FAST FACTS...2011/08/12  · FAST FACTS EXPAREL provides long-lasting pain control that reduces...

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FAST FACTS EXPAREL provides long-lasting pain control that reduces opioid requirements… without the need for catheters and pumps that may hinder recovery 1-9 Indicated for administration into the surgical site to produce postsurgical analgesia Indication supports broad use across surgical procedures The clinical benefit of the decrease in opioid consumption has not been demonstrated Innovative DepoFoam ® technology delivers bupivacaine over time to extend pharmacologic effect 10 Encapsulates bupivacaine via a multivesicular liposomal drug delivery technology and releases over time as lipid membranes reorganize 10 Dosing and Preparation EXPAREL is intended for single-dose administration only and is available as a 20 mL single-use vial (1.3%, 266 mg/20 mL) The recommended dose of EXPAREL is based on the following factors: Size of the surgical site Volume required to cover the area Individual patient factors that may impact the safety of an amide local anesthetic Maximum dose should not exceed 266 mg (one 20 mL vial) Volume can be expanded to accommodate larger surgical sites A 20 mL vial of EXPAREL can be administered undiluted or expanded up to a total of 300 mL with normal (0.9%) saline or lactated Ringer’s solution Bupivacaine HCl may be administered immediately before EXPAREL or admixed in the same syringe, as long as the ratio of the milligram dose of bupivacaine HCl to EXPAREL does not exceed 1:2 In determining this ratio, consider the following: One 20 mL vial of EXPAREL contains 266 mg of free base bupivacaine; 266 mg of free base bupivacaine is molar equivalent to 300 mg of bupivacaine HCl One 30 mL vial of 0.5% bupivacaine contains 150 mg bupivacaine HCl Admixing may impact the pharmacokinetic and/or physiochemical properties of EXPAREL, and this effect is concentration dependent The toxic effects of these drugs are additive and their administration should be used with caution, including monitoring for neurological and cardiovascular effects related to toxicity Vials of EXPAREL should be inverted multiple times to re-suspend the particles immediately prior to withdrawal from the vial Administration EXPAREL should be injected slowly into soft tissues of the surgical site using a deep tissue infiltration technique with frequent aspiration to check for blood and minimize the risk of intravascular injection Administer with a 25-gauge or larger-bore needle Use a series of injections to effectively cover the surgical area Compatibility Considerations Wait 20 minutes after administration of other non-bupivacaine– based local anesthetics before administering EXPAREL into the same surgical site Allow topical antiseptics to dry before administering EXPAREL into the same surgical site Other than bupivacaine, EXPAREL should not be admixed with other drugs prior to administration Please see Important Safety Information on reverse and see accompanying full Prescribing Information.

Transcript of FAST FACTS...2011/08/12  · FAST FACTS EXPAREL provides long-lasting pain control that reduces...

Page 1: FAST FACTS...2011/08/12  · FAST FACTS EXPAREL provides long-lasting pain control that reduces opioid requirements… without the need for catheters and pumps that may hinder recovery1-9

FAST FACTSEXPAREL provides long-lasting pain control that reduces opioid requirements… without the need for catheters and pumps that may hinder recovery1-9

• Indicated for administration into the surgical site to produce postsurgical analgesia

— Indication supports broad use across surgical procedures• The clinical benefit of the decrease in opioid consumption has not

been demonstrated• Innovative DepoFoam® technology delivers bupivacaine over

time to extend pharmacologic effect10

— Encapsulates bupivacaine via a multivesicular liposomal drug delivery technology and releases over time as lipid membranes reorganize10

Dosing and Preparation• EXPAREL is intended for single-dose administration only and is available as a 20 mL single-use vial (1.3%, 266 mg/20 mL)• The recommended dose of EXPAREL is based on the following factors: — Size of the surgical site — Volume required to cover the area — Individual patient factors that may impact the safety of an amide local anesthetic — Maximum dose should not exceed 266 mg (one 20 mL vial)• Volume can be expanded to accommodate larger surgical sites — A 20 mL vial of EXPAREL can be administered undiluted or expanded up to a total of 300 mL with normal (0.9%) saline

or lactated Ringer’s solution• Bupivacaine HCl may be administered immediately before EXPAREL or admixed in the same syringe, as long as the

ratio of the milligram dose of bupivacaine HCl to EXPAREL does not exceed 1:2 — In determining this ratio, consider the following: – One 20 mL vial of EXPAREL contains 266 mg of free base bupivacaine; 266 mg of free base bupivacaine is molar

equivalent to 300 mg of bupivacaine HCl – One 30 mL vial of 0.5% bupivacaine contains 150 mg bupivacaine HCl — Admixing may impact the pharmacokinetic and/or physiochemical properties of EXPAREL, and this effect

is concentration dependent — The toxic effects of these drugs are additive and their administration should be used with caution, including

monitoring for neurological and cardiovascular effects related to toxicity• Vials of EXPAREL should be inverted multiple times to re-suspend the particles immediately prior to withdrawal from the vial

Administration• EXPAREL should be injected slowly into soft tissues of the surgical site using a deep tissue infiltration technique with

frequent aspiration to check for blood and minimize the risk of intravascular injection — Administer with a 25-gauge or larger-bore needle• Use a series of injections to effectively cover the surgical area

Compatibility Considerations• Wait 20 minutes after administration of other non-bupivacaine–

based local anesthetics before administering EXPAREL into the same surgical site

• Allow topical antiseptics to dry before administering EXPAREL into the same surgical site

• Other than bupivacaine, EXPAREL should not be admixed with other drugs prior to administration

Please see Important Safety Information on reverse and see accompanying full Prescribing Information.

Page 2: FAST FACTS...2011/08/12  · FAST FACTS EXPAREL provides long-lasting pain control that reduces opioid requirements… without the need for catheters and pumps that may hinder recovery1-9

Storage and Handling• EXPAREL vials should be stored refrigerated between 2°C to 8°C (36°F to 46°F)

• EXPAREL may be held at a controlled room temperature of 20°C to 25°C (68°F to 77°F) for up to 30 days in sealed, intact (unopened) vials. Vials should not be re-refrigerated

• EXPAREL should not be frozen or exposed to high temperatures (greater than 40°C or 104°F) for an extended period

• Do not administer EXPAREL if it is suspected of having been frozen or exposed to high temperatures. Vials should be visually inspected before use. Do not use the vial if the stopper is bulging

• Open vials of EXPAREL should be used within 4 hours

Important Safety Information

EXPAREL is contraindicated in obstetrical paracervical block anesthesia.

EXPAREL has not been studied for use in patients younger than 18 years of age.

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. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL.

Monitoring of cardiovascular and neurological status as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products.

Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations.

In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting.

Please see accompanying full Prescribing Information.

For more information about EXPAREL, please visit www.EXPAREL.com or call 1-855-RX EXPAREL (793-9727).

Please contact your Pacira Surgical Account Specialist with any questions.

Name:_____________________________________________

Email:______________________________________________ Phone:______________________________________

References: 1. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552-1559. 2. Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. [published online August 12, 2011]. Adv Ther. 2011;28(9):776-788. doi:10.1007/s12325-011-0052-y. 3. Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33(4):383-391. 4. Ilfeld BM, Loland VJ, Sandhu NS, Suresh PJ, Bishop MJ, Donohue MC, et al. Continuous femoral nerve blocks: the impact of catheter tip location relative to the femoral nerve (anterior versus posterior) on quadriceps weakness and cutaneous sensory block. [published online June 28, 2012]. Anesth Analg. 2012;115(3):721-727. doi:10.1213/ANE.0b013e318261f326. 5. Kinder R, Hsiung RL. Overview of peripheral nerve blocks. In: Chu LF, Fuller A, eds. Manual of Clinical Anesthesiology. Philadelphia, PA: Lippincott Williams & Wilkins; 2011. https://www.inkling.com/read/manual-clinical-anesthesiology-chu-fuller-1st/chapter-34/overview-of-peripheral-nerve. Accessed January 20, 2016. 6. Process for handling elastomeric pain relief balls (ON-Q PainBuster and others) requires safety improvements. Institute for Safe Medication Practices website. https://www.ismp.org/newsletters/acutecare/articles/20090716.asp. Accessed January 20, 2016. 7. I-Flow ON-Q Pump with ONDEMAND Bolus Button: class I recall - risk of continuous infusion at a rate greater than expected. US Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm317851.htm. Accessed January 20, 2016. 8. Continuous peripheral nerve blocks in outpatients. NYSORA–The New York School of Regional Anesthesia website. http://www.nysora.com/regional-anesthesia/foundations-of-ra/3055-continuous-peripheral-nerve-blocks-in-outpatients.html. Accessed January 20, 2016. 9. Frost & Sullivan. New opportunities for hospitals to improve economic efficiency and patient outcomes: the case of EXPAREL™, a long-acting, non-opioid local analgesic. http://www.frost.com/prod/servlet/cpo/252218999. Accessed January 20, 2016. 10. About DepoFoam®. Pacira Pharmaceuticals, Inc. website. http://www.exparel.com/hcp/about-EXPAREL/about-depofoam.shtml. Accessed January 20, 2016.

©2016 Pacira Pharmaceuticals, Inc. Parsippany, NJ 07054 PP-EX-US-0680 01/16

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