- EXPAREL is intended for single-dose administration only
- EXPAREL should be administered with a 25-gauge or larger-bore needle
- Vials of EXPAREL should be inverted to re-suspend the particles immediately prior to withdrawal from the vial
- EXPAREL should be used within 4 hours of preparation in a syringe
- The maximum dosage of EXPAREL should not exceed 266 mg (20 mL, 1.3% of undiluted drug)
Please see Dosing EXPAREL, EXPAREL Administration, and Storage and Handling sections for full information.
Administration technique: critical for success
EXPAREL should be injected slowly into soft tissues of the surgical site using a deep tissue administration technique. Aspirate frequently to check for blood and minimize the risk of intravascular injection.
- In clinical trials, EXPAREL was infiltrated below the fascia, above the fascia, and into the subcutaneous tissue
- When infiltrating it is important to consider the neuroanatomy of where the pain from the surgical insult originates from
- Utilize a moving needle technique as pictured below, to cover all layers of the surgical insult and ensure delivery of EXPAREL to the areas with the greatest concentration of nerve endings
- 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
- 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)
- 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
- 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
- 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
Compatibility with medications and implantable materials commonly used during surgery1:
- No significant interaction with the following materials:
- Stainless steel
- In vivo compatibility studies have not been conducted, but when the following classes of compounds were tested in vitro with EXPAREL, they did not cause excessive release of bupivacaine from the liposomal formulation:
- Tranexamic acid
- Other than bupivacaine, EXPAREL should not be admixed with other drugs prior to administration
This site is for informational purposes only and is intended to address medical questions from healthcare professionals in the United States.
To report an adverse event, e-mail firstname.lastname@example.org
or dial 1-855-RX-EXPAREL (1-855-793-9727).
For medical inquiries related to EXPAREL, to Medical Information or call 1-855-RX-EXPAREL (1-855-793-9727).
These are not all of the potential important safety considerations for EXPAREL; please see the full Prescribing Information.
Non-US healthcare professionals can submit a request to email@example.com
If you are not a healthcare professional, please discuss any questions you have regarding your health or treatment with your physician, pharmacist, nurse, or other healthcare professional.
Important information about EXPAREL®
The FDA confirms that EXPAREL has always been approved for "administration into the surgical site to produce postsurgical analgesia" for use in a variety of surgeries not limited to those studied in its pivotal trials.
"We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate."
- Dave Stack, Chief Executive Officer and Chairman of Pacira
The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
Important Safety Information
- EXPAREL is contraindicated in obstetrical paracervical block anesthesia
- In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting
- EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients
- 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
Warnings and Precautions Specific to EXPAREL
- EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use
- 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
Warnings and Precautions for Bupivacaine-Containing Products
- Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesias. CNS reactions are characterized by excitation and/or depression
- Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias sometimes leading to death
- Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients
- Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use
Please refer to full Prescribing Information.