Dronedarone Disease Interactions

Dronedarone has shown to double the risk of death in patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure. It has also shown to double the risk of stroke and death and hospitalization due to heart failure in patients with atrial fibrillation. Other patients at risk include patients with second or third degree AV block, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker), patients with bradycardia < 50 bpm, and patients with QT interval prolongation. The use of dronedarone is contraindicated in these patients.

Dronedarone is extensively metabolized by the liver. There is little clinical experience with moderate hepatic impairment and none in patients with severe hepatic impairment. No dosage adjustment is recommended for patients with moderate hepatic impairment, however its use is contraindicated in patients with severe hepatic impairment. Additionally hepatocellular liver injury, including acute liver failure has been reported in patients using dronedarone in the postmarketing setting. Patients should be advised to report immediately any symptoms suggesting hepatic injury, such as anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine or itching.