Clinical Information
Gen. Code and Des.
80770 meloxicam INTRAVEN VIAL 30 MG/ML
GCN and Des.
47743 meloxicam INTRAVEN VIAL 30 MG/ML
Strength
30MG
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
28080492 OTHER NONSTEROIDAL ANTI-INFLAM. AGENTS
Active Ingredients
6272 meloxicam 71125387
Inactive Ingredients
2537 povidone 9003398
2598 sucrose 57501
These highlights do not include all the information needed to use ANJESO safely and effectively. See full prescribing information for ANJESO.
ANJESO® (meloxicam) injection, for intravenous use
Initial U.S. Approval: 2000
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning.
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 (5.1)
ANJESO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (4, 5.1)
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 (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS) (5.10) 04/2021
Warnings and Precautions, Fetal Toxicity (5.11) 04/2021
INDICATIONS AND USAGE
ANJESO is an NSAID 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. (1)
DOSAGE AND ADMINISTRATION
Use for the shortest duration consistent with individual patient treatment goals. (2)
30 mg once daily, administered by intravenous bolus injection over 15 seconds. (2)
Monitor patient analgesic response and administer a short-acting, non-NSAID, immediate-release analgesic if response is inadequate. (2)
Patients must be well hydrated before ANJESO administration. (2)
DOSAGE FORMS AND STRENGTHS
ANJESO (meloxicam) injection, single-dose vial containing 30 mg/mL per vial. (3)
CONTRAINDICATIONS
Known hypersensitivity to meloxicam or any components of the drug product. (4)
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. (4)
In the setting of coronary artery bypass graft (CABG) surgery. (4)
Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion. (4)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: 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. (5.3)
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking ANJESO. Monitor blood pressure. (5.4, 7)
Heart Failure and Edema: Avoid use of ANJESO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. (5.5)
Renal Toxicity: 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. (5.6)
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. (5.7)
Exacerbation of Asthma Related to Aspirin Sensitivity: ANJESO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). (5.8)
Serious Skin Reactions: Discontinue ANJESO at first appearance of skin rash or other signs of hypersensitivity. (5.9)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically. (5.10)
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. (5.12, 7)
Fetal Toxicity: Limit use of NSAIDs, including ANJESO, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. (5.11,8.1)
ADVERSE REACTIONS
The most common adverse reactions (≥ 2% and greater than placebo) in controlled clinical trials include constipation, GGT increased, and anemia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Baudax Bio at 1-844-303-5510 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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. (7)
ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Concomitant use with ANJESO may diminish the antihypertensive effect of these drugs. Monitor blood pressure. (7)
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. (7)
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. (7)
USE IN SPECIFIC POPULATIONS
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ANJESO in women who have difficulties conceiving. (8.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2022
