Icatibant universal farma

Icatibant Universal Farma, 30 mg, solution for injection in pre-filled syringe
Icatibantum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the 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. Contents of the pack 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 intended for the treatment of symptoms of hereditary angioedema (HAE) in adults, adolescents, and children aged 2 years and older.
In HAE, there is an increased concentration in the blood of a substance called bradykinin, which leads to symptoms such as swelling, pain, nausea, and diarrhea.
Icatibant Universal Farma blocks the activity of bradykinin, thereby interrupting the progression of HAE attack symptoms.

2. Important information before using Icatibant Universal Farma

When not to use Icatibant Universal Farma

• if the patient is allergic to icatibant or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Icatibant Universal Farma, discuss the following with your doctor:

• if the patient has angina pectoris (reduced blood flow to the heart muscle);
• if the patient has recently had a stroke.

Some of the adverse reactions associated with the use of Icatibant Universal Farma are similar
to the symptoms of the disease.
If worsening of attack symptoms occurs after administration of Icatibant Universal Farma,
the doctor should be notified immediately.
Moreover:

• Before self-injecting Icatibant Universal Farma or before administering Icatibant Universal Farma by a caregiver, the patient or caregiver must be trained in performing subcutaneous injections.
• A patient experiencing an attack involving the larynx (upper airway obstruction), who self-injects Icatibant Universal Farma or receives it from a caregiver, should seek immediate medical assistance at a healthcare facility.
• If symptoms do not resolve after a single self-administered injection of Icatibant Universal Farma or a single dose administered by a caregiver, the patient should seek medical attention or the caregiver should take the patient to a doctor for administration of the next dose of Icatibant Universal Farma. No more than two additional injections should be administered to adult patients within 24 hours.

Children and adolescents
Icatibant Universal Farma is not recommended for use 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 medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
No interactions between Icatibant Universal Farma and other medicines are known. However, if the patient is taking a medicine known as an angiotensin-converting enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril), used to lower blood pressure or for any other reason, the doctor should be informed before using Icatibant Universal Farma.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before starting treatment with this medicine.
The patient should not breastfeed for 12 hours after taking Icatibant Universal Farma.
Driving and operating machinery
Do not drive or operate machinery if the patient experiences fatigue or dizziness due to an HAE attack or after using Icatibant Universal Farma.
Icatibant Universal Farma contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, meaning the medicine is considered "sodium-free".

3. How to use Icatibant Universal Farma

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
If the patient is receiving Icatibant Universal Farma for the first time, the first dose is always administered
by a doctor or nurse. The doctor will inform the patient when it is safe to return home.
After speaking with a doctor or nurse and receiving training in subcutaneous injections,
the patient may self-administer Icatibant Universal Farma, or a caregiver may administer Icatibant Universal Farma
to the patient, in case of an attack of hereditary angioedema (HAE). It is important to administer the subcutaneous
injection of Icatibant Universal Farma as soon as possible after recognizing an angioedema attack. The treating physician
will train the patient and caregiver on how to safely administer Icatibant Universal Farma according to the instructions
provided in the patient leaflet.
When and how often to use Icatibant Universal Farma
The doctor will determine the exact dose of Icatibant Universal Farma and advise the patient on how often it should be used.
Adults

• The recommended dose of Icatibant Universal Farma is one subcutaneous injection (3 mL, 30 mg), administered immediately after recognizing an angioedema attack (e.g., worsening skin swelling, particularly in the face and neck area, or increased abdominal pain).
• If symptoms do not improve after 6 hours, seek medical advice regarding administration of a second dose of Icatibant Universal Farma. Adult patients should not receive more than two additional injections within 24 hours.
• Do not administer more than 3 injections within 24 hours. If the patient requires more than 8 injections per month, consult the doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant Universal Farma is one subcutaneous injection of 1 mL up to a maximum of 3 mL, depending on body weight, administered immediately after recognizing symptoms of an angioedema attack (e.g., worsening skin swelling, particularly in the face and neck area, or increased abdominal pain).
• For further information on dosing, see “Detailed injection instructions”.
• If the patient is unsure of the correct dose, consult a doctor, pharmacist, or nurse.
• If symptoms worsen or do not improve, seek immediate medical attention.

How to administer Icatibant Universal Farma
Icatibant Universal Farma is intended for subcutaneous administration. Each syringe must be used only once.
Icatibant Universal Farma is administered using a short needle into the fatty tissue beneath the skin of the abdomen.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.
The detailed instructions below apply to:

• Self-administration (adults)
• Administration by a caregiver or healthcare professional to adults, adolescents, and children aged over 2 years (with body weight not less than 12 kg).

The instructions include the following main steps:

1. General information
   2a) Preparation of the pre-filled syringe for children and adolescents (2–17 years) with body weight of 65 kg or less
   2b) Preparation of the pre-filled syringe and needle for injection (all patients)
2. Preparation of the injection site
3. Injection of the solution
4. Disposal of injection equipment
   Detailed injection instructions
   1) General information

• Before beginning, clean the work surface.
• Wash hands with soap and water.
• Open the packaging by peeling off the seal.
• Remove the pre-filled syringe from the packaging.
• Unscrew and remove the cap from the end of the pre-filled syringe.
• After removing the cap, set aside the pre-filled syringe. Do not allow the exposed syringe tip to come into contact with any surface.

2a) Preparation of the pre-filled syringe for children and adolescents (aged 2 to 17 years) with body weight of 65 kg or less:
Important information for healthcare professionals and caregivers:
When the dose is less than 30 mg (3 mL), the following items are required to obtain the correct dose from the pre-filled syringe:
a) Pre-filled syringe containing Icatibant Universal Farma (solution of icatibant)
b) Connector (adapter)
c) 3 mL syringe with graduations

The required dose volume in millilitres should be drawn into an empty 3 mL syringe with graduations (see table below).
Table 1: Dosing schedule for children and adolescents
Body weight Solution 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 body weight above 65 kg should receive the full content of the pre-filled syringe (3 mL).

If the patient is unsure of the volume of solution to draw, consult a doctor, pharmacist, or nurse.

1. Remove the protective caps from both ends of the adapter.

Avoid touching the ends and tip of the adapter or syringe to prevent contamination.
2) Attach the adapter to the pre-filled syringe.
3) Connect the graduated syringe to the other end of the adapter so that both ends are securely joined.

Drawing icatibant solution into the graduated syringe:

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

2. If the icatibant solution does not begin to flow into the graduated syringe, gently pull back the plunger of the syringe until the solution begins to flow into it (see illustration below).

3. Continue pressing the plunger of the pre-filled syringe until the required volume of solution (dose) has transferred into the graduated syringe. Dosing information is provided in Table 1.
   If air is present in the graduated syringe:

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

• Press the plunger of the graduated syringe to return the air into the pre-filled syringe (this step may need to be repeated several times).
• Draw the required volume of icatibant solution.

4. Disconnect the pre-filled syringe with adapter from the graduated syringe.
5. Place the pre-filled syringe with adapter into a designated sharps container.
   2b) Preparation of the pre-filled syringe and needle for injection:
   All patients (adults, children, and adolescents)

• Remove the needle shield from its packaging. Do not remove the needle from the shield.
• Twist the upper part of the needle shield to break the seal (the needle should remain in the shield).

• Firmly hold the pre-filled syringe. Carefully place the needle onto the pre-filled syringe containing the clear solution.
• Screw the pre-filled syringe onto the needle while the needle is still in the shield.
• Remove the needle from the shield by pulling the syringe body. Do not pull the plunger of the pre-filled syringe.
• The pre-filled syringe is now ready for injection.

3) Preparation of the injection site

• Select the injection site. The injection site should be a skin fold on the abdomen, approximately 5–10 cm below the navel, on either side. This area should be at least 5 cm away from any scars. Do not use injection sites with bruising, swelling, or tenderness.
• Clean the injection site by wiping it with an alcohol-soaked gauze pad and allow it to dry.

4) Injection of the solution

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

• Hold the pre-filled syringe at a 45–90 degree angle to the skin, with the needle pointing toward the skin.
• While holding the pre-filled syringe with one hand, use the other hand to gently pinch the skin between the thumb and fingers at the previously disinfected 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 while keeping the hand steady, until the entire fluid is injected into the skin and the pre-filled syringe is completely emptied.
• Press the plunger slowly over approximately 30 seconds.
• Release the skin fold and gently withdraw the needle.

5) Disposal of injection equipment

• Place the pre-filled syringe, needle, and needle shield into a sharps container designed for the disposal of waste materials that may cause injury.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
A reaction at the injection site (irritation, swelling, pain, itching, redness of the skin, and burning sensation) occurs in almost all patients receiving Icatibant Universal Farma.
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, sensory disturbances and/or numbness, itchy raised rash above the surface of the surrounding skin, and feeling of warmth).

Common (may affect up to 1 in 10 people):
Nausea
Headache
Dizziness
Fever
Itching
Rash
Skin redness
Abnormal liver function test results

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

Patients should immediately inform their doctor if they notice worsening of symptoms or exacerbation of the disease episode after administration of Icatibant Universal Farma.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, patients should contact their doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, they should be reported to a doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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

Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Icatibant Universal Farma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label following: "Expiry date (EXP)". The expiry date refers to the last day of the specified month.
Do not store above 30°C. Do not freeze.
Do not use this medicine if the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example, if the solution is cloudy, contains particles, or has changed colour.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Icatibant Universal Farma contains
The active substance in Icatibant Universal Farma is icatibant. Each pre-filled syringe contains
30 milligrams of icatibant (as 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, colourless solution for injection in a 3 mL glass pre-filled syringe. A subcutaneous needle is included in the pack.
Icatibant Universal Farma is available in a single pack containing one pre-filled syringe with one needle in a cardboard box, or in a multipack containing three pre-filled syringes with three needles, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the EEA Member States under the following names:
Netherlands: Icatibant HIKMA 30 mg oplossing voor injectie, in voorgevulde spuit
Austria: Icatibant HIKMA 30 mg Injektionslösung in einer Fertigspritze
Finland: Icatibant Universal Farma 30 mg injektioneste, liuos esitäytetyssä ruiskussa
Italy: Icatibant HIKMA
Portugal: Icatibant HIKMA
Romania: Icatibant Universal Farma 30 mg soluție injectabilă în seringă preumplută
France: Icatibant HIKMA 30 mg, solution injectable en seringue pré-remplie
Czech Republic: Icatibant Universal Farma
Hungary: Icatibant Universal Farma 30 mg oldatos injekció előretöltött fecskendőben
Norway: Icatibant Universal Farma
Sweden: Icatibant Universal Farma 30 mg injektionsvätska, lösning, i förfylld spruta
Poland: Icatibant Universal Farma
Germany: Icatibant HIKMA 30 mg Injektionslösung in einer Fertigspritze
Denmark: Icatibant Universal Farma

Other sources of information
Detailed information about this medicinal product is available on the European Medicines Agency website
http://www.ema.europa.eu. This site also contains links to websites on rare diseases and treatment options.