Icatibant Aguettant

Package leaflet: Information for the user

Icatibant Aguettant 30 mg solution for injection in pre-filled syringe

icatibant
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Icatibant Aguettant is and what it is used for
2. What you need to know before using Icatibant Aguettant
3. How to use Icatibant Aguettant
4. Possible side effects
5. How to store Icatibant Aguettant
6. Contents of the pack and other information

1. What Icatibant Aguettant is and what it is used for

Icatibant Aguettant contains the active substance Icatibant.
Icatibant Aguettant is used for the treatment of symptoms of hereditary angioedema (HAE) in adults,
adolescents, and children from 2 years of age.
In HAE, levels in the blood of a substance called bradykinin increase, causing symptoms such as
swelling, pain, nausea, and diarrhoea.
Icatibant Aguettant blocks the activity of bradykinin and thus stops the progression of symptoms during an HAE attack.

2. What you need to know before using Icatibant Aguettant

Do not use Icatibant Aguettant

• if you are allergic to icatibant or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Icatibant Aguettant:

• if you suffer from angina (reduced blood flow to the heart muscle)
• if you have recently had a stroke

Some of the side effects associated with Icatibant Aguettant are similar to the symptoms of the disease you have. Immediately inform your doctor if you notice that your attack symptoms worsen after administration of Icatibant Aguettant.
In addition:

• You or the person caring for you must have been trained in the subcutaneous injection technique (under the skin) before self-administering or administering Icatibant Aguettant.
• Immediately after self-administering Icatibant Aguettant or after administration by the person caring for you during a laryngeal attack (obstruction of the upper airways), you must seek medical assistance at a healthcare facility.
• If your symptoms have not resolved after self-administering or after having received an injection of Icatibant Aguettant, consult a doctor for additional injections of Icatibant Aguettant. For adult patients, up to 2 additional injections may be administered within 24 hours.

Children and adolescents
The use of Icatibant Aguettant is not recommended in children under 2 years of age or weighing less than 12 kg, as it has not been studied in these patients.
Other medicines and Icatibant Aguettant
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
No interactions of Icatibant Aguettant with other medicines are known. If you are taking a medicine known as an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example, captopril, enalapril, ramipril, quinapril, lisinopril), used to lower blood pressure or for other reasons, inform your doctor before taking Icatibant Aguettant.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before starting to take this medicine.
If you are breastfeeding, you must not breastfeed for 12 hours following the last administration of Icatibant Aguettant.
Driving and using machines
Do not drive or operate machinery if you feel tired or dizzy after an HAE attack or after administration of Icatibant Aguettant.
Icatibant Aguettant contains sodium
This medicine contains less than 1 mmol (23 milligrams) of sodium per pre-filled syringe, i.e. essentially ‘sodium-free’.

3. How to use Icatibant Aguettant

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
If you have never received Icatibant Aguettant before, the first dose of Icatibant Aguettant will be administered by your doctor or a nurse. Your doctor will advise when it is safe to return home. After discussing with your doctor or nurse and receiving training in the subcutaneous injection technique (under the skin), you may self-administer Icatibant Aguettant during an HAE attack, or a caregiver may administer it to you. It is important that Icatibant Aguettant is injected subcutaneously (under the skin) at the first sign of an angioedema attack. The healthcare professional managing your care will teach you and your caregiver how to safely inject Icatibant Aguettant according to the instructions in the package leaflet.

When and how often should Icatibant Aguettant be used?
Your doctor will determine the exact dose and frequency of use of Icatibant Aguettant.

Adults

• The recommended dose of Icatibant Aguettant is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) at the first sign of an angioedema attack (e.g., increasing swelling of the skin, especially on the face and neck, or increasing abdominal pain).
• If you do not experience symptom relief within 6 hours, contact your doctor for additional Icatibant Aguettant injections. In adults, up to 2 additional injections may be administered within 24 hours.
• Do not administer more than 3 injections within a 24-hour period, and if more than 8 injections are required in a month, consult your doctor.

Children and adolescents aged 2–17 years

• The recommended dose of Icatibant Aguettant is one subcutaneous injection (under the skin) of 1 ml up to a maximum of 3 ml, depending on body weight, at the first sign of an angioedema attack (e.g., increasing skin swelling, especially on the face and neck, or increasing abdominal pain).
• For the specific dose to be injected, refer to the instructions for use section.
• If you are unsure about which dose to administer, consult your doctor, pharmacist, or nurse.
• If your symptoms worsen or you experience no relief, seek immediate medical assistance.

How should Icatibant Aguettant be administered?
Icatibant Aguettant is intended for subcutaneous injection (under the skin). Each syringe must be used only once.

Icatibant Aguettant should be injected with a short needle into the fatty tissue beneath the skin of the abdomen (stomach).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

Step-by-step instructions are provided for:

• Self-administration (adults)
• Administration to adults, adolescents, or children aged over 2 years (with a minimum body weight of 12 kg) by a caregiver or healthcare professional.

The instructions include the following main steps:

1. General information
   2a) Preparation of the syringe for children and adolescents (aged 2–17 years) weighing ≤65 kg
   2b) Preparation of the syringe and needle for injection (all patients)
2. Preparation of the injection site
3. Injection of the solution
4. Disposal of the injection kit

Step-by-step injection instructions

1) General information

• Before starting, clean the work area (surface) to be used.
• Wash your hands with soap and water.
• Open the tray by removing the seal.
• Remove the pre-filled syringe from the tray.
• Unscrew and remove the cap from the end of the pre-filled syringe.
• After removing the cap, place the syringe on a flat surface.

2a) Preparation of the syringe for children and adolescents (aged 2–17 years) weighing ≤65 kg

Important information for healthcare professionals and caregivers:
When the dose is less than 30 mg (3 ml), the following materials are required to withdraw the appropriate dose (see below):

a) Pre-filled Icatibant Aguettant syringe (containing icatibant solution)
b) Connector (adaptor)
c) Graduated 3 ml syringe

The required volume in ml must be withdrawn into an empty graduated 3 ml syringe (see table below).
Table 1: Dosing regimen for children and adolescents
Body weight Dose (Injection volume)
12–25 kg 10 mg (1.0 ml)
26–40 kg 15 mg (1.5 ml)
41–50 kg 20 mg (2.0 ml)
51–65 kg 25 mg (2.5 ml)
Patients weighing over 65 kg will use the entire contents of the pre-filled syringe (3 ml).

If you are unsure about the volume of solution to withdraw, consult your doctor, pharmacist, or nurse.

1. Remove the caps from both ends of the connector.

Avoid touching the ends of the connector or the tips of the syringes 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 both connections are securely fastened.

Transferring the icatibant solution to the graduated syringe:

1. To begin transferring the icatibant solution, push the plunger of the pre-filled syringe down (far left in the figure below).

2. If the icatibant solution does not transfer into the graduated syringe, gently pull the plunger of the graduated syringe until the solution begins to flow into it (see figure below).

3. Continue pushing the plunger of the pre-filled syringe until the required injection volume (dose) has been transferred into the graduated syringe. For dosing information, refer to Table 1.
   If air is present in the graduated syringe:

• Invert the connected syringes so that the pre-filled syringe is on top (see figure below).

• Push the plunger of the graduated syringe to transfer the air back into the pre-filled syringe (this step may need to be repeated several times).
• Withdraw the required volume of icatibant solution.

4. Detach the pre-filled syringe and connector from the graduated syringe.
5. Dispose of the pre-filled syringe and connector in a sharps container.

2b) Preparation of the syringe and needle for injection:
All patients (adults, adolescents, and children)

• Remove the needle cap from its blister pack.
• Peel off the foil from the cap (the needle should remain in the cap).

• Hold the syringe firmly. Carefully attach the needle to the pre-filled syringe containing the clear solution.
• Screw the pre-filled syringe onto the needle while the needle is still in the cap.
• Remove the needle from the cap by pulling the syringe, without pulling the plunger.
• The syringe is now ready for injection.

3) Preparation of the injection site

• Choose the injection site, which should be a skin fold on the abdomen approximately 5–10 cm to the right or left of the navel. The area should be at least 5 cm away from any scars. Do not select an area that is bruised, swollen, or tender.
• Clean the injection site by wiping with an alcohol-soaked cotton swab and allow to dry.

4) Injection of the solution

• Hold the syringe between two fingers of one hand, with your thumb on the plunger.
• Ensure there are no air bubbles in the syringe by pushing the plunger until the first drop appears at the needle tip.

• Hold the syringe at a 45–90 degree angle to the skin, with the needle pointing toward the injection site.
• While holding the syringe in one hand, use the other hand to gently pinch a skin fold between your thumb and fingers at the previously disinfected injection site.
• While maintaining the skin fold, bring the syringe close and quickly insert the needle into the skin fold.
• Slowly and steadily push the syringe plunger until all the liquid is injected and the syringe is empty.
• Push slowly: the injection should take about 30 seconds.
• Release the skin fold and gently withdraw the needle.

5) Disposal of the injection kit

• Dispose of the syringe, needle, and its cap in a designated sharps container intended for the disposal of waste that could injure others if not handled properly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Almost all patients treated with Icatibant Aguettant experience a reaction at the injection site (such as skin irritation, swelling, pain, itching, redness, and burning sensation). These effects are usually mild in intensity and resolve spontaneously without the need for further treatment.

Very common (may affect more than 1 in 10 people):
Additional reactions at the injection site (feeling of pressure, bruising, loss of sensitivity and/or numbness, itchy and swollen skin rash, warmth).

Common (may affect up to 1 in 10 people):
Feeling unwell
Headache
Dizziness
Fever
Itching
Skin rashes
Skin redness
Abnormal liver function tests

Not known (frequency cannot be estimated from the available data):
Urticaria

Contact your doctor immediately if you notice that symptoms of the attack worsen after administration of Icatibant Aguettant.

If you experience any side effect, including those not listed in this leaflet, talk to your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Icatibant Aguettant

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.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are obvious signs of deterioration, for example if the solution is cloudy, contains floating particles, or if the colour of the solution has changed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Icatibant Aguettant contains

• The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate).
• The excipients are sodium chloride, glacial acetic acid, sodium hydroxide (for pH adjustment), and water for injections.

Description of the appearance of Icatibant Aguettant and contents of the pack
Icatibant Aguettant is a clear, colourless injectable solution in a 3 ml glass pre-filled syringe.
A hypodermic needle is included in the pack.
Icatibant Aguettant is available in a single pack containing one pre-filled syringe and one needle, or in a multiple pack containing three pre-filled syringes and three needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France
Wessling Hungary Kft.
Anonymus Utca. 6,
1045 Budapest,
Hungary
Wessling GmbH
Johann-Krane-Weg 42,
48149 Münster,
Germany

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco)