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Clinically-proven results in adults 18 years and older in 56-week Qsymia studies1,2

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Average results at 56 weeks

Review the results by dose and time points.

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Weight loss by threshold

Patients who achieved 15%, 20% and 25% weight-loss results.

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Weight loss by obesity class

15% and 20% weight-loss thresholds by obesity class.

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Review the results by dose at the 12, 28 and 56 week time points1,2†

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 you evaluate your patients’ status and assess their treatment plan.1,2†

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On average, adult patients achieved significant weight loss across doses of Qsymia at 56 weeks1,2†

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Clinically-proven weight-management results across doses and obesity classes1,2†

Weight-loss threshold results by obesity class and dose at 56 Weeks (percent of subjects)

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The results presented here are from the combined studies supporting FDA approval of Qsymia. Qsymia was studied in 2 large trials that involved 3,754 patients 18 years and older whose BMI was 27 kg/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. 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 first 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, Qsymia 7.5 mg/46 mg, and Qsymia 15 mg/92 mg, respectively, at 12 weeks; 5.4 lbs, 19.5 lbs, and 24.3 lbs with placebo, Qsymia 7.5 mg/46 mg, and Qsymia 15 mg/92 mg, respectively, at 28 weeks; and 3.8 lbs, 19.5 lbs, and 24.7 lbs with placebo, Qsymia 7.5 mg/46 mg, and Qsymia 15 mg/92 mg, respectively, at 56 weeks. The reduction in waist circumference was 1.1 inches, 2.2 inches, and 2.5 inches with placebo, Qsymia 7.5 mg/46 mg, and Qsymia 15 mg/92 mg, respectively, at 12 weeks; 1.3 inches, 3.2 inches, and 3.7 inches with placebo, Qsymia 7.5 mg/46 mg, and Qsymia 15 mg/92 mg, respectively, at 28 weeks; and 1.2 inches, 3.4 inches, and 4.0 inches with placebo, Qsymia 7.5 mg/46 mg, and Qsymia 15 mg/92 mg, respectively, at 56 weeks.

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

PRESCRIBE THE #1 NON INJECTION[SM] WEIGHT-MANAGEMENT BRAND FOR ADULTS**

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*Retail and Home Delivery Pharmacy - $75 is the average retail pharmacy price for a 30-day Rx for patients covered by commercial insurance after covering $70 copay. $134 is the average price for patients paying cash or if Qsymia is not covered by commercial insurance. Source: McKesson Specialty Health, calculated between Jan-Sep 2023. Pharmacy fees may vary by location. Patients with commercial insurance coverage are eligible to receive $65 off 3.75 mg/23 mg dose quantities of 14-15 days and all other doses with quantities of 28-30 days. Patients paying cash or if Qsymia is not covered by commercial insurance, can receive $70 off 3.75 mg/23 mg dose quantities of 14-15 days and $75 off all other doses with quantities of 28-30 days. Please note that quantity claims of 16-27 days are not eligible for the Qsymia Savings Card. See full terms and conditions. $98 home delivery pharmacy pricing includes 6-week New Patient Packs, 6-week Titration Packs and all 30-day prescriptions. Additional shipping and handling costs will apply. This is a cash only program - insurance claims will not be processed. Please see QsymiaEngage.com for full program details.

**IQVIA Reporting - July 2023

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 comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia
  • Pediatric patients aged 12 years and older with an initial BMI in the 95th percentile or greater standardized for age and sex

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

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, in adults include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Common side effects in pediatric patients aged 12 years and older at ≥4% and greater than placebo include depression, dizziness, arthralgia, pyrexia, influenza, and ligament sprain.

Qsymia can cause fetal harm. Data from a pregnancy registry and epidemiologic studies indicate that 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). Pregnancy testing is recommended before initiating Qsymia treatment in patients who can become pregnant and monthly during Qsymia therapy. Advise patients who can become pregnant of the potential risk to a fetus and to use effective contraception during Qsymia therapy.

Qsymia is associated with a reduction in height velocity (centimeters of height gained per year) in obese pediatric patients 12 to 17 years of age. Monitor height velocity in pediatric patients treated with Qsymia. Consider dosage reduction or discontinuation of Qsymia if pediatric patients are not growing or gaining height as expected.

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.

Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. In clinical trials, most of these events were reversible after topiramate discontinuation. If visual problems occur at any time during treatment, consider discontinuing 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.

Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. Qsymia should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. Inform patients about the signs of serious skin reactions.

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 LCC 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 Patients of Reproductive Potential for Qsymia.

Site References: 1. Qsymia Full Prescribing Information. Campbell, CA: VIVUS LLC; 2023. 2. Data on file. VIVUS LCC. 3. Contrave [package insert]. Brentwood, TN; CurraxTM Pharmaceuticals LLC; 2021. 4. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2022. 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. 11. Hampl SE, Hassink SG, Skinner AC, et al. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics. 2023;151(2):

Indication

Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management inadults with an initial body mass index (BMI)…

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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