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Belviq

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Belviq

INDICATIONS

BELVIQ 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]

Limitations of Use

  • The safety and efficacy of coadministration of BELVIQ 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 on cardiovascular morbidity and mortality has not been established

DOSAGE AND ADMINISTRATION

The recommended dose of BELVIQ is 10 mg administered orally twice daily. Do not exceed recommended dose [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

BELVIQ can be taken with or without food. Response to therapy should be evaluated by week 12. If a patient has not lost at least 5% of baseline body weight, discontinue BELVIQ, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment [see Clinical Studies].

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

HOW SUPPLIED

Dosage Forms And Strengths

BELVIQ is provided as blue, film-coated, 10 mg tablets. The tablets are round, biconvex, debossed with “A” on one side and “10” on the other side.

Storage And Handling

BELVIQ 10-mg tablets are supplied as blue-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “10” on the other side and are available as follows:

NDC 62856-529-10 Bottle of 100
NDC 62856-529-51 Blister pack of 10

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

Manufactured by Arena Pharmaceuticals GmbH, Untere Brühlstrasse 4, CH-4800, Zofingen, Switzerland Distributed by Eisai Inc., Woodcliff Lake, NJ 07677. Revised: 06/2012

Last reviewed on RxList: 7/5/2012
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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