Patient Information Leaflet: Information for the Patient and User

Praxbind 2.5g/50ml Injectable Solution and for Infusion

idarucizumab

Read this leaflet carefully before use, as it contains important information for you. Note that this medicine is mainly used in emergency situations in which your doctor has decided that you need it.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor or nurse,even if they are not listed in this leaflet. See section4.

1. What isPraxbindand for what it is used

2. What you need to know before starting toreceive Praxbind

3. How touse Praxbind

4. Possible side effects

5. Storage ofPraxbind

6. Contents of the package and additional information

What is Praxbind

Praxbind contains the active ingredient idarucizumab.Idarucizumabis a specific reversal agent for dabigatran, a medication that thins the blood and blocks a substance in the body that intervenes in the formation of blood clots.

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

What is Praxbind 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.
• For potentially life-threatening or uncontrolled bleeding.

Warnings and precautions

Inform your doctor or nursebefore starting to receive Praxbind:

• If you are allergic to idarucizumab or to any of the other components included in section6.
• If you have a genetic disease called hereditary fructose intolerance. In this case, the sorbitol substance contained in this medication may cause severe adverse reactions.

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

This medication only eliminates dabigatran from your body. It does not eliminate other medications used to prevent blood clot formation.

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

Children and adolescents

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

Other medications and Praxbind

Inform your doctor if you are taking, have takenrecently or may have to take any other medication.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctorbefore receiving this medication.

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

Praxbind contains sodium

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

This medication is for hospital use only.

The recommended dose is 5g (2vials of2,5g/50ml).

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

Your doctor or nurse will administer this medication through injection or infusion into a vein.

After receivingthis medication, your doctor will decide if you should continue treatment to prevent blood clot formation.Dabigatránmay be administered again 24hoursafter administration ofthis medication.

At the end of this leaflet, detailed instructions for the doctor or nurse on how to administerthis medicationare included (see “Handling Instructions”).

If you have any other questions about using this medication, ask your doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Up to now, no adverse effects have been identified.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is possible adverse effects that do not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the vial and on the box after “CAD”. The expiration date is the last day of the month indicated.

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

Do not freeze.

Store in the original packaging to protect it from light.

Once opened, this medication is for immediate use.

Composition of Praxbind

• The active ingredient is idarucizumab.
• The other components are: sodium acetate trihydrate (E262), acetic acid (E260, for pH adjustment), sorbitol (E420), polisorbate 20 (E432) and water for injection.

Appearance of the product and contents of the pack

Praxbind is a transparent to slightly opalescent and colourless to slightly yellowish solution supplied in a closed glass vial with a butyl rubber stopper and an aluminium cap.

Each pack contains two vials.

Marketing authorisation holder

Boehringer Ingelheim International GmbH

Binger Str. 173

55216 Ingelheim am Rhein

Germany

Responsible for manufacturing

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

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

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

The treatment with Praxbind can be used in combination with other standard supportive measures, if these are considered medically appropriate.

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

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

Dosage and administration:

The recommended dose is 5g of idarucizumab (2vials of2,5g/50ml).

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

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

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

No maximum daily dose has been investigated.

Praxbind (2vials of2,5g/50ml) is administered by intravenous infusion over 5to10minutes or as a rapid bolus injection.

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

Dabigatran etexilate treatment may be reinitiated 24hours after administration ofidarucizumab, provided the patient is clinically stable and haemostasis is adequate.

After administration ofidarucizumab, another antithrombotic treatment (e.g. with low molecular weight heparin) may be initiated at any time, provided the patient is clinically stable and haemostasis is adequate.

Handling instructions:

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

Praxbind is for single use only and does not contain preservatives.

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

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

No incompatibilities have been observed between Praxbind and PVC, polyethylene or polyurethane infusion equipment, or with polypropylene syringes.