TIVACOMA 30 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Patient

Tivacoma 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 pack

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

1. What is Tivacoma and what is it used for

Tivacoma 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.

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

2. What you need to know before you use Tivacoma

Do not use Tivacoma

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

Warnings and precautions

Talk to your doctor before starting to use this medicine:

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

The side effects related to this medicine are similar to the symptoms of your own illness. Consult your doctor immediately if you notice that the symptoms of the attack worsen after you have been given this medicine.

In addition:

• You or your caregiver should learn the technique for subcutaneous injections (under the skin) before you self-administer or your caregiver administers this medicine to you.
• Immediately after self-administering this medicine or after your caregiver administers it to you while you are experiencing a laryngeal attack (obstruction of the upper airway), you should seek medical attention at a medical center.
• If your symptoms do not resolve after a self-administered injection of this medicine or after 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 use in children under 2 years of age or weighing less than 12 kg, as it has not been studied in these patients.

Other medicines and Tivacoma

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

No interactions of this medicine 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 for 12 hours after the last administration of this medicine.

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 this medicine.

Tivacoma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per syringe; this is essentially "sodium-free".

3. How to use Tivacoma

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

If you have never been administered this medicine before, the first dose should always be injected by medical or nursing staff. Your doctor will discharge you when they consider 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 caregiver can administer this medicine to you if you have an HAE attack. It is essential to inject this medicine 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 Tivacoma?

Your doctor has determined the exact dose of this medicine and will tell you how often you should use it.

Adults

• The recommended dose of this medicine 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, you should seek medical advice about the administration of additional injections of this medicine. 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, you should seek medical advice.

Children and adolescents from 2 to 17 years

• The recommended dose of this medicine 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).

• Consult the section on instructions for use 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, you should seek medical advice immediately.

How should Tivacoma be administered?

This medicine 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 (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 (weighing 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) 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 injection materials

Step-by-step instructions for injection

1. General information

• Clean the work surface (area) you are going to use before starting the process.
• Wash your hands with water and soap.
• Remove the pre-filled syringe from the tray.
• Unscrew and remove the cap from the end of the pre-filled syringe.
• Leave the pre-filled syringe with the cap unscrewed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients who receive this medicine will experience a reaction at the injection site (such as skin irritation, swelling, pain, itching, redness of the skin, and a burning sensation). These effects are usually mild and disappear without the need for any additional treatment.

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 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)

Tell your doctor immediately if you notice that the symptoms of the attack worsen after you have received this medicine.

If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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

5. Storing Tivacoma

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 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 you notice visible signs of deterioration; for example, if the solution is cloudy, contains floating particles, or has changed color.

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. Container contents and additional information

Tivacoma composition

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

Appearance of Tivacoma and container contents

Tivacoma is presented as a clear and colorless injectable solution in a 3 ml pre-filled glass syringe with a plunger stopper.

The container includes a hypodermic needle (25 G, 16 mm).

This medicinal product is available in a single unit pack of one pre-filled syringe with one needle or in a multiple pack of three pre-filled syringes with three needles.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Day Zero ehf.

Reykjavíkurvegi 62

220 Hafnarfjördur

Iceland

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143, Blaubeuren

Germany

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

Date of last revision of this leaflet: December 2021

Detailed 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/.