Obesity:

Indications for: QSYMIA

As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight related co-morbidity (eg, hypertension, type 2 diabetes, or dyslipidemia); or pediatric patients aged ≥12yrs with BMI in the 95th percentile or greater standardized for age and sex.

Limitations of Use:

Effects on cardiovascular morbidity/mortality not established. Safety, effectiveness in combination with other weight loss products not established.

Adults and Children:

<12yrs: not established. Take once daily in the AM. ≥12yrs: Initially 3.75mg/23mg for 14 days; then increase to 7.5mg/46mg and evaluate weight loss after 12 weeks on this dose. If patient has not lost ≥3% baseline body wt. or BMI, increase to 11.25mg/69mg for 14 days; followed by an increase to 15mg/92mg and evaluate weight loss after 12 weeks on this dose. If patient has not lost ≥5% baseline body wt. or BMI, discontinue by taking 15mg/92mg every other day for at least 1 week prior to stopping altogether. Consider dose reduction if weight loss exceeds 2lbs (0.9kg) per week. Renal (moderate or severe), hepatic (moderate) impairment: max 7.5mg/46mg once daily.

QSYMIA Contraindications:

Pregnancy. Glaucoma. Hyperthyroidism. During or within 14 days of MAOIs.

QSYMIA Warnings/Precautions:

Embryo-fetal toxicity: obtain a negative pregnancy test before initiating and monthly during therapy; advise females of reproductive potential to use effective contraception. Recent or unstable cardiac or cerebrovascular disease: not recommended. Measure resting heart rate regularly. History of suicidal attempts or active suicidal ideation: avoid. Monitor for worsening of depression, suicidal thoughts, unusual behaviors; discontinue if occurs. History of depression. Sleep disorders. Discontinue if acute myopia and secondary angle-closure glaucoma syndrome occur. Consider discontinuing if visual field defects occur. Kidney stones. Maintain adequate hydration; avoid ketogenic diets. Measure electrolytes including serum bicarbonate, potassium, creatinine, blood glucose (in diabetics), BP (in patients on antihypertensives) prior to starting and during therapy. Monitor height velocity in children. Monitor for decreased sweating and increased body temperature during physical activity. Discontinue at the 1st sign of a rash. Avoid abrupt withdrawal (seizure risk). ESRD on dialysis, severe hepatic impairment: avoid. Elderly. Nursing mothers: not recommended.

QSYMIA Classification:

Sympathomimetic amine + antiepileptic.

QSYMIA Interactions:

See Contraindications. May potentiate CNS depression with concomitant alcohol or other CNS depressants (eg, barbiturates, benzodiazepines, hypnotics). Avoid excessive alcohol intake. Increased risk of hypokalemia with concomitant non-K+-sparing diuretics (eg, furosemide, HCTZ). Avoid other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, methazolamide). Hyperammonemia (w/ or w/o encephalopathy) and/or hypothermia possible with valproic acid. May be antagonized by phenytoin, carbamazepine. May antagonize pioglitazone (monitor glucose control). May affect oral contraceptives (spotting may occur). May potentiate amitriptyline.

Adverse Reactions:

Paraesthesia, dizziness, dysgeusia, insomnia, constipation, dry mouth; also in children: depression, arthralgia, pyrexia, influenza, ligament sprain; cognitive impairment, metabolic acidosis, increased serum creatinine, oligohidrosis, hyperthermia, serious skin reactions (eg, SJS, TEN).

Note:

Only available through certified pharmacies enrolled in Qsymia REMS program. For more information call (888) 998-4887.

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

Caps 3.75mg/23mg—14, 30; 7.5mg/46mg, 11.25mg/69mg, 15mg/92mg—30; Starter Pack (3.75mg/23mg + 7.5mg/46mg)—28; Dose Escalation Pack (11.25mg/69mg + 15mg/92mg)—28

Pricing for QSYMIA

7.5mg/46mg capsule (Qty: 30)
Appx. price $198
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