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)125130135140145150155160165170175180185190195200205210215220225
(kg)56.859.161.463.665.968.270.572.775.077.379.581.884.186.488.690.993.295.597.7100.0102.3
Height                     
(in)(cm)                     
58147.3262728293031323435363738394041424344454647
59149.9252627282930313233343536373839404143444546
60152.4242526272829303132333435363738394041424344
61154.9242526272728293031323334353637383940414243
62157.5232425262727282930313233343536373838394041
63160.0222324252627282829303132333435363637383940
64162.6222223242526272828293031323334343536373839
65165.1212223232425262728282930313233333435363738
66167.6202122232324252627272829303132323334353636
67170.2202021222324242526272728293031313233343535
68172.7192021212223242425262727282930303132333434
69175.3181920212122232424252627272829303031323333
70177.8181919202122222324242526272728292930313232
71180.3171819202021222223242425262727282929303131
72182.9171818192020212222232424252627272829293031
73185.4171718191920202122222324242526262728282930
74188.0161717181919202121222323242425262627282829
75190.5161617181819192021212223232424252626272828
76193.0151616171818192020212122232324242526262727

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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