QSYMIA (phentermine hydrochloride)

AbsorptionPhentermine Upon oral administration of a single QSYMIA 15 mg/92 mg, the resulting mean plasma phentermine maximum concentration (C max ), time to C max (T max ), area under the concentration curve from time zero to the last time with measurable concentration (AUC 0-t ), and area under the concentration curve from time zero to infinity (AUC 0-∞ ) are 49.1 ng/mL, 6 hr, 1990 ng∙hr/mL, and 2000 ng∙hr/mL, respectively. A high fat meal does not affect phentermine pharmacokinetics for QSYMI...

Clinical Studies in Adults The effect of QSYMIA on weight loss in conjunction with reduced caloric intake and increased physical activity was studied in two randomized, double-blind, placebo-controlled studies in patients with obesity (Study 1) and patients with obesity or overweight with two or more significant co-morbidities (Study 2). Both studies had a 4-week titration period, followed by 52 weeks of treatment. There were two co-primary efficacy outcomes measured after 1 year of treatment (Week 56): 1) the percent weight loss from baseline; and 2) treatment response defined as achieving at...

The following clinically significant adverse reactions are described elsewhere in the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.6) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Risk of Ophthalmologic Adverse Reactions [see Warnings and Precautions (5.3) ] Mood and Sleep Disorders [see Warnings and Precautions (5.4) ] Cognitive Impairment [see Warnings and Precautions (5.5) ] Slowing of Linear Growth [see ...

QSYMIA is contraindicated in patients: Who are pregnant [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] With glaucoma [see Warnings and Precautions (5.3) ] With hyperthyroidism Taking or within 14 days of stopping a monoamine oxidase inhibitors [see Drug Interactions (7) ] With known hypersensitivity to phentermine, topiramate or any of the excipients in QSYMIA, or idio...

Embryo-Fetal Toxicity : Can cause fetal harm. In patients who can become pregnant, a negative pregnancy test is recommended before initiating QSYMIA and monthly during therapy; advise use of effective contraception. QSYMIA is available through a limited program under a Risk Evaluation and Mitigation Strategy (REMS) ( 5.1 ). Suicidal Behavior and Ideation : Monitor for depression or suicidal thoughts. Discontinue QSYMIA if symptoms develop ( 5.2 ). Risk of Ophthalmologic Adverse Reactions : Acute...

7 DRUG INTERACTIONS Table 5 displays clinically significant drug interactions with QSYMIA. Table 5. Clinically Significant Drug Interactions with QSYMIA Monoamine Oxidase Inhibitors Clinical Impact Concomitant use of phentermine with monoamine oxidase inhibitors (MAOIs) increases the risk of hypertensive crisis. Intervention Concomitant use of QSYMIA is contraindicated during MAOI treatment and wi...