QMIIZ ODT- meloxicam tablet, orally disintegrating
TerSera Therapeutics LLC
See full prescribing information for complete boxed warning.
- Nonsteroidal 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 Warning and Precautions (5.1) ]
- QMIIZ ODT is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contradictions (4), Warnings and Precautions (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 ( see Warnings and Precautions (5.2)].
QMIIZ ODT is indicated for relief of the signs and symptoms of osteoarthritis in adults [see Clinical Studies (14.1) ].
QMIIZ ODT is indicated for relief of the signs and symptoms of rheumatoid arthritis in adults [see Clinical Studies (14.1) ].
QMIIZ ODT is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in pediatric patients who weigh greater than or equal to 60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].
Carefully consider the potential benefits and risks of QMIIZ ODT and other treatment options before deciding to use QMIIZ ODT. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ].
After observing the response to initial therapy with QMIIZ ODT, adjust the dose to suit an individual patient’s needs.
In adults, the maximum recommended daily oral dose of QMIIZ ODT is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
With QMIIZ ODT, administration with liquid is not necessary. QMIIZ ODT may be taken without regard to timing of meals.
QMIIZ ODT should be taken as follows:
- Leave QMIIZ ODT in the original package until the time of administration.
- Be sure that hands are dry when handling an orally disintegrating tablet.
- Open the carton and peel back the foil on the blister. Do not push the tablet through the foil as this could damage the tablet.
- Gently remove the tablet from the blister and place it in the mouth, or onto the tongue, immediately after removing from the blister.
- The tablet will disintegrate quickly in saliva and can be easily swallowed with or without drinking liquid.
For the relief of the signs and symptoms of osteoarthritis, the recommended starting and maintenance oral dose of QMIIZ ODT is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of QMIIZ ODT is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of QMIIZ ODT is 7.5 mg once daily in children who weigh greater than or equal to 60 kg. There was no additional benefit demonstrated by increasing the dose above 7.5 mg in clinical trials.
Only use QMIIZ ODT tablets in children who weigh greater than or equal to 60 kg.
The use of QMIIZ ODT in subjects with severe renal impairment is not recommended.
QMIIZ ODT (meloxicam) orally disintegrating tablets have not shown equivalent systemic exposure with a comparable pharmacokinetic profile to other approved formulations of oral meloxicam. Therefore, QMIIZ ODT tablets are not interchangeable with other formulations of oral meloxicam product even if the total milligram strength is the same. Do not substitute similar dose strengths of QMIIZ ODT with other formulations of oral meloxicam products.
QMIIZ ODT (meloxicam) orally disintegrating tablet is a freeze-dried orally administered formulation containing 7.5 mg or 15 mg meloxicam and is designed to rapidly disintegrate in the mouth. Both strengths are orange-flavored, yellow, circular tablets and are debossed with an identifying marking: either 7.5 or 15 (see images below).
|7.5mg dose||15mg dose|
QMIIZ ODT 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, 5.9)]
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)]
- In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ]
- Patients with phenylketonuria [see Warnings and Precautions (5.14)]
Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as meloxicam, increases the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2) ].
Status Post-Coronary Artery Bypass Graft (CABG) Surgery
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see Contraindications (4) ].
Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of QMIIZ ODT in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If QMIIZ ODT is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
NSAIDs, including meloxicam, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.
Risk Factors for GI Bleeding, Ulceration, and Perforation
Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status. Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.
Strategies to Minimize the GI Risks in NSAID-treated patients:
- Use the lowest effective dosage for the shortest possible duration.
- Avoid administration of more than one NSAID at a time.
- Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs.
- Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy.
- If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue QMIIZ ODT until a serious GI adverse event is ruled out.
- In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding [see Drug Interactions (7) ].
Elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported.
Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs including meloxicam.
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 clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue QMIIZ ODT immediately, and perform a clinical evaluation of the patient [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
NSAIDs, including QMIIZ ODT, can lead to new onset or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs [see Drug Interactions (7) ].
Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.
The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.
Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of meloxicam may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]) [see Drug Interactions (7) ].
Avoid the use of QMIIZ ODT in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If QMIIZ ODT is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Long-term administration of NSAIDs, including QMIIZ ODT, has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
The renal effects of QMIIZ ODT may hasten the progression of renal dysfunction in patients with preexisting renal disease. Because some QMIIZ ODT metabolites are excreted by the kidney, monitor patients for signs of worsening renal function.
Correct volume status in dehydrated or hypovolemic patients prior to initiating QMIIZ ODT. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of QMIIZ ODT [see Drug Interactions (7) ].
No information is available from controlled clinical studies regarding the use of QMIIZ ODT in patients with advanced renal disease. Avoid the use of QMIIZ ODT in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. If QMIIZ ODT is used in patients with advanced renal disease, monitor patients for signs of worsening renal function [see Clinical Pharmacology (12.3)].
Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.
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