BELVIQ / BELVIQ XR Film-coated tablet / Extended-release tablet Ref.[10124] Active ingredients: Lorcaserin

Source: FDA, National Drug Code (US)  Revision Year: 2018 

1. Indications and Usage

BELVIQ/BELVIQ XR 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/m² or greater (obese), or
  • 27 kg/m² or greater (overweight) in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes)

[see Dosage and Administration (2)]

Limitations of Use:

  • The safety and efficacy of coadministration of BELVIQ/BELVIQ XR with other products intended for weight loss including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations have not been established.
  • The effect of BELVIQ/BELVIQ XR on cardiovascular morbidity and mortality has not been established.

2. Dosage and Administration

  • The recommended dose for BELVIQ is one 10 mg tablet administered orally twice daily.
  • The recommended dose for BELVIQ XR is one 20 mg tablet administered orally once daily.
  • Do not exceed recommended dose [see Warnings and Precautions (5.4)].
  • BELVIQ/BELVIQ XR can be taken with or without food.
  • Swallow BELVIQ XR tablets whole and do not chew, crush, or divide.
  • Response to therapy should be evaluated by week 12. If a patient has not lost at least 5% of baseline body weight, discontinue BELVIQ/BELVIQ XR, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment [see Clinical Studies (14)].
  • BMI is calculated by dividing weight (in kg) by height (in meters) squared. A BMI chart for height in inches and weight in pounds is provided below:

Table 1. BMI Conversion Chart:

Weight (lb) 125 130 135 140 145 150 155 160 165 170 175 180 185 190 195 200 205 210 215 220 225
(kg) 56.8 59.1 61.4 63.6 65.9 68.2 70.5 72.7 75.0 77.3 79.5 81.8 84.1 86.4 88.6 90.9 93.2 95.5 97.7 100.0 102.3
Height                      
(in) (cm)                      
58 147.3 26 27 28 29 30 31 32 34 35 36 37 38 39 40 41 42 43 44 45 46 47
59 149.9 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 43 44 45 46
60 152.4 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44
61 154.9 24 25 26 27 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43
62 157.5 23 24 25 26 27 27 28 29 30 31 32 33 34 35 36 37 38 38 39 40 41
63 160.0 22 23 24 25 26 27 28 28 29 30 31 32 33 34 35 36 36 37 38 39 40
64 162.6 22 22 23 24 25 26 27 28 28 29 30 31 32 33 34 34 35 36 37 38 39
65 165.1 21 22 23 23 24 25 26 27 28 28 29 30 31 32 33 33 34 35 36 37 38
66 167.6 20 21 22 23 23 24 25 26 27 27 28 29 30 31 32 32 33 34 35 36 36
67 170.2 20 20 21 22 23 24 24 25 26 27 27 28 29 30 31 31 32 33 34 35 35
68 172.7 19 20 21 21 22 23 24 24 25 26 27 27 28 29 30 30 31 32 33 34 34
69 175.3 18 19 20 21 21 22 23 24 24 25 26 27 27 28 29 30 30 31 32 33 33
70 177.8 18 19 19 20 21 22 22 23 24 24 25 26 27 27 28 29 29 30 31 32 32
71 180.3 17 18 19 20 20 21 22 22 23 24 24 25 26 27 27 28 29 29 30 31 31
72 182.9 17 18 18 19 20 20 21 22 22 23 24 24 25 26 27 27 28 29 29 30 31
73 185.4 17 17 18 19 19 20 20 21 22 22 23 24 24 25 26 26 27 28 28 29 30
74 188.0 16 17 17 18 19 19 20 21 21 22 23 23 24 24 25 26 26 27 28 28 29
75 190.5 16 16 17 18 18 19 19 20 21 21 22 23 23 24 24 25 26 26 27 28 28
76 193.0 15 16 16 17 18 18 19 20 20 21 21 22 23 23 24 24 25 26 26 27 27

10. Overdosage

No experience with overdose of BELVIQ/BELVIQ XR is available. In clinical studies that used doses that were higher than the recommended dose, the most frequent adverse reactions associated with BELVIQ were headache, nausea, abdominal discomfort, and dizziness. Single 40- and 60-mg doses of BELVIQ caused euphoria, altered mood, and hallucination in some subjects. Treatment of overdose should consist of BELVIQ/BELVIQ XR discontinuation and general supportive measures in the management of overdosage. Lorcaserin is not eliminated to a therapeutically significant degree by hemodialysis.

16.2. Storage and Handling

Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].

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