Usual Adult Dose for Weight Loss

All doses expressed as phentermine/topiramate XR:

Initial dose: 3.75 mg/23 mg orally once a day for 14 days, then 7.5 mg/46 mg orally once a day

• After 12 weeks of dosing at 7.5 mg/46 mg once a day; evaluate weight loss and if weight loss is less than 3% of baseline weight, discontinue therapy or escalate dose:

Dose escalation: 11.25 mg/69 mg orally once a day for 14 days, then 15 mg/92 mg orally once a day

• After 12 weeks of dosing at 15 mg/92 mg once a day; evaluate weight loss and if weight loss is less than 5% of baseline weight, discontinue therapy

Maintenance dose: 7.5 mg/46 mg OR 15 mg/92 mg orally once a day

• Doses of 3.75 mg/23 mg and 11.25 mg/69 mg are for titration purposes only

Comments:

• Dosing should be in the morning (with or without food) to avoid the possibility of insomnia.
• Doses should be titrated and weight loss evaluated as described above; if percent weight loss is not achieved by stated timeline it is unlikely that patients will achieve and sustain clinically meaningful weight loss and therefore discontinuation is recommended.
• Discontinuation from dose of 15 mg/92 mg once a day should be gradual; decrease to every other day for at least 1 week prior to stopping treatment.

Uses: As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients:

• With an initial body mass index (BMI) of 30 kg/m2 or greater (obese)
• With an initial BMI of 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.

Renal Dose Adjustments

• Mild renal impairment (CrCl 50 mL/min or more): No adjustment recommended
• Moderate to severe renal impairment (CrCl less than 50 mL/min): Maximum dose: phentermine 7.5 mg/topiramate XR 46 mg orally once a day

Liver Dose Adjustments

• Mild liver impairment (Child-Pugh score 5 to 6): No adjustment recommended
• Moderate liver impairment (Child-Pugh score 7 to 9): Maximum dose: 7.5 mg/topiramate XR 46 mg orally once a day
• Severe liver impairment (Child-Pugh score 10 to 15): Not recommended

Dose Adjustments

Elderly: Dose selection should be cautious

Drug Discontinuation:

• To prevent a possible seizure, discontinue treatment gradually by taking a dose every other day for at least 1 week prior to stopping treatment altogether.

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes a medication guide, elements to assure safe use, and an implementation system. For additional information: www.fda.gov/REMS.

CONTRAINDICATIONS:

• Pregnancy
• Glaucoma
• Hyperthyroidism
• During or within 14 days following the administration of monoamine oxidase inhibitors
• Known hypersensitivity or idiosyncrasy to the sympathomimetic amines

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Avoid use

Other Comments

Administration advice:

• Take orally in the morning with or without food

Missed dose: If a dose is missed, skip the missed dose and wait until the next morning to take usual dose; do not double dose

General:

• The effect of this drug on cardiovascular morbidity and mortality has not been established.
• The safety and effectiveness of this drug in combination with other weight loss products, including prescription and over-the-counter drugs and herbal preparations, have not been established.
• This drug is only available through certified pharmacies enrolled in the Qsymia certified network; additional information may be obtained via the website www.QsymiaREMS.com

Monitoring:

• Obtain a negative pregnancy test before treatment initiation and monthly thereafter in females of reproductive potential.
• Measure blood pressure prior to and during treatment in patients being treated with antihypertensive medications.
• Measure electrolytes including serum bicarbonate prior to and during treatment.
• Monitor patients for the appearance or worsening of metabolic acidosis if they are concomitantly taking a carbonic anhydrase inhibitor and have a predisposing condition for metabolic acidosis.
• Measure blood glucose levels prior to and during treatment in type 2 diabetic patients.
• Monitor for hypokalemia per standard of care.
• Perform appropriate monitoring in situations where immediate termination of this drug is medically required as abrupt withdrawal of topiramate has been associated with seizures in individuals without a history of seizures or epilepsy.
• Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
• Measure serum creatinine levels prior to and during treatment.
• Obtain a blood chemistry profile that includes bicarbonate, creatinine, potassium, and glucose at baseline and periodically during treatment.

Patient Advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should be instructed to follow prescribed diet and exercise plan and maintain adequate hydration.
• Patients should be instructed to report persistently elevated pulse or periods of heart pounding or racing at rest; severe side or back pain and/or blood in their urine; changes in attention, concentration, memory, and/or difficulty finding words; changes in mood or depression, or suicidal ideation; and/or symptoms of severe or persistent eye pain or vision changes.
• Patients should avoid driving or operating hazardous machinery until they gauge how this drug affects their performance.
• Patients should avoid alcohol while on therapy.
• Patients should understand this drug may cause fetal harm; a negative pregnancy test is necessary prior to starting therapy and effective contraception are necessary during therapy.
• Patients should be instructed to monitor for decreased sweating and increased body temperature during physical activity, especially in hot weather.
• Patients with diabetes should be instructed to monitor blood sugars carefully and contact their healthcare provider for changes in glycemic control.
• Patients should be instructed not to abruptly discontinue therapy.