Average Weight Loss With Phentermine – SD=standard deviation; SE=standard error. Least squares (LS) mean. Study 1 adjusted for baseline body weight and diabetic status. ‡Statistically significant compared to placebo based on pre-specified multi-dose control for Type I error.
$79 is the average retail price at a pharmacy after a surcharge, calculated between January and June 2022. Source: McKesson Specialty Health 2022. The average price after a surcharge without commercial insurance is $128. As of July 19, 2022, GoodRx reports the lowest price for the most commonly prescribed dose of Qsymia is approximately $192.81, which is 17% lower than the average retail price of $234.19. Source: www.goodrx.com/qsymia. Pharmacy prices and fees may vary by location.
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The $98 home delivery pharmacy price includes 6-week new patient packs, 6-week titration packs, and all 30-day prescriptions. For cash patients only. Insurance claims will not be considered. Additional shipping and handling charges apply. Limit of one new patient pack and one titration pack per patient for the duration of the program.
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Qsymia should be used in conjunction with a reduced calorie diet and increased physical activity for chronic weight management in:
Qsymia is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days of stopping treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity or idiosyncrasy to sympathomimetic amines, topiramate or any of the inactive ingredients of Qsymia.
The most frequently observed adverse reactions in controlled clinical trials in adults, 5% or more and at least 1.5 times more than placebo, are paraesthesia, dizziness, dysgeusia, insomnia, constipation and dry mouth. Common side effects in pediatric patients 12 years of age and older at levels ≥4% and greater than placebo include depression, dizziness, arthralgia, fever, influenza and ligament sprain.
Qsymia may cause fetal harm. Data from a pregnancy registry and epidemiological studies indicate that a fetus exposed to the topiramate component of Qsymia during the first trimester of pregnancy is at an increased risk of cleft mouth (cleft lip with or without cleft palate). A pregnancy test is recommended prior to initiation of treatment with Qsymia in patients of childbearing potential and monthly during treatment with Qsymia. Women of childbearing potential should be informed of the potential risk to the fetus and the need to use effective contraception during treatment with Qsymia.
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Qsymia is associated with a decrease in growth rate (the number of centimeters of height per year) in obese children and adolescents aged 12 to 17 years. Growth rate should be monitored in pediatric patients treated with Qsymia. Dose reduction or discontinuation of Qsymia should be considered if pediatric patients are not growing or gaining height as expected.
Qsymia may cause an increase in heart rate at rest. It is recommended that resting heart rate be measured regularly in all patients taking Qsymia, especially those with cardiac or cerebrovascular disease, and when starting or increasing the dose of Qsymia. Qsymia has not been studied in patients with recent or unstable heart or cerebrovascular disease and is therefore not recommended. Patients should inform healthcare professionals about palpitations or the feeling of a fast heartbeat at rest during treatment with Qsymia. For patients who experience a sustained increase in resting heart rate while taking Qsymia, the dose should be reduced or Qsymia should be discontinued.
Topiramate, a component of Qsymia, increases the risk of suicidal thoughts or behavior in patients taking these medicines for any indication. Patients should be monitored for the development or worsening of depression, suicidal ideation or behavior and/or any unusual changes in mood or behavior. Qsymia should be discontinued in patients who experience suicidal ideation or behavior. Qsymia is not recommended in patients with a history of suicide attempts or active suicidal thoughts.
Cases of acute angle closure glaucoma have been reported in patients treated with the topiramate component of Qsymia. Symptoms include sudden decrease in visual acuity and/or eye pain. Symptoms usually appear within 1 month of starting treatment with topiramate, but can occur at any time during treatment. 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.
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Qsymia can cause mood disorders including depression and anxiety, as well as insomnia. Patients with a history of depression may be at increased risk. Dose reduction or discontinuation of Qsymia should be considered for clinically significant or persistent symptoms.
Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and post-marketing experience in patients receiving topiramate. In clinical trials, most of these events were reversible upon discontinuation of topiramate. If visual problems occur at any time during treatment, discontinuation of Qsymia should be considered.
Qsymia may cause cognitive impairment (e.g. impaired concentration/attention, memory difficulties, and problems with speech or language, especially finding words). As Qsymia may impair cognitive function, patients should be cautioned against operating dangerous machinery, including cars.
Hyperchloraemia, anion gap metabolic acidosis, has been reported in patients treated with Qsymia. It is recommended to measure electrolytes, including serum bicarbonate, prior to initiation of treatment with Qsymia and during treatment with Qsymia. Dose reduction or discontinuation of Qsymia should be considered if metabolic acidosis develops and persists.
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Qsymia may cause an increase in serum creatinine, reflecting deterioration in renal function (glomerular filtration rate). In the phase III studies, peak increases in serum creatinine were observed after 4 to 8 weeks of treatment. On average, serum creatinine gradually declined but remained elevated relative to baseline creatinine values. Changes in serum creatinine (and measured GFR) during short-term treatment with Qsymia appear to be reversible upon discontinuation of treatment, but the effect of long-term treatment on renal function is unknown. Therefore, it is recommended that serum creatinine be measured prior to initiating treatment with Qsymia and during treatment with Qsymia. If a persistent increase in creatinine occurs while taking Qsymia, the dose should be reduced or Qsymia should be discontinued.
Severe 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 rash, unless the rash is clearly not drug related. If signs or symptoms are suggestive of SJS/TEN, this drug should not be restarted and alternative treatment should be considered. Patients should be informed of the symptoms of severe skin reactions.
Weight loss may increase the risk of hypoglycaemia in type 2 diabetic patients treated with insulin and/or insulin secretagogues (e.g. sulfonylureas). The use of Qsymia in combination with insulin has not been studied. In patients with type 2 diabetes, it is recommended that blood glucose levels be measured prior to initiation of treatment with Qsymia and during treatment with Qsymia. To reduce the risk of hypoglycaemia, dose reduction of non-glucose dependent antidiabetic drugs should be considered.
In hypertensive patients treated with antihypertensive drugs, weight loss may increase the risk of hypotension. In patients being treated for hypertension, it is recommended that blood pressure be measured prior to initiating treatment with Qsymia and during treatment with Qsymia. If a patient develops symptoms related to low blood pressure after initiation of treatment with Qsymia, appropriate changes to the antihypertensive regimen should be made.
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Concomitant use of alcohol or central nervous system depressants (e.g. barbiturates, benzodiazepines and hypnotics) with phentermine or topiramate may potentiate the central nervous system depression or other central effects of these drugs. Therefore, the concomitant consumption of alcohol with Qsymia should be avoided.
In situations where medical reasons require immediate discontinuation of treatment with Qsymia, appropriate monitoring is recommended. Patients discontinuing Qsymia 15 mg/92 mg should gradually reduce the dose as recommended.
Adjust the 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. The use of Qsymia should be avoided in this patient population.
Adjust the dose of Qsymia for patients with moderate hepatic impairment. Qsymia has not been studied in patients with severe hepatic impairment. The use of Qsymia should be avoided in this patient population.
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The use of Qsymia with other agents that inhibit carbonic anhydrase (e.g. zonisamide, acetazolamide or methazolamide) should be avoided. The 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 your fluid intake to increase urine output, which can reduce the concentration of substances involved in the formation of kidney stones.
Patients treated with Qsymia should be advised to monitor for decreased sweating and elevated body temperature during physical activity, especially in hot weather. Caution should be exercised when prescribing Qsymia with other drugs that predispose patients to heat disorder; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and anticholinergics.
When prescribing Qsymia, patients should be monitored for hypokalaemia. It is recommended that a blood chemistry profile be performed at the start of treatment and periodically during treatment.
Review the Important Safety Information, Full Prescribing Information and Healthcare Professionals Guidance Tool for Patients of Potential for Qsymia.
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Links to pages: 1. Full information on prescribing Qsymia. Campbell, CA: VIVUS LLC; 2022. 2. Data on file. VIVUS LCC. 3. Contrave [information leaflet]. Brentwood, Tennessee; currax
Pharmaceuticals LLC; 2021. 4. Saxenda [flyer]. Plainsboro, NJ: Novo Nordisk Inc; 2022. 5. Hill AJ et al.
Qsymia is indicated as an adjunct to a reduced-calorie, increased-activity diet for chronically weight-controlled adults with a baseline body mass index (BMI)… Personalized Lifestyle Intervention and Functional Assessment Health Outcomes Survey: Presentation of the LIFEHOUSE Study using N- of -One tent-umbrella-bucket
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