There are no contraindications to idarucizumab use, although there are precautions.
When there are precautions, risk of idarucizumab use needs to be weighed against the potential benefit of emergency treatment.1
A summary of idarucizumab precautions is provided below. See the idarucizumab Product Information for complete information.1
Thromboembolic events: reversal of dabigatran exposes patients to the thrombotic risk of their underlying disease.
Hereditary fructose intolerance: the recommended dose of idarucizumab contains 4 g sorbitol as an excipient.
Urinary protein testing: idarucizumab causes transient proteinuria as a physiological reaction to renal protein overflow.
Re-elevation of coagulation parameters: in a limited number of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant elevated coagulation parameters have occurred up to 24 hours after idarucizumab administration.
Sodium: idarucizumab contains 2.2 mmol (50 mg) of sodium per dose, which should be taken into consideration for patients on a controlled sodium diet.
Based on pharmacokinetic analyses in healthy volunteers, sex, age, race and body weight are not expected to have a clinically meaningful effect on the pharmacokinetics of idarucizumab.1
Idarucizumab may be used during pregnancy, if the expected clinical benefit outweighs the potential risks.1
The safety and efficacy of idarucizumab in children has not been established.1
No dose adjustment is required in patients with renal impairment, and hepatic impairment is not expected to impact the pharmacokinetics of idarucizumab.1
Safety data from RE-VERSE AD
Safety data for idarucizumab are limited, although no safety concerns have been identified to date.5,6
In RE-VERSE AD, after 90 days of follow-up, thrombotic events had occurred in 6.3% in group A (bleeds group) and 7.4% in group B (surgery group), and mortality rates were 18.8% and 18.9% respectively.5,6
Serious adverse events that occurred within 5 days of treatment with idarucizumab were reported 23.3% of patients (n = 117), with 21.9% (n = 66) in group A and 25.2% (n = 51) in group B.5 Most of the events appeared to be a worsening of the initial index event (ie, a major bleed or condition requiring surgery). The most common events were delirium for group A (occurring in 2.3% of patients) and cardiac arrest and septic shock for group B (3.5% and 3% of patients, respectively).
The number of deaths that occurred within 5 days of treatment was 19 (6.3%) in group A and 16 (7.9%) in group B. The event leading to death varied across groups, with intracranial haemorrhage being the main event for the group A. Wider variation in events leading to death was noted in group B, with peritonitis, gastrointestinal necrosis, sepsis, infection, septic shock, small bowel obstruction, and cardiac arrest as some examples.