idarucizumab

Idarucizumab (Praxbind) is an antibody used for reversing the effect of Pradaxa (dabigatran) for emergency surgery/urgent procedures or if life-threatening or uncontrolled bleeding occurs while taking dabigatran. Dabigatran is an anticoagulant (blood thinner) that is used for preventing blood clots in people with non-valvular atrial fibrillation and for treating deep venous thrombosis (DVT) and pulmonary embolism (PE).

Dabigatran prevents blood clots by binding to thrombin and preventing thrombin from combining with other proteins to form a blood clot. Dabigatran increases the risk of bleeding because it reduces the ability of blood to clot. Patients who are taking dabigatran may develop serious or life threatening bleeding or may require surgery urgently. In such situations the effect of dabigatran needs to be reversed so that blood can clot normally.

Idarucizumab reverses the effect of dabigatran by binding to Pradaxa and preventing it from binding to thrombin, allowing blood to clot normally. The FDA approved idarucizumab on October 2015.

Common side effects of idarucizumab include:

• Headache
• Low blood potassium
• Delirium
• Constipation
• Fever
• Pneumonia

Other reported side effects include:

• Allergic reactions
• Increased levels of laboratory markers for blood clotting
• Idarucizumab antibodies

Possible serious side effects of idarucimab include:

• Reversing the effect of dabigatran removes the protective effect of dabigatran in people who are at risk for blood clots. Therefore, anticoagulation should be started as soon as possible after treatment with idarucizumab.
• If patients continue to bleed or require a second emergency surgery/urgent procedure, an additional 5 g dose of idarucizumab may be considered.
• Idarucizumab contains sorbitol. Patients with hereditary fructose intolerance may be at risk for adverse reactions. 

The recommended dose of idarucizumab is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab (see Figure 1). Both vials are packaged together in one carton.

For intravenous use only.

There is limited data to support administration of an additional 5 g of idarucizumab.

• There are no known drug interactions for idarucizumab.

• There are no adequate or well-controlled trials of idarucizumab use in pregnant women. Therefore, idarucizumab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• It is not known if idarucizumab is excreted into human milk.

What preparations of idarucizumab are available?

• Solution for injection: Two single use vials each containing 2.5 g/50 ml.

How should I keep idarucizumab stored?

• Store idarucizumab vials in the refrigerator at 2 C to 8 C (36 F to 46 F).
• Do not freeze.
• Do not shake.