For U.S. Audiences Only

Posimir®

(bupivacaine solution)

for infiltration use

660 mg per 5 mL
(132 mg/mL)

WHAT IS POSIMIR?

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.

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

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF POTENTIAL ADVERSE EMBOLIC EFFECTS RESULTING FROM INADVERTENT INTRAVASCAULAR 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: Caution should be taken to avoid accidental intravascular injection of POSIMIR. 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 more susceptible to developing clinical manifestations of methemoglobinemia close monitoring for symptoms and signs of the condition 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.

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.

Patients who are administered POSIMIR are at increased risk of developing methemoglobinemia when concurrently exposed to drugs associated with methemoglobinemia, which could include other local anesthetics.

Special Populations

Pregnancy: There are no studies conducted with POSIMIR in pregnant women. Bupivacaine is contraindicated for obstetrical paracervical block anesthesia.

Lactation: POSIMIR has not been studied in nursing mothers.

Pediatric: Safety and effectiveness in patients below the age of 18 have not been established.

Geriatric: Consider increased monitoring for local anesthetic systemic toxicity when administering POSIMIR to elderly patients.

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.

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact DURECT Corporation at 1-844-767-4647 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch.

U.S. Medical Information inquiries

For medical inquiries related to POSIMIR, submit a request to Medical Information at medical.info@posimir.com or call 1-844‑767-4647.