Coagulation factor Xa (recombinant), inactivated-zhzo (andexanet alfa; Andexxa – Portola) has received accelerated approval from the FDA for urgent reversal of the anticoagulant effect of the direct factor Xa inhibitors apixaban (Eliquis) and rivaroxaban (Xarelto). Andexanet alfa is the second antidote for a direct oral anticoagulant to become available in the US, and the first for factor Xa inhibitors. Idarucizumab (Praxbind) was approved in 2015 for reversal of the anticoagulant effect of the direct thrombin inhibitor dabigatran etexilate (Pradaxa).1 Andexanet alfa has not been approved to date for reversal of anticoagulation with the direct factor Xa inhibitors edoxaban (Savaysa)2 or betrixaban (Bevyxxa).3

BLEEDING WITH FACTOR Xa INHIBITORS — As with all anticoagulants, severe, potentially...  Continue reading

The FDA has approved erenumab-aooe (Aimovig – Amgen/Novartis), a once-monthly, subcutaneously-injected, monoclonal antibody against the calcitonin gene-related peptide receptor, for preventive treatment of migraine in adults. It is the first drug in its class to be approved by the FDA.

MIGRAINE PREVENTION — Patients with frequent or severe disabling migraine headaches and those who cannot take or are refractory to acute treatment should receive preventive treatment.1,2

Beta blockers and antiepileptic drugs are commonly used for prevention of migraine, but some patients find their adverse effects difficult to tolerate. Propranolol (Inderal LA, and others) and timolol are the only beta blockers that are FDA-approved for this indication, but metoprolol (Lopressor, and others), ... Continue reading