BELVIQ XR Extended Release Extended Release

BELVIQ XR EXTENDED RELEASE EXTENDED RELEASE- lorcaserin hydrochloride anhydrous tablet, film coated, extended release
Eisai Inc.

1 INDICATIONS AND USAGE

BELVIQ XR (lorcaserin hydrochloride) extended-release tablet 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)

[s ee Dosage and Administration (2)]

Limitations of Use:

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

2 DOSAGE AND ADMINISTRATION

The recommended dose of BELVIQ XR is 20 mg administered orally once daily. BELVIQ XR tablet must be swallowed whole and must not be chewed, crushed, or divided. Do not exceed recommended dose [s ee Warnings and Precautions (5.4) and Patient Counseling Information (17)].

BELVIQ XR 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 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