Qsymia is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate extended-release, an antiepileptic drug, indicated as an adjunct to 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) (1) 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 (1)

Limitations of Use:

• The effect of Qsymia on cardiovascular morbidity and mortality has not been established (1).
• 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 (1).

• Take once daily in morning. Avoid evening dose to prevent insomnia (2.1).
• Recommended dose: Qsymia 3.75 mg/23 mg (phentermine 3.75 mg/topiramate 23 mg extended-release) daily for 14 days; then increase to 7.5 mg/46 mg daily (2.1).
• Discontinue or escalate dose (as described) if 3% weight loss is not achieved after 12 weeks on 7.5 mg/46 mg dose (2.1).
• Discontinue Qsymia if 5% weight loss is not achieved after 12 weeks on maximum daily dose of 15 mg/92 mg (2.1).
• Discontinue 15 mg/92 mg dose gradually (as described) to prevent possible seizure (2.1).
• Do not exceed 7.5 mg/46 mg dose for patients with moderate or severe renal impairment or patients with moderate hepatic impairment (2.2, 2.3).

• Fetal Toxicity: Females of reproductive potential: Obtain negative pregnancy test before treatment and monthly thereafter; use effective contraception. Qsymia is available through a limited program under a Risk eva luation and Mitigation Strategy (REMS) (5.1).
• Increase in Heart Rate: Monitor heart rate in all patients, especially those with cardiac or cerebrovascular disease (5.2).
• Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue Qsymia if symptoms develop (5.3).
• Acute Myopia and Secondary Angle Closure Glaucoma: Discontinue Qsymia (5.4).
• Mood and Sleep Disorders: Consider dose reduction or withdrawal for clinically significant or persistent symptoms (5.5).
• Cognitive Impairment: May cause disturbances in attention or memory. Caution patients about operating automobiles or hazardous machinery when starting treatment (5.6).
• Metabolic Acidosis: Measure electrolytes before/during treatment (5.7).
• Elevated Creatinine: Measure creatinine before/during treatment (5.8).
• Use of Antidiabetic Medications: Weight loss may cause hypoglycemia. Measure serum glucose before/during treatment (5.9).

Most common adverse reactions (incidence greater than or equal to 5% and at a rate at least 1.5 times placebo) are: paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact VIVUS, Inc., at 1-888-998-4887 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Oral contraceptives: Altered exposure may cause irregular bleeding but not increased risk of pregnancy. Advise patients not to discontinue oral contraceptives if spotting occurs (7.2).
• CNS depressants including alcohol: Potentiate CNS depressant effects. Avoid concomitant use of alcohol (7.3).
• Non-potassium sparing diuretics: May potentiate hypokalemia. Measure potassium before/during treatment (7.4).

• Nursing Mothers: Discontinue drug or nursing (8.3).
• Pediatric Use: Safety and effectiveness not established and use not recommended (8.4).