ICATIBANT 30 mg Roztwór Do Wstrzykiwań

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1. Icatibant Accord 30 mg injectable solution in pre-filled syringe
   1. What is Icatibant Accord and what is it 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. Package Contents and Other Information

Icatibant Accord 30 mg injectable solution in pre-filled syringe

icatibant

Read this leaflet carefully before you start using this medicine as 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Icatibant Accord and what is it 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 starting from 2 years of age.
In HAE, the levels in the blood of a substance called bradykinin increase, which causes
symptoms such as swelling, pain, nausea and diarrhoea.
Icatibant Accord blocks the activity of bradykinin and therefore stops the progression of
symptoms of 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 had a recent stroke

in case some of the undesirable effects associated with Icatibant Accord are similar to the symptoms of the condition you have. Immediately inform your doctor if you find that the symptoms of the attack worsen after administration of Icatibant Accord.
Also:

• You or the person who cares for you must have been trained in the subcutaneous (under the skin) injection technique before self-administering/administering Icatibant Accord.
• Immediately after self-administration of Icatibant Accord or administration of Icatibant Accord by the person who cares for you during a laryngeal attack (upper airway obstruction), you must seek medical assistance at a healthcare facility.
• If your symptoms have not resolved after self-administration or after you have been given an injection of Icatibant Accord, consult a doctor to receive additional injections of Icatibant Accord. For adult patients, a maximum of 2 additional injections may be given 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 because it has not been studied in these patients.

Other medicines and Icatibant Accord
Tell 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), which is used to lower blood pressure or for other reasons, tell your doctor before taking Icatibant Accord.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking Icatibant Accord.
If you are breastfeeding, you must not breastfeed for 12 hours after the last administration of Icatibant Accord.

Driving and using machines
Do not drive or use machines 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 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to use Icatibant Accord

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor.
If you have never received Icatibant Accord before, the first dose of Icatibant Accord will be
injected by the doctor or a nurse. The doctor will advise when it is possible to return home.
After discussing with the doctor or nurse and being trained in the subcutaneous injection technique (under the skin), during an attack of HAE you can self-administer, or the person who
cares for you can administer, Icatibant Accord. It is important that Icatibant Accord is
injected subcutaneously (under the skin) at the first sign of an angioedema attack.
The healthcare professional who follows you will teach you and the person assisting you how to inject

When and how often to use Icatibant Accord?
The doctor has established the exact dose of Icatibant Accord and will indicate how often to use it.

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 (for example, increased swelling of the skin, especially on the face and neck, or increasing abdominal pain).
• If you do not feel an improvement in symptoms after 6 hours, consult a doctor to receive additional injections of Icatibant Accord. For adults, a maximum of 2 additional injections can be administered within 24 hours.
• Do not administer more than 3 injections in a 24-hour period and, if more than 8injections are needed in a month, consult a doctor.Children and adolescents in the age group 2-17 years
• The recommended dose of Icatibant Accord 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 (for example, increased swelling of the skin, especially on the face and neck, increasing abdominal pain).
• For the specific dose to inject, see the instructions for use section.
• If you are not sure which dose to inject, consult your doctor, pharmacist or nurse.
• If your symptoms worsen or you do not experience any relief, seek immediate medical attention.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 doubts about the use of this medicine, consult your doctor or pharmacist.

The following are step-by-step instructions for:

• self-administration (adults)
• administration to adults, adolescents or children over 2 years of age (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) Preparing the syringe for children and adolescents (ages 2-17 years) weighing less than or
equal to 65 kg
2b) Preparing the syringe and needle for injection (all patients)

• 3) Preparing the injection site
• 4) Injecting the solution
• 5) Disposing of the injection kit

Step-by-step injection instructions

• 1) General information
• Before starting the process, clean the work (surface) area to be used.
• Wash your hands with soap and water.
• Open the tray by detaching the seal.
• Remove the pre-filled syringe from the tray.
• By unscrewing, 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) Preparing the syringe for
children and adolescents (ages 2-17 years)
weighing less than or equal to 65 kg
Important information for healthcare professionals and caregivers
When the dose is less than 30 mg (3 ml), the following materials are needed to extract the appropriate dose (see below):
a) Pre-filled syringe of Icatibant Accord (containing the icatibant solution)
b) Connector (adapter)
c) 3 ml graduated syringe

The volume in ml needed for the injection must be drawn into an empty 3 ml graduated syringe
(see table below).

Table 1: Dosage regimen for children and adolescents
Body weightInjection 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 kgwill use the entire contents of the pre-filled syringe (3 ml).

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

• 1) Remove the screw caps from both ends of the connector.

Avoid touching the ends of the connector and 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, making sure both connections are securely fastened.

Transfer the icatibant solution into the graduated syringe:

• 1) To start transferring the icatibant solution, lower the plunger of the pre-filled syringe (all the way to the 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 icatibant solution begins to flow into it (see figure below).

• 3) Continue to lower the plunger of the pre-filled syringe until you transfer the necessary injection volume (dose) into the graduated syringe. For dosage information see table
• 1.

If there is air in the graduated syringe:

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

• Lower the plunger of the graduated syringe so that the air is re-transferred into the pre-filled syringe (this step may need to be repeated several times).
• Draw the necessary volume of icatibant solution.
• 4) Detach the pre-filled syringe and the connector from the graduated syringe.
• 5) Dispose of the pre-filled syringe and the connector in a sharps container.

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

• Remove the cap containing the needle from the blister pack.
• Remove the film from the cap (the needle must still be 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 but do not pull the plunger.
• The syringe is now ready for injection.

• 3) Preparing the injection site

• Choose the injection site, which should be a skin fold on the abdomen about 5-10 cm located to the right or left below the navel. The area should be at least 5 cm away from any scars. Do not choose an area that is bruised, swollen or painful.
• Clean the injection site by rubbing it with a cotton ball soaked in alcohol and let it dry.
• 4) Injecting the solution

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

• Hold the syringe at an angle of 45-90 degrees to the skin, with the needle pointing towards the injection site.
• Holding the syringe in one hand, use the other hand to gently hold a skin fold between your thumb and fingers at the previously disinfected injection site.
• Keeping the skin fold, bring the syringe closer and quickly insert the needle into the fold.
• Slowly push the plunger of the syringe with a steady hand 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 remove the needle.

• 5) Disposing of the injection kit

• Dispose of the syringe, needle and its cap in the appropriate container for 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 Accord have a reaction at the injection site (such as skin irritation, swelling, pain, itching, redness and a burning sensation). The reaction may include a burning sensation, skin redness, pain, swelling, a feeling of warmth, itching and skin irritation. These effects are usually mild and resolve on their own without the need for further treatment.
Very common (may affect more than 1 in 10 people):
Further reactions at the injection site (feeling of compression, bruising, loss of sensation and/or numbness, raised, itchy rash and 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 available data):
Hives
Tell your doctor immediately if you notice that the symptoms of the attack worsen after administration of Icatibant Accord.
If any side effects occur, including any not listed in this leaflet, tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 particular storage temperature. 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, if it contains
floating particles or if the colour of the solution has changed.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Icatibant Accord contains
The active ingredient 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 and colourless injectable solution, practically free from foreign
particles in a 3 ml glass pre-filled syringe.
A hypodermic needle is included in the pack.
Icatibant Accord is available in a single pack, containing one pre-filled syringe and one needle, or
three pre-filled syringes and three needles.
Not all pack sizes may be 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.zo.o.
ul. Lutomierska 50,
95-200 Pabianice
Poland
Or
Accord Healthcare B.V.
Winthontlaan 200, 3526KV Utrecht
Netherlands
Further detailed information on this medicinal product is available on the European Medicines Agency website, http://www.ema.europa.eu. Additionally, links to other websites on rare diseases and
related therapeutic treatments are provided.