Adult Dosing

Obesity

• 10 mg PO bid with or without food

Note:

• Recommended dose is not to be exceeded
• Therapy should be discontinued if patient does not achieve 5% weight loss by week 12

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• For chronic weight management in adults in addition to a reduced-calorie diet and increased physical activity
• Indicated for adults with 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)

• Hypersensitivity to any of the ingredients of the product
• Pregnancy

• N/A

Renal Dose Adjustment

• Mild impairment (CrCl 30-60 mL/min): No dosage adjustments
• Moderate impairment (CrCl 15-30 mL/min): Use with caution
• Severe impairment (CrCl <15 mL/min or ESRD): Not recommended

Hepatic Dose Adjustment

• Mild-moderate impairment (Child-Pugh score 5-6): No dosage adjustments
• Severe impairment (Child-Pugh score 7-9): Use with caution

• Coadministration of the drug with other serotonergic or antidopaminergic agents should be monitored to avoid the development of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions. Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
• Patient should be monitored for the occurrence of signs and symptoms of valvular heart disease which may primarily affect mitral and/or aortic valves. Use cautiously in patients with CHF.
• If signs or symptoms of valvular heart disease such as dyspnea, dependent edema, CHF or a new cardiac murmur occur, therapy should be discontinued
• Patients should be cautioned about operating hazardous machinery, including automobiles, while on therapy as their cognitive potential may be impaired
• The recommended dose should not be exceeded as the patient may be liable to psychiatric disorders including euphoria and dissociation. Depression and suicidal thoughts may also develop. Closely monitor patients for worsening of depression, suicidal thoughts or behavior, or any other unusual changes in mood or behavior
• Weight loss may increase the risk of hypoglycemia in patients with diabetes mellitus on antidiabetic therapy; blood glucose levels should be measured before initiating and throughout the therapy in patients with type 2 diabetes
• May cause priapism, i.e, painful or painless erection lasting >4 hours in men at risk (with sickle cell anemia, multiple myeloma, or leukemia) or in men with anatomical deformation of the penis (e.g., Angulation, cavernosal fibrosis, or Peyronie's disease)
• Patient may experience decrease in heart rate and an increase in prolactin levels, use cautiously in patients with bradycardia or a history of heart block
• Therapy may cause decrease in white blood cell count and other hematological changes; periodic monitoring of CBC is recommended

Pregnancy Category:X; contraindicated

Breastfeeding: It is unknown if lorcaserin is excreted in human milk; patient should be advised to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

• CNS: Headache, dizziness, fatigue
• NEURO: Serotonin syndrome or neuroleptic malignant syndrome, cognitive impairment
• PSYCHIATRY: Anxiety, insomnia, stress, depression, euphoria, suicidality
• GI: Nausea, diarrhea, constipation, gastroenteritis, dry mouth, vomiting, toothache
• RESP: Upper respiratory tract infection, nasopharyngitis, cough, oropharyngeal pain, sinus congestion
• MUSC: Back pain, musculoskeletal pain, muscle spasms
• DERM: Rash
• CV: Valvular Heart Disease, decreased heart rate, hypertension
• METABOLIC: Hypoglycemia, worsening of diabetes mellitus, decreased appetite
• GU: Urinary tract infection
• HYPERSENSITIVITY: Seasonal allergy
• MISC: Peripheral edema

• Selective 5-HT2C receptor agonist; Exact mechanism is unknown, however it selectively interacts with 5-HT2C receptors on anorexigenic pro-opiomelanocortin neurons located in the hypothalamus which decreases the food consumption and promotes satiety
• Absorbed from the gastrointestinal tract
• Metabolized by the liver
• Excreted in urine (93.2%) and feces (2.2 %)
• Half-life: Approx. 11 hours

US Trade Name(s)

• Belviq

US Availability

Belviq

• TABS: 10 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Metabolic Agents

Serotonin 2C Receptor Agonist