Extensively studied and prescribed, Qsymia is the once-daily pill that helps you manage your weight-loss plan and set realistic expectations.1,2
Qsymia can help you take control of the hunger and cravings you struggle with.1,2
Qsymia is clinically proven to help patients lose weight and inches off their waist.1,2
See the clinically proven results in 56‑week Qsymia studies1,2
See the average results of patients who were participating in the studies at the 12, 28 and 56‑week time points. These are important time points to help your healthcare provider evaluate your status and assess your treatment plan.1,2‡
‡The results presented here are from the combined studies supporting FDA approval of Qsymia. The dosing schedule in those studies differ from the dosing schedule that your physician may recommend. As a result of this dosing differential, your results may vary depending on your weight, BMI, diet, activity level, dose of Qsymia, and other factors.
Qsymia was studied in 2 large trials that involved 3754 patients whose BMI was 27 kg/m2 or greater. For the subjects in the 2 studies the average baseline weight was 256 lbs and 227 lbs, and the average baseline waist circumference was 47 inches and 45 inches. Patients were randomized to placebo, phentermine 3.75 mg/topiramate 23 mg (starter dose), phentermine 7.5 mg/topiramate 46 mg (recommended dose), or phentermine 15 mg/topiramate 92 mg (top dose). In these trials, it was recommended that patients eat a well-balanced diet and reduce their caloric intake by 500 kcal/day.
The chart presents data for patients who completed treatment at each time point. Some patients left the study or stopped taking Qsymia prior to completing the full 56 weeks. The drop off rate for placebo was 47% (687/1477), recommended dose was 31% (150/488) and top dose was 38% (561/1479). The most common reasons (>2% of patients) were: adverse events, patients lost to follow up, patients who withdrew consent, or lack of efficacy.
Analysis of all patients (including those who dropped off) results in slightly smaller reductions in weight and waist circumference. Weight loss in all patients was 4.7 lbs, 14.1 lbs, and 17.2 lbs with placebo, recommended dose, and top dose, respectively, at 12 weeks; 5.4 lbs, 19.5 lbs, and 24.3 lbs with placebo, recommended dose, and top dose, respectively, at 28 weeks; and 3.8 lbs, 19.5 lbs, and 24.7 lbs with placebo, recommended dose, and top dose, respectively, at 56 weeks. The reduction in waist circumference was 1.1 inches, 2.2 inches, and 2.5 inches with placebo, recommended dose, and top dose, respectively, at 12 weeks; 1.3 inches, 3.2 inches, and 3.7 inches with placebo, recommended dose, and top dose, respectively, at 28 weeks; and 1.2 inches, 3.4 inches, and 4.0 inches with placebo, recommended dose, and top dose, respectively, at 56 weeks.1,2
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Indication
Qsymia should be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese) or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol
LIMITATIONS OF USE:
- It is not known if Qsymia changes your risk of heart problems or stroke or of death due to heart problems or stroke
- It is not known if Qsymia is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products
- It is not known if Qsymia is safe and effective in children under 18 years old
Important Safety Information
Do not take Qsymia if you are pregnant, planning to become pregnant, or become pregnant during Qsymia treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia. See the end of the Medication Guide for a complete list of ingredients in Qsymia.
Qsymia can cause serious side effects, including:
Birth defects (cleft lip/cleft palate). If you take Qsymia during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. Patients who are pregnant must not take Qsymia. Patients who can become pregnant should have a pregnancy test before taking Qsymia and every month while taking Qsymia and use effective birth control (contraception) consistently while taking Qsymia. Talk to your healthcare provider about how to prevent pregnancy.
If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away. Healthcare providers and patients should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088, and the Qsymia Pregnancy Surveillance Program at 1-888-998-4887.
Increases in heart rate. Qsymia can increase your heart rate at rest. Your healthcare provider should check your heart rate while you take Qsymia. Tell your healthcare provider if you experience, while at rest, a racing or pounding feeling in your chest lasting several minutes when taking Qsymia.
Suicidal thoughts or actions. Topiramate, an ingredient in Qsymia, may cause you to have suicidal thoughts or actions. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity or talking (mania); other unusual changes in behavior or mood.
Serious eye problems, which include any sudden decrease in vision, with or without eye pain and redness or a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These problems can lead to permanent vision loss if not treated. Tell your healthcare provider right away if you have any new eye symptoms.
Common side effects of Qsymia include:
Numbness or tingling in the hands, arms, feet, or face (paraesthesia); dizziness; changes in the way foods taste or loss of taste (dysgeusia); trouble sleeping (insomnia); constipation; and dry mouth.
Possible side effects of Qsymia include:
Mood changes and trouble sleeping. Qsymia may cause depression or mood problems, and trouble sleeping. Tell your healthcare provider if symptoms occur.
Concentration, memory, and speech difficulties. Qsymia may affect how you think and cause confusion, problems with concentration, attention, memory or speech. Tell your healthcare provider if symptoms occur.
Increases of acid in bloodstream (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: feel tired, not feel hungry (loss of appetite), feel changes in heartbeat, or have trouble thinking clearly. Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Qsymia.
Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking Qsymia and while you take Qsymia.
High blood pressure medicines. If you are taking medicines for your blood pressure, your doctor may need to adjust these medicines while taking Qsymia.
Central Nervous System (CNS) side effects. The use of prescription sleep aids, anxiety medicines, or drinking alcohol with Qsymia may cause an increase in CNS symptoms such as dizziness and light-headedness. Do not drink alcohol with Qsymia.
Possible seizures if you stop taking Qsymia too fast. Seizures may happen in people who may or may not have had seizures in the past if you stop Qsymia too fast. Your healthcare provider will tell you how to stop taking Qsymia slowly.
Kidney stones. Drink plenty of fluids when taking Qsymia to help decrease your chances of getting kidney stones. If you get severe side or back pain, and/or blood in your urine, call your healthcare provider.
Decreased sweating and increased body temperature (fever). People should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of Qsymia. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to VIVUS, Inc. at 1-888-998-4887 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the Qsymia Medication Guide, Full Prescribing Information and Risk of Birth Defects with Qsymia Patient Brochure.
The Q and Me® Patient Support Program is based on the LEARN® Program provided under copyright license (September 15, 2010). All rights reserved.
*BMI (body mass index) measures the amount of fat in the body based on height and weight. BMI is measured in kg/m2.
†Or a BMI of 27 or more with one weight-related medical condition.
References
1. Qsymia Full Prescribing Information. Campbell, CA: VIVUS, Inc; 2020. 2. Data on File. VIVUS, Inc.
