Pfizer is reporting a shortage of Tikosyn (dofetilide) 0.25mg and 0.5mg capsules. This product outage is a result of an unforeseen manufacturing issue coupled with distribution regulations and is not the result of any efficacy or safety concerns relating to Tikosyn. In efforts to bridge this shortage, healthcare professionals are advised to substitute four 0.125mg strength capsules for one 0.5mg capsule, as confirmed by a bioequivalence study. There is no bioequivalence study directly comparing Tikosyn 0.125mg and 0.25mg.
Tikosyn 0.25mg and 0.5mg capsules are expected to be available for re-order soon, but healthcare professionals are encouraged to refrain from placing new patients on Tikosyn until then. Tikosyn is indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of >1 week and for the conversion of atrial fibrillation/atrial flutter to normal sinus rhythm.
For more information call (800) 438-1985 or visit www.tikosyn.com.