Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients 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.
DOSAGE AND ADMINISTRATION
General Dosing And Administration
In adults with an initial BMI of 30 kg/m2 or greater or 27 kg/m2 or greater when accompanied by weight-related co-morbidities such as hypertension, type 2 diabetes mellitus, or dyslipidemia prescribe Qsymia as follows:
- Take Qsymia once daily in the morning with or without food. Avoid dosing with Qsymia in the evening due to the possibility of insomnia.
- Start treatment with Qsymia 3.75 mg/23 mg (phentermine 3.75 mg/topiramate 23 mg extended-release) daily for 14 days; after 14 days increase to the recommended dose of Qsymia 7.5 mg/46 mg (phentermine 7.5 mg/topiramate 46 mg extended-release) once daily.
- Evaluate weight loss after 12 weeks of treatment with Qsymia 7.5 mg/46 mg.
If a patient has not lost at least 3% of baseline body weight on Qsymia 7.5 mg/46 mg, discontinue Qsymia or escalate the dose, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss at the Qsymia 7.5 mg/46 mg dose.
To escalate the dose: Increase to Qsymia 11.25 mg/69 mg (phentermine 11.25 mg/topiramate 69 mg extended-release) daily for 14 days; followed by dosing Qsymia 15 mg/92 mg (phentermine 15 mg/topiramate 92 mg extended-release) once daily.
- Evaluate weight loss following dose escalation to Qsymia 15 mg/92 mg after an additional 12 weeks of treatment.
If a patient has not lost at least 5% of baseline body weight on Qsymia 15 mg/92 mg, discontinue Qsymia as directed, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
- Qsymia 3.75 mg/23 mg and Qsymia 11.25 mg/69 mg are for titration purposes only.
The following important adverse reactions are described below and elsewhere in the labeling:
- Fetal Toxicity:
- Elevation in Heart Rate
- Suicidal Behavior and Ideation
- Acute Angle Closure Glaucoma
- Mood and Sleep Disorders
- Cognitive Impairment
- Metabolic Acidosis