What is idarucizumab, and how does it work (mechanism of action)?
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.
What brand names are available for idarucizumab?
Praxbind
Is idarucizumab available as a generic drug?
No
Do I need a prescription for idarucizumab?
Yes
What are the uses for 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).
What are the side effects of idarucizumab?
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.
What is the dosage for idarucizumab?
- The recommended dose of idarucizumab is 5 g (2 vials) given as two 2.5 mg
intravenous infusions or two injections. - An additional 5 g may be considered for patients who continue to bleed.
Which drugs or supplements interact with idarucizumab?
- There are no known drug interactions for idarucizumab.
Is idarucizumab safe to take if I’m pregnant or breastfeeding?
- 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 else should I know about idarucizumab?
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.