BELVIQ and BELVIQ XR are 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 (e.g., hypertension, dyslipidemia, type 2 diabetes).
Limitations of Use: The safety and efficacy of coadministration of BELVIQ or BELVIQ XR with other products in-tended for weight loss, including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations, have not been established. The effect of BELVIQ or BELVIQ XR on cardiovascular morbidity and mortality has not been established.
IMPORTANT SAFETY INFORMATION FOR BELVIQ® AND BELVIQ XR®
Important Safety Information
BELVIQ or BELVIQ XR should not be taken during pregnancy or by women who are planning to become pregnant.
Patients with prior hypersensitivity reactions to lorcaserin or to any of the product components should not take this medicine. Hypersensitivity reactions have been reported.
Warnings and Precautions
BELVIQ and BELVIQ XR are serotonergic drugs. 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 or BELVIQ XR 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 or BELVIQ XR in combination with potent 5-HT2B receptor agonists that have been associated with regurgitant valvular heart disease (e.g., cabergoline). In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo developed valvular regurgitation: none of these patients were symptomatic. BELVIQ and BELVIQ XR 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 or BELVIQ XR 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 or BELVIQ XR affects them.
The recommended daily dose 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 or BELVIQ XR 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 or BELVIQ XR is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered.
Men who experience priapism should immediately discontinue BELVIQ or BELVIQ XR and seek emergency medical attention. BELVIQ or BELVIQ XR should be used with caution with erectile dysfunction medications. BELVIQ or BELVIQ XR should be used with caution in men who have conditions that might predispose them to priapism (e.g., 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).
Because BELVIQ or BELVIQ XR 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, signs and symptoms of prolactin excess, and pulmonary hypertension.
Most Common Adverse Reactions for BELVIQ®
- 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%).
Most Common Adverse Reactions for BELVIQ XR®
- Common side effects in patients on BELVIQ XR were similar to those seen in patients on BELVIQ.
BELVIQ or BELVIQ XR should not be taken by women who are nursing.
BELVIQ® and BELVIQ XR® are federally controlled substances that may lead to abuse or dependence.
For more information about BELVIQ®, see full Prescribing Information.
For more information about BELVIQ XR®, see full Prescribing Information.