QAMZOVA

QAMZOVA is an FDA-registered drug product whose active ingredient is MELOXICAM. It is labelled by Nanjing Delova Biotech Co., Ltd. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 82972-001, application NDA217593, label effective 20260716. It is one of 43 FDA drug label records sharing the active ingredient MELOXICAM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MELOXICAM are most often described in connection with: onset analgesia, management moderate-to-severe, pain alone, non-nsaid analgesics, usage qamzova, contains meloxicam. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS 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. 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. ( 1 )

2 DOSAGE AND ADMINISTRATION Use for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. 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 [ see Clinical Studies ( 14) ] . 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 [ see Clinical Studies ( 14 ) ]. 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 [ see Dosage Forms and Strengths ( 3 ) ]. Use for the shortest duration consistent with individual patient treatment goals. ( 2 ) The recommended dose is 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 QAMZOVA administration. ( 2 )

4 CONTRAINDICATIONS 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 [ see Warnings and Precautions ( 5.7 ) ]. 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 [ see Warnings and Precautions ( 5.8 ) ]. In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ]. Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion [ see Warnings and Precautions ( 5.6 ) ]. 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 )

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration, and Perforation [ see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] Hypertension [ see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.12 )] 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 Nanjing Delova Biotech Co., Ltd. at 1-844-406-8288 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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 Table 1 are derived from the three Phase 3 trials comparing meloxicam injection to placebo in patients who may have also received opioid rescue medication. 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 Meloxicam Injection Placebo Adverse Reaction N=748 N=393 Constipation 57 (7.6%) 24 (6.1%) Gamma-Glutamyl transferase Increased 21 (2.8%) 6 (1.5%) Anemia 18 (2.4%) 4 (1.0%) 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 Body as a Whole asthenia, back pain, edema, fatigue, hyperthermia, infusion site reactions (including pain, pruritus, phlebitis and thrombosis), muscle spasms, noncardiac chest pain, pyrexia, vaginal discharge, weight decrease Central and Peripheral Nervous System disturbance in attention, migraine, presyncope, somnolence, syncope Gastrointestinal abdominal discomfort, abdominal distension, abdominal pain, diarrhea, dry mouth, epigastric discomfort, flatulence, frequent bowel movements, gastritis, gastroesophageal reflux, gastrointestinal pain, rectal hemorrhage Heart Rate and Rhythm tachycardia Hematologic increased bleeding time, neutropenia, thrombocytosis Infections and Infestations cellulitis, gastroenteritis, urinary tract infection, vulval abscess Liver and Biliary System liver function test abnormal Metabolic and Nutritional hypokalemia, hypomagnesemia Procedural Complications incision site hemorrhage, incision site rash, wound dehiscence, wound hematoma Psychiatric confusion, hallucination, insomnia Respiratory dyspnea, epistaxis, hypoxia, oropharyngeal pain Skin and Appendages contact dermatitis, ecchymosis, rash Urinary System pollakiuria, urinary retention 6.2 Postmarketing 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.

FDA lists 43 drug label records with MELOXICAM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is QAMZOVA used for?
1 INDICATIONS 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. QAMZOVA contains meloxicam, which is an NSAID, and is indicated for use in adults for the …

Who makes QAMZOVA?
Nanjing Delova Biotech Co., Ltd. is the labeler of record for QAMZOVA. 43 FDA label records share the active ingredient MELOXICAM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does QAMZOVA come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is QAMZOVA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MELOXICAM?
Yes. 43 FDA drug label records list MELOXICAM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has QAMZOVA been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.