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ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe

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About the medicine

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

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Contents of the leaflet

  1. Introduction
  2. What is Icatibant Stada and what is it used for
  3. What you need to know before you use Icatibant Stada
  4. How to use Icatibant Stada
  5. Possible side effects
  6. Storage of Icatibant Stada
  7. Packaging Contents and Additional Information

Introduction

Package Leaflet: Information for the User

Icatibant Stada 30 mg solution for injection in pre-filled syringe EFG

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.

of side effects that are not listed in this leaflet. See section 4.

Contents of the pack

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

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

Icatibant Stada contains the active substance icatibant.

This medicine is used to treat the symptoms of hereditary angioedema (HAE) in adults, adolescents and children over 2 years of age.

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

Icatibant blocks the action of bradykinin and thus slows down the progression of the symptoms of an HAE attack.

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

Do not use Icatibant Stada

  • 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 to use icatibant:

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

The side effects related to icatibant are similar to the symptoms of your own disease. Consult your doctor immediately if you notice that the symptoms of the attack worsen after icatibant is administered.

In addition:

  • You or your caregiver should learn the technique for subcutaneous injections (under the skin) before self-administering or having your caregiver administer this medicine.
  • Immediately after self-administering icatibant or having your caregiver administer it while experiencing a laryngeal attack (upper airway obstruction), you should seek medical attention at a medical institution.
  • If your symptoms do not resolve after a self-administered injection of icatibant or an injection administered by your caregiver, you should consult your doctor about the administration of additional injections of this medicine. In adult patients, up to 2 additional injections can be administered within 24 hours.

Children and adolescents

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

Other medicines and Icatibant Stada

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 (ACE inhibitor) (e.g. captopril, enalapril, ramipril, quinapril, lisinopril) to lower blood pressure or for any other reason, inform your doctor before using this medicine.

Pregnancy and breastfeeding

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

If you are breastfeeding, you should not breastfeed 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 the HAE attack or after using icatibant.

Icatibant Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially “sodium-free”.

3. How to use Icatibant Stada

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor again.

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

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

It is essential to inject icatibant subcutaneously (under the skin) as soon as you notice an angioedema attack. The healthcare staff will teach you and your caregiver how to inject this medicine safely, following the instructions in the package leaflet.

When and how often should you use Icatibant Stada?

Your doctor has determined the exact dose of this medicine 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 the angioedema attack (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 six hours, ask your doctor about the administration of additional injections of icatibant. In adults, up to 2 additional injections can be administered within 24 hours.
  • You should not receive more than 3 injections in a 24-hour period and if you need more than 8 injections in a month, ask your doctor.

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 based 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).
  • See the instructions for use section to see the dose you should inject.
  • If you are unsure about the dose to inject, consult your doctor, pharmacist or nurse.
  • If your symptoms worsen or do not improve, consult your doctor immediately.

Method of administration

Icatibant is administered by subcutaneous injection (under the skin). Use each syringe only once.

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

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

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

  • self-administration (adults)
  • administration by a caregiver or healthcare professional for adults, adolescents or children over 2 years of age (who weigh at least 12 kg).

The instructions include the following main steps:

  1. General information

2a) Preparation of the syringe for children and adolescents (2-17 years) who weigh 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 injection materials

Step-by-step instructions for injection

  1. General information
  • Clean the work surface (area) before starting the process.
  • Wash your hands with water and soap
  • Remove the pre-filled syringe from the case
  • Unscrew and remove the cap from the end of the pre-filled syringe
  • Leave the pre-filled syringe once the cap is unscrewed

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

Important information for healthcare professionals and caregivers:

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

  • Icatibant pre-filled syringe (with icatibant solution)
  • Connector (adapter)
  • 3 ml graduated syringe

Pre-filled syringe with medication showing graduated plunger and removable needle protector with its components

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

Table 1: Dosage 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 who weigh more than 65 kgwill use the entire contents of the pre-filled syringe (3 ml).

If you are unsure about the volume of solution to extract, 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 initiate the transfer of the icatibant solution, push the plunger of the pre-filled syringe (on the left end of the image below).

Needle with metal cylinder and two gray threaded ends with black arrows pointing in both directions

  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 medication showing retracted plunger and luer lock connector on 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. See Table 1 for dosage 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 showing measurement marks and arrows indicating 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).
  • Extract the required volume of icatibant solution.
  1. Remove the pre-filled syringe and connector from the graduated syringe.
  1. Dispose of the pre-filled syringe and connector in the sharps container.

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

Hypodermic needle in transparent syringe held by a hand outlined in black and white

  • 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 advancement with arrow and partially removed needle protector

  • Hold the syringe firmly. Carefully connect the needle to the pre-filled syringe with the colorless 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 with thumb and index finger forming a fold for injection

  • Choose the injection site. The injection site should be a fold of the abdomen, at a distance of 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 inserted into the skin, arrow indicates direction of injection, subcutaneous technique

  • 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

Hand holding syringe with needle inserted into the skin, showing subcutaneous injection technique with low angle

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

Hand holding an insulin applicator with needle inserted into a practice device with arrow indicating direction

  • Discard the syringe, needle and cap in the sharps container intended for disposal of waste that can harm others if not handled properly.
Medicine questions

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients who receive icatibant 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.

Tell your doctor immediately if you notice that the symptoms of the attack worsen after receiving icatibant.

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 through 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 Stada

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 label and carton after “EXP”. The expiry date is the last day of the month shown.

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; for example, if the solution is cloudy, if it contains floating particles or if the color of the solution has changed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Icatibant Stada

  • The active ingredient is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as icatibant 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.

Appearance of Icatibant Stada and Packaging Contents

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory Stada, S.L.

C/Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park,

Paola PLA 3000

Malta

or

STADA Arzneimittel GmbH

Muthgasse 36/2 1190 Wien,

Austria

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Eurofins PROXY Laboratories (PRX)

Archimedesweg 25 2333 CM Leiden

Netherlands

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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Frequently Asked Questions

Is a prescription required for ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe?
ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe?
The active ingredient in ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe is icatibant. This information helps identify medicines with the same composition but different brand names.
Who manufactures ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe?
ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe is manufactured by Laboratorio Stada S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ICATIBANTO STADA 30 mg Injectable Solution in Pre-filled Syringe?
Other medicines with the same active substance (icatibant) include FIRAZYR 30 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, ICATIBANT ACCORD 30 mg Injectable Solution in Pre-filled Syringe, ICATIBANTO AGUETTANT 30 mg Injectable Solution in Pre-filled Syringe EFG. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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