b'Important Safety Information (contd)CONTRAINDICATIONS Exacerbation of Asthma Related to Aspirin Sensitivity: ANJESO is ANJESO is contraindicated in patients with: contraindicated in patients with aspirin-sensitive asthma. Monitor Known hypersensitivity (eg, anaphylactic reactions and serious skinpatients with preexisting asthma (without aspirin sensitivity).reactions) to meloxicam or any components of the drug product. Serious Skin Reactions: NSAIDs, including ANJESO, can cause History of asthma, urticaria, or other allergic-type reactions afterserious skin reactions, including exfoliative dermatitis, Stevens-taking aspirin or other NSAIDs.Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), In the setting of coronary artery bypass graft (CABG) surgery. which can be fatal and can occur without warning. Discontinue Moderate to severe renal insufficiency patients who are at risk forANJESO at first appearance of skin rash or other signs of renal failure due to volume depletion hypersensitivity.WARNINGS AND PRECAUTIONS Hematologic Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any Hepatotoxicity: Elevations of ALT or AST have been reported insigns or symptoms of anemia. NSAIDs, including ANJESO, may patients with NSAIDs. In addition, rare, sometimes fatal, cases ofincrease the risk of bleeding events. Monitor patients for signs of severe hepatic injury including fulminant hepatitis, liver necrosis, andbleeding.hepatic failure have been reported. Inform patients of warning signsDRUG INTERACTIONSand symptoms of hepatotoxicity. Discontinue ANJESO immediately Drugs That Interfere With Hemostasis (e.g., warfarin, if abnormal liver tests persist or worsen or if clinical signs andaspirin, SSRIs/SNRIs): Monitor patients for bleeding who are symptoms of liver disease develop. concomitantly taking ANJESO with drugs that interfere with Hypertension: NSAIDs including ANJESO can lead to new onset ofhemostasis. Concomitant use of ANJESO and analgesic doses of hypertension or worsening of preexisting hypertension, which mayaspirin is not generally recommended.contribute to the increased incidence of cardiovascular (CV) events.Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Patients taking some antihypertensive medications may haveReceptor Blockers (ARB), or Beta-Blockers: Concomitant use with impaired response to these therapies when taking NSAIDs. MonitorANJESO may diminish the antihypertensive effect of these drugs. blood pressure. Monitor blood pressure. Heart Failure and Edema: NSAID use increased the risk of myocardialACE Inhibitors and ARBs: Concomitant use with ANJESO in elderly, infarction (MI), hospitalization for heart failure, and death. Avoid usevolume depleted, or those with renal impairment may result in of ANJESO in patients with severe heart failure unless benefits aredeterioration of renal function. In such high risk patients, monitor expected to outweigh risk of worsening heart failure. If ANJESO isfor signs of worsening renal function. used in patients with severe heart failure, monitor patients for signs of worsening heart failure. Diuretics: NSAIDs can reduce natriuretic effect of furosemide and Post MI Patients: Avoid the use of ANJESO in patients with recentthiazide diuretics. Monitor patients to ensure diuretic efficacy MI unless the benefits are expected to outweigh the risk ofincluding antihypertensive effects.recurrent CV thrombotic events. If ANJESO is used in these patients,ADVERSE REACTIONSmonitor for signs of cardiac ischemia.The most common adverse reactions in controlled clinical trials Renal Toxicity: Long-term administration of NSAIDs has resulted inoccurring in2% of patients treated with ANJESO and at a greater renal papillary necrosis, renal insufficiency, acute renal failure, andfrequency than placebo include: constipation, gamma-glutamyl other renal injury. ANJESO is not recommended in patients withtransferase increased, and anemia. moderate to severe renal insufficiency and is contraindicated inUSE IN SPECIFIC POPULATIONSpatients with moderate to severe renal insufficiency who are at riskPregnancy: Use of NSAIDs during the third trimester of pregnancy for renal failure due to volume depletion. Correct volume statusincreases the risk of premature closure of the fetal ductus in dehydrated or hypovolemic patients prior to initiating ANJESO.arteriosus. Avoid use of NSAIDs in pregnant women starting atMonitor renal function in patients with renal or hepatic impairment,30 weeks gestation.heart failure, dehydration, or hypovolemia. Avoid use of ANJESO in patients with advanced renal disease unless benefits are expectedInfertility: NSAIDs are associated with reversible infertility. Consider to outweigh risk of worsening renal function. If ANJESO is used inwithdrawal of ANJESO in women who have trouble conceiving.patients with advanced renal disease, monitor patients for signs ofPlease see brief summary of full Prescribing Information on worsening renal function. inside pages and additional Important Safety Information Anaphylactic Reactions: Meloxicam has been associated withon front cover. For full Prescribing Information, including anaphylactic reactions in patients with and without knownBoxed Warning, visit www.anjeso.com.References: 1. ANJESO [package insert]. Malvern, PA: Baudax Bio, Inc.; 2020. 2. Pollak RA, Gottlieb IJ, hypersensitivity to meloxicam and in patients with aspirin-sensitiveHakakian F, et al. Efficacy and safety of intravenous meloxicam in patients with moderate-to-severe asthma. Seek emergency help if an anaphylactic reaction occurs.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 safetyof intravenous meloxicam in subjects with moderate-to-severe pain following abdominoplasty. Plast Reconstr Surg Glob Open. 2018;6:e1846; doi:10.1097/GOX.0000000000001846.0520-234.aCopyright2020 Baudax Bio. All rights reserved.ANJESO is a trademark of Baudax Bio.20-MCAM-0071_b_Branded_JrnlAd_TheCompendium_DR2.indd 4 5/11/20 2:03 PM'