Clinically proven weight loss at 12, 28 and 56 weeks1,2
Make a realistic weight-loss plan with your patients and help them succeed
Qsymia is the only once-daily combination pill proven to significantly reduce weight1-5
See the results over time1,2 — help patients set realistic expectations
| Treatment Assessment Milestone |  |
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| Weight Loss (lbs) | -14.93 to -18.96 | -22.18 to -29.37 | -23.63 to -32.52 |
| Waist Circumference Reduction (in) | -2.41 to -2.82 | -3.75 to -4.53 | -4.11 to -5.30 |
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Mean Change from Baseline Weight Loss (lbs) and Waist Circumference Reduction (inches) over time. Data from Combined Equip and Conquer clinical trials (n=3754) – Modified intent to treat (MITT) BMI ≥ 27.1,2 |
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| Mean Change from Baseline Weight Loss (lbs) and Waist Circumference Reduction (inches) over time. Data from Combined Equip and Conquer clinical trials (n=3754) – Modified intent to treat (MITT) BMI ≥ 27.1,2 |
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- Qsymia was studied in 2 large trials supporting FDA approval that involved 3754 patients whose BMI was 27 kg/m2 or greater. Presented here are weight loss and waist circumference reduction in the subset of subjects (N=2076) with a baseline BMI of 27 kg/m2 or greater, and who used study drug for the planned 56-week course of treatment. Patients were randomized to placebo, phentermine 3.75 mg/topiramate 23 mg, phentermine 7.5 mg/topiramate 46 mg, or phentermine 15 mg/topiramate 92 mg. In these trials, it was recommended that patients eat a well-balanced diet and reduce their caloric intake by 500 kcal/day. Your patients’ results may vary depending on their BMI, diet, activity, dose of Qsymia, and other factors1,2
- The titration schedule for the studies was faster than what is recommended in the Qsymia package insert. Subjects took the 3.75/23 strength for one week, then the 7.5/46 strength for one week (unless randomized to this arm); then the 11.25/69 strength for one week, followed by the 15/92 strength1
Over 2 million Qsymia prescriptions have been filled to help patients achieve their weight-loss goals1‡
Review Clinical Data in Detail
‡Source: McKesson Specialty Health, 2017.
Video: Optimizing Patient Outcomes with Qsymia
This video addresses common challenges in obesity treatment and discusses optimizing patient outcomes with Qsymia.
Learn about the release of the components of once-daily Qsymia.1
HOW QSYMIA WORKS
Eligible Qsymia patients can get a free 2-week starter dose and get their savings card and prescription refill reminders via text message.
SEE QSYMIA SAVINGS OFFERQuick links and resources
Efficacy and clinical trial data
- Clinically proven a loss at 12, 28 and 56 weeks
- Clinical trials: EQUIP and CONQUER
Dosing and therapy initiation
Resources and downloads
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:
- The effect of Qsymia on cardiovascular morbidity and mortality has not been established
- The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established
Important Safety Information
Qsymia is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity or idiosyncrasy to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
Qsymia can cause an increase in resting heart rate. Regular measurement of resting heart rate is recommended for all patients taking Qsymia, especially patients with cardiac or cerebrovascular disease or when initiating or increasing the dose of Qsymia. Qsymia has not been studied in patients with recent or unstable cardiac or cerebrovascular disease and therefore use is not recommended.
Topiramate, a component of Qsymia, increases the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Qsymia in patients who experience suicidal thoughts or behaviors. Qsymia is not recommended in patients with a history of suicidal attempts or active suicidal ideation.
Acute angle closure glaucoma has been reported in patients treated with topiramate, a component of Qsymia. Symptoms include acute onset of decreased visual acuity and/or eye pain. Symptoms typically occur within 1 month of initiating treatment with topiramate but may occur at any time during therapy. The primary treatment to reverse symptoms is immediate discontinuation of Qsymia.
Qsymia can cause mood disorders, including depression, and anxiety, as well as insomnia. Qsymia can cause cognitive dysfunction (e.g., impairment of concentration/attention, difficulty with memory, and speech or language problems, particularly word-finding difficulties). Since Qsymia has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles.
Hyperchloremic, non-anion gap, metabolic acidosis has been reported in patients treated with Qsymia. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Qsymia.
Qsymia can cause an increase in serum creatinine. If persistent elevations in creatinine occur while taking Qsymia, reduce the dose or discontinue Qsymia.
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g, sulfonylureas).
Qsymia has not been studied in combination with insulin. A reduction in the dose of antidiabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.
The most commonly observed side effects in controlled clinical studies, ≥5% and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
To report negative side effects, contact 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 and Full Prescribing Information.
This site is intended only for residents of the United States, its territories, and Puerto Rico.
*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.
Site References
1. Qsymia Full Prescribing Information. Campbell, CA: VIVUS, Inc; 2017. 2. Data on file. VIVUS, Inc. 3. Belviq [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2014. 4. Contrave [package insert]. La Jolla, CA: Orexigen Therapeutics, Inc; 2014. 5. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2015. 6. Hill AJ et al. Appetite. 1991;17(3):187-197. 7. Stubbs RJ et al. Physiol Behav. 2001;72(4):615-619. 8. Isaksson H et al. Food Nutr Res. 2008;52. 9. Pelchat ML. Appetite. 1997;28(2):103-113. 10. Hill AJ, Heaton-Brown L. J Psychosom Res. 1994;38(8):801-814. 11. Garber, AJ, Abrahamson MJ, Barzilay Jl, et al. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013; 19(2):327-336.