Posted from: Wednesday, April 29, 2015 - 11:27 AM - Present

Corlanor Approved for Heart Failure

April 15, 2015 - The U.S. Food and Drug Administration (FDA) approved Corlanor (ivabradine) manufactured by Amgen. Corlanor is indicated to decrease the risk of hospitalization due to worsening heart failure for chronic heart failure patients who already are taking the highest tolerated beta blocker dose. Corlanor will be used for stable patients who have symptoms of chronic heart failure, resting heart rates of at least 70 beats per minute and left ventricular ejection fractions (LVEFs) of 35% or lower. After two weeks on a recommended starting dose of one 5mg tablet twice a day with a meal, doses may be increased to an upper limit of 7.5mg twice a day to achieve a resting heart rate between 50 beats and 60 beats per minute.

Corlanor is the first drug in a new class called hyperpolarization-activated cyclic nucleotide-gated channel (HCN) blockers. It blocks a specific ionic current that activates the sinoatrial node, which is the pacemaker for the heart. HCN blockers slow down heart rate without affecting heart contractions or blood vessel constriction. Corlanor also blocks retinal ion channels that are highly similar to those in the sinoatrial node. As a result, 30 days to 60 days after beginning to take Corlanor, about 15% of patients in clinical trials experienced phosphenes, also called luminous phenomena. Affected patients sometimes saw multiple or distorted images; bright, colored or flashing lights; halos around bright objects and other kinds of visual disturbances. Phosphenes were not considered major by most patients who experienced them and most disappeared during or after treatment.  Corlanor is expected to launch late April 2015 and is expected to cost approximately $4,500 annually.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Wednesday, October 23, 2019 - 04:29 PM.