Patients were adults aged ≥18 years and undergoing arthroscopic subacromial decompression surgery under general anesthesia1
PATIENT RANDOMIZATION 2:1:1 (N=107)1
CO-PRIMARY OUTCOME: Mean pain intensity on movement scores from Time 0 through 72 hours and total opioid rescue analgesia from Time 0 through 72 hours
POSIMIR indication is based on safety and efficacy data from 3 clinical studies in shoulder arthroscopy, predominantly arthroscopic subacromial decompression. Adequate evidence of effectiveness was demonstrated in 1 of those 3 studies (Study 1).1
*Doses above 660 mg per patient have not been studied in clinical trials.1
†Intravenous morphine provided until patients were able to tolerate oral morphine.1 HCl=hydrochloride; QID=four times a day.
PROVEN EFFICACY WHILE IN THE PACU
POSIMIR patients averaged mild to moderate pain on movement and only mild pain at rest through the first 6 hours post‑surgery in Study 1
MEAN PAIN INTENSITY ON MOVEMENT
(Based on a 1-10 Numerical Rating Scale)
Time (hours)
POSIMIR
Vehicle Control
1
4.6
8.1
2
4.4
7.7
4
4.1
7.3
6
3.7
7.7
MEAN PAIN INTENSITY AT REST
(Based on a 1-10 Numerical Rating Scale)
Time (hours)
POSIMIR
Vehicle Control
1
3.7
6.9
2
3.2
5.9
4
2.3
4.9
6
2.2
4.8
POSIMIR patients saw less of a need for opioid introduction while still under facility care
MEDIAN TIME TO FIRST USE OF OPIOID RESCUE MEDICATION
POSIMIR 12.4 hours
Vehicle Control 1.2 hours
P=0.014
SIGNIFICANT PAIN RELIEF FOR UP TO 72 HOURS
POSIMIR patients had a 20% reduction in pain on movement while using 66% fewer opioids vs Vehicle Control in Study 1
MEAN PAIN INTENSITY ON MOVEMENT FOR UP TO 72 HOURS
(Based on a 1-10 Numerical Rating Scale)
MEAN PAIN INTENSITY AT REST FOR UP TO 72 HOURS
(Based on a 1-10 Numerical Rating Scale)
TOTAL USE OF OPIOID ANALGESIA FROM TIME 0-72 HOURS
(median IV morphine mg equivalent)
POSIMIR 4.0 mg
Vehicle Control 12.0 mg
P=0.010
The outcomes of Study 2 and Study 3, both evaluating POSIMIR in arthroscopic shoulder surgery, favored POSIMIR in analgesic and opioid-use endpoints over Vehicle Control, but did not reach statistical significance.
40% OF POSIMIR PATIENTS DID NOT REQUIRE ANY OPIOIDS THROUGH 72 HOURS POST-SURGERY IN STUDY 1
% OF PATIENTS NOT REQUIRING OPIOID RESCUE MEDICATION, 0-72 HOURS
REQUEST A REPRESENTATIVE
A representative can discuss POSIMIR with you to review administration instructions and respond to your questions.
INDICATIONS AND USAGE
POSIMIR is a bupivacaine solution indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF POTENTIAL ADVERSE EMBOLIC EFFECTS RESULTING FROM INADVERTENT INTRAVASCULAR INJECTION.
INDICATIONS AND USAGE
POSIMIR is a bupivacaine solution indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.
Limitations of Use
Safety and effectiveness have not been established in other surgical procedures, including soft tissue surgical procedures, other orthopedic procedures, including for intra-articular administration, and boney procedures, or when used for neuraxial or peripheral nerve blockade.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF POTENTIAL ADVERSE EMBOLIC EFFECTS RESULTING FROM INADVERTENT INTRAVASCULAR INJECTION. Inadvertent intravascular injection could cause POSIMIR droplets to be deposited in the pulmonary and other capillary beds. Administer POSIMIR into the subacromial space at the end of arthroscopic shoulder surgery. Direct arthroscopic visualization must be used to confirm proper placement of the needle tip before injecting POSIMIR.
Contraindications
POSIMIR is contraindicated in patients with a known hypersensitivity to any amide local anesthetic or to other components of POSIMIR, and in patients undergoing obstetrical paracervical block anesthesia.
Warnings and Precautions
Risk of Potential Adverse Embolic Effects Resulting from Inadvertent Intravascular Injection: Inadvertent intravascular injection could cause POSIMIR droplets to be deposited in the pulmonary and other capillary beds. Direct arthroscopic visualization must be used to confirm proper placement of the needle tip in the subacromial space before injecting POSIMIR.
Risk of Joint Cartilage Necrosis with Unapproved Intra-articular Use: The safety and effectiveness of POSIMIR in surgical procedures other than subacromial decompression have not been established, and POSIMIR is not approved for use via intra-articular injection. A study of POSIMIR in dogs following an intra-articular administration demonstrated joint cartilage necrosis.
Risk of Systemic Toxicity: Unintended intravascular injection of POSIMIR may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest.
Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness should be performed after injection of bupivacaine. Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness.
Avoid additional use of local anesthetics within 168 hours following administration of POSIMIR. Consider increased monitoring for systemic toxicity in debilitated, elderly, or acutely ill patients.
Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. If local anesthetics must be used in patients known to be more susceptible to methemoglobinemia, close monitoring for symptoms and signs of methemoglobinemia is recommended.
Chondrolysis with Intra-Articular Infusion of Local Anesthetics: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. Do not inject POSIMIR intra-articularly.
Risk of Toxicity in Patients with Hepatic Impairment: Consider reduced dosing and increased monitoring for bupivacaine systemic toxicity in patients with moderate to severe hepatic impairment.
Risk of Use in Patients with Impaired Cardiovascular Function: Care should be taken when considering the use of POSIMIR in patients with impaired cardiovascular function (e.g., hypotension, heartblock). Consider reduced dosing. Monitor patients closely for blood pressure, heart rate, and ECG changes.
Adverse Reactions
Adverse events reported with an incidence greater than or equal to 10% and greater than control following POSIMIR administration in shoulder surgery were dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, and vomiting.
Adverse events reported with an incidence greater than or equal to 10% and greater than control following POSIMIR administration in soft tissue surgical procedures were anemia, bradycardia, constipation, C-reactive protein increased, diarrhea, dizziness, dysgeusia, headache, nausea, post‑procedural contusion (bruising), procedural pain, pruritus, pyrexia, somnolence, surgical site bleeding, visible bruising, and vomiting.
Drug Interactions
Do not dilute or mix POSIMIR with local anesthetics or other drugs or diluents.
Special Populations
Hepatic Impairment: Consider reduced dosing and increased monitoring for bupivacaine toxicity in patients with moderate to severe hepatic impairment.
Renal Impairment: Consider increased monitoring for local anesthetic systemic toxicity when administering POSIMIR to patients with impaired renal function.
For additional safety information, please see full Prescribing Information, including BOXED WARNING.
References: 1. Data on File. Innocoll Pharmaceuticals Limited. 2. Shah J, Ellis D, Verity N. Pharmacokinetic characteristics of SABER® Bupivacaine in humans demonstrate sustained drug delivery for up to 72 hours in a variety of surgical models. Poster presented at: 39th Annual American Society of Regional Anesthesia and Pain Medicine Meeting. Chicago, IL; Apr 5, 2014. 3. Bardsley H, Gristwood R, Baker H, Watson N, Nimmo W. A comparison of the cardiovascular effects of levobupivacaine and rac-bupivacaine following intravenous administration to healthy volunteers. Br J Clin Pharmacol. 1998;46(3):245-249. 4. Kastrissios H, Triggs EJ, Sinclair F, Moran P, Smithers M. Plasma concentrations of bupivacaine after wound infiltration of an 0.5% solution after inguinal herniorrhaphy: a preliminary study. Eur J Clin Pharmacol. 1993;44(6):555-557.
Request a Representative
Enter your information below and a representative will contact you.
The fields marked with an asterisk (*) are mandatory.
