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IMPORTANT SAFETY INFORMATION AND INDICATION FOR PRAXBIND

WARNINGS AND PRECAUTIONS

Thromboembolic Risk

• Dabigatran-treated patients have underlying diseases predisposing them to thromboembolic events. Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.

Re-elevation of Coagulation Parameters

• Elevated coagulation parameters (e.g., 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.

Hypersensitivity Reactions

• There is insufficient clinical experience evaluating risk of hypersensitivity to idarucizumab, but a possible relationship could not be excluded. Risk of hypersensitivity (e.g., 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 (e.g. hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure and death) may occur.

ADVERSE REACTIONS

• The most frequently reported adverse reaction in ≥5% of idarucizumab-treated healthy volunteers was headache (12/224). The most frequently reported adverse reactions in ≥5% of patients were hypokalemia (9/123), delirium (9/123), constipation (8/123), pyrexia (7/123) and pneumonia (7/123).
• As with all proteins there is a potential for immunogenicity with idarucizumab. In treated patients, treatment-emergent antibodies with low titers were observed (9/224).

USE IN SPECIFIC POPULATIONS

Pregnancy and Nursing Mothers

• PRAXBIND should be given to a pregnant or nursing woman only if clearly needed.

INDICATIONS AND USAGE

PRAXBIND 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

This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study.

Please click here for full Prescribing Information for PRAXBIND.

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Praxbind^®, PRAXBIND with associated design ^®, Pradaxa^®, and RE-VERSE AD™ under license.

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