Icatibant Accord

Package leaflet: Information for the user

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

icatibant
Please read all of this leaflet carefully before you use 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 pass it on to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Icatibant Accord contains the active substance icatibant.
Icatibant Accord is used for the treatment of symptoms of hereditary angioedema (HAE) in adults, adolescents, and children from the age of 2 years.
In HAE, blood levels of a substance called bradykinin increase, causing symptoms such as swelling, pain, nausea, and diarrhoea.
Icatibant Accord 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 Accord

Do not use Icatibant Accord 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 Accord:

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

in case some of the side effects associated with Icatibant Accord are similar to the symptoms of the
disease you are suffering from. Immediately inform your doctor if you notice that your attack symptoms
worsen after administration of Icatibant Accord.
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 Accord.
• Immediately after self-administering Icatibant Accord or after it has been administered 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 Accord, consult a doctor to receive additional injections of Icatibant Accord. For adult patients, up to 2 additional injections may be administered within 24 hours. Children and adolescents

The use of Icatibant Accord 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 Accord

Inform your doctor if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known for Icatibant Accord. If you are taking a medicine
known as an angiotensin-converting enzyme (ACE) inhibitor (for example, captopril, enalapril, ramipril, quinapril, lisinopril), used to lower blood pressure or for other reasons, inform your doctor before taking Icatibant Accord.
Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before starting to take Icatibant Accord.
If you are breastfeeding, you must not breastfeed for 12 hours following the last administration of Icatibant Accord.
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 Accord.
Icatibant Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 milligrams), i.e. essentially ‘sodium-free’.

3. How to use Icatibant Accord

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor.
If you have never received Icatibant Accord before, your first dose of Icatibant Accord 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
(under the skin) technique, you may self-administer Icatibant Accord during an HAE attack, or the
person caring for you may administer it to you. It is important that Icatibant Accord be injected
subcutaneously (under the skin) at the first sign of an angioedema attack.
Your healthcare provider will teach you and the person assisting you how to safely inject
Icatibant Accord following the instructions in the package leaflet.

When and how often to take Icatibant Accord?
Your doctor has determined the exact dose of Icatibant Accord and will indicate the frequency of use.

Adults

• The recommended dose of Icatibant Accord is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) at the first sign of an angioedema attack (e.g., increasing skin swelling, especially in the face and neck, or increasing abdominal pain).
• If you do not experience symptom relief within 6 hours, contact your doctor for additional Icatibant Accord injections. For 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 needed in one month, consult your doctor.

Children and adolescents aged 2–17 years

• The recommended dose of Icatibant Accord is one subcutaneous (under the skin) injection 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 in the face and neck, or increasing abdominal pain).
• For the specific dose to be injected, see the instructions for use section.
• If you are unsure which dose to inject, consult your doctor, pharmacist, or nurse.
• If your symptoms worsen or you do not get relief, seek immediate medical assistance.

How should Icatibant Accord be administered?

Icatibant Accord is intended for subcutaneous injection (under the skin). Each syringe must be
used only once.
Icatibant Accord should be injected with a short needle into the fatty tissue under 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 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 screw cap from the end of the pre-filled syringe.
• After unscrewing the screw 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 draw up the appropriate dose (see below):
a) Pre-filled syringe of Icatibant Accord (containing icatibant solution)
b) Connector (adaptor)
c) Graduated 3 ml syringe

The required injection volume in ml must be drawn into an empty graduated 3 ml syringe (see table below).
Table 1: Dosing regimen for children and adolescents
Body weight Injection volume
12–25 kg 1.0 ml
26–40 kg 1.5 ml
41–50 kg 2.0 ml
51–65 kg 2.5 ml
Patients weighing more than 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 screw 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:

1. To begin transferring the icatibant solution, push down the plunger of the pre-filled syringe (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 down the plunger of the pre-filled syringe until the required injection volume (dose) has been transferred into the graduated syringe. For dosing information, see 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 down 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 the 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 slightly 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.
• 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 holding the skin fold, bring the syringe close and quickly insert the needle into the skin fold.
• Slowly and steadily push the plunger of the syringe until all the liquid has been 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 container for sharps and other potentially infectious waste that could injure others if not properly handled.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Almost all patients treated with Icatibant Accord experience a reaction at the injection site (such as skin irritation, swelling, pain, itching, redness, and burning sensation).
The reaction may include a burning sensation, skin redness, pain, swelling, feeling of warmth, itching, and skin irritation. 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 sensation and/or numbness, itchy and swollen skin rash, and warmth).

Common (may affect up to 1 in 10 people):
Feeling unwell
Headache
Dizziness
Fever
Itching
Skin rash
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 your attack symptoms worsen after administration of Icatibant Accord.

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

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Icatibant Accord

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 label after 'Exp.'. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions. Do not freeze.
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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Icatibant Accord contains
The active substance is icatibant. Each 3 ml pre-filled syringe contains icatibant acetate equivalent to
30 mg of icatibant. Each ml of solution contains 10 mg of icatibant. The excipients are sodium
chloride, glacial acetic acid, sodium hydroxide and water for injections.
Description of the appearance of Icatibant Accord and contents of the pack
Icatibant Accord is supplied as a clear, colourless, almost particle-free injectable solution in a 3 ml glass pre-filled syringe.
A hypodermic needle is included in the pack.
Icatibant Accord is available in single packs containing one pre-filled syringe and one needle, or packs containing three pre-filled syringes and three needles.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona, Spain
Manufacturer:
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50,
95-200 Pabianice
Poland
Or
Accord Healthcare B.V.
Winthontlaan 200, 3526KV Utrecht
The Netherlands
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.