Ikatybant ranbaxy

DK/H/3244/001/IA/003
DK/H/3244/001/IA/003

Package leaflet: Information for the patient

Ikatybant Ranbaxy, 30 mg, solution for injection in
pre-filled syringe
ikatibant
Please read the entire leaflet carefully before using this medicine, as it contains important
information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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

1. What Ikatybant Ranbaxy is and what it is used for
2. Important information before using Ikatybant Ranbaxy
3. How to use Ikatybant Ranbaxy
4. Possible side effects
5. How to store Ikatybant Ranbaxy
6. Contents of the pack and other information

1. What Ikatybant Ranbaxy is and what it is used for

Ikatybant Ranbaxy contains the active substance ikatibant.
This medicine is intended for the treatment of symptoms of hereditary angioedema (HAE) in adult patients, adolescents, and children aged 2 years and above.
In HAE, there is an increased concentration in the blood of a substance called bradykinin, which leads to the development of symptoms such as swelling, pain, nausea, and diarrhea.
Ikatybant Ranbaxy blocks the activity of bradykinin, thereby interrupting the progression of HAE attack symptoms.

2. Information before using Ikatybant Ranbaxy

When not to use Ikatybant Ranbaxy

• 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 Ikatybant Ranbaxy, discuss with your doctor:

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

Adverse reactions associated with the use of Ikatybant Ranbaxy are similar to the symptoms
of the disease.
If worsening of symptoms occurs after administration of this medicine, contact your doctor immediately.
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Additionally:

• Before self-injecting or before administering the medicine 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-administers Ikatybant Ranbaxy or receives it from a caregiver, should seek immediate medical assistance at a healthcare facility.
• If symptoms do not resolve after a single self-injection of Ikatybant Ranbaxy or a single administration 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 Ikatybant Ranbaxy. No more than two additional injections should be administered to adult patients within 24 hours.

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

3. How to use Ikatybant Ranbaxy

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor.
If the patient is receiving Ikatybant Ranbaxy for the first time, the first dose will always be
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 Ikatybant Ranbaxy, or a caregiver may administer the medicine to the patient,
in the event of an attack of hereditary angioedema (HAE).
It is important to administer the subcutaneous injection of Ikatybant Ranbaxy as soon as possible
after the onset of an angioedema attack. The treating physician will train the patient and caregiver
on how to safely administer this medicine according to the instructions provided in the Patient Leaflet.
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When and how often to use Ikatybant Ranbaxy
The doctor will determine the exact dose of Ikatybant Ranbaxy and advise the patient on how often
it should be used.
Adults

• The recommended dose of Ikatybant Ranbaxy is one subcutaneous injection (3 mL, 30 mg), administered immediately after the onset of an angioedema attack (e.g. severe swelling of the skin, particularly in the face and neck area, or worsening abdominal pain).
• If symptoms have not improved after 6 hours, medical advice should be sought regarding administration of a second injection of Ikatybant Ranbaxy. No more than two injections should be given to adult patients within 24 hours.
• Do not administer more than 3 injections within 24 hours. If a patient requires more than 8 injections per month, consult the doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Ikatybant Ranbaxy is one subcutaneous injection of 1 mL up to a maximum of 3 mL, depending on body weight, administered immediately after the onset of symptoms of an angioedema attack (e.g. severe swelling of the skin, particularly in the face and neck area, or worsening abdominal pain).
• Further information on dosing can be found in the instructions.
• If the patient is unsure of the correct dose, consult the doctor, pharmacist, or nurse. If symptoms worsen or do not improve, seek immediate medical help.

How to administer Ikatybant Ranbaxy
Ikatybant Ranbaxy is intended for subcutaneous administration. Each syringe must be used only once.
This medicine is injected using a short needle into the fatty tissue under the skin of the abdomen.
If there are any further doubts regarding the use of this medicine, consult your 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 of at least 12 kg).

The instructions include the following main steps:

1. General information
   2a) Preparation of the pre-filled syringe for children and adolescents (aged 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
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   Detailed injection instructions
   1) General information

• Before starting, clean the work surface.
• Wash hands with soap and water.
• Remove the pre-filled syringe from its packaging.
• Unscrew and remove the cap from the end of the pre-filled syringe.
• After removing the cap, place the pre-filled syringe aside.

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 are required to obtain the correct dose from
the pre-filled syringe:
a) pre-filled syringe containing Ikatybant Ranbaxy (solution of icatibant)
b) adapter
c) 3 mL graduated syringe

The required dose volume in millilitres should be drawn into an empty 3 mL graduated syringe (see
table below).
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Table 1: Dosing schedule for children and adolescents

For patients with body weight above 65 kg, the entire contents of the pre-filled syringe (3 mL) should be administered.

If the patient is unsure about the volume of solution to draw up, they should consult a
physician, pharmacist, or nurse.

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

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

Drawing up the icatibant solution into the graduated syringe:

1. To draw up 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 start flowing into the graduated syringe, gently pull back the plunger of the syringe until the icatibant solution begins to flow into it (see illustration below).
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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 there is air in the graduated syringe:

• Rotate 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 up 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.
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   2b) Preparing the pre-filled syringe and needle for injection:
   All patients (adults, children, and adolescents)

• Remove the needle with protective cap from its packaging.
• Remove the sealing layer from the needle cap (the needle should remain in the cap).

• Hold the syringe firmly. Carefully place the needle onto the syringe containing the clear solution.
• Screw the syringe onto the needle while the needle is still in the protective cap.
• Remove the needle from the cap by pulling the syringe body (do not pull the plunger).
• The syringe is now ready for injection.

3) Preparing the injection site

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• 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 areas of skin with bruising, swelling, or tenderness for injection.
• Clean the injection site by wiping it with an alcohol-soaked gauze pad and allow it to dry.

4) Injecting the solution

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

• Hold the syringe at a 45–90 degree angle to the skin, with the needle pointing toward the skin.
• While holding the syringe with one hand, gently pinch the skin fold between the thumb and fingers at the previously disinfected site with the other hand.
• Hold the skin fold, bring the syringe close to the skin, and quickly insert the needle into the skin fold.

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• Slowly press the syringe plunger while keeping the hand steady until all the liquid has been injected into the skin and the 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 syringe, needle, and needle cap into a sharps container designed for the disposal of waste that may cause injury.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Injection site reactions (irritation, swelling, pain, itching, redness of the skin, and burning sensation) occur in almost all patients receiving Ikatybant Ranbaxy. These reactions are usually mild and resolve without the need for additional treatment.
Patients should immediately inform their doctor if they notice worsening of disease symptoms after administration of this medicine.

Very common (may affect more than 1 in 10 people):
Additional injection site reactions (feeling of pressure, bruising, impaired sensation and/or numbness, itchy and raised rash, 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 unknown (frequency cannot be estimated from the available data):
Urticaria

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Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

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

5. How to store Ikatybant Ranbaxy

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 carton.
The expiry date refers to the last day of the stated month.
Do not store above 25°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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ikatybant Ranbaxy contains

• The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). Each mL of solution contains 10 mg of icatibant.
• The other ingredients are: sodium chloride, glacial acetic acid, sodium hydroxide (for pH adjustment) and water for injections (see section 2).

What Ikatybant Ranbaxy looks like and contents of the pack
Ikatybant Ranbaxy is a clear, colourless solution for injection in a 3 mL glass pre-filled syringe. A subcutaneous needle is supplied with the pack.
Ikatybant Ranbaxy is available in a single pack containing one pre-filled syringe with one needle, or in a multipack containing three pre-filled syringes with three needles.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75
Manufacturer/Importer
Terapia SA
Str. Fabricii nr. 124,
400632 Cluj Napoca
Romania
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
PLA 3000 Paola
Malta
Eurofins PROXY Laboratories B.V.
Archimedesweg 25
2333 Leiden
The Netherlands
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Denmark: Icatibant SUN
Romania: Icatibant Terapia 30 mg solution for injection in pre-filled syringe