INDICATION
Qsymia is 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) 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
Important Safety Information
Qsymia® is contraindicated in pregnancy; in patients with glaucoma;
in hyperthyroidism; in patients receiving treatment or within 14 days following
treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity
or idiosyncrasy to sympathomimetic amines, topiramate, or any of the inactive ingredients
in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative
pregnancy test before treatment and monthly thereafter and use effective contraception
consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia,
treatment should be discontinued immediately, and the patient should be informed
of the potential hazard to the fetus.
Qsymia can cause an increase in resting heart rate. Regular measurement of resting
heart rate is recommended for all patients taking Qsymia, especially patients with
cardiac or cerebrovascular disease or when initiating or increasing the dose of
Qsymia. Qsymia has not been studied in patients with recent or unstable cardiac
or cerebrovascular disease and therefore use is not recommended.
Topiramate, a component of Qsymia, increases the risk of suicidal thoughts or behavior
in patients taking these drugs for any indication. Patients should be monitored
for the emergence or worsening of depression, suicidal thoughts or behavior, and/or
any unusual changes in mood or behavior. Discontinue Qsymia in patients who experience
suicidal thoughts or behaviors. Qsymia is not recommended in patients with a history
of suicidal attempts or active suicidal ideation.
Acute angle closure glaucoma has been reported in patients treated with topiramate,
a component of Qsymia. Symptoms include acute onset of decreased visual acuity and/or
eye pain. Symptoms typically occur within 1 month of initiating treatment with topiramate
but may occur at any time during therapy. The primary treatment to reverse symptoms
is immediate discontinuation of Qsymia.
Qsymia can cause mood disorders, including depression, and anxiety, as well as insomnia.
Qsymia can cause cognitive dysfunction (e.g., impairment of concentration/attention,
difficulty with memory, and speech or language problems, particularly word-finding
difficulties). Since Qsymia has the potential to impair cognitive function, patients
should be cautioned about operating hazardous machinery, including automobiles.
Hyperchloremic, non-anion gap, metabolic acidosis has been reported in patients
treated with Qsymia. If metabolic acidosis develops and persists, consideration
should be given to reducing the dose or discontinuing Qsymia.
Qsymia can cause an increase in serum creatinine. If persistent elevations in creatinine
occur while taking Qsymia, reduce the dose or discontinue Qsymia.
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes
mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas).
Qsymia has not been studied in combination with insulin. A reduction in the dose
of antidiabetic medications which are non-glucose-dependent should be considered
to mitigate the risk of hypoglycemia.
The most commonly observed side effects in controlled clinical studies, ≥5% and
at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia,
constipation, and dry mouth.
To report negative side effects, contact VIVUS, Inc. at 1-888-998-4887 or FDA at
1-800-FDA-1088
or
www.fda.gov/medwatch.
