Warnings and Precautions

Fetal toxicity -+

  • Qsymia can cause fetal harm. A fetus exposed to topiramate, a component of Qsymia, in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate)
  • 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

Increase in heart rate -+

  • 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
  • Patients should inform healthcare providers of palpitations or feelings of a racing heartbeat while at rest during Qsymia treatment. For patients who experience a sustained increase in resting heart rate while taking Qsymia, the dose should be reduced or Qsymia discontinued

Suicidal behavior and ideation -+

  • 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 myopia and secondary angle glaucoma -+

  • 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
  • Elevated intraocular pressure of any etiology, if left untreated, can lead to serious adverse events, including permanent loss of vision

Mood and sleep disorders -+

  • Qsymia can cause mood disorders, including depression and anxiety, as well as insomnia. Patients with a history of depression may be at increased risk
  • For clinically significant or persistent symptoms consider dose reduction or withdrawal of Qsymia

Cognitive impairment -+

  • 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

Metabolic acidosis -+

  • Hyperchloremic, non-anion gap, metabolic acidosis has been reported in patients treated with Qsymia
  • Measurement of electrolytes including serum bicarbonate prior to starting Qsymia and during Qsymia treatment is recommended
  • If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Qsymia

Elevation in creatinine -+

  • Qsymia can cause an increase in serum creatinine. Therefore, measurement of serum creatinine prior to starting Qsymia and during Qsymia treatment is recommended
  • If persistent elevations in creatinine occur while taking Qsymia, reduce the dose or discontinue Qsymia

Use of antidiabetic medications -+

  • 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
  • Measurement of blood glucose levels prior to starting Qsymia and during Qsymia treatment is recommended in patients with type 2 diabetes
  • A reduction in the dose of antidiabetic medications that are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia

Potential risk of hypotension in patients treated with antihypertensive medications -+

  • In hypertensive patients being treated with antihypertensive medications, weight loss may increase the risk of hypotension. Measurement of blood pressure prior to starting Qsymia and during Qsymia treatment is recommended in patients being treated for hypertension
  • If a patient develops symptoms associated with low blood pressure after starting Qsymia, appropriate changes should be made to the antihypertensive drug regimen

CNS depression with concomitant CNS depressants including alcohol -+

  • The concomitant use of alcohol or central nervous system (CNS) depressant drugs (e.g., barbiturates, benzodiazepines, and sleep medications) with phentermine or topiramate may potentiate CNS depression or other centrally mediated effects of these agents. Therefore, avoid concomitant use of alcohol with Qsymia

Potential seizures with abrupt withdrawal of Qsymia -+

  • In situations where immediate termination of Qsymia is medically required, appropriate monitoring is recommended
  • Patients discontinuing Qsymia 15 mg/92 mg should be gradually tapered as recommended

Patients with renal impairment -+

  • Adjust dose of Qsymia (phentermine and topiramate extended-release) capsules CIV for patients with moderate or severe renal impairment
  • Qsymia has not been studied in patients with end-stage renal disease on dialysis. Avoid use of Qsymia in this patient population

Patients with hepatic impairment -+

  • Adjust dose of Qsymia for patients with moderate hepatic impairment
  • Qsymia has not been studied in patients with severe hepatic impairment. Avoid use of Qsymia in this patient population

Kidney stones -+

  • Avoid the use of Qsymia with other drugs that inhibit carbonic anhydrase (e.g., zonisamide, acetazolamide or methazolamide)
  • Use of topiramate by patients on a ketogenic diet may also result in a physiological environment that increases the likelihood of kidney stone formation
  • Increase fluid intake to increase urinary output which can decrease the concentration of substances involved in kidney stone formation

Oligohidrosis and hyperthermia -+

  • Patients treated with Qsymia should be advised to monitor for decreased sweating and increased body temperature during physical activity, especially in hot weather. Caution should be used when Qsymia is prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity

Hypokalemia -+

  • When prescribing Qsymia, patients should be monitored for hypokalemia

Monitoring: laboratory tests -+

  • It is recommended that a blood chemistry profile is obtained at baseline and periodically during treatment

Drug abuse and dependence -+

  • Phentermine, a component of Qsymia, has known potential for abuse

Choose Qsymia as first-line choice for a range of overweight and obese patient types who need to achieve significant weight loss1,2

Qsymia has been clinically proven to provide effective and well-tolerated treatment for a range of overweight and obese patient types1-2

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