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ICATIBANTO GLENMARK 30 mg Injectable Solution in Pre-filled Syringe

Ask a doctor about a prescription for ICATIBANTO GLENMARK 30 mg Injectable Solution in Pre-filled Syringe

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Doctor

Tarek Agami

General medicine10 years of experience

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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

How to use ICATIBANTO GLENMARK 30 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Patient

Icatibant Glenmark 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 Package Leaflet

  1. What is Icatibant Glenmark and what is it used for
  2. What you need to know before you use Icatibant Glenmark
  3. How to use Icatibant Glenmark
  4. Possible side effects
  5. Storage of Icatibant Glenmark
  6. Contents of the pack and other information

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

Icatibant Glenmark contains the active substance icatibant.

Icatibant is used to treat acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and above.

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

Icatibant blocks the action of bradykinin and therefore reduces the symptoms of an HAE attack.

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

Do not use Icatibant Glenmark

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

Warnings and precautions

Consult your doctor before starting treatment with icatibant:

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

Side effects related to icatibant are similar to the symptoms of your disease. Consult your doctor immediately if you notice that your attack symptoms worsen after you have been given icatibant.

Also:

  • You or your carer must learn how to administer subcutaneous injections (under the skin) before you self-administer or your carer administers this medicine to you.
  • Immediately after self-administering icatibant or after your carer has administered 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 or after an injection administered by your carer, you should consult your doctor about the administration of additional injections of icatibant. In adult patients, up to 2 additional injections can be administered within 24 hours.

Children and adolescents

Icatibant is not recommended for use in children below 2 years of age or weighing less than 12 kg because it has not been studied in these patients.

Other medicines and Icatibant Glenmark

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

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are breast-feeding, you should not breast-feed your child during the 12 hours following the last administration of icatibant.

Driving and using machines

Do not drive or use machines if you feel tired or dizzy as a result of an HAE attack or after using this medicine.

Icatibant Glenmark contains sodium

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

3. How to use Icatibant Glenmark

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor again.

If you have never been given icatibant before, the first dose must always be injected by medical or nursing staff. Your doctor will discharge you when he/she considers it safe for you to go home.

After discussing with your doctor or nurse and learning the technique for subcutaneous injections (under the skin), you or your carer can administer Icatibant Glenmark if you have an HAE attack.

It is important to inject Icatibant Glenmark subcutaneously (under the skin) as soon as you notice an attack of angioedema. Healthcare staff will teach you and your carer how to inject icatibant safely, following the instructions in the package leaflet.

When and how often to use Icatibant Glenmark

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

Adults

  • The recommended dose of icatibant is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice an attack of angioedema (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 6 hours, you should seek medical advice about the administration of additional injections of Icatibant Glenmark. In adults, up to 2 additional injections can be administered within 24 hours.

-

Children and adolescents from 2 to 17 years

  • The recommended dose of icatibant is an injection of 1 ml up to a maximum of 3 ml depending 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).
  • Refer to the section on instructions for use to see the dose that you should inject.
  • If you are not sure about the dose to inject, consult your doctor, pharmacist or nurse.

-

Administration of Icatibant Glenmark

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

This medicine is injected with a short needle into the fatty tissue under the skin of the abdomen (tummy).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

The following step-by-step instructions are intended for:

  • self-administration (adults)
  • administration by a carer or healthcare professional for adults, adolescents or children over 2 years (weighing at least 12 kg).

Instructions include the following main steps:

  1. General information

2a) Preparation of the syringe for children and adolescents (2-17 years) weighing 65 kg or less

2b) Preparation of the syringe and needle for injection (all patients)

  1. Preparation of the injection site
  2. Injection of the solution
  3. Disposal of the injection materials

Step-by-step instructions for administration

  1. General information
  • Clean the work surface (area) before you start the process.
  • Wash your hands with water and soap
  • Remove the pre-filled syringe from the box
  • Remove the cap from the end of the pre-filled syringe by unscrewing it
  • Leave the pre-filled syringe with the cap removed

2a) Preparation of the syringe for children and adolescents (2-17 years) weighing 65 kg or less:

Important information for healthcare professionals and carers:

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

  1. Icatibant Glenmark pre-filled syringe (with icatibant solution)
  2. Connector (adapter)
  3. 3 ml graduated syringe

Pre-filled syringe with medication showing retracted plunger and needle guard at the bottom

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

Table 1: Dosing Schedule for Children and Adolescents

Body weight

Injection 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 weighing more than 65 kgwill use the entire contents of the pre-filled syringe (3 ml).

If you are not sure about the volume of solution to withdraw, consult your doctor, pharmacist or nurse

  1. Remove the caps from each end of the connector.

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

  1. Screw the connector onto the pre-filled syringe.
  1. Attach the graduated syringe to the other end of the connector, making sure that both connections fit securely.

Medical device with metal cylinder and plunger showing black arrows indicating direction of liquid flow

Transfer the icatibant solution to the graduated syringe:

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

Pre-filled syringe with transparent cylinder and grey plunger and two metal needles at the ends, black arrows indicate direction of flow

  1. 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).

Pre-filled syringe with transparent cylinder showing plunger and metal connections at both ends, arrow indicates direction

  1. 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).

Transparent syringe with black plunger and graduated scale, black arrow indicates direction of 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).
  • Withdraw the required volume of icatibant solution.
  1. Remove the pre-filled syringe and connector from the graduated syringe.
  2. Dispose of the pre-filled syringe and connector in the puncture-proof container.

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

Syringe needle with visible bevel held by a hand showing sharp tip and transparent cylinder

  • Remove the needle cap from the blister pack
  • Remove the seal from the needle cap (the needle should remain inside the cap)

Syringe with needle inserted showing direction of injection indicated by a small arrow

  • Hold the syringe firmly. Carefully attach the needle to the pre-filled syringe with the colourless 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
  1. Preparation of the injection site

Hand pinching the skin in a fold with thumb and index finger preparing for an injection

  • Choose the injection site. The injection site should be a skin fold of 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.
  1. Injection of the solution

Hand holding syringe with needle being inserted into the skin, arrow indicates direction of insertion and plunger retracted

  • 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

Two hands holding a syringe with needle inserted into the skin, showing point of injection and technique of administration

  • Hold the syringe with the needle at an angle of 45 to 90 degrees to the skin
  • Holding the syringe in one hand, use the other hand to gently take a skin fold between your thumb and fingers at the previously cleaned site
  • Hold the skin fold, bring the syringe close and quickly insert the needle into the skin fold
  • Press the plunger slowly with a firm pulse, until all of 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
  1. Disposal of the injection materials

Hand holding auto-injector pressing against a surface with an opening and arrow indicating direction of injection

  • Throw away the syringe, needle and cap in the puncture-proof container for disposal of sharp objects.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Almost all patients who receive Icatibant Glenmark 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.

Consult your doctor immediately if you notice that your HAE attack symptoms worsen after you have been given this medicine.

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 skin 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)

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 via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Icatibant Glenmark

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 refers to the last day of that month.

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 you notice visible signs of deterioration, e.g. 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. Packaging Contents and Additional Information

Composition of Icatibant Glenmark

  • The active ingredient is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). Each ml of solution contains 10 mg of icatibant.
  • The other components are sodium chloride, glacial acetic acid, sodium hydroxide (for pH adjustment), and water for injectable preparations (see section 2).

Appearance of Icatibant Glenmark and Packaging Contents

Icatibant Glenmark is presented as a clear and colorless injectable solution in a 3 ml pre-filled glass syringe. The packaging contains a hypodermic needle.

Icatibant Glenmark is available in a single-unit packaging of one pre-filled syringe with a needle or in a multi-unit packaging of three pre-filled syringes with three needles.

Only certain packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate, Paola

PLA 3000

Malta

Eurofins PROXY Laboratories B.V.

Archimedesweg 25

2333 CM Leiden

Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country

Medicinal Product Name

Denmark

Icatibant Glenmark

Czech Republic

Icatibant Glenmark

Germany

Icatibant Glenmark 30 mg Injektionslösung in einer Fertigspritze

Spain

Icatibanto Glenmark 30 mg solution for injection in a pre-filled syringe EFG

Netherlands

Icatibant Glenmark 30 mg oplossing voor injectie in een voorgevulde spuit

Finland

Icatibant Glenmark 30 mg injection solution, liquid, pre-filled syringe

Sweden

Icatibant Glenmark 30 mg injection solution, liquid, pre-filled syringe

Norway

Icatibant Glenmark

Slovakia

Icatibant Glenmark 30 mg injectable solution in a pre-filled syringe

Date of the last revision of this leaflet:September 2021.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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Alternative to ICATIBANTO GLENMARK 30 mg Injectable Solution in Pre-filled Syringe in Poland

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Online doctors for ICATIBANTO GLENMARK 30 mg Injectable Solution in Pre-filled Syringe

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for ICATIBANTO GLENMARK 30 mg Injectable Solution in Pre-filled Syringe – subject to medical assessment and local rules.

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Tarek Agami

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Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Doctor

Hocine Lokchiri

General medicine20 years of experience

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€75
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