Dofetilide (Tikosyn) is an oral anti-arrhythmic medication approved by the Food and Drug Administration (FDA) in 1999 for the management of persistent atrial fibrillation and flutter. A cautionary statement describing the side effect profile, including life-threatening arrhythmias and conduction abnormalities as well as monitoring strategies, accompanied the drug’s approval. The dofetilide package insert contains a black box warning that addresses the special requirements for initiation of the drug and prescribing and dispensing privileges. 1 As part of the warning, the FDA required that a distribution and education program for prescribers be developed to minimize the risk of potentially life-threatening arrhythmia as a condition for approval of dofetilide in the United States. In response, Pfizer developed a risk-management program that: 1) restricts dofetilide initiation to hospitalized patients, 2) places restrictions on outpatient dispensing, 3) requires prescribing physicians, physician assistants, and nurse practitioners complete an educational program on dofetilide, and 4) directs that healthcare institutions establish detailed dosing and monitoring recommendations for the drug. Additional information on this program can be found at www.tikosyn.com. Dofetilide is available only to hospitals and prescribers who have received appropriate dofetilide dosing and treatment initiation education. Retail pharmacies must be enrolled in the TIPS’ (Tikosyn in Pharmacy System) program in order to stock and dispense dofetilide. The black box warning also states that healthcare facilities should provide continuous electrocardiographic (ECG) monitoring, creatinine clearance calculation, and have cardiac resuscitation capability during the first 3 days of initiation and re-initiation of dofetilide. Indications Dofetilide is indicated for the conversion to and maintenance of normal sinus rhythm in patients with persistent atrial fibrillation or atrial flutter. Dofetilide should be used only in highly symptomatic patients (eg, palpitations, chest pain, dyspnea, fatigue, lightheadedness, syncope, and heart failure exacerbation) because of the risk of life-threatening ventricular arrhythmias associated with its administration. Adequate ventricular rate control can be achieved by using such agents as � -blockers (eg, esmolol or metroprolol), calcium channel blockers (such as diltiazem or verapamil), or digoxin. Management of atrial fibrillation