PRAXBIND SOLUTION FOR INJECTION/INFUSION 50 MG/ML [SIN15083P]

Product Info

PRAXBIND SOLUTION FOR INJECTION/INFUSION 50 MG/ML

[SIN15083P]

4.1 THERAPEUTIC INDICATIONS

Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa when rapid reversal of the anticoagulant effects of dabigatran is required:

• For emergency surgery/urgent procedures

• In life-threatening or uncontrolled bleeding

4.2 POSOLOGY AND METHOD OF ADMINISTRATION

Posology

The recommended dose of Praxbind is 5 g (2 x 2.5 g/50 ml)

Praxbind (2x2.5 g/50mL) is administered intravenously, as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.

In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab (see Pharmacological properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Administration of a second 5 g dose of Praxbind may be considered in the following situations:

• recurrence of clinically relevant bleeding together with prolonged clotting times, or

• if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or

• patients require a second emergency surgery/urgent procedure and have prolonged clotting times.

Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see Pharmacological properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

A maximum daily dose has not been investigated.

Restarting Antithrombotic Therapy
Pradaxa treatment can be re-initiated 24 hours after administration of Praxbind, if the patient is clinically stable and adequate hemostasis has been achieved.

After administration of Praxbind, other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate hemostasis has been achieved.

Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.

Patients with renal impairment
No dose adjustment is required in renally impaired patients. Renal impairment did not impact the reversal effect of idarucizumab.

Patients with hepatic impairment
No dose adjustment is required in hepatically impaired patients (see Pharmacokinetic – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Elderly
No dose adjustment is required in elderly patients aged 65 years and above (see Pharmacokinetic – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of Praxbind in children below the age of 18 years have not yet been established. No data are available.

Method of administration

Instructions for use/ handling

Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration.

Praxbind must not be mixed with other medicinal products. A pre-existing intravenous line may be used for administration of Praxbind. The line must be flushed with sterile sodium chloride 9 mg/ml (0.9 %) solution prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.

Praxbind is for single-use only and does not contain preservatives (storage condition, see 6.3 Shelf Life – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

No incompatibilities between Praxbind and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.

Traceability

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

4.3 CONTRAINDICATIONS

None.