Praxbind 2.5g Injection is used in adults taking Dabigatran when rapid reversal of its anticoagulant effect is required:

• Emergency surgery or urgent procedures: It can be used when a patient taking Dabigatran needs an urgent procedure that cannot safely be delayed.

• Life-threatening or uncontrolled bleeding: It is used when bleeding needs rapid reversal of Dabigatran's blood-thinning effect.

Praxbind specifically reverses the effects of Dabigatran. It does not reverse the effects of other blood-thinning medicines.

Praxbind 2.5g Injection contains Idarucizumab, which binds very strongly and specifically to Dabigatran and its active metabolites.

This forms a stable complex that prevents Dabigatran from exerting its blood-thinning effect. As a result, the anticoagulant activity of Dabigatran is rapidly neutralised, helping doctors manage serious bleeding or perform urgent procedures when necessary.

Praxbind specifically binds to Dabigatran and does not reverse the effects of other anticoagulants.

No clinically significant interactions with other medicines are expected based on its mechanism. However, tell your doctor about all medicines you are receiving, particularly:

• Other anticoagulants: Praxbind does not reverse medicines such as heparin, low-molecular-weight heparin, warfarin or factor Xa inhibitors.

• Blood-clotting factor concentrates: Medicines such as prothrombin complex concentrates or recombinant factor VIIa may be used when medically appropriate, but Praxbind does not neutralise their effects.

• Dabigatran: Treatment with Dabigatran may be restarted when your doctor considers it appropriate and adequate bleeding control has been achieved.

• Store Praxbind 2.5g Injection in a refrigerator at 2°C to 8°C.

• Do not freeze.

• Keep the vial in its original package to protect it from light.

• An unopened vial may be kept at room temperature up to 30°C for up to 48 hours when protected from light.

• Once the vial is opened, it should generally be used immediately. Chemical and physical stability has been demonstrated for up to 6 hours at room temperature.

• Praxbind is for single use only. Any unused medicine should be discarded according to local requirements.

Praxbind 2.5g Injection is given intravenously by a healthcare professional in a hospital.

The recommended dose is 5g of Idarucizumab, given as two 2.5g vials. The two vials are administered consecutively either as separate intravenous infusions over 5 to 10 minutes each or as consecutive bolus injections.

A second 5g dose may be considered in certain situations, such as when clinically significant bleeding returns with prolonged clotting times or when another emergency procedure is required.

After Praxbind is given, doctors may monitor blood-clotting tests and the patient's clinical condition to check whether the anticoagulant effect has been adequately reversed.

Common side effects

Side effects reported in patients receiving Praxbind have included:

• Constipation

• Nausea

• Headache

• Low potassium levels

• Confusion or delirium

• Fever

• Pneumonia

Some of these effects may also be related to the serious illness or emergency condition for which Praxbind is being given.

Serious side effects

• Thromboembolic events: Reversing Dabigatran removes its protective blood-thinning effect, which can increase the risk of blood clots related to the patient's underlying condition.

• Severe allergic reactions: Hypersensitivity reactions, including serious allergic reactions, may occur.

• Reappearance of anticoagulant activity: Dabigatran activity may return in some patients, which can lead to recurrent bleeding or require further treatment.

• Serious reactions in hereditary fructose intolerance: Praxbind contains sorbitol. People with hereditary fructose intolerance may develop serious metabolic reactions after receiving it.

Seek immediate medical attention for difficulty breathing, swelling, severe rash, sudden chest pain, sudden weakness, severe headache or other symptoms suggesting an allergic reaction or blood clot.

• Praxbind 2.5g Injection is an emergency reversal medicine and should only be administered under medical supervision.

• The usual complete dose is 5g, requiring two 2.5g vials.

• Tell your doctor if you have hereditary fructose intolerance, as Praxbind contains sorbitol.

• Your healthcare team may repeat clotting tests after treatment because Dabigatran activity can return in some patients.

• Reversal of Dabigatran also removes its protection against blood clots. Anticoagulant treatment should therefore be restarted when your doctor considers it medically appropriate.

• Tell your doctor about all anticoagulants and other medicines you are receiving. Praxbind only reverses the effect of Dabigatran.

• The name and batch number of the product should be recorded to maintain treatment traceability.