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Generic Name
Meloxicam
Brand Names
Qamzova, Symbravo, Xifyrm, Zybic
FDA approval date: November 01, 2005
Classification: Nonsteroidal Anti-inflammatory Drug
Form: Injection, Tablet, Suspension, Capsule
What is Qamzova (Meloxicam)?
QAMZOVA 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, QAMZOVA alone is not recommended for use when rapid onset of analgesia is required. QAMZOVA contains meloxicam, which is an NSAID, and 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, QAMZOVA alone is not recommended for use when rapid onset of analgesia is required.
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Brand Information
QAMZOVA (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 [
- QAMZOVA 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 us e 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 [
1INDICATIONS AND USAGE
QAMZOVA 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, QAMZOVA alone is not recommended for use when rapid onset of analgesia is required.
2DOSAGE AND ADMINISTRATION
Use for the shortest duration consistent with individual patient treatment goals [
For intravenous administration only.
The recommended dose of QAMZOVA is 30 mg once daily, administered by intravenous bolus injection over 15 seconds.
When initiating QAMZOVA, monitor patient analgesic response. Because the median time to meaningful pain relief was 2 and 3 hours after meloxicam injection 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 QAMZOVA.
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 [
3DOSAGE FORMS AND STRENGTHS
QAMZOVA (meloxicam) injection is a sterile, clear, greenish-yellow, non-pyrogenic, aqueous solution intended for intravenous use available as a clear, single-dose vial containing 30 mg/mL per vial.
4CONTRAINDICATIONS
QAMZOVA is contraindicated in the following patients:
- Known hypersensitivity (e.g., 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. Severe, sometimes fatal anaphylactic-like reactions to NSAIDs have been reported in such patients [
- 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 [
5ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in the other sections of the labeling:
- Cardiovascular Thrombotic Events [
- GI Bleeding, Ulceration, and Perforation [
- Hepatotoxicity [
- Hypertension [
- Heart Failure and Edema [
- Renal Toxicity and Hyperkalemia [
- Anaphylactic Reactions [
- Serious Skin Reactions [
- Hematologic Toxicity [
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.
During clinical development, 1426 patients were exposed to meloxicam injection in controlled and open-label Phase 2 and Phase 3 trials. Meloxicam injection was studied across a range of surgical procedures, including bunionectomy, abdominoplasty, soft tissue surgery, total knee replacement surgery, gynecologic surgery, complex foot surgery and total hip replacement surgery. In these trials, 381 patients received a single dose of meloxicam injection and 1045 patients received multiple doses of meloxicam injection daily for up to 7 days. The incidence rates of adverse reactions listed in
The following is a list of adverse drug reactions occurring in <2% of patients receiving meloxicam injection in clinical trials.
5.2Postmarketing Experience
The following adverse reactions have been identified during postapproval 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.
Adverse reactions reported in worldwide post marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson syndrome; toxic epidermal necrolysis, and infertility female.
6DRUG INTERACTIONS
See
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 [
Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may be employed but are not likely to be useful due to high protein binding.
There is limited experience with meloxicam overdose. In four reported cases of meloxicam overdose, patients took 6 to 11 times the highest available oral dose of meloxicam tablets (15 mg); all recovered. Cholestyramine is known to accelerate the clearance of meloxicam. Accelerated removal of meloxicam by 4 g doses of cholestyramine given three times a day was demonstrated in a clinical trial. Administration of cholestyramine may be useful following an overdosage.
In case of an overdosage, discontinue QAMZOVA therapy and contact a regional poison control center at 1-800-222-1222.
8DESCRIPTION
QAMZOVA contains meloxicam, which is a nonsteroidal anti-inflammatory drug (NSAID). It is a sterile clear, greenish-yellow, aqueous solution containing the active pharmaceutical ingredient meloxicam for intravenous administration. Each mL of aqueous solution contains 30 mg of meloxicam and 300 mg of polyethylene glycol 400 in water for injection. The pH of the solution is adjusted with sodium hydroxide and citric acid monohydrate if necessary. The solution pH ranges from 7.4 to 8.4.
Meloxicam is a pale yellow powder, practically insoluble in water, slightly soluble in acetone, soluble in dimethylformamide, and very slightly soluble in methanol and in alcohol. Meloxicam is designated chemically as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2- benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2 and the structural formula of meloxicam is:
Figure 1: Structural Formula of Meloxicam
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 1 (Bunionectomy Surgery)
In the first controlled, multiple-dose trial (NCT02675907) of adult patients with postoperative pain who underwent bunionectomy surgery, 201 patients were treated with meloxicam injection 30 mg or placebo administered once daily for two days starting on the day after surgery. An optional third dose was permitted just prior to discharge. A minimum postoperative baseline pain intensity of 4 on the Numeric Pain Rating Scale (NPRS) (range 0-10) and pain categorized as moderate or severe were required for randomization. The majority of patients were female (85%). The average age was 48 years. The mean overall baseline pain intensity on the NPRS was 6.8. A statistically significant difference demonstrating efficacy was observed in the primary efficacy endpoint of the summed pain intensity difference over the first 48 hours (SPID48). The average pain intensity over time is depicted for the treatment groups in
Figure 2
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
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
QAMZOVA (meloxicam) injection, is a clear, greenish-yellow aqueous solution intended for intravenous use supplied as a 1 mL fill (30 mg/mL) in a clear single-dose vial with a blue flip-off cap.
Single-dose vial: NDC 82972-001-30
11PATIENT COUNSELING INFORMATION
Inform patients of the following information before initiating therapy with QAMZOVA.
Cardiovascular Thrombotic Effects
Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately[
Gastrointestinal Bleeding, Ulceration, and Perforation
Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding [
Hepatotoxicity
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop QAMZOVA and seek immediate medical therapy [
Heart Failure and Edema
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [
Anaphylactic Reactions
Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [
Serious Skin Reactions including DRESS
Advise patients to stop taking QAMZOVA immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [
Female Fertility
Advise females of reproductive potential who desire pregnancy that NSAIDs, including QAMZOVA, may be associated with a reversible delay in ovulation [
Fetal Toxicity
Inform pregnant women to avoid use of QAMZOVA and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with QAMZOVA is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [
Avoid Concomitant Use of NSAIDs
Inform patients that the concomitant use of QAMZOVA with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [
Use of NSAIDs and Low-Dose Aspirin
Inform patients not to use low-dose aspirin concomitantly with QAMZOVA until they talk to their healthcare provider [
This PRESCRIBING INFORMATION has been approved by the US Food and Drug Administration.
Manufactured for:
Nanjing Delova Biotech Co., Ltd.
Nanjing, Jiangsu 210042, China
Made in China
Prescribing Information issued: April 2025