Qsymia

QSYMIA- phentermine hydrochloride and topiramate capsule, extended release
Vivus, Inc.

1 INDICATIONS AND USAGE

Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of

  • 30 kg/m 2 or greater (obese), or
  • 27 kg/m 2 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.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing and Administration

Determine the patient’s BMI. BMI is calculated by dividing weight (in kilograms) by height (in meters) squared. A BMI conversion chart (Table 1) based on height [inches (in) or centimeters (cm)] and weight [pounds (lb) or kilograms (kg)] is provided below.

Table 1. BMI Conversion Chart
Table 1
(click image for full-size original)

In adults with an initial BMI of 30 kg/m2 or greater or 27 kg/m2 or greater when accompanied by weight-related co-morbidities such as hypertension, type 2 diabetes mellitus, or dyslipidemia prescribe Qsymia as follows:

  • Take Qsymia once daily in the morning with or without food. Avoid dosing with Qsymia in the evening due to the possibility of insomnia.
  • Start treatment with Qsymia 3.75 mg/23 mg (phentermine 3.75 mg/topiramate 23 mg extended-release) daily for 14 days; after 14 days increase to the recommended dose of Qsymia 7.5 mg/46 mg (phentermine 7.5 mg/topiramate 46 mg extended-release) once daily.
  • Evaluate weight loss after 12 weeks of treatment with Qsymia 7.5 mg/46 mg.
    If a patient has not lost at least 3% of baseline body weight on Qsymia 7.5 mg/46 mg, discontinue Qsymia or escalate the dose, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss at the Qsymia 7.5 mg/46 mg dose.
    To escalate the dose: Increase to Qsymia 11.25 mg/69 mg (phentermine 11.25 mg/topiramate 69 mg extended-release) daily for 14 days; followed by dosing Qsymia 15 mg/92 mg (phentermine 15 mg/topiramate 92 mg extended-release) once daily.
  • Evaluate weight loss following dose escalation to Qsymia 15 mg/92 mg after an additional 12 weeks of treatment. If a patient has not lost at least 5% of baseline body weight on Qsymia 15 mg/92 mg, discontinue Qsymia as directed, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
  • Qsymia 3.75 mg/23 mg and Qsymia 11.25 mg/69 mg are for titration purposes only.
Table 1

Discontinuing Qsymia

  • Discontinue Qsymia 15 mg/92 mg gradually by taking a dose every other day for at least 1 week prior to stopping treatment altogether, due to the possibility of precipitating a seizure [see Warnings and Precautions (5.12)].

2.2 Dosing in Patients with Renal Impairment

In patients with moderate (creatinine clearance [CrCl] greater than or equal to 30 and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment dosing should not exceed Qsymia 7.5 mg/46 mg once daily. Renal impairment is determined by calculating CrCl using the Cockcroft-Gault equation with actual body weight [see Warnings and Precautions (5.13) and Clinical Pharmacology (12.3)].

2.3 Dosing in Patients with Hepatic Impairment

In patients with moderate hepatic impairment (Child-Pugh score 7 — 9), dosing should not exceed Qsymia 7.5 mg/46 mg once daily [see Warnings and Precautions (5.14) and Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Qsymia capsules are formulated in the following four strength combinations (phentermine mg/topiramate mg extended-release):

  • 3.75 mg/23 mg [Purple cap imprinted with VIVUS, Purple body imprinted with 3.75/23]
  • 7.5 mg/46 mg [Purple cap imprinted with VIVUS, Yellow body imprinted with 7.5/46]
  • 11.25 mg/69 mg [Yellow cap imprinted with VIVUS, Yellow body imprinted with 11.25/69]
  • 15 mg/92 mg [Yellow cap imprinted with VIVUS, White body imprinted with 15/92]

4 CONTRAINDICATIONS

Qsymia is contraindicated in the following conditions:

5 WARNINGS AND PRECAUTIONS

5.1 Fetal Toxicity

Qsymia can cause fetal harm. Data from pregnancy registries and epidemiology studies indicate that 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). If Qsymia is used during pregnancy or if a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be apprised of the potential hazard to a fetus. Females of reproductive potential should have a negative pregnancy test before starting Qsymia and monthly thereafter during Qsymia therapy. Females of reproductive potential should use effective contraception during Qsymia therapy [see Use in Specific Populations (8.1) and (8.6)] .

Qsymia Risk Evaluation and Mitigation Strategy (REMS)

Because of the teratogenic risk associated with Qsymia therapy, Qsymia is available through a limited program under the REMS. Under the Qsymia REMS, only certified pharmacies may distribute Qsymia. Further information, is available at www.QsymiaREMS.com or by telephone at 1-888-998-4887.

5.2 Increase in Heart Rate

Qsymia can cause an increase in resting heart rate.

A higher percentage of Qsymia-treated overweight and obese adults experienced heart rate increases from baseline of more than 5, 10, 15, and 20 beats per minute (bpm) compared to placebo-treated overweight and obese adults. Table 2 provides the numbers and percentages of patients with elevations in heart rate in clinical studies of up to one year.

Table 2. Number and Percentage of Patients with an Increase in Heart Rate at a Single Time Point from Baseline
Placebo N=1561 n (%) Qsymia 3.75 mg/23 mg N=240 n (%) Qsymia 7.5 mg/46 mg N=498 n (%) Qsymia 15 mg/92 mg N=1580 n (%)
Greater than 5 bpm 1021 (65.4) 168 (70.0) 372 (74.7) 1228 (77.7)
Greater than 10 bpm 657 (42.1) 120 (50.0) 251 (50.4) 887 (56.1)
Greater than 15 bpm 410 (26.3) 79 (32.9) 165 (33.1) 590 (37.3)
Greater than 20 bpm 186 (11.9) 36 (15.0) 67 (13.5) 309 (19.6)

The clinical significance of a heart rate elevation with Qsymia treatment is unclear, especially for patients with cardiac and cerebrovascular disease (such as patients with a history of myocardial infarction or stroke in the previous 6 months, life-threatening arrhythmias, or congestive heart failure).

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.

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