Proven results

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BELVIQ® is clinically proven to work

When combined with diet and exercise, BELVIQ 10 mg twice daily can help you lose weight and improve certain health risk factors such as high blood pressure, high blood sugar, and high cholesterol levels. BELVIQ was tested in 2 major clinical studies in patients without diabetes: one lasting a year (4,008 adults) and one lasting 2 years (3,182 adults).

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The combined results of these 2 studies showed that:

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Almost half of the adults (47.1%) taking BELVIQ lost 5% or more of their body weight during the first year, compared with those using diet and exercise alone (22.6%).

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Some adults (22.4%) lost as much as 10% or more of their body weight after 1 year of treatment, compared with those using diet and exercise alone (8.7%). Adults without diabetes treated with BELVIQ were 3 times* more likely to achieve at least 10% weight loss compared with those using diet and exercise alone.

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Some adults taking BELVIQ lost an average of 12.8 lb after 1 year, compared with 5.5 lb for those who used diet and exercise alone. Some saw results in as early as 2 weeks. After 2 weeks, adults taking BELVIQ lost an average of 3.3 lb compared with 2.0 lb for those using diet and exercise alone.

Among other factors, your healthcare provider should tell you to stop taking BELVIQ/BELVIQ XR if you haven't achieved at least 5% weight loss by the end of the first 12 weeks of treatment.

During the clinical studies, 44% of patients taking BELVIQ (n=3098) and 51% of patients using diet and exercise alone (n=3038) withdrew prior to Week 52. The average baseline body weight was 221.3 lb for BELVIQ and 220.9 lb for placebo.

Though BELVIQ is not a treatment for high cholesterol or high blood pressure, adults taking BELVIQ with diet and exercise had significant improvements in their blood pressure and cholesterol levels, compared with those using diet and exercise alone.

It is not known if BELVIQ changes your risk of heart problems, stroke, or death due to heart problems or stroke.

BELVIQ may help keep weight off

In one study, adults taking BELVIQ 10 mg twice daily were able to lose weight and maintain weight loss for up to 2 years. Patients in all groups who completed the study including those on diet and exercise alone, regained some weight, but they remained under their starting weight.

BELVIQ may help overweight/obese patients living with type 2 diabetes lose weight

BELVIQ 10 mg twice daily was also studied in overweight men and women with type 2 diabetes. During the study, 251 adults received BELVIQ, while 248 adults used diet and exercise alone. The results showed that over a third of adults (37.5%) taking BELVIQ lost 5% or more of their body weight, compared with those using diet and exercise alone (16.1%). And 16.3% of adults taking BELVIQ with diet and exercise lost 10% or more of their body weight, compared with those using diet and exercise alone (4.4%). Though BELVIQ is not a treatment for type 2 diabetes, the group showed significant improvement in blood sugar levels, compared with adults using diet and exercise alone.

During the study, 34% of patients taking BELVIQ and 38% of patients using diet and exercise alone withdrew prior to Week 52.

Patients with type 2 diabetes treated with BELVIQ were 4 times* more likely to achieve at least 10% weight loss compared with diet and exercise alone.

*This data was determined based upon odds ratio. Odds ratio is the likelihood of achieving the weight loss goal with medication versus with diet and exercise alone.

The most common side effects for BELVIQ were headache, dizziness, fatigue, nausea, dry mouth, constipation, low blood sugar (in patients with type 2 diabetes), and back pain.

Discontinuation rates due to side effects were similar between BELVIQ and placebo (8.6% and 6.7%, respectively). The most common side effects leading to discontinuation more often with BELVIQ than placebo were headache, depression, and dizziness.

 

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What is BELVIQ®/BELVIQ XR®?

BELVIQ/BELVIQ XR is an FDA-approved prescription weight-loss medication that, when used with diet and exercise, can help some adults (body mass index [BMI] 27 kg/m2) living with extra weight, with a weight-related medical problem, or adults living with obesity (BMI 30 kg/m2), lose weight and keep it off. It is not known if BELVIQ/BELVIQ XR when taken with other prescription, over-the-counter, or herbal weight-loss products is safe and effective. It is not known if BELVIQ/BELVIQ XR changes your risk of heart problems, stroke, or death due to heart problems or stroke.

IMPORTANT SAFETY INFORMATION FOR BELVIQ®/BELVIQ XR®:

  • Pregnancy: Do not take if you are pregnant or planning to become pregnant, as weight loss offers no benefit during pregnancy and BELVIQ/BELVIQ XR may harm your unborn baby.
  • Hypersensitivity reactions: Do not take if you are allergic to lorcaserin or any of the ingredients in BELVIQ/BELVIQ XR.
  • Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)–like reactions: Before using, tell your Healthcare Provider about all the medicines you take, especially medicines that treat depression, migraines, mental problems, or the common cold. These medicines may cause serious or life-threatening side effects if taken with BELVIQ/BELVIQ XR. Call your Healthcare Provider right away if you experience agitation, hallucinations, confusion, or other changes in mental status; coordination problems; uncontrolled muscle spasms; muscle twitching; restlessness; racing or fast heartbeat; high or low blood pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles.
  • Valvular heart disease: Some people taking medicines like BELVIQ/BELVIQ XR have had heart valve problems. Call your Healthcare Provider right away if you experience trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or weakness that will not go away; or fast or irregular heartbeat. Before taking BELVIQ/BELVIQ XR, tell your Healthcare Provider if you have or have had heart problems.
  • Changes in attention or memory: BELVIQ/BELVIQ XR may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ/BELVIQ XR affects you.
  • Mental problems: Taking too much BELVIQ/BELVIQ XR may cause hallucinations, a feeling of being high or in a very good mood, or feelings of standing outside your body.
  • Depression or thoughts of suicide: Call your Healthcare Provider right away if you notice any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings, or if you have depression or thoughts of suicide.
  • Low blood sugar: Weight loss can cause low blood sugar in people taking medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood sugar levels should be checked before and while taking BELVIQ/BELVIQ XR. Changes to diabetes medication may be needed if low blood sugar develops.
  • Painful erections: If you have an erection lasting more than 4 hours while on, stop taking BELVIQ/BELVIQ XR and call your Healthcare Provider or go to the nearest emergency room right away.
  • Slow heartbeat: BELVIQ/BELVIQ XR may cause your heart to beat slower.
  • Decreases in blood cell count: BELVIQ/BELVIQ XR may cause your red and white blood cell counts to decrease.
  • Increase in prolactin: BELVIQ/BELVIQ XR may increase the amount of a hormone called prolactin. Tell your Healthcare Provider if your breasts begin to make milk or a milky fluid, or if you are a male and your breasts increase in size.
  • Most common side effects of BELVIQ/BELVIQ XR: Headache, dizziness, fatigue, nausea, dry mouth, constipation, cough, low blood sugar (hypoglycemia) in patients with diabetes, and back pain.
  • Nursing: BELVIQ/BELVIQ XR should not be taken while breastfeeding.
  • Drug interactions: Before taking BELVIQ/BELVIQ XR, tell your Healthcare Provider if you take medicines for depression, migraines, or other medical conditions, such as: triptans; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an antibiotic); tramadol; dextromethorphan (an over-the-counter [OTC] common cold/cough medicine); OTC supplements such as tryptophan or St. John’s Wort; or erectile dysfunction medicines.

BELVIQ/BELVIQ XR is a federally controlled substance (CIV) because it may be abused or lead to drug dependence.
For more information about BELVIQ/BELVIQ XR talk to your Healthcare Provider and see the full Product Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.