Becker's Spine Review

9 SPINE SURGEONS • In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL ) of EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block. Local Analgesia via Infiltration Dosing in Pediatric Patients The recommended dose of EXPAREL for single-dose infiltration in pediatric patients, aged 6 to less than 17 years, is 4 mg/kg (up to a maximum of 266 mg), and is based upon two studies of pediatric patients undergoing either spine surgery or cardiac surgery. Regional Analgesia via Interscalene Brachial Plexus Nerve Block Dosing in Adults The recommended dose of EXPAREL for interscalene brachial plexus nerve block in adults is 133 mg (10 mL), and is based upon one study of patients undergoing either total shoulder arthroplasty or rotator cuff repair. Compatibility Considerations Admixing EXPAREL with drugs other than bupivacaine HCl prior to administration is not recommended. • Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. • Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2. The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. • When a topical antiseptic such as povidone iodine (e.g., Betadine ® ) is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution. Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL. Non-Interchangeability with Other Formulations of Bupivacaine Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa. Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug's functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute. CLINICAL PHARMACOLOGY Pharmacokinetics Administration of EXPAREL results in significant systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration. Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy. PATIENT COUNSELING Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue. Pacira Pharmaceuticals, Inc. San Diego, CA 92121 USA Patent Numbers: 6,132,766 5,891,467 5,766,627 8,182,835 Trademark of Pacira Pharmaceuticals, Inc. For additional information call 1-855-RX-EXPAREL (1-855-793-9727) Rx only March 2021 Spine surgeon advises New York Jets player to retire at 24 By Carly Behm N ew York Jets offensive lineman Cameron Clark is retiring at age 24 aer suffer- ing a spinal cord injury that sidelined him for the 2021 season, ESPN reported Feb. 2. Mr. Clark suffered a spinal cord contusion in training camp Aug. 3. Although he is ex- pected to recover, continuing to play puts him at risk of paralysis. e prognosis came from Andrew Hecht, MD, of New York City-based Mount Sinai. "Based on the advice of Dr. Andrew Hecht … Cameron will not be able to continue to play football for the New York Jets," Mr. Clark's agent, Alan Herman, told ESPN. Dr. Hecht is director of the NFL Spine Care Program for retired players and oversees the acute spinal injury program for the Jets. He is also one of two orthopedic surgeons on the NFL Brain and Spine Committee. n 'I've got bad news for you': Spine surgery delayed after patient waits three hours on gurney By Laura Dyrda N onurgent surgeries across the U.S. have been canceled as COVID-19 cases surge and hospitals face critical staffing shortages. Most of the time, the surgeries are canceled well in advance. But for one patient in California, that wasn't the case. Joe Sanders, a 74-year-old patient, was prepped for his spine sur- gery and left waiting on a gurney for three hours before being told he wouldn't be able to undergo the procedure, according to a Cal Mat- ters report. "I have some bad news for you," Mr. Sanders' surgeon told him at his bedside. The surgery would have to be postponed because there wasn't enough operating room staff. In January, around 25 percent of U.S. hospitals had a critical staffing shortage, according to HHS, with California updating its policy to allow healthcare workers who test positive for COVID-19, but are asymptom- atic, to return to work immediately. n

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