PRAXBIND 2.5 G/50 ML INJECTABLE SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient and User

Praxbind 2.5g/50ml Solution for Injection and Infusion

idarucizumab

Read all of this leaflet carefully, because it contains important information for you. Note that this medicine is used mainly in emergency situations where your doctor has decided that you need it.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Praxbind and what is it used for

What is Praxbind

Praxbind contains the active substance idarucizumab. Idarucizumab is a specific reversal agent for dabigatran, a medicine that thins the blood and blocks a substance in the body that is involved in the formation of blood clots.

Praxbind is used to quickly capture dabigatran in order to neutralize its effect.

What Praxbind is used for

Praxbind is used in adults in emergency situations when your doctor decides that it is necessary to quickly neutralize the effect of dabigatran:

• For emergency surgical interventions or urgent procedures.
• In cases of potentially life-threatening or uncontrolled bleeding.

2. What you need to know before you are given Praxbind

Warnings and Precautions

Tell your doctor or nurse before you are given Praxbind:

• if you are allergic to idarucizumab or any of the other ingredients included in section 6.
• if you have a genetic disorder called hereditary fructose intolerance. In this case, the sorbitol contained in this medicine may cause serious adverse reactions.

These professionals will take these factors into account before treating you with Praxbind.

This medicine only removes dabigatran from your body. It does not remove other medicines used to prevent blood clot formation.

After dabigatran has been removed from your body, you will not be protected against blood clot formation. Your doctor will continue to treat you with medicines used to prevent blood clot formation as soon as your medical situation allows it.

Children and Adolescents

There is no information on the use of Praxbind in children.

Other Medicines and Praxbind

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

This medicine has been developed to bind only to dabigatran. It is unlikely that Praxbind will interfere with the effect of other medicines, or that other medicines will interfere with Praxbind.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine.

There is no information on the effects of this medicine in pregnant or breastfeeding women. Praxbind does not affect any function in the body as such, so your doctor may decide to administer this medicine if the expected benefits outweigh the potential risks.

Praxbind contains Sodium

This medicine contains 50 mg of sodium (main component of table/cooking salt) per dose. This is equivalent to 2.5% of the maximum recommended daily intake of sodium for an adult.

3. How Praxbind is given

This medicine is for hospital use only.

The recommended dose is 5 g (2 vials of 2.5 g/50 ml).

In rare cases, you may still have too much dabigatran in your blood after a first dose of this medicine, and your doctor may decide to administer a second dose of 5 g in specific situations.

Your doctor or nurse will administer this medicine by injection or infusion into a vein.

After receiving this medicine, your doctor will decide whether you should continue treatment to prevent blood clot formation. Dabigatran can be administered again 24 hours after administration of this medicine.

At the end of this leaflet, detailed instructions for the doctor or nurse on how to administer this medicine are included (see "Handling Instructions").

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

4. Possible Side Effects

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

So far, no side effects have been identified.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Praxbind

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial and carton after "EXP". The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect from light.

Once opened, this medicine is for immediate use.

6. Contents of the Pack and Other Information

Composition of Praxbind

• The active substance is idarucizumab.
• The other ingredients are: sodium acetate trihydrate (E262), acetic acid (E260, for pH adjustment), sorbitol (E420), polysorbate 20 (E432), and water for injections.

Appearance and Pack Contents

Praxbind is a clear to slightly opalescent and colorless to slightly yellow solution supplied in a glass vial closed with a butyl rubber stopper and an aluminum cap.

Each pack contains two vials.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Str. 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Birkendorfer Strasse 65

88397 Biberach an der Riss

Germany

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

Praxbind specifically binds to dabigatran and reverses its anticoagulant effect. It does not reverse the effects of other anticoagulants.

Treatment with Praxbind may be used in combination with other standard supportive measures, if these are deemed medically appropriate.

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

The recommended dose of Praxbind contains 4 g of sorbitol as an excipient. In patients with hereditary fructose intolerance, there is a risk of serious adverse reactions, which should be weighed against the benefit of emergency treatment with Praxbind. If Praxbind is administered to these patients, medical supervision should be intensified during exposure to Praxbind and within 24 hours after exposure to Praxbind.

Posology and Method of Administration:

The recommended dose is 5 g of idarucizumab (2 vials of 2.5 g/50 ml).

A second dose of 5 g of idarucizumab may be considered in the following situations:

• recurrence of clinically relevant bleeding together with prolonged coagulation times, or
• if a potential new bleed would be life-threatening and prolonged coagulation times are observed, or
• patients require a second emergency surgical intervention or urgent procedure and have prolonged coagulation times.

The main parameters of coagulation are activated partial thromboplastin time (aPTT), diluted thrombin time (dTT), or ecarin clotting time (ECT).

No maximum daily dose has been investigated.

Praxbind (2 vials of 2.5 g/50 ml) is administered intravenously in two consecutive infusions of 5 to 10 minutes each or as a rapid injection (bolus).

Patients receiving dabigatran treatment have underlying diseases that predispose them to thromboembolic events. Reversal of dabigatran treatment exposes patients to the risk of thrombosis derived from their underlying disease. To reduce this risk, resumption of anticoagulant treatment should be considered as soon as medically appropriate.

Treatment with dabigatran etexilate may be restarted 24 hours after administration of idarucizumab, provided the patient is clinically stable and adequate hemostasis has been achieved.

After administration of idarucizumab, another antithrombotic treatment (e.g., with low molecular weight heparin) may be initiated at any time, provided the patient is clinically stable and adequate hemostasis has been achieved.

Handling Instructions:

Praxbind must not be mixed with other medicines. For administration of Praxbind, a pre-existing intravenous line may be used. This line should be flushed with a 9 mg/ml sodium chloride solution (0.9%) before and after infusion. No other infusion should be administered in parallel through the same intravenous access.

Praxbind is for single use and does not contain preservatives.

Before use, the unopened vial may be stored at room temperature (up to 30°C) for up to 48 hours, if kept in the original packaging to protect from light. After opening the vial, the chemical and physical stability of idarucizumab has been demonstrated for 6 hours at room temperature (up to 30°C). The solution should not be exposed to light for more than 6 hours (in the unopened vial and/or in use).

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

No incompatibilities have been observed between Praxbind and infusion equipment made of polyvinyl chloride, polyethylene, or polyurethane, or with polypropylene syringes.