INDICATIONS AND USAGE FOR PRAXBIND
Praxbind® (idarucizumab) is indicated in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed:
For emergency surgery/urgent procedures
In life-threatening or uncontrolled bleeding
IMPORTANT SAFETY INFORMATION FOR PRAXBIND
WARNINGS AND PRECAUTIONS
Dabigatran-treated patients have underlying diseases predisposing them to thromboembolic events. Reversing dabigatran therapy exposes patients to thrombotic risk. Consider resumption of anticoagulant therapy as soon as medically appropriate.
Re-elevation of Coagulation Parameters
Elevated coagulation parameters (eg, activated partial thromboplastin time or ecarin clotting time) have been observed in a limited number of PRAXBIND-treated patients. If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed, or if patients requiring a second emergency surgery/urgent procedure have elevated coagulation parameters, an additional full dose may be considered.
There is insufficient clinical experience evaluating risk of hypersensitivity to idarucizumab, but a possible relationship could not be excluded. Risk of hypersensitivity (eg, anaphylactoid reaction) to idarucizumab or excipients needs to be weighed cautiously against the potential benefit. If serious allergic reaction occurs, immediately discontinue PRAXBIND and institute appropriate treatment.
Risk in Patients With Hereditary Fructose Intolerance
PRAXBIND contains 4 g sorbitol as an excipient. When prescribing PRAXBIND in patients with hereditary fructose intolerance, consider the total daily amount of sorbitol/fructose consumption from all sources, as serious adverse reactions (eg, hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure, and death) may occur.
The most frequently reported adverse reaction in ≥5% of idarucizumab-treated healthy volunteers was headache (5%). The most frequently reported adverse reactions in ≥5% of patients were constipation (7%) and nausea (5%).
Treatment-emergent antibodies with low titers were observed in 4% of healthy subjects and 2% of patients treated with idarucizumab.
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation
PRAXBIND should be given to a pregnant woman only if clearly needed. Caution should be exercised when PRAXBIND is administered to a nursing woman.
CL-PB-100001 April 2018
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