Anjeso

Anjeso is a nonsteroidal anti-inflammatory drug (NSAID) used in adults to manage moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

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.

Side effects of Anjeso include:

• constipation,
• GGT increased, and
• anemia

• Use for the shortest duration consistent with individual patient treatment goals.
• For intravenous administration only.
• The recommended dose of Anjeso is 30 mg once daily, administered by intravenous bolus injection over 15 seconds. 
• When initiating Anjeso, monitor patient analgesic response. Because the median time to meaningful pain relief was 2 and 3 hours after Anjeso administration in two clinical studies, a non-NSAID analgesic with a rapid onset of effect may be needed, for example, upon anesthetic emergence or resolution of local or regional anesthetic blocks.
• Some patients may not experience adequate analgesia for the entire 24-hour dosing interval and may require administration of a short-acting, non-NSAID, immediate-release analgesic.
• To reduce the risk of renal toxicity, patients must be well hydrated prior to administration of Anjeso.
• Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. Should the contents appear discolored or contain particulate matter, discard the vial.

See Table 3 for clinically significant drug interactions with meloxicam.

Table 3: Clinically Significant Drug Interactions with Meloxicam

• Use of NSAIDs, including Anjeso, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Anjeso, in pregnant women starting at 30 weeks of gestation (third trimester).
• There are no adequate and well-controlled studies of meloxicam in pregnant women.
• There are no human data available on whether meloxicam is present in human milk, or on the effects on breastfed infants, or on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Anjeso and any potential adverse effects on the breastfed infant from the Anjeso or from the underlying maternal condition.