For patients with a body mass index (BMI)* of 30+† or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition.

Now $98 Pricing Across All Doses

Qsymia can help patients you frequently see1,2

Along with diet and exercise, prescription Qsymia has been clinically proven to help a broad range of patients significantly reduce weight1,2

Explore the clinical data by patient population

For patients with comorbidities, choose Qsymia as first-line for obesity treatment1,2

Qsymia provides reliable efficacy for overweight and obese patients with comorbidities1,2

Presented here are weight loss and waist circumference reduction in patients (N=2473) who participated in 1 of the 2 trials and who used study drug for the planned 56-week course of treatment. In this trial, all patients had a baseline BMI of ≥ 27 kg/m2 with additional weight-related comorbidities. See full study design below.

56 Weeks

Absolute Weight and Waist Circumference Reduction by Patient Population with a BMI ≥ 27 After 56 Weeks1,2

 
Diet and Exercise Alone
(Placebo)
Diet and Exercise with Qsymia 7.5/46 mg§
(Recommended dose)
Recommended does pill image
Diet and Exercise with Qsymia 7.5/46 mg§
(High dose)
High does pill image

Type 2 Diabetes

Previous diagnosis of type 2 diabetes managed with lifestyle modification or metformin therapy (16% of subjects).

Weight Reduction in lbs
-6
-18
-25
Waist Circumference Reduction in inches
-2
-4
-4
Number of Patients (N)
101
46
107
+

Hypertension

BP of ≥ 140/90 or using 2 or more antihypertensive medications (53% of subjects).

Weight Reduction in lbs
-6
-23
-29
Waist Circumference Reduction in inches
-2
-4
-5
Number of Patients (N)
304
176
332
+

Pre-Diabetes

Impaired glucose tolerance/impaired fasting glucose (68% of subjects): fasting glucose > 100 mg/dL and/or > 140 mg/dL 2 hours post 75 gm glucose load in OGTT and/or diagnosis of type 2 diabetes managed with lifestyle modification or metformin therapy.

Weight Reduction in lbs
-7
-23
-30
Waist Circumference Reduction in inches
-2
-4
-5
Number of Patients (N)
383
233
424
+

Dyslipidemia

Hypertriglyceridemia (36% of subjects): triglyceride level ≥ 200 mg/dL or using 2 or more lipid-lowering medications.

Weight Reduction in lbs
-7
-26
-30
Waist Circumference Reduction in inches
-2
-5
-5
Number of Patients (N)
206
116
236
+

In addition to weight loss and reduction in waist circumference, overweight and obese patients with comorbidities also achieved statistically significant reduction vs placebo in some comorbid medications. Qsymia is not indicated for the treatment of type 2 diabetes, hypertension or dyslipidemia.1

§P<.0001 vs placebo.
Mean change from baseline.
Statistical significance for reduction in comorbid medications was P=.0121 for type 2 diabetes medications and P<.0001 for anti- hypertensive medications; P values are from Fisher’s exact test.2

Qsymia was studied in 2 large trials supporting FDA approval that involved 3754 patients whose BMI was 27kg/m2 or greater. For the subjects in the 2 trials the average baseline weight was 256 lbs and 227 lbs, and the average baseline waist circumference was 47 inches and 45 inches. The chart below presents data for patients who completed the full 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 weight, BMI, diet, activity level, dose of Qsymia, and other factors.

The titration schedule for the studies was faster than what is recommended in the Qsymia package insert. Subjects took the 3.75 mg/23 mg strength for one week, then the 7.5 mg/46 mg strength for one week (unless randomized to this arm); then the 11.25 mg/69 mg strength for one week, followed by the 15 mg/92 mg strength.1,2

56 Weeks

Absolute Weight and Waist Circumference Reduction by Patient Population with a BMI ≥ 27 After 56 Weeks1,2

Number of Patients (N)
Weight Reduction in lbs
Waist Circumference Reduction in inches

Type 2 Diabetes

Previous diagnosis of type 2 diabetes managed with lifestyle modification or metformin therapy (16% of subjects).

Diet and Exercise Alone (Placebo)

101
-6
-2
Patients
Pounds
Inches

Diet and Exercise with
Qsymia 7.5/46 mg

(Recommended dose)

Recommended does pill image
46
-18
-4
Patients
Pounds
Inches

Diet and Exercise with
Qsymia 15/92 mg

(High dose)

High does pill image
107
-24
-4
Patients
Pounds
Inches
+

Hypertension

BP of ≥ 140/90 or using 2 or more antihypertensive medications (53% of subjects).

Diet and Exercise Alone (Placebo)

304
-6
-2
Patients
Pounds
Inches

Diet and Exercise with
Qsymia 7.5/46 mg

(Recommended dose)

Recommended does pill image
176
-23
-4
Patients
Pounds
Inches

Diet and Exercise with
Qsymia 15/92 mg

(High dose)

High does pill image
332
-29
-5
Patients
Pounds
Inches
+

Pre-Diabetes

Impaired glucose tolerance/impaired fasting glucose (68% of subjects): fasting glucose > 100 mg/dL and/or > 140 mg/dL 2 hours post 75 gm glucose load in OGTT and/or diagnosis of type 2 diabetes managed with lifestyle modification or metformin therapy.

Diet and Exercise Alone (Placebo)

383
-7
-2
Patients
Pounds
Inches

Diet and Exercise with
Qsymia 7.5/46 mg

(Recommended dose)

Recommended does pill image
233
-23
-4
Patients
Pounds
Inches

Diet and Exercise with
Qsymia 15/92 mg

(High dose)

High does pill image
424
-30
-5
Patients
Pounds
Inches
+

Dyslipidemia

Hypertriglyceridemia (36% of subjects): triglyceride level ≥ 200 mg/dL or using 2 or more lipid-lowering medications.

Diet and Exercise Alone (Placebo)

207
-7
-2
Patients
Pounds
Inches

Diet and Exercise with
Qsymia 7.5/46 mg

(Recommended dose)

Recommended does pill image
116
-26
-5
Patients
Pounds
Inches

Diet and Exercise with
Qsymia 15/92 mg

(High dose)

High does pill image
236
-31
-5
Patients
Pounds
Inches
+

In addition to weight loss and reduction in waist circumference, overweight and obese patients with comorbidities also achieved statistically significant reduction vs placebo in some comorbid medications. Qsymia is not indicated for the treatment of type 2 diabetes, hypertension or dyslipidemia.1

§P<.0001 vs placebo.
Mean change from baseline.
Statistical significance for reduction in comorbid medications was P=.0121 for type 2 diabetes medications and P<.0001 for anti- hypertensive medications; P values are from Fisher’s exact test.2

Qsymia was studied in 2 large trials supporting FDA approval that involved 3754 patients whose BMI was 27kg/m2 or greater. For the subjects in the 2 trials the average baseline weight was 256 lbs and 227 lbs, and the average baseline waist circumference was 47 inches and 45 inches. The chart below presents data for patients who completed the full 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 weight, BMI, diet, activity level, dose of Qsymia, and other factors.

The titration schedule for the studies was faster than what is recommended in the Qsymia package insert. Subjects took the 3.75 mg/23 mg strength for one week, then the 7.5 mg/46 mg strength for one week (unless randomized to this arm); then the 11.25 mg/69 mg strength for one week, followed by the 15 mg/92 mg strength.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

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.

The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.

Qsymia can cause fetal harm. A fetus exposed to topiramate, a component of Qsymia, in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate). 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. Patients should inform healthcare providers of palpitations or feelings of a racing heartbeat while at rest during Qsymia treatment. For patients who experience a sustained increase in resting heart rate while taking Qsymia, the dose should be reduced or Qsymia discontinued.

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. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious adverse events including permanent loss of vision.

Qsymia can cause mood disorders, including depression and anxiety, as well as insomnia. Patients with a history of depression may be at increased risk. For clinically significant or persistent symptoms consider dose reduction or withdrawal of Qsymia.

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. Measurement of electrolytes including serum bicarbonate prior to starting Qsymia and during Qsymia treatment is recommended. 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 that reflects a decrease in renal function (glomerular filtration rate). In phase 3 trials, peak increases in serum creatinine were observed after 4 to 8 weeks of treatment. On average, serum creatinine gradually declined but remained elevated over baseline creatinine values. The changes in serum creatinine (and measured GFR) with short-term Qsymia treatment appear reversible with treatment discontinuation, but the effect of chronic treatment on renal function is not known. Therefore, measurement of serum creatinine prior to starting Qsymia and during Qsymia treatment is recommended. 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. Measurement of blood glucose levels prior to starting Qsymia and during Qsymia treatment is recommended in patients with type 2 diabetes. A reduction in the dose of antidiabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.

In hypertensive patients being treated with antihypertensive medications, weight loss may increase the risk of hypotension. Measurement of blood pressure prior to starting Qsymia and during Qsymia treatment is recommended in patients being treated for hypertension. If a patient develops symptoms associated with low blood pressure after starting Qsymia, appropriate changes should be made to the antihypertensive drug regimen.

The concomitant use of alcohol or central nervous system (CNS) depressant drugs (e.g., barbiturates, benzodiazepines, and sleep medications) with phentermine or topiramate may potentiate CNS depression or other centrally mediated effects of these agents. Therefore, avoid concomitant use of alcohol with Qsymia.

In situations where immediate termination of Qsymia is medically required, appropriate monitoring is recommended. Patients discontinuing Qsymia 15 mg/92 mg should be gradually tapered as recommended.

Adjust dose of Qsymia for patients with moderate or severe renal impairment. Qsymia has not been studied in patients with end-stage renal disease on dialysis. Avoid use of Qsymia in this patient population.

Adjust dose of Qsymia for patients with moderate hepatic impairment. Qsymia has not been studied in patients with severe hepatic impairment. Avoid use of Qsymia in this patient population.

Avoid the use of Qsymia with other drugs that inhibit carbonic anhydrase (e.g., zonisamide, acetazolamide or methazolamide). Use of topiramate by patients on a ketogenic diet may also result in a physiological environment that increases the likelihood of kidney stone formation. Increase fluid intake to increase urinary output which can decrease the concentration of substances involved in kidney stone formation.

Patients treated with Qsymia should be advised to monitor for decreased sweating and increased body temperature during physical activity, especially in hot weather. Caution should be used when Qsymia is prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity.

When prescribing Qsymia, patients should be monitored for hypokalemia. It is recommended that a blood chemistry profile is obtained at baseline and periodically during treatment.

Phentermine, a component of Qsymia, has known potential for abuse.

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 see the Important Safety Information, Full Prescribing Information, and Healthcare Provider Counseling Tool for Females of Reproductive Potential for Qsymia.

*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; 2018. 2. Data on file. VIVUS, Inc. 3. Contrave [package insert]. La Jolla, CA: Orexigen Therapeutics, Inc; 2014. 4. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2015. 5. Hill AJ et al. Appetite. 1991;17(3):187-197. 6. Stubbs RJ et al. Physiol Behav. 2001;72(4):615-619. 7. Isaksson H et al. Food Nutr Res. 2008;52. 8. Pelchat ML. Appetite. 1997;28(2):103-113. 9. Hill AJ, Heaton-Brown L. J Psychosom Res.1994;38(8):801-814. 10. Garber, AJ, Abrahamson MJ, Barzilay Jl, et al. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013; 19(2):327-336.

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.

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