This information is intended for US healthcare professionals.

Once-Daily ANJESO—Systemic Availability With Analgesia up to 24 Hours1

  • Following IV administration of ANJESO 30 mg, plasma concentrations exceed those of oral meloxicam 15 mg1

Pharmacokinetics of ANJESO and oral meloxicam1,2

ANJESO pharmacokinetics: AUCinf (ng•hr/mL), 107,508.7 (34,443.0); Cmax (ng/mL), 5642.9 (1009.0); Ke (l/hr), 0.03 (0.02); t1/2 (h), 23.3 (9.36).1,2
AUCinf, area under the curve; Cmax, maximum serum concentration; Ke, elimination rate constant; t1/2, elimination half-life.

Time to onset of pain relief with ANJESO:

  • Because of delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required1
  • The majority of patients in the clinical trials reached meaningful pain relief within 2-3 hours1,3,*
  • 57.3% of patients first perceived pain relief within 30 minutes3,*

*Onset of action may be delayed in some patients.1

Phase 3: BunionectomySignificantly Reduced Pain Following Bunionectomy1,4,*

*Pain reduction observed with once-daily dosing¹

Statistically significant secondary endpoints:

  • Proportion of patients who achieved ≥30% pain reduction at 24 hours (P=0.0107)4
  • Pain reduction at all postdose intervals (hour 6, hour 12, hour 24, and hours 24-48 [P<0.05]) with ANJESO4,†

Plus oxycodone 5 mg Q2H PRN.3

PRN, as needed; Q2H, every 2 hours.

Rescue medication was provided Q2H PRN.3

SPID-48, summed pain intensity difference over the first 48 hours.

Phase 3: AbdominoplastySignificantly Reduced Pain Following Abdominoplasty1,5,*

*Pain reduction observed with once-daily dosing¹

Statistically significant secondary endpoints:

  • Proportion of patients who achieved ≥30% pain reduction at 24 hours (P=0.0178)5
  • Pain reduction at all postdose intervals (hour 12, hour 24, and hours 24-48 [P<0.05]) except for 0-6 hours5

Based on actual SPID data from the clinical trials.6

Rescue medication was provided every 2 hours as needed for pain.5

SPID-24, summed pain intensity difference over the first 24 hours.

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. Data on file. Phase I single-ascending-dose crossover study to evaluate the pharmacokinetics of N1539 following intravenous administration. Elan Drug Delivery, Inc; December 2009. 3. Data on file. Integrated Summary of Efficacy. Baudax Bio. 4. 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. 5. 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. 6. Data on file. CSR-15-015. Baudax Bio; April 2017.