Icatibant Universal Farma

Patient Information Leaflet: User Information

Icatibant Universal Farma, 30 mg, Solution for Injection in a Pre-filled Syringe

Icatibant

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Icatibant Universal Farma and what is it used for
• 2. Important information before using Icatibant Universal Farma
• 3. How to use Icatibant Universal Farma
• 4. Possible side effects
• 5. How to store Icatibant Universal Farma
• 6. Package contents and other information

1. What is Icatibant Universal Farma and what is it used for

Icatibant Universal Farma contains the active substance icatibant.
Icatibant Universal Farma is used to treat symptoms of hereditary angioedema (HAE) in adult patients and adolescents and children aged 2 years and older.
In HAE, there is an increase in the level of a substance in the blood called bradykinin, which leads to symptoms such as swelling, pain, nausea, and diarrhea.
Icatibant Universal Farma blocks the action of bradykinin, thereby interrupting the development of HAE attack symptoms.

2. Important information before using Icatibant Universal Farma

When not to use Icatibant Universal Farma

Warnings and precautions

Before starting to take Icatibant Universal Farma, the patient should discuss the following with their doctor:

Some of the side effects associated with Icatibant Universal Farma are similar to the symptoms of the disease.
In case of worsening symptoms after administration of Icatibant Universal Farma, the patient should immediately inform their doctor.
Additionally:

• Before self-administering Icatibant Universal Farma or before a caregiver administers Icatibant Universal Farma, the patient or caregiver should be trained in performing subcutaneous injections.
• A patient with a laryngeal attack (upper airway obstruction) who self-administers Icatibant Universal Farma or has it administered by a caregiver should seek medical help immediately.
• If after a single self-administration of Icatibant Universal Farma or a single administration by a caregiver the symptoms do not subside, the patient should consult a doctor for a subsequent injection of Icatibant Universal Farma. Adult patients should not receive more than two additional injections within 24 hours.

Children and adolescents

Icatibant Universal Farma should not be used in children under 2 years of age or weighing less than 12 kg, as it has not been studied in this age group.

Icatibant Universal Farma and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
No interactions between Icatibant Universal Farma and other medications are known. If the patient is taking an ACE inhibitor (e.g., captopril, enalapril, ramipril, quinapril, lisinopril) for the treatment of high blood pressure or for any other reason, they should inform their doctor before using Icatibant Universal Farma.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before starting to use this medication.
The patient should not breastfeed for 12 hours after taking Icatibant Universal Farma.

Driving and operating machinery

The patient should not drive or operate machinery if they experience fatigue or dizziness due to an HAE attack or after using Icatibant Universal Farma.

Icatibant Universal Farma contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, which means it is considered "sodium-free".

3. How to use Icatibant Universal Farma

This medication should always be used as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
If the patient is receiving Icatibant Universal Farma for the first time, the first dose should always be administered by a doctor or nurse. The doctor will tell the patient when they can safely go home.
After discussing with a doctor or nurse and being trained in performing subcutaneous injections, the patient can self-administer Icatibant Universal Farma or a caregiver can administer it if the patient experiences an HAE attack. It is essential to administer the subcutaneous injection of Icatibant Universal Farma as soon as possible after noticing the symptoms of an HAE attack. The attending doctor will teach the patient and their caregiver how to safely administer Icatibant Universal Farma according to the instructions in the patient information leaflet.

When and how often to use Icatibant Universal Farma

The doctor will determine the exact dose of Icatibant Universal Farma and tell the patient how often to use it.

Adults

• The recommended dose of Icatibant Universal Farma is one injection (3 mL, 30 mg) administered subcutaneously immediately after noticing symptoms of an HAE attack (e.g., severe skin swelling, especially on the face and neck, or severe abdominal pain).
• If symptoms persist after 6 hours, the patient should consult a doctor about administering a subsequent injection of Icatibant Universal Farma. Adult patients should not receive more than two additional injections within 24 hours.
• Do not take more than 3 injections within 24 hours. If the patient requires more than 8 injections per month, they should consult a doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant Universal Farma is one injection of 1 mL to a maximum of 3 mL, depending on body weight, administered subcutaneously immediately after noticing symptoms of an HAE attack (e.g., severe skin swelling, especially on the face and neck, or severe abdominal pain).
• For more information on dosing, see "Detailed injection instructions".
• If the patient is unsure about the volume of the solution to be administered, they should consult a doctor, pharmacist, or nurse.
• If symptoms worsen or do not subside, the patient should seek medical help immediately.

How to administer Icatibant Universal Farma

Icatibant Universal Farma is intended for subcutaneous administration. Each syringe should be used only once.
Icatibant Universal Farma is administered via a short needle into the subcutaneous tissue of the abdomen.
In case of further doubts about using this medication, consult a doctor or pharmacist.

Detailed injection instructions

• -Self-administration (adults)
• -Administration by a caregiver or healthcare professional to adults, adolescents, and children over 2 years of age (with a body weight of 12 kg or more).

The instructions include the following main steps:

• 1) General information 2a) Preparing the pre-filled syringe for children and adolescents (2-17 years) with a body weight of 65 kg or less 2b) Preparing the pre-filled syringe and needle for injection (all patients)
• 3) Preparing the injection site
• 4) Injecting the solution
• 5) Disposing of the injection equipment

Detailed injection instructions

• 1) General information
• Before starting, clean the surface to be used.
• Wash hands with water and soap.
• Open the packaging by tearing off the protective layer.
• Remove the pre-filled syringe from the packaging.
• Remove the cap from the tip of the pre-filled syringe by twisting it.
• After removing the cap, put the pre-filled syringe aside. Do not allow the exposed tip of the syringe to come into contact with any surface.

2a) Preparing the pre-filled syringe for children and adolescents (aged 2 to 17 years) with a body weight of 65 kg or less:

Important information for healthcare professionals and caregivers:

In case the dose is less than 30 mg (3 mL), to obtain the correct dose from the pre-filled syringe, the following will be needed:
a)
A pre-filled syringe with Icatibant Universal Farma (containing the icatibant solution)
b)
An adapter (connector)
c)
A 3 mL syringe with graduations

The required dose volume in milliliters should be drawn into an empty 3 mL syringe with graduations (see the table below).

Table 1: Administration scheme for children and adolescents

Body weight Dose 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 with a body weight of more than 65 kgshould be administered the entire contents of the pre-filled syringe (3 mL).

If the patient is unsure about the volume of the solution to be administered, they should consult a doctor, pharmacist, or nurse.

• 1) Remove the protective covers from both sides of the adapter.

Avoid touching the tip and end of the adapter and the syringe to prevent contamination.

• 2) Screw the adapter onto the pre-filled syringe.
• 3) Attach the syringe with graduations to the other end of the adapter, ensuring both ends are securely connected.

Withdrawing the icatibant solution into the syringe with graduations:

• 1) To withdraw the dose of the icatibant solution, press the plunger of the pre-filled syringe (on the left in the illustration below).

• 2) If the icatibant solution does not start flowing into the syringe with graduations, gently pull the syringe plunger until the solution starts flowing into it (see the illustration below).

• 3) Continue pressing the plunger of the pre-filled syringe until the required dose volume has flowed into the syringe with graduations. Information on dosing can be found in Table 1.

If there is air in the syringe with graduations, the following steps should be taken:

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

• Press the plunger of the syringe with graduations so that the air returns to the pre-filled syringe (this step may need to be repeated several times).
• Withdraw the required volume of the icatibant solution.
• 4) Disconnect the pre-filled syringe with the adapter from the syringe with graduations.
• 5) Place the pre-filled syringe with the adapter in a special container for sharp objects.

2b) Preparing the pre-filled syringe and needle for injection:

All patients (adults, children, and adolescents)

• Remove the needle cover from the packaging. Do not remove the needle from the cover.
• Twist the top part of the needle cover to break the seal (the needle should still be inside the cover).

• Firmly hold the pre-filled syringe. Carefully attach the needle to the pre-filled syringe containing the colorless solution.
• Screw the pre-filled syringe onto the needle still secured in the cover.
• Remove the needle from the cover by pulling on the pre-filled syringe. Do not pull on the plunger of the pre-filled syringe.
• The pre-filled syringe is now ready for injection.
• 3) Preparing the injection site

• Choose the injection site. The injection site should be a skin fold on the abdomen, about 5-10 cm below the navel, on either side. This area of skin should be at least 5 cm away from any scars. Do not choose an area of skin with bruising, swelling, or pain for injection.
• Clean the injection site by wiping it with a swab moistened with alcohol and let it dry.
• 4) Injecting the solution

• Hold the pre-filled syringe with one hand, between two fingers, with the thumb on the end of the plunger.
• Make sure there are no air bubbles in the pre-filled syringe by pressing the plunger until the first drop appears at the tip of the needle.

• Hold the pre-filled syringe at an angle of 45-90 degrees to the skin, with the needle pointing towards the skin.
• Holding the pre-filled syringe with one hand, use the other hand to gently grasp the skin fold between the thumb and fingers at the previously cleaned site.
• Hold the skin fold, bring the pre-filled syringe close to the skin, and quickly insert the needle into the skin fold.
• Slowly press the plunger of the pre-filled syringe, keeping the hand still, until the entire liquid has been injected into the skin and the pre-filled syringe is completely empty.
• Press the plunger slowly, over about 30 seconds.
• Release the skin fold and gently pull out the needle.

• 5) Disposing of the injection equipment

• Place the pre-filled syringe, needle, and needle cover in a container for sharp objects, intended for disposing of waste that can cause puncture wounds.

4. Possible side effects

Like all medications, Icatibant Universal Farma can cause side effects, although not everybody gets them.
Almost all patients treated with Icatibant Universal Farma experience a reaction at the injection site (irritation, swelling, pain, itching, redness of the skin, and a burning sensation). These reactions are usually mild and resolve without the need for additional treatment.
Very common (may affect more than 1 in 10 people):
Additional reactions at the injection site (feeling of pressure, bruising, altered sensation, and (or) numbness, itchy rash elevated above the surrounding skin, and a feeling of warmth).
Common (may affect up to 1 in 10 people):
Nausea
Headache
Dizziness
Fever
Itching
Rash
Redness of the skin
Abnormal liver function test results
Frequency not known (cannot be estimated from the available data):
Hives
The patient should immediately inform their doctor if they notice an increase in symptoms or worsening of the disease after using Icatibant Universal Farma.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should consult their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medication.
Side effects can also be reported to the marketing authorization holder.

5. How to store Icatibant Universal Farma

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the label after "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
Do not store above 30°C. Do not freeze.
Do not use this medication if the syringe or needle packaging is damaged or if there are any visible signs of deterioration, such as the solution being cloudy, containing solid particles, or having changed color.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Package contents and other information

What Icatibant Universal Farma contains

The active substance of Icatibant Universal Farma is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as icatibant acetate). The other ingredients are sodium chloride, glacial acetic acid, sodium hydroxide, and water for injections.

What Icatibant Universal Farma looks like and contents of the pack

Icatibant Universal Farma is a clear, colorless solution for injection in a glass pre-filled syringe with a capacity of 3 mL. The packaging includes a subcutaneous needle. Icatibant Universal Farma is available in a single packaging containing one pre-filled syringe with one needle in a cardboard box or in a collective packaging containing three pre-filled syringes with three needles in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Universal Farma, S.L.
Calle Dulcinea, s/n,
Alcalá de Henares

• 28805- Madrid Spain Telephone: + 34 949 34 97 00

Manufacturer

Universal Farma S.L.
Calle El Tejido 2, Polígono Industrial Miralcampo
19200 Azuqueca De Henares, Guadalajara
Spain

This medication is authorized in the EEA member states under the following names:

Netherlands:
Icatibant HIKMA 30 mg solution for injection, in a pre-filled syringe
Austria:
Icatibant HIKMA 30 mg injection solution, in a pre-filled syringe
Finland:
Icatibant Universal Farma 30 mg injectable solution, in a pre-filled syringe
Italy:
Icatibant HIKMA
Portugal:
Icatibant HIKMA
Romania:
Icatibant Universal Farma 30 mg injectable solution, in a pre-filled syringe
France:
Icatibant HIKMA 30 mg, solution for injection, in a pre-filled syringe
Czech Republic:
Icatibant Universal Farma
Hungary:
Icatibant Universal Farma 30 mg solution for injection, in a pre-filled syringe
Norway:
Icatibant Universal Farma
Sweden:
Icatibant Universal Farma 30 mg injectable solution, in a pre-filled syringe
Poland:
Icatibant Universal Farma
Germany:
Icatibant HIKMA 30 mg solution for injection, in a pre-filled syringe
Denmark:
Icatibant Universal Farma

Date of last revision of the leaflet: April 2024

Other sources of information

Detailed information on this medication can be found on the European Medicines Agency website http://www.ema.europa.eu. There are also links to websites about rare diseases and treatments.