This episode is brought to you by Heron Therapeutics. Please see full Prescribing Information, including Boxed Warning or visit www.ZYNRELEF.com.
Dr. Alexander Sah joins for this episode from Sah Orthopaedic Associates at theInstitute for Joint Restoration in Fremont, CA. He is an orthopedic surgeon, specializing in minimally invasivehip and knee replacements,knee arthroscopy, as well as complex hip and knee revision surgeries.
-We hear about his patient-first emphasis with thorough and compassionate care. He has a deep commitment to the Bay Area community going home to practice at the same hospital he was born, Washington Hospital.
-We discuss his family influence in becoming a physician with his uncles, grandfather, and father practicing medicine. He completed his orthopedic training at Harvard in Boston and specialized fellowship training in minimally invasive and revision hip and knee surgery at Rush University in Chicago.
-Dr. Sah has built his brand with minimally invasive surgery where patients seek him out as a destination practice at Sah Orthopaedic Associates.
-We talk ambulatory surgery centers (ASCs) and answer these questions: Is it safe? Is it cost effective? What is the patient satisfaction?
-Dr. Sah discusses his interest in orthopedic research and remains active in publishing articles and presenting this work at national meetings. He worked with Heron Therapeutics as an expert in total knee replacement as the company developed the pivotal clinical study program to help inform FDA submissions and meet FDA guidelines for ZYNRELEF. ZYNRELEF utilizes a novel synergistic mechanism of action that combines bupivacaine with a low dose of meloxicam to overcome the challenges of the inflammatory process at the surgical site. ZYNRELEF is the first and only extended-release dual-acting local anesthetic (DALA) and delivers 72 hours of postoperative pain relief via a single needle-free application. It has been clinically proven to better manage pain than standard of care bupivacaine HCl solution over 72 hours and to significantly reduce opioid utilization following surgery.
-ZYNRELEF was initially approved by the FDA in May 2021 and in December 2021, the FDA approved an expansion of ZYNRELEF’s indication.
-Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use
• ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery
• NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events
ZYNRELEF is contraindicated for:
• Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components of ZYNRELEF OR history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
• Patients undergoing obstetrical paracervical block anesthesia OR coronary artery bypass graft (CABG) surgery
WARNINGS AND PRECAUTIONS include –
Cardiovascular (CV) Thrombotic Events with NSAID Use; Gastrointestinal Bleeding, Ulceration, and Perforation with NSAID Use; Dose-Related Toxicity; Risk of Use in Patients with Impaired Cardiovascular Function; Hepatotoxicity; Hypertension; Heart Failure and Edema; Renal Toxicity and Hyperkalemia; Anaphylactic Reactions; Chondrolysis; Methemoglobinemia; Exacerbation of Asthma Related to Aspirin Sensitivity; Serious Skin Reactions; Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); Hematologic Toxicity; Masking of Inflammation and Fever.
Find out more about Dr. Alexander Sah here.