No 5- Bempedoic acid - (NEXLETOL ) - (Feb 2020)

 PATIENT COUNSELING INFORMATION

Advise patients to read the FDA-approved patient labeling.

Risk of Hyperuricemia-                                                                                          Advise patients of the risk of elevated serum uric acid levels, including development of gout. Inform patients that serum uric acid levels may be monitored during treatment with NEXLETOL.

Patients with signs or symptoms of hyperuricemia should contact their healthcare provider if symptoms occur 

Risk of Tendon Rupture-                                                                                       Inform patients of the risk of tendon rupture.                                                           Advise patients to rest at the first sign of tendinitis or tendon rupture and to immediately contact their healthcare provider if tendinitis or tendon rupture symptoms occur 

Risk of Myopathy with Concomitant Use of Simvastatin or Pravastatin-                     Advise patients to notify their healthcare provider(s) if they are taking, or plan to take simvastatin or pravastatin.                                                                                          The risk of myopathy occurring with the use of simvastatin or pravastatin may be increased when taken with NEXLETOL. 

Pregnancy-                                                                                                               Advise pregnant women of the potential risk to a fetus based on NEXLETOL’s mechanism of action.                                                                                                Advise females to inform their healthcare provider of a known or suspected pregnancy 

Manufactured by: Piramal Healthcare UK Limited Northumberland NE61 3YA United Kingdom

Manufactured for: Esperion Therapeutics, Inc. 3891 Ranchero Drive, Suite 150 Ann Arbor, MI 48108