BELVIQ® (lorcaserin HCl) C-IV A Pharmacotherapeutic Option for Chronic Weight Management

This monograph was sponsored by Eisai

The prevalence of overweight and obesity continues to grow in the United States. Today, 69% of American adults are either obese or overweight.^1-3 The FDA has stated that “Obesity threatens the overall well-being of patients and is a major public health concern.”⁴

Excessive caloric intake and low caloric expenditure contribute to obesity. Diet and exercise remain the best interventions for reducing overall caloric intake. To support healthy lifestyle changes, public health authorities have initiated state and national campaigns to raise awareness of public health concerns regarding sedentary lifestyles, poor diet, and a lack of physical activity. Despite these efforts, obesity remains a public health challenge.^5-7

This Product Monograph will help you improve your knowledge with one of the recently FDA approved medicines for obesity, BELVIQ. The monograph contains information on the novel mechanism of action of BELVIQ, the effectiveness of treatment with BELVIQ, and important information that may help you advise patients. To access the Product Monograph, click here or the image below.

INDICATION

BELVIQ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults 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 (eg, hypertension, dyslipidemia, type 2 diabetes).

Limitations of Use:

• The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss, including prescription drugs (eg, 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• BELVIQ should not be taken during pregnancy or by women who are planning to become pregnant.

WARNINGS & PRECAUTIONS

• BELVIQ is a serotonergic drug. The development of potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported during use of serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors, and selective serotonin reuptake inhibitors, tricyclic antidepressants, bupropion, triptans, dietary supplements such as St. John’s Wort and tryptophan, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists, particularly when used in combination. Patients should be monitored for the emergence of serotonin syndrome symptoms or NMS-like reactions, including agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea, and muscle rigidity. Treatment with BELVIQ and any concomitant serotonergic or antidopaminergic agents should be discontinued immediately if the above events occur, and supportive symptomatic treatment should be initiated.
• Patients should not take BELVIQ in combination with drugs that have been associated with valvular heart disease (eg, cabergoline). In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo developed valvular regurgitation: none of these patients was symptomatic. BELVIQ should be used with caution in patients with congestive heart failure (CHF). Patients who develop signs and symptoms of valvular heart disease, including dyspnea, dependent edema, CHF, or a new cardiac murmur, should be evaluated and discontinuation of BELVIQ should be considered.
• Impairment in attention, memory, somnolence, confusion, and fatigue, have been reported in patients taking BELVIQ. Patients should not drive a car or operate heavy machinery until they know how BELVIQ affects them.
• The recommended dose of 10 mg twice daily should not be exceeded, as higher doses may cause euphoria, hallucination, and dissociation. Monitor patients for the development or worsening of depression, suicidal thoughts or behaviors, and/or any changes in mood. Discontinue BELVIQ in patients who develop suicidal thoughts or behaviors.
• Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus who are being treated with antidiabetic medications, so measurement of blood sugar levels before and during treatment with BELVIQ is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered.
• Men who experience priapism should immediately discontinue BELVIQ and seek emergency medical attention. BELVIQ should be used with caution with erectile dysfunction medications. BELVIQ should be used with caution in men who have conditions that might predispose them to priapism (eg, sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, or Peyronie’s disease).
• Because BELVIQ may cause a slow heartbeat, it should be used with caution in patients with a history of bradycardia or heart block greater than first degree.
• Consider monitoring for CBC changes, prolactin excess, and pulmonary hypertension.

Most Common Adverse Reactions

• In patients without diabetes: headache (17%), dizziness (9%), fatigue (7%), nausea (8%), dry mouth (5%), and constipation (6%).
• In patients with diabetes: hypoglycemia (29%), headache (15%), back pain (12%), cough (8%), and fatigue (7%).

Nursing Mothers

• BELVIQ should not be taken by women who are nursing.

For more information about BELVIQ, see Full Prescribing Information.

References

• Flegal KM, Carroll MD, Kuczmarski RJ, Johnson CL. Overweight and obesity in the United States: prevalence and trends, 1960-1994. Int J Obes. 1998;22(1):39-47.
• Flegal KM, Caroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in distribution of body mass index among US adults, 1999-2010. JAMA. 2012;307(5):491-497.
• Self-Reported Obesity Among US Adults in 2011. Centers for Disease Control and Prevention; 2011. www.cdc.gov/obesity/downloads/DNPAO_State_Obesity_Prevalence_Map_2011_508.pdf.
• US Food and Drug Administration. FDA approves Belviq to treat some overweight or obese adults. US Dept of Health and Human Services. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htm. Published June 27, 2012. Accessed October 5, 2012.
• World Health Organization. Obesity and Overweight. www.who.int/mediacentre/factsheets/fs311/en/. Fact sheet No. 311. Published May 2012. Accessed October 3, 2012.
• Snow V, Barry P, Fitterman N, Qaseem A, Weiss K. Pharmacologic and surgical management of obesity in primary care: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2005;142:525-531.
• VA/DoD Clinical Practice Guidelines for Screening and Management of Overweight and Obesity. Dept of Veterans Affairs and Dept of Defense; 2006. www.healthquality.va.gov/obesity/ObesitySum508.pdf.

BELVIQ

^®

is a registered trademark of Arena Pharmaceuticals GmbH, Zofingen, Switzerland

Manufactured by Arena Pharmaceuticals GmbH, Untere Brühlstrasse 4, CH-4800, Zofingen, Switzerland

Distributed by Eisai Inc., Woodcliff Lake, NJ 07677

© 2013 Eisai Inc. All rights reserved. 07/2013