BELVIQ^® and BELVIQ XR^® Reimbursement Information for Patients

BELVIQ^® and BELVIQ XR^® are FDA-approved prescription weight-loss medications that, when used with diet and exercise, can help some overweight (Body Mass Index [BMI] ≥27 kg/m²) adults with a weight-related medical problem, or obese (BMI ≥30 kg/m²) adults, lose weight and keep it off.

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

Important Safety Information

• Pregnancy:

  Do not take if you are pregnant or planning to become pregnant, as weight loss offers no potential benefit during pregnancy and BELVIQ or BELVIQ XR may harm your unborn baby.

• Hypersensitivity Reactions:

  Do not take if you are allergic to either of these medicines or any of their ingredients.

• 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 or 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 or 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 or BELVIQ XR, tell your healthcare provider if you have or have had heart problems.

• Changes in attention or memory:

  BELVIQ or BELVIQ XR may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ or BELVIQ XR affects you.

• Mental problems:

  Taking too much BELVIQ or 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 or 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 BELVIQ or BELVIQ XR, stop taking BELVIQ or BELVIQ XR and call your healthcare provider or go to the nearest emergency room right away.

• Slow heartbeat:

   Both BELVIQ or BELVIQ XR may cause your heart to beat slower.

• Decreases in blood cell count:

  BELVIQ or BELVIQ XR may cause your red and white blood cell counts to decrease.

• Increase in prolactin:

  BELVIQ or 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^® or BELVIQ XR^®:

  Headache, dizziness, fatigue, nausea, dry mouth, constipation, cough, low blood sugar (hypoglycemia) in patients with diabetes, and back pain.

• Nursing:

  BELVIQ or BELVIQ XR should not be taken while breastfeeding.

• Drug interactions:

  Before taking BELVIQ or 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 and BELVIQ XR are federally controlled substances (CIV) because they may be abused or lead to drug dependence.

For more information about BELVIQ^® or BELVIQ XR^® talk to your healthcare provider and see the full Product Information for BELVIQ^® or BELVIQ XR^®.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch