Ikatibant Ranbaxi

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

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

2. Important information before using Icatibant Ranbaxy

When not to use Icatibant Ranbaxy

Warnings and precautions

Before starting to take Icatibant Ranbaxy, you should discuss this with your doctor:

Side effects related to the use of Icatibant Ranbaxy are similar to the symptoms of the disease.
In case of worsening symptoms of the attack after receiving this medicine, you should immediately inform your doctor.
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Additionally:

• Before self-injecting or administering the medicine by a caregiver, the patient or caregiver should be trained in performing subcutaneous injections.
• A patient with a laryngeal attack (upper airway obstruction) who self-administers Icatibant Ranbaxy or is administered Icatibant Ranbaxy by a caregiver should seek medical help immediately in a healthcare facility.
• If after a single self-administered injection of Icatibant Ranbaxy or a single administration of Icatibant Ranbaxy by a caregiver the symptoms do not subside, the patient should consult a doctor for the administration of a further injection of Icatibant Ranbaxy. Adult patients should not be given more than two additional injections within 24 hours.

Children and adolescents

Icatibant Ranbaxy 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 Ranbaxy and other medicines

Please tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions of Icatibant Ranbaxy with other medicines are known. If you are taking a medicine called an ACE inhibitor (e.g., captopril, enalapril, ramipril, quinapril, lisinopril) used to lower blood pressure or for any other reason, you should inform your doctor before using this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, please consult your doctor before using this medicine.
You should not breastfeed for 12 hours after taking Icatibant Ranbaxy.

Driving and using machines

Do not drive or use machines if you experience fatigue or dizziness due to an HAE attack or after using Icatibant Ranbaxy.

Icatibant Ranbaxy contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to use Icatibant Ranbaxy

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor.
If you are receiving Icatibant Ranbaxy for the first time, the first dose of the medicine will always be injected by a doctor or nurse. The doctor will tell you when you can safely go home.
After talking to your doctor or nurse and being trained in performing subcutaneous injections, you can self-administer Icatibant Ranbaxy or a caregiver can administer it to you if you have an HAE attack.
It is essential to perform the subcutaneous injection of Icatibant Ranbaxy as soon as possible after noticing the symptoms of an HAE attack. Your doctor will teach you and your caregiver how to safely inject this medicine according to the instructions provided in the Patient Leaflet.
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When and how often to use Icatibant Ranbaxy

Your doctor will decide the exact dose of Icatibant Ranbaxy and tell you how often to use it.

Adults

• The recommended dose of Icatibant Ranbaxy is one injection (3 mL, 30 mg), administered subcutaneously immediately after noticing the 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, you should consult your doctor about administering another injection of Icatibant Ranbaxy. Adult patients should not be given more than two injections within 24 hours.
• Do not take more than 3 injections within 24 hours. If you require more than 8 injections per month, you should consult your doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant Ranbaxy is one injection of 1 mL to a maximum of 3 mL, depending on body weight, administered subcutaneously immediately after noticing the symptoms of an HAE attack (e.g., severe skin swelling, especially on the face and neck, or severe abdominal pain).
• More information on dosing can be found in the instructions
• If you are unsure about the volume of the solution to be administered, you should consult your doctor, pharmacist, or nurse.

If symptoms worsen or do not subside, you should seek medical help immediately.

How to administer Icatibant Ranbaxy

Icatibant Ranbaxy is intended for subcutaneous administration. Each syringe should only be used once.
The medicine is injected using a short needle into the fatty tissue under the skin of the abdomen.
If you have any further questions about using this medicine, you should ask your doctor or pharmacist.

The following detailed instructions apply to:

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

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Detailed injection instructions

• 1) General information
• Before starting, clean the surface you are using.
• Wash your hands with water and soap.
• Remove the pre-filled syringe from its packaging.
• Remove the cap from the tip of the pre-filled syringe by twisting it
• After removing the cap, put the pre-filled syringe down

2a) Preparation of 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:

If the dose is less than 30 mg (3 mL), to obtain the correct dose from the pre-filled syringe, you will need:
a) a pre-filled syringe with Icatibant Ranbaxy (containing the icatibant solution)
b) an adapter
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).
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Table 1: Administration schedule for children and adolescents

Patients with a body weight over 65 kgshould be given the entire contents of the pre-filled syringe (3 mL).

If you are unsure about the volume of the solution to be administered, you should consult your doctor, pharmacist, or nurse.

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

Avoid touching the tip and nozzle 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 so that 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 to flow into it (see the illustration below).

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

If there is air in the syringe with graduations, you should:

• 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.

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

All patients (adults, children, and adolescents)

• Remove the needle cap from its packaging.
• Remove the seal from the needle cap (the needle should still be in the cap).

• Hold the syringe firmly. Carefully attach the needle to the syringe containing the colorless solution.
• Screw the syringe onto the needle still secured in the cap.
• Remove the needle from the cap by pulling on the syringe body. Do not pull on the syringe plunger.
• The syringe is now ready for injection .
• 3) Preparation of the injection site

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• Choose an 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 of gauze soaked in alcohol and let it dry
• 4) Injection of the solution

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients taking Icatibant Ranbaxy 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.
Please inform your doctor immediately if you notice worsening symptoms of the disease after using this medicine.
Very common(may affect more than 1 in 10 people):
Additional reactions at the injection site (feeling of pressure, bruising, impaired sensation and/or numbness, itching, and raised rash, as well as 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 test results
Frequency not known(frequency cannot be estimated from the available data):
Hives
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Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Icatibant 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 month stated.
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, such as the solution being cloudy, containing solid particles, or having changed color.
Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Icatibant Ranbaxy contains

• The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as icatibant acetate). Each milliliter of the 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 Icatibant Ranbaxy looks like and contents of the pack

Icatibant Ranbaxy is a clear, colorless solution for injection in a glass pre-filled syringe with a capacity of 3 mL. A subcutaneous needle is provided with the packaging.
Icatibant Ranbaxy is available in a single packaging 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 authorization 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
Netherlands

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Icatibant SUN
Romania: Icatibant Terapia 30 mg solution for injection in a pre-filled syringe
Date of last revision of the leaflet: 02.05.2023