INDICATIONS AND USAGE
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.
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DOSAGE AND ADMINISTRATION
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 |
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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) 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]
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HOW SUPPLIED/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:
| Strength |
|
NDC Code |
| Unit of Use Bottle (14 capsules) |
3.75 mg/23 mg capsules |
62541-201-14 |
| Unit of Use Bottle (30 capsules) |
3.75 mg/23 mg capsules |
62541-201-30 |
| Unit of Use Bottle (30 capsules) |
7.5 mg/46 mg capsules |
62541-202-30 |
| Unit of Use Bottle (30 capsules) |
15 mg/92 mg capsules |
62541-204-30 |
| Pharmacy Bottle (30 capsules) |
11.25 mg/69 mg capsules |
62541-203-30 |
Store at controlled room temperature, 15 to 25°C (59 to 77°F). Keep container tightly closed and protect from moisture.
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