This information is intended for US healthcare professionals.

Phase 3: Major Surgery Safety StudyThe Largest Placebo-Controlled Safety Study Involving an IV NSAID to Date1-3,*

Safety and tolerability demonstrated up to 7 days in 538 ANJESO patients across various procedures1,4

ORTHOPEDIC (284)

Total knee replacement 117
Complex foot/ankle 53
Total hip replacement 50
Bunionectomy 40
Shoulder 13
Head, neck, and spine 11

SOFT TISSUE (254)

Hernia repair 132
Gynecologic 68
Abdominoplasty 32
GI 18
Other soft tissue 4

Patients were randomly assigned to treatment with ANJESO (538) or placebo (183) in a 3:1 ratio according to the randomization scheme.1

  • Excluded procedures included cranial surgeries, open heart procedures, CABG, organ transplant, and/or any procedure in which NSAIDs are contraindicated4

ANJESO met its primary objective of safety and tolerability over the course of 28 days with a similar rate of adverse events compared to placebo1

*As of March 2020. Study date: May 2017; N=721.1

Use for the shortest duration consistent with individual patient treatment goals.1

CABG, coronary artery bypass graft; GI, gastrointestinal.

*Randomization was stratified by risk status (high risk [age >65 years with GFR 60-89 mL/min/1.73 m2] vs non-high risk).3
Standard of care, including opioids, for pain management. IV NSAIDs (other than ANJESO) were not permitted.3
Patients must have remained in an inpatient setting for at least 24 to 48 hours and received at least 2 study doses.3
GFR, glomerular filtration rate; NSAID, nonsteroidal anti-inflammatory drug.

Safety and Tolerability Profile of ANJESO Across Phase 3 Studies5

Three adverse reactions occurred in ≥2% of ANJESO patients and at a greater frequency than placebo5

Reaction ANJESO 30 mg (n=748) % (n)  Placebo (n=393) % (n)
Constipation 7.6% (57) 6.1% (24)
Gamma-glutamyl transferase increase 2.8% (21) 1.5% (6)
Anemia 2.4% (18) 1.0% (4)
  • Constipation was patient-reported and characterized as a significant or unexpected worsening from baseline4,6,8
  • Gamma-glutamyl transferase elevations ≥10 x ULN were reported as adverse reactions7
  • Anemia was determined by the primary investigator based on laboratory assessments performed from baseline through 28 days post-op4-6,8

ULN, upper limit of normal.

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. 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. 2. Caldolor [package insert]. Nashville, TN: Cumberland Pharmaceuticals Inc; 2020. 3. Ketorolac [package insert]. Lake Forest, IL: Hospira, Inc; 2011. 4. Data on file. CSR REC-15-017. Baudax Bio; June 2017. 5. ANJESO [package insert]. Malvern, PA: Baudax Bio, Inc.; 2020. 6. Data on file. CSR-15-016. Baudax Bio; June 2017. 7. Data on file. Integrated Summary of Safety. Baudax Bio. 8. Data on file. CSR-15-015. Baudax Bio; June 2017.