Efficacy 2 Year - BLOOM 2-Year Data: Maintenance
for BELVIQ® 10 mg Twice Daily

BELVIQ® 5% Weight Loss Attained and Maintained1

Weight loss maintenance in BLOOM: patients on BELVIQ who maintained 5% weight loss from
Year 1 to Year 2
All patients received lifestyle modification counseling3

*Of  the 731 Year 1 responders, Patients who continued onto Year 2 were re-randomized to BELVIQ: n=380 ; Placebo n=175.

†LOCF: Last Observation Carried Forward method was employed for body weight

  • Of  3182 patients randomized in Year 1, 1553 were randomized in Year 2. Patients in all groups (BELVIQ Years 1 and 2, BELVIQ Year 1/placebo Year 2, placebo Years 1 and 2) regained weight in Year 2 but remained below their mean baseline weight3
  • Response to therapy should be evaluated by Week 12. If a patient has not lost at least 5% of baseline weight, discontinue BELVIQ®, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment. If a patient achieves 5% weight loss at 12 weeks, continuation of treatment may be considered among other factors3
  • Results from a 2-year trial with overweight adults with 1 weight-related comorbidity or obese adults. At Week 52, BELVIQ patients were randomly reassigned either to BELVIQ 10 mg BID with lifestyle modification or to placebo with lifestyle modification. The primary endpoint for Year 2 was the proportion of patients who had a reduction in baseline body weight of 5% at the end of
    Year 1 and maintained this reduction at Year 21,3

PRODUCT INDICATION FOR BELVIQ® AND BELVIQ XR®

INDICATION

BELVIQ/BELVIQ XR 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 (e.g., hypertension, dyslipidemia, type 2 diabetes).

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.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Pregnancy: BELVIQ/BELVIQ XR should not be taken during pregnancy or by women who are planning to become pregnant.
  • Hypersensitivity: Patients with prior hypersensitivity reactions to lorcaserin or to any of the product components should not take BELVIQ/BELVIQ XR. Hypersensitivity reactions have been reported.

Warnings and Precautions

  • Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)- like reactions: BELVIQ/BELVIQ XR 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/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.
  • Valvular heart disease: Patients should not take BELVIQ/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/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/BELVIQ XR should be considered.
  • Cognitive impairment: 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/BELVIQ XR affects them.
  • Psychiatric disorders: 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/BELVIQ XR in patients who develop suicidal thoughts or behaviors.
  • Hypoglycemia: 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/BELVIQ XR is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered.
  • Priapism: Men who experience priapism should immediately discontinue BELVIQ/BELVIQ XR and seek emergency medical attention. BELVIQ/BELVIQ XR should be used with caution with erectile dysfunction medications. BELVIQ/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).
  • Heart rate decreases: Because BELVIQ/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.
  • Monitoring Considerations: 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.

Nursing Mothers

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

BELVIQ®/BELVIQ XR® is a federally controlled substance (CIV) because it may be abused or lead to dependence.
For more information about BELVIQ®/BELVIQ XR®, see full Prescribing Information.