml
41 kg to 50 kg 2.0 ml
51 kg to 65 kg 2.5 ml
Patients weighing more than 65 kg will use the full contents of the pre-filled syringe (3 ml).
If you are not sure which volume of solution to extract, ask your doctor, pharmacist or nurse
1) Remove the protective caps on each end of the connector.
Avoid touching the ends of the connector and syringe tips, to prevent contamination
2) Screw the connector onto the pre-filled syringe.
3) Attach the graduated syringe to the other end of the connector ensuring that both connections fit securely.
Transferring the icatibant solution to the graduated syringe:
1) To start transfer of icatibant solution, push the pre-filled syringe plunger (on far left of below image).
2) If the icatibant solution does not begin to transfer to the graduated syringe, pull slightly on the graduated syringe plunger until the icatibant solution starts to flow into the graduated syringe (see below image).
3) Continue to push on the pre-filled syringe plunger until the required injection volume (dose) is transferred to the graduated syringe. Refer to table 1 for dosage information.
If there is air in the graduated syringe
4) Remove the pre-filled syringe and connector from the graduated syringe.
5) Discard the pre-filled syringe and connector into the sharps container.
2b) Preparing the syringe and needle for injection: All patients (adults, adolescents and children)
3) Preparing the injection site
4) Injecting the solution
5) Disposal of the injection material
Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients receiving Icatibant 30 mg will experience a reaction at the site of the injection (such as skin irritation, swelling, pain, itchiness, redness of the skin and burning sensation). These effects are usually mild and clear up without the need for any additional treatment.
Very common (may affect more than 1 in 10 people):
Additional injection site reactions (pressure sensation, bruising, reduced sensation and/or numbness, raised itchy skin rash and warmth).
Common (may affect up to 1 in 10 people) :
Not known (frequency cannot be estimated from the available data) :
Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received Icatibant 30 mg.
If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not freeze.
Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for injection.
Icatibant 30 mg is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml. A sterile hypodermic needle is included in the pack.
Icatibant 30 mg is available as a single pack containing one pre-filled syringe with one needle or as a pack containing three pre-filled syringes with three needles.
Not all pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in May 2022.
Other sources of information
Detailed information on this medicine is available on the Medicines & Healthcare products Regulatory Agency website: www.mhra.gov.uk
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