This information is intended for US healthcare professionals.

ANJESO Overview

ANJESO Is the First and Only Once-Daily IV Analgesic1,*

Image

Up to 24 hours pain relief 1,*

Image

Demonstrated safety and tolerability1

Image

COX-2 preferential IV NSAID2,3,†

Image

Once-daily IV push1

Available as a ready-to-use 30 mg/1 mL vial.
No refrigeration or reconstitution required.1
  • Once-daily, IV bolus injection push over 15 seconds1,*
    — Available as a small (2 mL) single-use vial
Vial

May not reflect actual size.

*When initiating ANJESO, monitor patient pain response. If patient experiences inadequate analgesia during the 24-hour dosing interval, consider adding a short-acting, non-NSAID, immediate-release analgesic.1

The mechanism of action of ANJESO, like other NSAIDs, is not completely understood, but involves inhibition of both COX-1 and COX-2 pathways. COX-2 activity is based on in vitro data, not clinical trial data.1

COX-1, cyclooxygenase 1; COX-2, cyclooxygenase 2; IV, intravenous, NSAID, nonsteroidal anti-inflammatory drug.

ANJESO Was Studied in 1400 Patients Across a Broad Range of Surgical Procedures1

Select a procedure to view phase 3 study design and more information

LOCF, last observation carried forward; NSAID, nonsteroidal anti-inflammatory drug; PGA, patient global assessment; SPID, summed pained intensity difference.

Bunionectomy (N=201)²
Hard Tissue Efficacy Study

Bunionectomy (N=201)²

Study design

A phase 3, double-blind, randomized controlled study of ANJESO 30 mg vs placebo (1:1 ratio).

Patients were randomized and given study drug or placebo after block was removed and once pain level of ≥4 was reported.

Dosing

Two doses of ANJESO were administered once every 24 hours, with an optional third dose prior to discharge.

Rescue medication

Oxycodone 5 mg, up to every 2 hours as requested for uncontrolled pain.

Primary endpoint

Pain reduction was evaluated by the SPID over 48 hours (ie, SPID-48) using a 2-hour windowed LOCF.

Secondary endpoints

  • SPID-6, SPID-12, SPID-24, and SPID-24-48
  • Time to perceptible and meaningful pain relief
  • Proportion of patients with improvement ≥30% and ≥50% within 6 and 24 hours
  • PGA of pain control at 24 hours and 48 hours
  • Time to first dose of rescue and number of times rescue was used
Head, Neck, and Spine (N=14)⁴
Major Surgery Safety Study

Head, Neck, and Spine (N=14)⁴

Study design

A phase 3, multicenter, randomized, double-blind, placebo-controlled study of ANJESO 30 mg vs placebo (3:1 ratio). Standard of care analgesia (by institution) was employed (with the exception of other NSAIDs).

Dosing

One dose of ANJESO was administered every 24 hours for up to 7 doses.

Rescue medication

Patients received opioid analgesia according to the practice of the investigator to treat uncontrolled pain symptoms. Patients received standard of care analgesia (except for NSAIDs) according to the institution for postoperative pain management.

Primary objective

Safety and tolerability of ANJESO 30 mg vs placebo, including number of patients with adverse events up to 28 days.

Shoulder (N=16)⁴
Major Surgery Safety Study

Shoulder (N=16)⁴

Study design

A phase 3, multicenter, randomized, double-blind, placebo-controlled study of ANJESO 30 mg vs placebo (3:1 ratio). Standard of care analgesia (by institution) was employed (with the exception of other NSAIDs).

Dosing

One dose of ANJESO was administered every 24 hours for up to 7 doses.

Rescue medication

Patients received opioid analgesia according to the practice of the investigator to treat uncontrolled pain symptoms. Patients received standard of care analgesia (except for NSAIDs) according to the institution for postoperative pain management.

Primary objective

Safety and tolerability of ANJESO 30 mg vs placebo, including number of patients with adverse events up to 28 days.

Other Soft Tissue (N=170)⁴
Major Surgery Safety Study

Other Soft Tissue (N=170)⁴

Study design

A phase 3, multicenter, randomized, double-blind, placebo-controlled study of ANJESO 30 mg vs placebo (3:1 ratio). Standard of care analgesia (by institution) was employed (with the exception of other NSAIDs).

Dosing

One dose of ANJESO was administered every 24 hours for up to 7 doses.

Rescue medication

Patients received opioid analgesia according to the practice of the investigator to treat uncontrolled pain symptoms. Patients received standard of care analgesia (except for NSAIDs) according to the institution for postoperative pain management.

Primary objective

Safety and tolerability of ANJESO 30 mg vs placebo, including number of patients with adverse events up to 28 days.

Gastrointestinal (N=39)⁴
Major Surgery Safety Study

Gastrointestinal (N=39)⁴

Study design

A phase 3, multicenter, randomized, double-blind, placebo-controlled study of ANJESO 30 mg vs placebo (3:1 ratio). Standard of care analgesia (by institution) was employed (with the exception of other NSAIDs).

Dosing

One dose of ANJESO was administered every 24 hours for up to 7 doses.

Rescue medication

Patients received opioid analgesia according to the practice of the investigator to treat uncontrolled pain symptoms. Patients received standard of care analgesia (except for NSAIDs) according to the institution for postoperative pain management.

Primary objective

Safety and tolerability of ANJESO 30 mg vs placebo, including number of patients with adverse events up to 28 days.

Abdominoplasty (N=219)³
Soft Tissue Efficacy Study

Abdominoplasty (N=219)³

Study design

A phase 3, double-blind, randomized controlled study of ANJESO 30 mg vs placebo (1:1 ratio).

Patients were randomized within 3 hours of surgery and given study drug or placebo once pain level of ≥4 was reported.

Dosing

ANJESO was administered once every 24 hours. Patients received a minimum of 2 doses, and a majority received an optional third dose prior to discharge at 48 hours.

Rescue medication

Oxycodone 5 mg was provided every 2 hours as needed for uncontrolled pain.

Primary endpoint

Pain reduction was evaluated by the SPID over 24 hours (ie, SPID-24) using a 2-hour windowed LOCF.

Secondary endpoints

  • SPID-6, SPID-12, SPID-48, and SPID-24-48
  • Time to perceptible and meaningful pain relief
  • Proportion of patients with improvement ≥30% and ≥50% within 6 hours
  • PGA of pain control at 24 hours and 48 hours
  • Time to first dose of rescue and number of times rescue was used
Total Hip Replacement (N=68)⁴
Major Surgery Safety Study

Total Hip Replacement (N=68)⁴

Study design

A phase 3, multicenter, randomized, double-blind, placebo-controlled study of ANJESO 30 mg vs placebo (3:1 ratio). Standard of care analgesia (by institution) was employed (with the exception of other NSAIDs).

Dosing

One dose of ANJESO was administered every 24 hours for up to 7 doses.

Rescue medication

Patients received opioid analgesia according to the practice of the investigator to treat uncontrolled pain symptoms. Patients received standard of care analgesia (except for NSAIDs) according to the institution for postoperative pain management.

Primary objective

Safety and tolerability of ANJESO 30 mg vs placebo, including number of patients with adverse events up to 28 days.

Gynecologic (N=89)⁴
Major Surgery Safety Study

Gynecologic (N=89)⁴

Study design

A phase 3, multicenter, randomized, double-blind, placebo-controlled study of ANJESO 30 mg vs placebo (3:1 ratio). Standard of care analgesia (by institution) was employed (with the exception of other NSAIDs).

Dosing

One dose of ANJESO was administered every 24 hours for up to 7 doses.

Rescue medication

Patients received opioid analgesia according to the practice of the investigator to treat uncontrolled pain symptoms. Patients received standard of care analgesia (except for NSAIDs) according to the institution for postoperative pain management.

Primary objective

Safety and tolerability of ANJESO 30 mg vs placebo, including number of patients with adverse events up to 28 days.

Total Knee Replacement (N=156)⁴
Major Surgery Safety Study

Total Knee Replacement (N=156)⁴

Study design

A phase 3, multicenter, randomized, double-blind, placebo-controlled study of ANJESO 30 mg vs placebo (3:1 ratio). Standard of care analgesia (by institution) was employed (with the exception of other NSAIDs).

Dosing

One dose of ANJESO was administered every 24 hours for up to 7 doses.

Rescue medication

Patients received opioid analgesia according to the practice of the investigator to treat uncontrolled pain symptoms. Patients received standard of care analgesia (except for NSAIDs) according to the institution for postoperative pain management.

Primary objective

Safety and tolerability of ANJESO 30 mg vs placebo, including number of patients with adverse events up to 28 days.

Complex Foot/Ankle (N=72)⁴
Major Surgery Safety Study

Complex Foot/Ankle (N=72)⁴

Study design

A phase 3, multicenter, randomized, double-blind, placebo-controlled study of ANJESO 30 mg vs placebo (3:1 ratio). Standard of care analgesia (by institution) was employed (with the exception of other NSAIDs).

Dosing

One dose of ANJESO was administered every 24 hours for up to 7 doses.

Rescue medication

Patients received opioid analgesia according to the practice of the investigator to treat uncontrolled pain symptoms. Patients received standard of care analgesia (except for NSAIDs) according to the institution for postoperative pain management.

Primary objective

Safety and tolerability of ANJESO 30 mg vs placebo, including number of patients with adverse events up to 28 days.

Consider Non-Opioid ANJESO an Essential Component of Your Multimodal Analgesic Regimen

Paper

Clinical practice guidelines recommend including NSAIDs as part of a multimodal approach to pain management.5-11

  • American College of Surgeons
  • American Society of PeriAnesthesia Nurses
  • American Society for Pain Management Nursing
  • American Geriatrics Society
  • American Pain Society
  • Enhanced Recovery After Surgery Society
  • American Society of Anesthesiologists
  • American Society of Regional Anesthesia and Pain Medicine

INDICATION

ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

Limitation of Use: Because of delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Risk

  • Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • ANJESO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

CONTRAINDICATIONS

ANJESO is contraindicated in patients with:

  • Known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
  • In the setting of coronary artery bypass graft (CABG) surgery.
  • Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue ANJESO immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

Hypertension: NSAIDs including ANJESO can lead to new onset of hypertension or worsening of preexisting hypertension, which may contribute to the increased incidence of cardiovascular (CV) events. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: NSAID use increased the risk of myocardial infarction (MI), hospitalization for heart failure, and death. Avoid use of ANJESO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If ANJESO is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Post MI Patients: Avoid the use of ANJESO in patients with recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ANJESO is used in these patients, monitor for signs of cardiac ischemia.

Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury. ANJESO is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency who are at risk for renal failure due to volume depletion. Correct volume status in dehydrated or hypovolemic patients prior to initiating ANJESO. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ANJESO in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. If ANJESO is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

Anaphylactic Reactions: Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.

Exacerbation of Asthma Related to Aspirin Sensitivity: ANJESO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

Serious Skin Reactions: NSAIDs, including ANJESO, can cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue ANJESO at first appearance of skin rash or other signs of hypersensitivity.

Hematologic Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including ANJESO, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

DRUG INTERACTIONS

Drugs That Interfere With Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking ANJESO with drugs that interfere with hemostasis. Concomitant use of ANJESO and analgesic doses of aspirin is not generally recommended.

Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with ANJESO may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

ACE Inhibitors and ARBs: Concomitant use with ANJESO in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to ensure diuretic efficacy including antihypertensive effects.

ADVERSE REACTIONS

The most common adverse reactions in controlled clinical trials occurring in ≥ 2% of patients treated with ANJESO and at a greater frequency than placebo include: constipation, gamma-glutamyl transferase increased, and anemia.

USE IN SPECIFIC POPULATIONS

Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ANJESO in women who have trouble conceiving.

Please see full Prescribing Information, including Boxed Warning at www.anjeso.com.

References: 1. ANJESO [package insert]. Malvern, PA: Baudax Bio, Inc.; 2020. 2. Pollak RA, Gottlieb IJ, Hakakian F, et al. Efficacy and safety of intravenous meloxicam in patients with moderate-to-severe pain following bunionectomy: a randomized, double-blind, placebo-controlled trial. Clin J Pain. 2018;34(10):918-926. 3. Singla N, Bindewald M, Singla S, et al. Efficacy and safety of intravenous meloxicam in subjects with moderate-to-severe pain following abdominoplasty. Plast Reconstr Surg Glob Open. 2018;6:e1846; doi:10.1097/GOX.0000000000001846. 4. Bergese SD, Melson TI, Candiotti KA, et al. A phase 3, randomized, placebo-controlled evaluation of the safety of intravenous meloxicam following major surgery. Clin Pharmacol Drug Dev. 2019;8(8):1062-1072. 5. American Society of Anesthesiologists Task Force. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273. 6. Majumder A, Fayezizadeh M, Neupane R, Elliott HL, Novitsky YW. Benefits of multimodal enhanced recovery pathway in patients undergoing open ventral hernia repair. J Am Coll Surg. 2016;222(6):1106-1115. 7. Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17(2):131-157. 8. Gelman D, Gelmanas A, Urbanaitė D, et al. Role of multimodal analgesia in the evolving enhanced recovery after surgery pathways. Medicina. 2018;54(2):20. doi:10.3390/medicina54020020. 9. Krenzischek DA, Wilson L, American Society of PeriAnesthesia Nurses. An introduction to the ASPAN pain and comfort clinical guideline. J Perianesth Nurs. 2003;18(4):228-236. 10. Jarzyna D, Jungquist CR, Willens JS, et al. American Society for Pain Management nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011;12(3):118-145. 11. American Geriatrics Society Panel on the Pharmacological Management of Persistent Pain in Older Persons. Pharmacological management of persistent pain in older persons. J Am Geriatr Soc. 2009;57(8):1331-1346.