Posimir

Last updated on RxList: 7/22/2021
Posimir Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Posimir?

Posimir (bupivacaine solution) contains an amide local anesthetic and is 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.

What Are Side Effects of Posimir?

Side effects of Posimir include:

  • dizziness,
  • changes in taste,
  • pain or discomfort when urinating,
  • headache,
  • numbness,
  • tingling,
  • ringing in the ears (tinnitus),
  • nausea,
  • vomiting,
  • anemia,
  • slow heart rate,
  • constipation,
  • increased C-reactive protein,
  • diarrhea,
  • post procedural bruising,
  • procedural pain,
  • itching,
  • fever,
  • drowsiness, and
  • surgical site bleeding

Dosage for Posimir

The recommended dose of Posimir is 660 mg (5 mL).

Posimir In Children

Safety and effectiveness of Posimir in pediatric patients below the age of 18 have not been established.

What Drugs, Substances, or Supplements Interact with Posimir?

Posimir may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Posimir During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Posimir; it is unknown how it would affect a fetus. Both Posimir and benzyl alcohol (an inactive ingredient in Posimir) have been reported to pass in breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Posimir (bupivacaine solution) for Infiltration Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Back Pain: 16 Back Pain Truths and Myths See Slideshow
Posimir Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, red rash, itching; sneezing, difficulty breathing; severe dizziness, vomiting; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • feeling anxious, restless, confused, dizzy, drowsy, or like you might pass out;
  • ringing in your ears, problems with speech or vision;
  • metallic taste in your mouth, numbness or tingling around your mouth;
  • muscle twitching, tremors, seizure (convulsions);
  • weak or shallow breathing;
  • fast heart rate, gasping, feeling unusually hot;
  • slow heart rate, weak pulse; or
  • little or no urination.

Seek medical attention right away if you develop a serious condition called methemoglobinemia. Symptoms include headache, fast heartbeats, shortness of breath, feeling tired or light-headed, or skin that looks pale, gray, or blue-colored.

Common side effects include:

  • weakness, long-lasting numbness or tingling;
  • feeling restless or drowsy;
  • tremors;
  • headache, blurred vision;
  • fast or slow heartbeats;
  • breathing problems;
  • chills or shivering;
  • back pain; or
  • nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Posimir (Bupivacaine Solution)

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Posimir Professional Information

SIDE EFFECTS

The following adverse reactions to bupivacaine hydrochloride are described in other sections of the prescribing information:

  • Systemic Toxicity with Intravascular Injection [see WARNINGS AND PRECAUTIONS]
  • Methemoglobinemia [see WARNINGS AND PRECAUTIONS]
  • Chondrolysis with Intra-Articular Infusion [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular System Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates observed in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of POSIMIR, doses ranging from 2.5 mL to 5 mL, was evaluated in 10 randomized, double-blind, controlled trials. Overall, POSIMIR 5 mL, the recommended dose, has been administered to a total of 735 patients in clinical trials using a variety of administration methods, including the recommend method of infiltration. Three trials were controlled with bupivacaine HCl, two trials were controlled with bupivacaine HCl and vehicle placebo, and five trials were controlled with vehicle placebo. An additional 47 patients were treated with saline placebo in one of the bupivacaine HCl-controlled trials. The evaluated surgical procedures included inguinal hernia repair, subacromial decompression of the shoulder, abdominal hysterectomy, laparotomy, laparoscopic cholecystectomy, and laparoscopically-assisted colectomy.

Shoulder Surgical Procedures

There were three studies evaluating the safety of POSIMIR administered during shoulder surgery. In Study 1, one of three treatments was administered into the subacromial space at the end of surgery: POSIMIR, vehicle placebo, or bupivacaine HCl. Table 1 presents commonly-reported adverse reactions from Study 1.

Table 1: Commonly Reported Adverse Reactions from Study 1 (Incidence ≥ 2% and More Frequent than Bupivacaine HCl or Vehicle Placebo).

Preferred Term, n (%)Posimir
(N=53)
Bupivacaine HCl
(n=29)
Vehicle Placebo
(N=25)
Headache3 (5.7%)1 (3.4%)1 (4.0%)
Electrocardiogram T wave inversion2 (3.8%)00
Hypoesthesia2 (3.8%)1 (3.4%)1 (4.0%)
Pruritus generalized2 (3.8%)00

In Study 2 and Study 3, patients were administered either POSIMIR or vehicle placebo into the subacromial space at the end of surgery. Table 2 presents commonly-reported adverse reactions from Studies 2 and 3.

Table 2: Commonly Reported Adverse Reactions Pooled from Study 2 and Study 3 (Incidence ≥ 2% and More Frequent than Vehicle Placebo).

Preferred Term, n (%)*Posimir
(N=75)
Vehicle Placebo
(N=44)
Dizziness30 (40.3%)17 (38.3%)
Vomiting22 (29.0%)12 (26.6%)
Headache17 (23.3%)7 (16.3%)
Paresthesia14 (18.4%)7 (15.4%)
Dysgeusia13 (17.6%)7 (14.9%)
Hypoesthesia13 (17.3%)7 (15.8%)
Tinnitus10 (13.2%)3 (6.7%)
Dysuria8 (10.1%)4 (10.1%)
Pyrexia7 (9.3%)2 (4.6%)
Insomnia5 (7.1%)0
Dyspnea3 (3.8%)0
Muscle twitching3 (3.8%)0
Peripheral swelling3 (3.9%)0
Urinary retention2 (2.7%)1 (2.1%)
Contusion2 (2.5%)0
Dysmenorrhea2 (2.7%)0
Incision site pruritus2 (2.7%)0
Nasal congestion2 (2.5%)0
Pruritus generalized2 (2.5%)0
* Percentages adjusted to account for the different sizes of the pooled studies.

Less common adverse reactions (incidence less than 2% and more frequent than either bupivacaine HCl or vehicle placebo) following POSIMIR administration in shoulder surgical procedures were angina pectoris, blepharospasm, electrocardiogram T wave amplitude decreased, fatigue, osteoarthritis, procedural nausea, procedural pain, and pulmonary arterial hypertension.

Additional follow-up safety data consisting of shoulder MRI, physical examination of the shoulder, and assessments of wound healing were collected at 6 months in Study 1 and at 18 months in Study 2. There were no specific long-term follow-up evaluations for patients treated in Study 3; however, study investigators did not report any cases of chondrolysis in follow-up surveys. All surgical incisions were found to have healed as expected in all three studies. Table 3 presents the results of the MRI and physical examinations for Study 1. Table 4 presents the results of the MRI and physical examinations for Study 2.

Table 3: 6-Month Follow-up Safety Data from Subacromial Decompression Study 1.

Safety EvaluationPosimirVehicle PlaceboBupivacaine HCl
Number enrolled532529
Shoulder MRI
Number at 6-month follow-up512525
Improved [1], n (%)6 (11.8%)2 (8.0%)6 (24.0%)
No change [1], n (%)31 (60.8%)14 (56.0%)9 (36.0%)
Worsened [1], n (%)14 (27.4%)9 (36%)10 (40%)
Constant-Murley score
Number at 6-month follow-up522526
Pre-surgery, mean (SD)44.7 (12.5%)41.7 (11.7%)42 (11.3%)
Follow-up, mean (SD)61.6 (15.2%)63.2 (12.4%)65.6 (6.8%)
Decreased from baseline. n (%)5 (9.6%)2 (8.0%)0 (0%)
[1] Compared with pre-surgical MRI

Table 4: 18-Month Follow-up Safety Data from Subacromial Decompression Study 2.

Safety EvaluationPosimirVehicle Placebo
Number enrolled4020
Shoulder MRI
Number at 18-month follow-up2714
Overall assessment
Unexpected injuries or findings compared with pre-surgical MRI, n (%)00
New-onset cartilage or bone lesions of concern (not present at baseline and unrelated to surgery or natural disease progression), n (%)00
Glenohumeral joint and humeral head
Presence of cartilage thinning - humeral head, n (%)
Grade 0: normal/none26 (96.3%)14 (100%)
Grade 1: mild00
Grade 2: moderate1 (3.7%) [1]0
Grade 3: severe00
Rotator cuff and labrum
Supraspinatus tendon tear, n (%)
No tear16 (59.3%)5 (35.7%)
Partial7 (25.9%)7 (50.0%)
Full thickness1 (3.7%)0
Other findings3 (11.1%)2 (14.3%)
Supraspinatus - other findings, n (%)
Interstitial tear00
Tendinosis2 (7.4%)1 (7.1%)
Surgically repaired tendon01 (7.1%)
Interstitial tear/tendinosis1 (3.7%)0
(blank)24 (88.9%)12 (85.7%)
Subacromial space - acromion
Acromion bony spur, n (%)
Yes1 (3.7%)0
No26 (96.3%)14 (100%)
Acromion bone resection, n (%)
Yes18 (66.7%)9 (64.3%)
No9 (33.3%)5 (35.7%)
Acromion signal abnormality (edema, fibrosis), n (%)
Yes2 (7.4%) [2]2 (14.3%) PI
No25 (92.6%) PI12 (85.7%) PI
Acromioclavicular joint
Bone resection at acromioclavicular joint/postoperative changes, n (%)
Yes10 (37.0%)4 (28.6%)
No16 (59.3%)10 (71.4%)
Not evaluable1 (3.7%)0
Joint effusion/synovitis, n (%)
Grade 0: normal/none9 (33.3%)2 (14.3%)
Grade 1: mild9 (33.3%) [3]7 (50.0%)
Grade 2: moderate3 (11.1%) [3]3 (21.4%) [3]
Grade 3: severe01 (7.1%) [3]
Not evaluable6 (22.2%)1 (7.1%)
Safety EvaluationPosimirVehicle Placebo
Bursa and Soft Tissue
Subacromial bursa - bursitis/excess fluid, n (%)
Grade 0: normal/none18 (66.7%)5 (35.7%)
Grade 1: mild6 (22.2%)9 (64.3%) [4]
Grade 2: moderate3 (11.1%)0
Grade 3: severe00
Physical Exam
Number at 18-month follow-up3116
Clinical assessment, n (%)
Normal27 (87.1%)13 (81.3%)
Abnormal4 (12.9%)3 (18.8%)
Pain intensity, 0-10 scale
Mean (SE)0.9 (0.4%)1.2 (0.6%)
Positive impingement sign, n (%)
Yes3 (9.7%)3 (18.8%)
No28 (90.3%)13 (81.3%)
Full passive range of motion, n (%)
Yes27 (87.1%)13 (81.3%)
No4 (12.9%)3 (18.8%)
[1] The humeral head cartilage thinning was unchanged from baseline.
[2] Two POSIMIR patients were positive for signal abnormalities at baseline and negative at 18 months. Two POSIMIR patients were negative for signal abnormalities at baseline and positive at 18 months. One placebo patient was positive for signal abnormality at baseline and negative at 18 months. Two placebo patients were positive for signal abnormalities at both baseline and 18 months.
[3] Two POSIMIR patients had joint effusion/synovitis that improved from moderate at baseline to mild at 18 months. One POSIMIR patient had joint effusion/synovitis that improved from severe at baseline to mild at 18 months. Four patients (1 POSIMIR, 3 placebo) had joint effusion/synovitis that worsened from mild at baseline to moderate at 18 months. One placebo patient had joint effusion/synovitis that worsened from mild at baseline to severe at 18 months.
[4] One placebo patient had bursitis/excess fluid that was severe at baseline and mild at 18 months.

Soft Tissue Surgical Procedures

There were two studies evaluating the safety of POSIMIR in patients undergoing inguinal hernia repair (hernioplasty). Patients in these studies were administered either POSIMIR 5 mL or vehicle placebo; 2.5 mL administered into the floor of the inguinal canal and 2.5 mL administered into the subcutaneous space. Table 5 presents commonly-reported adverse reactions from these studies.

Table 5: Commonly Reported Adverse Reactions Pooled from Studies in Inguinal Hernia Repair (Incidence ≥ 2% and More Frequent than Placebo)

Preferred Term, n (%)*Posimir
(N=69)
Vehicle Placebo
(N=53)
Bradycardia16 (22.9%)7 (14.2%)
Pruritus†15 (21.6%)9 (17.5%)
Post procedural contusion (bruising)10 (14.0%)5 (10.1%)
Vomiting6 (9.4%)4 (7.4%)
Incision site swelling4 (6.0%)3 (5.7%)
Dyspepsia4 (5.7%)2 (3.7%)
Pyrexia4 (6.0%)2 (4.0%)
Contusion4 (5.7%)0
Back pain3 (4.1%)2 (3.4%)
Viral infection3 (4.1%)2 (4.0%)
Incision site erythema3 (4.1%)0
Oropharyngeal pain3 (4.6%)0
Tachycardia3 (4.6%)0
Upper respiratory tract infection2 (3.0%)1 (2.0%)
Dry throat2 (3.2%)0
Hyperhidrosis2 (3.0%)0
Hypertension2 (2.8%)0
Local swelling2 (3.0%)0
Testicular swelling2 (3.2%)0
* Percentages adjusted to account for the different sizes of the pooled studies.
† Incision site pruritus, generalized pruritus, and genital pruritus were also reported, but none had incidence ≥2% and more frequent than placebo.

There were five studies evaluating the safety of POSIMIR in laparoscopic, laparoscopically-assisted, or open abdominal surgeries.

In two studies in patients undergoing laparoscopic cholecystectomy, POSIMIR or bupivacaine HCl was administered into the laparoscopic port incisions at the end of surgery. In one of these studies, a subset of patients received either POSIMIR or saline placebo. In a study of patients undergoing laparoscopicallyassisted colectomy, POSIMIR or vehicle placebo was administered predominantly into the hand port incision at the end of surgery. In a study of patients undergoing laparotomy, POSIMIR or bupivacaine HCl was administered into the full length of the surgical incision at the end of surgery. Table 6 presents commonly-reported adverse reactions from these four studies. Table 7 and Table 8 present, respectively, surgical-site adverse reactions and early-occurring central nervous system (CNS)-related adverse reactions from the laparoscopic cholecystectomy study that included a saline placebo control arm.

Table 6: Commonly Reported Adverse Reactions Pooled from Laparoscopic, Laparoscopically-Assisted, and Open Abdominal Surgery Studies (Incidence ≥ 2% and More Frequent than Bupivacaine HCl or Placebo).

Preferred Term, n (%)*Posimir
(N=337)
Bupivacaine HCl
(N=186)
Vehicle Placebo
(N=78)
Post procedural contusion (bruising)231 (71.2%)119 (61.8%)41 (52.6%)
Nausea189 (55.8%)111 (59.6%)40 (51.3%)
Constipation112 (35.2%)80 (41.8%)8 (10.3%)
Somnolence92 (30.4%)80 (41.0%)3 (3.8%)
Headache86 (27.2%)63 (32.3%)12 (15.4%)
Dizziness75 (23.5%)58 (30.1%)6 (7.7%)
Vomiting66 (19.4%)39 (21.0%)6 (7.7%)
Dysgeusia50 (16.2%)33 (16.9%)2 (2.6%)
Pruritus†45 (14.3%)36 (18.7%)5 (6.4%)
Procedural pain35 (11.4%)35 (17.8%)0
Diarrhea34 (9.8%)10 (5.5%)10 (12.8%)
Incision site hemorrhage30 (8.7%)6 (3.0%)3 (3.8%)
Pyrexia29 (8.2%)10 (5.7%)11 (14.1%)
Abdominal distension29 (8.2%)8 (4.8%)12 (15.4%)
Incision site erythema29 (8.1%)5 (2.7%)10 (12.8%)
Post procedural discharge26 (7.5%)8 (4.4%)7 (9.0%)
Paresthesia23 (7.5%)25 (13.1%)2 (2.6%)
Hypokalemia22 (5.9%)2 (1.4%)10 (12.8%)
Incision site hematoma18 (5.2%)3 (1.7%)4 (5.1%)
Anemia17 (4.5%)1 (0.7%)7 (9.0%)
Flatulence16 (4.6%)7 (4.0%)8 (10.3%)
Hypertension16 (4.6%)7 (3.6%)1 (1.3%)
Incision site infection16 (4.5%)4 (2.5%)2 (2.6%)
Musculoskeletal pain15 (4.2%)8 (4.9%)0
Abdominal pain15 (4.4%)1 (0.5%)1 (1.3%)
Insomnia14 (3.9%)5 (2.9%)7 (9.0%)
Dyspepsia13 (3.8%)3 (1.9%)4 (5.1%)
Wound dehiscence13 (3.6%)3 (1.5%)5 (6.4%)
Cough12 (3.6%)3 (1.8%)1 (1.3%)
Oropharyngeal pain12 (3.5%)2 (1.0%)0
Urinary retention10 (2.8%)2 (1.2%)4 (5.1%)
Chest pain10 (2.9%)1 (0.5%)1 (1.3%)
Ileus10 (2.7%)1 (0.7%)3 (3.8%)
Body temperature increased9 (2.4%)02 (2.6%)
Abdominal pain upper8 (2.5%)2 (1.0%)0
Rash7 (2.1%)7 (3.8%)1 (1.3%)
Pain in extremity7 (2.1%)5 (2.8%)1 (1.3%)
Dry mouth7 (2.2%)2 (1.0%)1 (1.3%)
Nasopharyngitis7 (2.1%)00
* Percentages adjusted to account for the different sizes of the pooled studies.
† Incision site pruritus, generalized pruritus, eye pruritus, anal pruritus, and infusion site pruritus were also reported, but none had incidence ≥2% and more frequent than placebo.

Table 7: Incidence of Surgical Site Adverse Reactions from Laparoscopic Cholecystectomy Study with Saline Placebo and Bupivacaine HCl Controls.

Prespecified Term*, n (%)Saline Placebo ControlBupivacaine HCl Control
Posimir
(N=45)
Saline Placebo
(N=47)
Posimir
(N=148)
Bupivacaine HCl
(N=148)
Visible bruising41 (91.1%)33 (70.2%)142 (95.9%)105 (70.9%)
Surgical site bleeding22 (48.9%)20 (42.6%)19 (12.8%)24 (16.2%)
Drainage from surgical incision(s)2 (4.4%)3 (6.4%)11 (7.4%)6 (4.1%)
Wound hematoma006 (4.1%)2 (1.4%)
Wound dehiscence002 (1.4%)3 (2.0%)
Surgical site infection002 (1.4%)1 (0.7%)
*Terms were prespecified for examination by a blinded assessor on postoperative days 0, 4, 7, 14, 28, and 59.

Table 8: CNS-related Adverse Reactions Solicited from Subjects at 6 Hours Post-surgery in Laparoscopic Cholecystectomy Study with Saline Placebo and Bupivacaine HCl Controls.

Dictionary-Derived Term (Symptom)*Saline Placebo ControlBupivacaine HCl Control
Posimir
(N=45)
Saline Placebo
(N=47)
Posimir
(N=148)
Bupivacaine HCl
(N=148)
Entire study, n (%)
Somnolence (Drowsiness)18 (40.0%)16 (34.0%)60 (40.5%)48 (32.4%)
Nausea (Nausea)9 (20.0%)13 (27.7%)48 (32.4%)57 (38.5%)
Dizziness (Dizziness)3 (6.7%)3 (6.4%)28 (18.9%)31 (20.9%)
Headache (Headache)5 (11.1%)4 (8.5%)23 (15.5%)18 (12.2%)
Vomiting (Vomiting)2 (4.4%)3 (6.4%)10 (6.8%)15 (10.1%)
Constipation (Constipation)0 (0.0%)4 (8.5%)9 (6.1%)10 (6.8%)
Pruritus (Itching)1 (2.2%)1 (2.1%)6 (4.1%)5 (3.4%)
Subset of study, n (%)N=23N=22
Dysgeusia (Metallic taste in mouth)3 (13.0%)2 (9.1%)26 (17.6%)22 (14.9%)
Paresthesia (Tingling)002 (1.4%)6 (4.1%)
Hypoesthesia (Numbness)001 (0.7%)1 (0.7%)
* Patients responded to a 10-symptom checklist (7 symptoms for part of the saline placebo-controlled portion of the study).

In a study of patients undergoing total abdominal hysterectomy, POSIMIR, vehicle placebo, or bupivacaine HCl was administered into the surgical incision at the end of surgery. Table 9 presents commonly-reported adverse reactions from this study.

Table 9: Commonly Reported Adverse Reactions from Total Abdominal Hysterectomy Study (Incidence ≥ 2% and More Frequent than Bupivacaine HCl).

Preferred TermPosimir
(N=60)
Bupivacaine HCl
(N=27)
Vehicle Placebo
(N=27)
Post procedural contusion (bruising)36 (60.0%)09 (33.3%)
Anemia10 (16.7%)3 (11.1%)4 (14.8%)
Dizziness9 (15.0%)4 (14.8%)3 (11.1%)
Vomiting9 (15.0%)4 (14.8%)8 (29.6%)
C-reactive protein increased7 (11.7%)1 (3.7%)0
Pyrexia7 (11.7%)7 (25.9%)3 (11.1%)
Somnolence5 (8.3%)2 (7.4%)0
Blood potassium decreased4 (6.7%)01 (3.7%)
Hypertension4 (6.7%)2 (7.4%)1 (3.7%)
Incision site hematoma3 (5.0%)00
Electrocardiogram change2 (3.3%)00
Procedural hemorrhage2 (3.3%)00
Vaginal hematoma2 (3.3%)00

Less common adverse reactions (incidence less than 2% and more frequent than either bupivacaine HCl or placebo) following POSIMIR administration in soft tissue surgical procedures were: application site irritation, atrial fibrillation, drug eruption, electrocardiogram QT prolonged, eructation, erythema, excessive granulation tissue, fatigue, genital pain, heart rate increased, hiccups, hypoesthesia, hypogeusia, incision site cellulitis, incision site erosion, incision site hypoesthesia, incision site inflammation, incision site edema, incision site pain, incision site rash, mean arterial pressure increased, micturition urgency,

night sweats, overdose, palpitations, procedural hypertension, pruritus generalized, rash generalized, seroma, sinus tachycardia, skin discoloration, tinnitus, and wound hemorrhage.

Read the entire FDA prescribing information for Posimir (Bupivacaine Solution)

© Posimir Patient Information is supplied by Cerner Multum, Inc. and Posimir Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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