§Qsymia was studied in 2 large trials supporting FDA approval that involved 3,754 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 data presented above is 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
‡Home Delivery Pharmacy
Doses include 6-week New Patient Packs, 6-week Titration Packs and all 30-day prescriptions. For cash patients only. Insurance claims will not be processed. Additional shipping and handling costs will apply. Limit of one New Patient Pack and one Titration Pack per patient for the duration of the program.
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. 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 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 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.
*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 LLC; 2020. 2. Data on file. VIVUS LCC. 3. Contrave [package insert]. Morristown, NJ: Nalproprion Pharmaceuticals LLC; 2020. 4. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020. 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.