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

Limitations of Use

• The effect of Qsymia on cardiovascular morbidity and mortality has not been established.
• The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs and herbal preparations have not been established.

General Dosing and Administration

Determine the patient's BMI. BMI is calculated by dividing weight in (kilograms) by height (in meters) squared. A BMI conversion chart (Table 1) based on height [inches (in) or centimeters (cm)] and weight [pounds (lb) or kilograms (kg)] is provided below.

Table 1: BMI Conversion Chart

In adults with an initial BMI of 30 kg/m² or greater or 27 kg/m² or greater when accompanied by weightrelated 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) 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.

Discontinuing Qsymia

• Discontinue Qsymia 15 mg/92 mg gradually by taking a dose every other day for at least 1 week prior to stopping treatment altogether, due to the possibility of precipitating a seizure [see WARNINGS AND PRECAUTIONS].

Dosing in Patients with Renal Impairment

In patients with moderate (creatinine clearance [CrCl] greater than or equal to 30 and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment dosing should not exceed Qsymia 7.5 mg/46 mg once daily. Renal impairment is determined by calculating CrCl using the Cockcroft-Gault equation with actual body weight [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Dosing in Patients with Hepatic Impairment

In patients with moderate hepatic impairment (Child-Pugh score 7 - 9), dosing should not exceed Qsymia 7.5 mg/46 mg once daily [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Dosage Forms And Strengths

Qsymia capsules are formulated in the following four strength combinations (phentermine mg/topiramate mg extended-release):

• 3.75 mg/23 mg [Purple cap imprinted with VIVUS, Purple body imprinted with 3.75/23]
• 7.5 mg/46 mg [Purple cap imprinted with VIVUS, Yellow body imprinted with 7.5/46]
• 11.25 mg/69 mg [Yellow cap imprinted with VIVUS, Yellow body imprinted with 11.25/69]
• 15 mg/92 mg [Yellow cap imprinted with VIVUS, White body imprinted with 15/92]

Storage And Handling

Qsymia is available as phentermine hydrochloride (as the free base)/topiramate extended-release gelatin capsules in the following strengths and colors:

• 3.75 mg/23 mg [Purple cap imprinted with VIVUS, Purple body imprinted with 3.75/23]
• 7.5 mg/46 mg [Purple cap imprinted with VIVUS, Yellow body imprinted with 7.5/46]
• 11.25 mg/69 mg [Yellow cap imprinted with VIVUS, Yellow body imprinted with 11.25/69]
• 15 mg/92 mg [Yellow cap imprinted with VIVUS, White body imprinted with 15/92]

The capsules are supplied as follows:

Store at controlled room temperature, 15 to 25°C (59 to 77°F). Keep container tightly closed and protect from moisture.

Manufactured for VIVUS Inc. by Catalent Pharma Solutions, LLC, 1100 Enterprise Drive, Winchester, KY 40391. 07/2012

Last reviewed on RxList: 4/8/2013
This monograph has been modified to include the generic and brand name in many instances.