QMIIZ ODT: Package Insert and Label Information (Page 5 of 5)

12.5 Pharmacogenomics

CYP2C9 activity is reduced in individuals with genetic variants such as CYP2C9*2 and CYP2C9*3 polymorphisms. Limited data from three published reports showed that meloxicam AUC was substantially higher in individuals with reduced CYP2C9 activity, particularly in poor metabolizers (e.g., *3/*3), compared to normal metabolizers (*1/*1). The frequency of CYP2C9 poor metabolizer genotypes varies based on racial/ethnic background but is generally present in <5% of the population.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered meloxicam at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.5- and 2.6-times, respectively, the maximum recommended human dose [MRHD] of 15 mg/day QMIIZ ODT based on body surface area [BSA] comparison).

Mutagenesis

Meloxicam was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.

Impairment of Fertility

Meloxicam did not impair male and female fertility in rats at oral doses up to 9 mg/kg/day in males and 5 mg/kg/day in females (up to 5.8- and 3.2-times greater, respectively, than the MRHD based on BSA comparison).

In a published study, oral administration of 1 mg/kg (0.6-times the MRHD based on BSA comparison) meloxicam to male rats for 35 days resulted in decreased sperm count and motility and histopathological evidence of testicular degeneration.

14 CLINICAL STUDIES

14.1 Osteoarthritis and Rheumatoid Arthritis

The use of meloxicam for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12-week, double-blind, controlled trial. Meloxicam (3.75 mg, 7.5 mg, and 15 mg daily) was compared to placebo. The four primary endpoints were investigator’s global assessment, patient global assessment, patient pain assessment, and total WOMAC score (a self-administered questionnaire addressing pain, function, and stiffness). Patients on meloxicam 7.5 mg daily and meloxicam 15 mg daily showed significant improvement in each of these endpoints compared with placebo.

The use of meloxicam for the management of signs and symptoms of osteoarthritis was evaluated in six double-blind, active-controlled trials outside the U.S. ranging from 4 weeks’ to 6 months’ duration. In these trials, the efficacy of meloxicam, in doses of 7.5 mg/day and 15 mg/day, was comparable to piroxicam 20 mg/day and diclofenac SR 100 mg/day and consistent with the efficacy seen in the U.S. trial.

The use of meloxicam for the treatment of the signs and symptoms of rheumatoid arthritis was evaluated in a 12-week, double-blind, controlled multinational trial. Meloxicam (7.5 mg, 15 mg, and 22.5 mg daily) was compared to placebo. The primary endpoint in this study was the ACR20 response rate, a composite measure of clinical, laboratory, and functional measures of RA response. Patients receiving meloxicam 7.5 mg and 15 mg daily showed significant improvement in the primary endpoint compared with placebo. No incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose.

14.2 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

The use of meloxicam for the treatment of the signs and symptoms of pauciarticular or polyarticular course JRA in patients 2 years of age and older was evaluated in two 12-week, double-blind, parallel-arm, active-controlled trials.

Both studies included three arms: naproxen and two doses of meloxicam. In both studies, meloxicam dosing began at 0.125 mg/kg/day (7.5 mg maximum) or 0.25 mg/kg/day (15 mg maximum), and naproxen dosing began at 10 mg/kg/day. One study used these doses throughout the 12-week dosing period, while the other incorporated a titration after 4 weeks to doses of 0.25 mg/kg/day and 0.375 mg/kg/day (22.5 mg maximum) of meloxicam and 15 mg/kg/day of naproxen.

The efficacy analysis used the ACR Pediatric 30 responder definition, a composite of parent and investigator assessments, counts of active joints and joints with limited range of motion, and erythrocyte sedimentation rate. The proportion of responders were similar in all three groups in both studies, and no difference was observed between the meloxicam dose groups.

16 HOW SUPPLIED/STORAGE AND HANDLING

QMIIZ ODT (meloxicam) orally disintegrating tablets are supplied as:

  • 7.5 mg — orange flavored, yellow, circular tablets imprinted with 7.5 on one side. They are packaged in aluminum blister packs which are subsequently packed into cardboard cartons.
    NDC (70720-175-30), Carton containing 3 blister packs of 10 tablets each, for a total of 30 tablets
    NDC (70720-175-90), Carton containing 9 blister packs of 10 tablets each, for a total of 90 tablets
    NDC (70720-175-99), Carton containing 10 blister packs of 10 tablets each, for a total of 100 tablets
  • 15 mg — orange flavored, yellow, circular tablets imprinted with 15 on one side. They are packaged in aluminum blister packs which are subsequently packed into cardboard cartons.
    NDC (70720-115-30), Carton containing 3 blister packs of 10 tablets each, for a total of 30 tablets
    NDC (70720-115-90), Carton containing 9 blister packs of 10 tablets each, for a total of 90 tablets
    NDC (70720-115-99), Carton containing 10 blister packs of 10 tablets each, for a total of 100 tablets

Storage

Store at room temperature, between 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C and 30 °C (59 °F to 86 °F) [See USP Controlled Room Temperature].
Keep package dry and away from moisture. Avoid high humidity and excessive heat above 40 °C (104 °F).

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed.

Inform patients, families or their caregivers of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.

Important Administration Instructions

Patients should be instructed not to remove the tablet from the blister from the carton until just prior to dosing. The blister pack should then be peeled open with dry hands and the orally disintegrating tablet placed on the tongue, where the tablet will disintegrate.

Cardiovascular Thrombotic Events

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 [see Warnings and Precautions (5.1) ].

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 [see Warnings and Precautions (5.2) ].

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 QMIIZ ODT and seek immediate medical therapy [see Warnings and Precautions (5.3) ].

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 [see Warnings and Precautions (5.5) ].

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 [see Contraindications (4) and Warnings and Precautions (5.7)].

Serious Skin Reactions, including DRESS

Advise patients to stop taking QMIIZ ODT immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see Warnings and Precautions (5.9, 5.10)].

Fertility

Female Fertility
Advise females of reproductive potential who desire pregnancy that NSAIDs, including QMIIZ ODT, may be associated with a reversible delay in ovulation [see Use in Specific Populations (8.3) ].

Male Fertility
Advise males of reproductive potential that QMIIZ ODT may compromise fertility. It is not known, if these effects are reversible [see Use in Specific Populations (8.3) ].

Fetal Toxicity

Inform pregnant women to avoid use of QMIIZ ODT and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with QMIIZ ODT 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 [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1)].

Avoid Concomitant Use of NSAIDs

Inform patients that the concomitant use of QMIIZ ODT 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 [see Warnings and Precautions (5.2) and Drug Interactions (7)]. Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia.

Use of NSAIDs and Low-Dose Aspirin

Inform patients not to use low-dose aspirin concomitantly with QMIIZ ODT until they talk to their healthcare provider [see Drug Interactions (7) ].

Phenylketonuria

Inform phenylketonuric patients that QMIIZ ODT contains phenylalanine (a component of aspartame). Each 7.5-mg orally disintegrating tablet contains 0.30 mg phenylalanine, and each 15-mg orally disintegrating tablet contains 0.59 mg phenylalanine [see Warnings and Precautions (5.13) ].

Manufactured for:
TerSera Therapeutics LLC, Deerfield, IL 60015

Manufactured by:
Catalent Pharma Solutions, Limited
Swindon, Wiltshire, SN5 8RU, UK
QMIIZ™ ODT is a trademark of TerSera Therapeutics LLC.
© 2021 TerSera Therapeutics LLC.Rev: 04/2021

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: 4/2021

Medication Guide for QMIIZ ODT (kew’-miz oh dee tee) (meloxicam) Orally Disintegrating Tablet

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including:

  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
    • with increasing doses of NSAIDs
    • with longer use of NSAIDs

    Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

    Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
    • anytime during use
    • without warning symptoms
    • that may cause death

    The risk of getting an ulcer or bleeding increases with:

    • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
    • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
  • increasing doses of NSAIDs
  • longer use of NSAIDs
  • smoking
  • drinking alcohol
  • older age
  • poor health
  • advanced liver disease
  • bleeding problems
NSAIDs should only be used:
  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed
What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.
Who should not take QMIIZ ODT? Do not take QMIIZ ODT:
  • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • right before or after heart bypass surgery.
  • if you have phenylketonuria (PKU). QMIIZ ODT contains phenylalanine (a component of aspartame).
Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:
  • have liver or kidney problems
  • have high blood pressure
  • have asthma
  • are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.
  • are breastfeeding or plan to breast feed.
Tell your healthcare provider about all the medicines you take, including prescription or over-the- counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.
How should I take QMIIZ ODT Orally Disintegrating Tablet (ODT)?
  • Take QMIIZ ODT exactly as prescribed.
  • Leave QMIIZ ODT in the package it comes in until you are ready to take it.
  • When you are ready to take your dose
    • Be sure your hands are dry
    • Open the carton and peel back the foil on the blister. Do not push the tablet through the foil.
    • As soon as you open the blister, remove the tablet and put it onto your tongue.
    • The tablet will disintegrate quickly in your saliva so that you can easily swallow it with or without drinking liquid.
What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Get emergency help right away if you get any of the following symptoms:
  • chest pain
  • weakness in one part or side of your body
  • swelling of the face or throat
Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or stomach pain
  • flu-like symptoms
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms, legs hands and feet
If you take too much of your NSAID, call your healthcare provider or get medical help right away. These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other information about NSAIDs
  • Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
How should I store QMIIZ ODT?
  • Store QMIIZ ODT at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Excursions permitted between 59 °F to 86 °F (15 °C to 30 °C).
  • Keep QMIIZ ODT dry and away from moisture. Avoid high humidity and excessive heat above 104 °F (40 °C)
Keep QMIIZ ODT and all medicines out of the reach of children.
General information about the safe and effective use of NSAIDs. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.
Manufactured for: TerSera Therapeutics LLC, Deerfield, IL 60015Manufactured by: Catalent Pharma Solutions, Limited, Swindon, Wilshire, SN5 8RU, UKQMIIZ ODT is a trademark of TerSera Therapeutics LLC.© 2021 TerSera Therapeutics LLCFor more information, call 1-(844) 334-4035.

PRINCIPAL DISPLAY PANEL — 7.5 mg, 100 ct Carton

Principal Display Panel

NDC 70720-175-99

Qmiiz™ ODT
(meloxicam) orally disintegrating tablets

7.5 mg
100 tablets

Contains: 100 tablets (10 x 10-count blister packs)

Rx Only
Pharmacist:
Dispense enclosed
Medication Guideto each patient

PRINCIPAL DISPLAY PANEL -- 7.5 mg, 100 ct Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mg, 100 ct Carton

Principal Display Panel

NDC 70720-115-99

Qmiiz™ ODT
(meloxicam) orally disintegrating tablets

15 mg
100 tablets

Contains: 100 tablets (10 x 10-count blister packs)

Rx Only
Pharmacist:
Dispense enclosed
Medication Guideto each patient

PRINCIPAL DISPLAY PANEL -- 15 mg, 100 ct Carton
(click image for full-size original)
QMIIZ ODT meloxicam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70720-175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
meloxicam (meloxicam) meloxicam 7.5 mg
Inactive Ingredients
Ingredient Name Strength
gelatin
mannitol
anhydrous citric acid
aspartame
Product Characteristics
Color yellow (yellow) Score no score
Shape ROUND (ROUND) Size 11mm
Flavor ORANGE (ORANGE) Imprint Code 7;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70720-175-99 10 BLISTER PACK1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 NDC:70720-175-10 10 BLISTER PACK1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within a CARTON (70720-175-99) and a CARTON (70720-175-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211210 02/21/2019
QMIIZ ODT meloxicam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70720-115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
meloxicam (meloxicam) meloxicam 15 mg
Inactive Ingredients
Ingredient Name Strength
gelatin
mannitol
anhydrous citric acid
aspartame
Product Characteristics
Color yellow (yellow) Score no score
Shape ROUND (ROUND) Size 13mm
Flavor ORANGE (ORANGE) Imprint Code 15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70720-115-99 10 BLISTER PACK1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 NDC:70720-115-10 10 BLISTER PACK1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within a CARTON (70720-115-99) and a CARTON (70720-115-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211210 02/21/2019
Labeler — TerSera Therapeutics LLC (080226115)

Revised: 04/2021 TerSera Therapeutics LLC

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