EXPAREL PI
What is the indication for EXPAREL?
EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.
1 – Indications and Usage
How much bupivacaine can I use with EXPAREL?
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 ration of milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.
2.4 – Compatibility Considerations
I’m new to EXPAREL for TKA. What is the maximum dose of EXPAREL I can use?
Local Analgesia via Infiltration
The recommended dose of EXPAREL for local infiltration in adults is up to a maximum dose of 266 mg (20 mL), and is based on the following factors:
2.2 – Recommended Dosing in Adults
A case is cancelled and the EXPAREL® vial is out of the fridge. What should I do?
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. Do not re-refrigerate vials.
16 – Storage
How is EXPAREL different than Marcaine?
EXPAREL is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam) drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of EXPAREL, bupivacaine is released from the multivesicular liposomes over a period of time.
11 – Description
I thought EXPAREL is only indicated for hemorrhoids and bunions
EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.
Study 1: Infiltration for Bunionectomy
Study 2: Infiltration for Hemorrhoidectomy
Study 3: Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty or Rotator Cuff Repair
1 – Indications and Usage
14 – Clinical Studies
14.1 – Studies Confirming Efficacy
Can I still use lidocaine in my cases?
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.
2.4 Compatibility Considerations
Can EXPAREL be used in TAP?
FDA Rescission letter confirming field blocks
Warning Letter Rescission
Do you have any active comparator studies?
Yes, The PILLAR Study
Won’t diluting the volume of EXPAREL make it less effective?
Administer EXPAREL undiluted or diluted to increase volume up to a final concentration of 0.89 mg/mL (i.e., 1:14 dilution by volume)
with normal (0.9%) saline or lactated Ringer’s solution.
2.3 Injection Instructions
I heard that EXPAREL doesn’t work immediately.
After injection of EXPAREL, bupivacaine is released from the multivesicular liposomes over a period of time.
Reference study results and confirm that while it doesn’t release from the liposome immediately, it can be combined with bupivacaine HCl to provide immediate analgesic benefit
Explain bupivacaine HCl and EXPAREL® may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL, as long as its ratio to EXPAREL® does not exceed 1:2.
11 – Description
14 – Clinical Studies
2.4 – Compatibility Considerations
Can I use EXPAREL in my pediatric patients?
Safety and effectiveness in pediatric patients have not been established
8.4 – Pediatric Use
Does it matter if I irrigate with Betadine?
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 site. EXPAREL should not be allowed to come in contact with antiseptics such as povidone iodine in solution.
2.4 Compatibility Considerations
Does EXPAREL have any warnings or precautions?
Reference PI
5.2 Warnings & Precautions Specific for EXPAREL
Can I mix EXPAREL with my current cocktail?
Some physicochemical incompatibilities exist between EXPAREL and certain other drugs.
2.4 Compatibility Considerations
7 Drug Interactions
What dose should I use for a (TKA or breast recon or TAP)?
Local Analgesia via Infiltration
The recommended dose of EXPAREL for local infiltration in adults is up to a maximum dose of 266 mg (20 mL), and is based on the following factors:
2.2 – Recommended Dosing in Adults
What are the general guidelines on infiltration technique?
Exparel should be injected slowly (generally 1-2 mL) per injection with frequent aspiration to check for blood and minimize the risk of intravascular injection.
Inject the tissues of the surgical site using a deep-tissue infiltration and injections should be close together about 1 to 1.5 cm apart.
2.3 Injection Instructions
How do I get a 20 mL vial to cover the area I need?
Administer EXPAREL undiluted or diluted to increase volume up to a final concentration of 0.89 mg/mL (i.e., 1:14 dilution by volume) with normal (0.9%) saline or lactated Ringer’s solution.
266 mg up to 300 mL
133 mg up to 150 mL
2.3 Injection Instructions
I heard EXPAREL only works for 24 hours.
Study 1: Infiltration for Bunionectomy
Study 2: Infiltration for Hemorrhoidectomy
Study 3: Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty or Rotator Cuff Repair
14 – Clinical Studies
14.1 – Studies Confirming Efficacy
Why is the brachial plexus trial compared to placebo and not bupivacaine?
FDA Requires placebo-controlled trials
Can I use half the vial on one patient, then the other half on another patient?
EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.
EXPAREL is intended for single-dose administration only.
1 – Indications and Usage
2.1 – Important Dosage and Administration Information
I’m concerned about safety?
Explain
Pharmacokinetics
MIRF
12.3 Pharmacokinetics
Can I use it for C-sections? Do you have any pregnancy or breastfeeding information?
Yes, EXPAREL can be used in C-Section after the baby is delivered
May mention the Mustafa paper (Bonus Points)
8 – USE IN SPECIFIC POPULATIONS
8.1 – Pregnancy
8.2 – Lactation
Can I use EXPAREL in any nerve block?
EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.
1 – Indications and Usage
Why didn’t EXPAREL get a broad indication for nerve block like it has with the infiltration indication?
Only one study; Study 3 Studies 4, 5, and 6
14.1 Studies Confirming Efficacy
14.2 Studies That Do Not Support an Indication in Nerve Block