This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use ICATIBANT ACCORD 30 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Icatibant Accord 30 mg solution for injection in pre-filled syringe EFG

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.

Contents of the pack

What is Icatibant Accord and what is it used for
What you need to know before you use Icatibant Accord
How to use Icatibant Accord
Possible side effects
Storing Icatibant Accord
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 to treat the symptoms of hereditary angioedema (HAE) in adults, adolescents and children over 2 years of age.

In HAE, the levels of a substance in the blood called bradykinin increase, producing symptoms such as swelling, pain, nausea and diarrhea.

Icatibant Accord blocks the action of bradykinin and thus slows down the progression of the symptoms of an HAE attack.

2. What you need to know before you use Icatibant Accord

Do not use Icatibant Accord

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 you start using Icatibant Accord:

If you have coronary heart disease (reduced blood flow to the heart).
If you have recently had a stroke.

The side effects related to Icatibant Accord are similar to the symptoms of your own illness. Consult your doctor immediately if you notice that the symptoms of the attack worsen after you have been given Icatibant Accord.

Also:

You or your caregiver must learn the technique of subcutaneous injections (under the skin) before you self-administer or your caregiver administers Icatibant Accord to you.
Immediately after you self-administer Icatibant Accord or your caregiver administers it to you while you are experiencing a laryngeal attack (obstruction of the upper airway), you should seek medical attention at a medical institution.
If your symptoms do not resolve after a self-administered injection of Icatibant Accord or after an injection administered by your caregiver, you should consult your doctor about the administration of additional injections of Icatibant Accord. In adult patients, up to 2 additional injections can be administered within 24 hours.

Children and adolescents

Icatibant Accord 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 Accord

Tell your doctor if you are taking, have recently taken or might take any other medicines.

No interactions of Icatibant Accord with other medicines are known. If you are taking any medicine that is an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. captopril, enalapril, ramipril, quinapril, lisinopril) to lower blood pressure or for any other reason, inform your doctor before using Icatibant Accord.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using Icatibant Accord.

If you are breastfeeding, you should not breastfeed your child during the 12 hours following the last administration of Icatibant Accord.

Driving and using machines

Do not drive or use machines if you feel tired or dizzy as a result of the HAE attack or after using Icatibant Accord.

Icatibant Accord contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per syringe; this is essentially “sodium-free”.

3. How to use Icatibant Accord

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor again.

If you have never been administered Icatibant Accord before, the first dose should always be injected by medical or nursing staff. Your doctor will discharge you when they consider it safe for you to go home. After discussing it with your doctor or nurse and learning the technique for subcutaneous injections (under the skin), you or your caregiver can administer Icatibant Accord to you if you have an HAE attack. It is important to inject Icatibant Accord subcutaneously (under the skin) as soon as you notice an angioedema attack. Healthcare staff will teach you and your caregiver how to safely inject Icatibant Accord, following the instructions in the package leaflet.

When and how often should you use Icatibant Accord

Your doctor has determined the exact dose of Icatibant Accord and will tell you how often to use it.

Adults

The recommended dose of Icatibant Accord is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice the angioedema attack (e.g. with increased skin swelling, especially on the face and neck, or increased abdominal pain).

If you do not notice an improvement in symptoms after six hours, you should seek medical advice about the administration of additional injections of Icatibant Accord. In adults, up to 2 additional injections can be administered within 24 hours.

You should not receive more than 3 injections in a 24-hour period and if you need more than 8 injections in a month, you should seek medical advice.

Children and adolescents from 2 to 17 years

The recommended dose of Icatibant Accord is an injection of 1 ml up to a maximum of 3 ml based on body weight, administered subcutaneously (under the skin) as soon as symptoms of an angioedema attack appear (e.g. increased skin swelling, especially on the face and neck, or increased abdominal pain).

See the section on instructions for use to find out what dose you should inject.

If you are unsure about the dose to inject, consult your doctor, pharmacist or nurse.
If your symptoms worsen or do not improve, you should seek medical advice immediately.

How to administer Icatibant Accord

Icatibant Accord is administered by subcutaneous injection (under the skin). Each syringe should only be used once.

Icatibant Accord is injected with a short needle into the fatty tissue under the skin of the abdomen (belly). 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 for adults, adolescents or children over 2 years (weighing at least 12 kg).

The instructions include the following main steps:

Text with numbering indicating preparation and injection steps for a solution for children and adolescents

Step-by-step instructions for injection

1) General information

Clean the work area (surface) before starting the process.

Wash your hands with water and soap

Open the tray by removing the seal

Remove the pre-filled syringe from the tray

Unscrew and remove the cap from the end of the pre-filled syringe

Leave the pre-filled syringe once the cap is unscrewed

2a) Preparation of the syringe for children and adolescents (2-17 years)

weighing 65 kg or less:

Important information for healthcare professionals and caregivers:

When the dose is less than 30 mg (3 ml), the following equipment is needed to extract the correct dose (see information below):

Pre-filled syringe of Icatibant Accord (with icatibant solution)

Connector (adapter)

3 ml graduated syringe

Pre-filled syringe with medication showing retracted piston and connected needle with diagram of connection to safety device

The required injection volume in ml should be prepared in an empty 3 ml graduated syringe (see table below).

Table 1: Dosage guideline for children and adolescents

Table with dose according to body weight and injection volume for ranges of 12 to 65 kg with 1 ml increments

Patient 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

Unscrew the caps at each end of the connector.

Avoid touching the ends of the connector and the tips of the syringes to prevent contamination

Screw the connector onto the pre-filled syringe.

Attach the graduated syringe to the other end of the connector, making sure both connections fit securely.

Needle with retracted safety shield showing plunger and transparent cylinder with measurement marks

Transfer the icatibant solution to the graduated syringe:

To start the transfer of the icatibant solution, push the plunger of the pre-filled syringe (on the left end of the image below).

Transparent syringe with plunger and two black rings, arrows pointing to and from the needle

If the icatibant solution does not start to transfer to the graduated syringe, gently pull the plunger of the graduated syringe until the icatibant solution starts to flow into the graduated syringe (see image below).

Transparent syringe with retracted plunger showing graduated scale and two black rings on the cylinder, arrow indicates direction

Continue pushing the plunger of the pre-filled syringe until the required injection volume (dose) is transferred to the graduated syringe. Refer to Table 1 for dosing information.

If there is air in the graduated syringe:

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

Pre-filled syringe with dark liquid and numerical measurement scale, arrows indicate direction of plunger movement

Push the plunger of the graduated syringe to transfer the air back to the pre-filled syringe (this step may need to be repeated several times).

Extract the required volume of icatibant solution.

Remove the pre-filled syringe and connector from the graduated syringe.

Discard the pre-filled syringe and connector in the sharps container.

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

Two hands holding a device with a needle and a gray circular button

Remove the needle cap from the blister pack

Remove the seal from the needle cap (the needle should remain inside the cap)

Hands holding syringe with needle and inserting it into the skin, arrow indicates direction of insertion

Hold the syringe firmly. Carefully attach the needle to the pre-filled syringe with the colorless solution.

Screw the pre-filled syringe onto the needle, still fixed in the cap

Pull the syringe to remove the needle from the cap. Do not pull the plunger.

The syringe is now ready to administer the injection

Preparation of the injection site

Hand holding a device applying pressure to the skin of the arm within a red circle

Choose the injection site. The injection site should be a fold in the abdomen, approximately 5-10 cm (2-4 inches) below the navel, to one side or the other. The area should be at least 5 cm (2 inches) away from any scar. Do not choose an area with bruises, inflammation or pain.

Clean the injection site by rubbing it with an alcohol swab and let it dry.

Injection of the solution

Syringe with needle pointing upwards and hand holding it with a white stabilizer device, arrow indicates direction

Hold the syringe between two fingers, with your thumb on the end of the plunger

Check that there is no air in the syringe by pressing the plunger until the first drop appears at the tip of the needle

Hand holding syringe with needle inserted into the skin of the arm, orange circle indicating injection area

Hold the syringe with the needle pointing to the skin at an angle of 45 to 90 degrees

Holding the syringe in one hand, gently take a skin fold between your thumb and fingers in the previously cleaned area

Holding the skin fold, bring the syringe close and quickly insert the needle into the fold

Slowly press the plunger with a firm pulse, until all the fluid has been injected into the skin and no liquid remains in the syringe

Press slowly, so that the process takes approximately 30 seconds

Release the skin fold and gently withdraw the needle

Disposal of injection materials

Syringe with needle inserted into a vial stopper, arrow indicating direction of injection and orange circle highlighting the area

Discard the syringe, needle and its cap in the sharps container intended for disposal of waste that can harm 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 who receive Icatibant Accord notice a reaction at the injection site (such as skin irritation, inflammation, pain, itching, redness of the skin and burning). These effects are usually mild and improve without the need for any additional treatment.

Very common (may affect more than 1 in 10 people):

Additional reactions at the injection site (feeling of pressure, bruising, decreased sensitivity and/or numbness, increased rash with itching and heat).

Common (may affect up to 1 in 10 people):

Nausea

Headache

Dizziness

Fever

Itching

Rash

Redness of the skin

Abnormal liver function tests

Frequency not known (cannot be estimated from the available data):

Hives (urticaria)

Tell your doctor immediately if you notice that the symptoms of the attack worsen after you have received Icatibant Accord.

If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special temperature storage conditions. Do not freeze.

Do not use this medicine if you notice that the syringe or needle packaging is damaged or if you notice visible signs of deterioration; for example, if the solution is cloudy, if it contains floating particles or if the color of the solution has changed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Icatibant Accord

The active ingredient is icatibant. Each 3 ml pre-filled syringe contains icatibant acetate equivalent to 30 milligrams of icatibant. Each ml of solution contains 10 mg of icatibant. The other components are sodium chloride, glacial acetic acid, sodium hydroxide, and water for injectable preparations.

Appearance of Icatibant Accord and Packaging Contents

Icatibant Accord is presented as a clear and colorless solution, practically free of foreign particles, in a 3 ml pre-filled glass syringe. The packaging contains a hypodermic needle.

Icatibant Accord is available in a single pack of one pre-filled syringe with one needle or three pre-filled syringes with three needles.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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.z.o.o.

ul. Lutomierska 50,

95-200, Pabianice,

Poland

Accord Healthcare B.V.

Winthontlaan 200, 3526KV Utrecht

Netherlands

Date of last revision of this leaflet: {MM/AAAA}.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

ICATIBANT ACCORD 30 mg Injectable Solution in Pre-filled Syringe