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 Injection is and what it is used for
2. What you need to know before you use Icatibant Injection
3. How to use Icatibant Injection
4. Possible side effects
5. How to store Icatibant Injection
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 using Icatibant Injection:

• 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 Injection 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 Injection, 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 Injection 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 per dose, 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.

• The recommended dose of Icatibant Injection 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 after6 hours, ask your doctor regarding additional injections of Icatibant Injection. For adults, up to 2 additional injections may be given within 24 hours.
• Do not 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.

• The recommended dose of Icatibant Injection 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 Injection 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).

• 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) Preparing the pre-filled syringe
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

1) Preparing the pre-filled syringe

• 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.
• Next steps for children and adolescents, see 2a below. For adults, see 2b.

2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less:

• Diagrams showing the pre-filled syringe, the connector, and the empty graduated syringe
• Diagram 1 shows how the pre-filled syringe, the connector and the empty graduated syringe are connected
• Diagrams 2 and 3 shows how solution is transferred from the pre-filled syringe to the graduated syringe
• Diagram 4 shows how to remove air from the now filled graduated syringe

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

• Diagrams show how the needle is attached to the syringe

3) Preparing the injection site

• Diagram shows how to prepare the injection site

4) Injecting the solution

• Diagrams show how to inject icatibant

5) Disposal of the injection material

• Diagram shows how to dispose of the now empty syringe and needle

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.mhra.gov.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 Injection 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 Injection 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.

If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact [email protected].