Icatibant 30 mg solution for injection in pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Talk to your doctor before taking Icatibant:

• if you are suffering from angina (reduced blood flow to the heart muscle)
• if you have recently suffered a stroke

Some of the side effects connected with Icatibant 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 this medicine.

In addition:

• You or your caregiver must be trained on subcutaneous (under the skin) injection technique before you self-inject or your caregiver injects you with this medicine.
• Immediately after you self-inject Icatibant or your caregiver injects you with this medicine while you are experiencing a laryngeal attack (obstruction of the upper airway), you must seek medical care in a medical institution.
• If your symptoms are not resolved following one self- or caregiver administered injection of Icatibant, ask your doctor regarding additional injections of this medicine. For adult patients, up to 2 additional injections may be given within 24 hours.

This medicine 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 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, ask your doctor before receiving this medicine.

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 this medicine.

If you are breast-feeding do not breast-feed for 12 hours after you have last received this medicine.

Do not drive or use machines if you feel tired or dizzy as a result of your HAE attack or after using this medicine.

The injection solution contains less than 1 mmol (23 mg) of sodium, so it is essentially ‘sodium-free’.

Your doctor has determined the exact dose of this medicine and will tell you how often it should be used.

Adults

• The recommended dose of Icatibant is one injection (3 ml, 30 mg) injected subcutaneously (under the skin) as soon as you notice the attack of angioedema (for example increased skin swelling, particularly affecting the face and neck, or increasing tummy pain).
• If you experience no relief of symptoms after 6 hours, ask your doctor regarding additional injections of Icatibant. For adults, up to 2 additional injections may be given within 24 hours.
• Do have more than 3 injections in a 24-hour period and if you require more than 8 injections in a month, talk to your doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant is one injection of 1 ml up to a maximum of 3 ml based on body weight injected subcutaneously (under the skin) as soon as you develop symptoms of an angioedema attack (for example increased skin swelling, particularly affecting the face and neck, increasing tummy pain).
• See section on instructions for use for the dose to inject.
• If you are not sure which dose to inject, ask your doctor, pharmacist or nurse.
• If your symptoms get worse or do not improve, you must immediately seek medical help.

Icatibant is intended for subcutaneous injection (under the skin). Use each syringe only once.

This medicine 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 following step-by step instructions are intended for:

• self-administration (adults)
• administration by a caregiver or healthcare professional to adults, adolescents or children aged over 2 years (weighing at least 12 kg).

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

Step-by-Step Instructions for Injection

1) General information

• Clean the work area (surface) to be used before beginning the process.
• Wash your hands with soap and water.
• Remove the pre-filled syringe from the carton.
• Remove the cap from the end of the pre-filled syringe by unscrewing the cap.
• Put down the pre-filled syringe after unscrewing the cap.

2a) Preparing the syringe for children and adolescents (2-17years) 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 pre-filled syringe (containing icatibant solution)

b) Connector (adapter)

c) 3 ml graduated syringe

The required injection volume in ml should be drawn up in an empty 3 ml graduated syringe (see table 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 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:

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

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

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)

• Remove the needle cap from the blister.
• Remove the seal from the needle cap (the needle should be still in the needle cap).

• Grip the syringe firmly. Carefully attach the needle to the syringe containing the colourless solution.
• Screw the syringe on the needle still fixed in the needle cap.
• Remove the needle from the needle cap by pulling the syringe. Do not pull up on the plunger.
• The syringe is now ready for injection.

3) Preparing the injection site

• Choose the injection site. The injection site should be a skin fold on your abdomen approximately 5-10 cm (2-4 inches) below your navel on either side. This area should be at least 5 cm (2 inches) away from any scars. Do not choose an area that is bruised, swollen, or painful.
• Clean the injection site with a rubbing alcohol pad and allow it to dry.

4) Injecting the solution

• Hold the syringe in one hand between two fingers with your thumb at the bottom of the plunger.
• Make sure that there is no air bubble in the syringe by pressing the plunger until the first drop appears on the tip of the needle.

• Hold the syringe between 45-90 degrees angle to the skin with needle facing the skin.
• Keeping the syringe in one hand, use your other hand to gently hold a fold of skin between your thumb and fingers at the previously disinfected injection site.
• Hold the fold of skin, bring the syringe to the skin and quickly insert the needle into the skin fold.
• Slowly push the plunger of the syringe with a steady hand until all the fluid is injected into the skin and no liquid remains in the syringe.
• Press slowly so that this takes approximately 30 seconds.
• Release the skin fold and gently pull the needle out.

5) Disposal of the injection material

• Discard the syringe, needle and needle cap into the sharps container for throwing away waste that might hurt others if not handled properly

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 via the Yellow Card Scheme at www.mhra.gov.co.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.

• The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). Each mL of the solution contains 10 mg of icatibant.
• The other ingredients are: sodium chloride, acetic acid glacial (for ph adjustment), sodium hydroxide (for ph adjustment) and water (see section 2).

Icatibant is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml. A hypodermic needle is included in the pack.

Icatibant is available as a single pack containing one pre-filled syringe with one needle or as a multipack containing three pre-filled syringes with three needles.

Not all pack sizes may be marketed.

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