Praxbind

Package leaflet: Information for the patient and user

Praxbind 2.5 g/50 mL concentrate for solution for infusion

idarucizumab
Please read this leaflet carefully as it contains important information for you. This
medicine is used mainly in emergency situations and your doctor has already decided that
you need this treatment.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What Praxbind is and what it is used for

What Praxbind is
Praxbind contains the active substance idarucizumab. Idarucizumab is a specific inactivator of
dabigatran, a medicine used to thin the blood by blocking a substance in the body involved in blood
clot formation.
Praxbind specifically binds to dabigatran in order to neutralize its effect.

What Praxbind is used for
Praxbind is used in adults in emergency situations where the doctor decides that rapid inactivation of dabigatran’s effect is necessary:

• during emergency surgery/urgent procedures;
• in cases of uncontrolled or life-threatening bleeding.

2. What you need to know before receiving Praxbind

Warnings and precautions
Talk to your doctor or nurse before using Praxbind.

• if you are allergic to idarucizumab or to any of the other ingredients of this medicine (listed in section 6).
• if you have a genetic condition called hereditary fructose intolerance. In this case, the sorbitol contained in this medicine may cause serious adverse reactions. They will take these factors into consideration before treating you with Praxbind.

This medicine removes only dabigatran from the body. It does not remove other medicines used to
prevent blood clot formation.
After dabigatran has been removed from the body, you are no longer protected against blood clot
formation. Your doctor will resume treatment with medicines used to prevent blood clot formation as
soon as your clinical condition allows.
Children and adolescents
There is no information available 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 exclusively to dabigatran. It is unlikely that Praxbind will affect the action of other medicines or that other medicines will affect the action of Praxbind.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
There is no information available on the effects of this medicine in pregnant or breastfeeding women. Praxbind itself has no effect on body functions; therefore, 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 (a main component of table salt) per dose.
This is equivalent to 2.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use Praxbind

This medicinal product is intended for hospital use only.
The recommended dose is 5 g (2 vials of 2.5 g/50 mL).
In rare cases, after administration of the first dose of this medicinal product, you may still have excessive levels of dabigatran in your blood, and the doctor, in specific situations, may decide to administer a second 5 g dose.
Your doctor or nurse will administer this medicinal product to you as an injection or infusion into a vein.
After you have received this medicinal product, your doctor will decide whether to continue treatment to prevent blood clots from forming. Dabigatran may be re-administered 24 hours after administration of this medicinal product.
Detailed information for the doctor or nurse on how to administer this medicinal product is provided at the end of this leaflet (see “Instructions for handling”).
If you have any doubts about the use of this medicinal product, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To date, no side effects have been identified.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 after EXP and on the
carton after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep in the original packaging to protect from light.
Once opened, this medicine should be used immediately.

6. Package contents and other information

What Praxbind contains

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

Description of the appearance of Praxbind and contents of the pack
Praxbind is a solution ranging from clear to slightly opalescent, colourless to slightly yellow,
supplied in a glass vial closed with a butyl rubber stopper and an aluminium seal.
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

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

België/Belgique/Belgien Lietuva
Boehringer Ingelheim SComm Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ – Boehringer Ingelheim SComm
клон България Tél/Tel: +32 2 773 33 11
Тел: +359 2 958 79 98

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel: +36 1 299 89 00

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf: +45 39 15 88 88 Tel: +353 1 295 9620

Deutschland Nederland
Boehringer Ingelheim Pharma GmbH & Co. KG Boehringer Ingelheim B.V.
Tel: +49 (0) 800 77 90 900 Tel: +31 (0) 800 22 55 889

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Danmark
Eesti filiaal Norwegian branch
Tel: +372 612 8000 Tlf: +47 66 76 13 00

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Boehringer Ingelheim RCV GmbH & Co KG
A.E. Tel: +43 1 80 105-7870
Tηλ: +30 2 10 89 06 300

España Polska
Boehringer Ingelheim España S.A. Boehringer Ingelheim Sp. z o.o.
Tel: +34 93 404 51 00 Tel: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S. Boehringer Ingelheim Portugal, Lda.
Tél: +33 3 26 50 45 33 Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +385 1 2444 600 Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +353 1 295 9620 Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor ehf. Boehringer Ingelheim RCV GmbH & Co KG
Sími: +354 535 7000 organizačná zložka
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A. Boehringer Ingelheim Finland Ky
Tel: +39 02 5355 1 Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Boehringer Ingelheim AB
A.E. Tel: +46 8 721 21 00
Tηλ: +30 2 10 89 06 300

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Ireland Ltd.
Latvijas filiāle Tel: +353 1 295 9620
Tel: +371 67 240 011

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

The following information is intended exclusively for healthcare professionals:

Praxbind specifically binds to dabigatran and inactivates its anticoagulant effect. It does not inactivate the effects of other anticoagulants.
Treatment with Praxbind may be used concomitantly with standard supportive measures considered clinically appropriate.
To improve traceability of biological medicinal products, the name and batch number of the administered product must be clearly documented.
The recommended dose of Praxbind contains 4 g of sorbitol as an excipient. In patients with hereditary fructose intolerance, there is a risk of severe adverse reactions, which must be weighed against the benefit of emergency treatment with Praxbind. If Praxbind is administered to these patients, intensified medical care is required during exposure to Praxbind and for 24 hours following exposure.

Dosage and administration
The recommended dose is 5 g of idarucizumab (2 vials of 2.5 g/50 mL).
Administration of a second 5 g dose of idarucizumab may be considered in the following situations:

• in the presence of recurrent clinically relevant bleeding with prolonged coagulation times, or
• if recurrence of bleeding is potentially life-threatening and prolonged coagulation times are observed, or
• if patients require a second emergency surgical intervention/second urgent procedure and have prolonged coagulation times.

Coagulation parameters to consider are activated partial thromboplastin time (aPTT), diluted thrombin time (dTT), or ecarin clotting time (ECT).
The maximum daily dose has not been studied.
Praxbind (2 vials of 2.5 g/50 mL) is administered intravenously either as two consecutive infusions of 5–10 minutes each or as an intravenous bolus injection.

Patients receiving dabigatran therapy have underlying medical conditions that predispose them to thromboembolic events. Inactivation of the anticoagulant effect of dabigatran exposes patients to the thrombotic risk inherent to their underlying condition. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as clinically appropriate.
Dabigatran etexilate therapy 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, alternative antithrombotic therapy (e.g., low molecular weight heparin) may be initiated at any time, provided the patient is clinically stable and adequate hemostasis has been achieved.

Instructions for handling
Praxbind must not be mixed with other medicinal products. A pre-existing intravenous line may be used for administration of Praxbind. The intravenous line must be flushed before and after infusion with an injectable solution of sodium chloride 9 mg/mL (0.9%).
Other infusions must not be administered simultaneously using the same intravenous access.
Praxbind is for single use only and contains no preservatives.
Prior to use, the unopened vial may be stored at room temperature (up to 30°C) for a maximum of 48 hours, provided it is kept in the original packaging to protect from light. After opening the vial, the chemical and physical stability of idarucizumab during use has been demonstrated for 6 hours at room temperature (up to 30°C). The solution must not be exposed to light for more than 6 hours (in the closed vial and/or during use).
From a microbiological standpoint, the product should be used immediately after opening, unless the method of opening excludes the risk of microbial contamination. If not used immediately, the user is responsible for the storage duration and conditions prior to administration.
No incompatibilities have been observed between Praxbind and infusion sets made of polyvinyl chloride, polyethylene, or polyurethane, or polypropylene syringes.