ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

1. what icatibant 30 mg is and what it is used for

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.

2. what you need to know before you use icatibant 30 mg

Do not use Icatibant 30 mg

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

Warnings and precautions

Talk to your doctor before taking Icatibant 30 mg:

• – 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 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:

• – You or your caregiver must be trained on subcutaneous (under the skin) injection technique before you self-inject or your caregiver injects you with Icatibant 30 mg.

• – Immediately after you self-inject Icatibant 30 mg or your caregiver injects you with Icatibant 30 mg 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 30 mg, you should seek medical advice regarding additional injections of Icatibant 30 mg. For adult patients, up to 2 additional injections may be given within 24 hours.

Children and adolescents

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.

Other medicines and Icatibant 30 mg

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

Icatibant 30 mg contains sodium

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

3. how to use icatibant 30 mg

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.

to 2 additional injections may be given within 24 hours.

• – You should not have more than 3 injections in a 24 hour period and if you require more than 8 injections in a month, you should seek medical advice.

Children and adolescents aged 2 to 17 years

• – The recommended dose of Icatibant 30 mg 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 seek immediate medical help.

How should Icatibant 30 mg be administered?

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 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 tray.
• 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. Do not allow the exposed tip of the syringe to touch any surfaces.

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

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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

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 prefilled 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.

• 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).

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• 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 capped needle from the blister. Do not remove the needle from the cap.
• Remove the seal from the needle cap (Leave the needle in the needle cap).
• Grip the syringe firmly. With the needle still inside the cap, carefully attach the needle to the syringe containing the colourless solution.
• Screw the syringe onto the needle while it is still inside in the needle cap. The capped needle is now attached to the syringe.
• Hold the barrel of the syringe and remove the cap from the needle 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 vertically 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.

• 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.

4. possible side effects

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) :

• Feeling sick
• Headache
• Dizziness
• Fever
• Itching Rash
• Skin redness
• Abnormal liver function test

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

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.

Reporting of side effects

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 Yellow Card Scheme at: www.m hra.gov.u k/ye 11 owca rd 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.

5. how to store icatibant 30 mg

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.

6. contents of the pack and other information

What Icatibant 30 mg contains

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.

What Icatibant 30 mg looks like and contents of the pack

Icatibant 30 mg is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml. As 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 multipack containing three pre-filled syringes with three needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Universal Farma, S.L.

c/ Dulcinea, s/n

28805 Alcala de Henares, Madrid

(Spain)

This leaflet was last revised in July 2021.

When and how often should you use Icatibant 30 mg?

Your doctor has determined the exact dose of Icatibant 30 mg and will tell you how often it should be used.

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).

Adults

• – The recommended dose of Icatibant 30 mg 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).

  Hold the syringe between 45–90 degrees angle to skin with the needle facing the skin.

  
  

• – If you experience no relief of symptoms after 6 hours, you should seek medical advice regarding additional injections of Icatibant. For adults, up