For US Healthcare Professionals only

Qmiiz™ ODT (meloxicam) logo

7.5 mg and 15 mg

NOW AVAILABLE
First & Only ODT NSAID Bioequivalent to Meloxicam Tablets

WHEN DEALING WITH OA, RA, AND JRA SYMPTOMS

Swallowing a pill may be a TALL ORDER

Qmiiz ODT is a new orally disintegrating NSAID tablet that rapidly dissolves on the tongue.

Indication: QMIIZ ODT is a nonsteroidal anti‑inflammatory drug indicated for relief of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults, and juvenile rheumatoid arthritis (JRA) pauciarticular and polyarticular course in pediatric patients ≥60 kg.

May be an affordable option for OA, RA, and JRA pain relief

Eligible* patients may pay as little as $50 for Qmiiz ODT—no savings card needed.

*Patients are not eligible if prescriptions are paid by any state or other federally funded programs, including, but not limited to Medicare or Medicaid, Medigap, VA or DOD or TRICARE, or where prohibited by law. This offer is for eligible commercially insured patients only. This offer is only available at participating pharmacies.

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Indication and Important Safety Information

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • QMIIZ ODT is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
  • 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.

QMIIZ™ ODT (meloxicam) orally disintegrating tablets

Indication

  • QMIIZ ODT is a nonsteroidal anti-inflammatory drug indicated for relief of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults, and juvenile rheumatoid arthritis (JRA) pauciarticular and polyarticular course in pediatric patients ≥60 kg.
  • CONTRAINDICATIONS: Patients with a known hypersensitivity to meloxicam or its inactive ingredients; In patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs as anaphylactic reactions have been reported; In CABG surgery; Those with a history of phenylketonuria as QMIIZ ODT contains phenylalanine.

ADDITIONAL WARNINGS AND PRECAUTIONS: QMIIZ ODT should be used at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

Elevation of 1 or more liver tests may occur during therapy with QMIIZ ODT. Rare, sometimes fatal, cases of severe hepatic injury have been reported with NSAIDs. Discontinue QMIIZ ODT immediately if clinical signs and symptoms of liver disease or systemic manifestations develop.

NSAIDs, including QMIIZ ODT, can lead to the new onset or worsening of existing hypertension, which may contribute to the increased incidence of CV events. Blood pressure should be monitored during treatment with QMIIZ ODT. NSAIDs may diminish the antihypertensive activity of loop and thiazide diuretics, ACE inhibitors, angiotensin receptor blockers (ARB), or beta-blockers.

NSAID use has been associated with an increase in the risk of MI, hospitalizations due to heart failure, and death. Also, fluid retention and edema have been observed in patients taking NSAIDs. Avoid QMIIZ ODT in patients with severe heart failure unless benefits outweigh the risks.

Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. QMIIZ ODT should be used with caution in patients at greatest risk of this reaction, those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly. Avoid the use of QMIIZ ODT in patients with advanced renal disease unless benefits outweigh the risks. Increases in serum potassium concentrations, including hyperkalemia, have been reported with NSAID use.

Anaphylactic reactions may occur in patients with the asthma triad or in patients without prior exposure to meloxicam. Monitor signs and symptoms in patients with preexisting asthma even without known aspirin sensitivity.

NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. QMIIZ ODT should be discontinued if rash or other signs of local skin reaction occur.

Starting at 30 weeks of gestation, QMIIZ ODT and other NSAIDs should be avoided by pregnant women, as premature closure of the ductus arteriosus in the fetus may occur.

Anemia has occurred in NSAID-treated patients. NSAIDs, including QMIIZ ODT, may increase the risk of bleeding. Concomitant administration of anticoagulants, antiplatelet agents (e.g., aspirin), SSRIs, SNRIs, salicylates may increase this risk.

QMIIZ ODT may mask the signs of infection due to the anti-inflammatory and anti-pyretic activity.

Since serious GI, hepatic, and renal events can occur without warning with NSAID use, consider monitoring CBC and chemistry profile in patients on long-term NSAID therapy.

ADVERSE REACTIONS: In clinical trials of meloxicam, the most common (≥5% and greater than placebo) adverse events in adults were diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms. Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience, although there were differences in frequency.

For more information, please see the full Prescribing Information including Boxed WARNING, and Medication Guide for QMIIZ ODT

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also contact TerSera Therapeutics at 1-844-334-4035 or medicalinformation@tersera.com