Generic Name
Meloxicam
Brand Names
Xifyrm, Qamzova, Symbravo
FDA approval date: November 01, 2005
Classification: Nonsteroidal Anti-inflammatory Drug
Form: Injection, Tablet, Suspension, Capsule
What is Xifyrm (Meloxicam)?
Meloxicam oral suspension is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis .
Approved To Treat
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Brand Information
XIFYRM (meloxicam)
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. [see Warnings and Precautions (].
• XIFYRM is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (].
• 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. [see Warnings and Precautions (].
• XIFYRM is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (].
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 [see Warnings and Precautions (].
1INDICATIONS AND USAGE
XIFYRM is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.
2DOSAGE AND ADMINISTRATION
Use for the shortest duration consistent with individual patient treatment goals [
3DOSAGE FORMS AND STRENGTHS
XIFYRM (meloxicam injection) is a sterile, clear, pale yellow to yellow color solution intended for intravenous use available as a clear, single-dose vial containing 30 mg/mL per vial.
4CONTRAINDICATIONS
XIFYRM is contraindicated in the following patients:
5ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in the other sections of the labeling:
5.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 1: Proportion of Patients Experiencing Common Adverse Reactions in Placebo- Controlled Phase 3 Clinical Trials occurring in greater than or equal to 2% of Patients Treated with Meloxicam injection and at a greater frequency than Placebo
The following is a list of adverse drug reactions occurring in <2% of patients receiving meloxicam injection in clinical trials.
Table 2: Additional Adverse Reactions for Meloxicam Injection
5.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of meloxicam. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
6DRUG INTERACTIONS
See Table 3 for clinically significant drug interactions with meloxicam.
Table 3: Clinically Significant Drug Interactions with Meloxicam
7OVERDOSAGE
Symptoms following acute NSAID overdoses have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare. [
8DESCRIPTION
XIFYRM (meloxicam injection) is a nonsteroidal anti-inflammatory drug (NSAID). It is a sterile clear, pale-yellow to yellow color solution, containing the active pharmaceutical ingredient meloxicam for intravenous administration. Each mL of aqueous solution contains 30 mg of meloxicam, 150 mg of hydroxypropyl betadex, 20 mg of meglumine, 60 mg of povidone and water for injection. The pH of the meloxicam injection is 8.0 to 9.5.
9CLINICAL STUDIES
The efficacy and safety of meloxicam injection in the treatment of moderate to severe pain was evaluated in two Phase 3 randomized, double-blind, placebo-controlled, multiple-dose clinical trials in patients with postoperative pain. In both trials, oral oxycodone 5 mg was permitted as rescue medication for pain management.
Study 2 (Abdominoplasty Surgery)In the second controlled, multiple-dose trial (NCT02678286) of adult patients with postoperative pain who underwent elective abdominoplasty surgery, 219 patients were treated with meloxicam injection 30 mg or placebo administered once daily for two days starting on the day of surgery. An optional third dose was permitted just prior to discharge. A minimum postoperative baseline pain intensity of 4 on the NPRS (range 0-10) and pain categorized as moderate or severe were required for randomization. The majority of patients were female (98%). The average age was 40 years. The mean overall baseline pain intensity on the NPRS was 7.3. A statistically significant difference demonstrating efficacy was observed in the primary efficacy endpoint of the summed pain intensity difference over the first 24 hours (SPID24) as well as over the first 48 hours (SPID48). The average pain intensity over time is depicted for the treatment groups in Figure 3. A generally consistent separation in pain scores between the meloxicam injection and placebo group was observed from time of onset through most of the dosing interval with a narrowing at the end of the first 24-hour dosing interval.
Onset of Meaningful Pain Relief and Use of Rescue Analgesic Medication
The median time to first rescue analgesic use in patients treated with meloxicam injection (2 hours in Study 1 and 1 hour in Study 2) came before the median time to patient-reported meaningful pain relief in both studies (2 hours in Study 1 and 3 hours in Study 2). Fifty percent of patients treated with meloxicam injection and 49% of patients treated with placebo in Study 1 received rescue analgesia medication in the first 2 hours after the start of dosing. Seventy-eight percent of patients treated with meloxicam injection and 78% of patients treated with placebo in Study 2 received rescue in the first 3 hours after the start of dosing.
10HOW SUPPLIED/STORAGE AND HANDLING
XIFYRM (meloxicam injection) is a clear, pale-yellow to yellow color solution intended for intravenous use supplied as a 1 mL fill (30 mg/mL) in a clear, single-dose vial with a blue tamper-evident top.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep vial in carton to protect from light.
Discard unused portion.
11PATIENT COUNSELING INFORMATION
Inform patients of the following information before initiating therapy with XIFYRM.
06/2025 Rev00
12PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
XIFYRM (meloxicam injection) 30 mg/mL - Carton Label
NDC 24338-153-02
10 x 1 mL Single-Dose Vials
PRINCIPAL DISPLAY PANEL -
XIFYRM (meloxicam injection) 30 mg/mL
NDC:
1mL Single-Dose Vial
