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Icatibant 30 mg Solution for Injection in pre-filled Syringe

Active Ingredient:
icatibant acetate
Company:  
Celix Pharma Ltd See contact details
ATC code: 
B06AC02
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 29 Jul 2022

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 53835/0005.

Icatibant 30 mg Solution for Injection in pre-filled Syringe

Package leaflet: Information for the user

Icatibant 30 mg Solution for Injection in pre-filled Syringe

icatibant

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
  • 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.

What is in this leaflet

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

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

This medicine contains the active substance icatibant.

Icatibant Injection 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 Injection blocks the activity of bradykinin and therefore ends the further progression of the symptoms.

2. What you need to know before you use Icatibant Injection
Do not use Icatibant Injection
  • 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 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.

Children and adolescents

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.

Other medicines and Icatibant Injection

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.

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 this medicine.

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

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 this medicine.

Icatibant Injection contains sodium

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

3. How to use Icatibant Injection

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 Injection previously, your first dose of this medicine 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 Injection or your caregiver may inject this medicine for you when you have an HAE attack.

It is important that Icatibant Injection 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 this medicine by following the instructions in the Package Leaflet.

When and how often to use Icatibant Injection?

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 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.

Children and adolescents aged 2 to 17 years
  • 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 administration

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).

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) 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

Step-by-Step Instructions for Injection

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients receiving Icatibant Injection 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.

Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received this medicine.

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)

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.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.

5. How to store Icatibant Injection

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and box after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°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 Injection contains
  • 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).

What Icatibant Injection looks like and contents of the pack

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.

Marketing Authorisation Holder
Celix Pharma Ltd
12 Constance Street
London
E16 2DQ
United Kingdom

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

Eurofins PROXY Laboratories (PRX)
Archimedesweg 25 2333 CM Leiden
The Netherlands

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

This leaflet was last revised in March 2022

Celix Pharma Ltd
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Address
12 Constance Street, International House, London, E16 2DQ, UK
Medical Information e-mail
[email protected]
Medical Information Direct Line
0800 669 6825
Telephone
0800 669 6825
Customer Care direct line
+44 (0)203 105 6525