INDICATIONS

BELVIQ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients 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 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 on cardiovascular morbidity and mortality has not been established

DOSAGE

The recommended dose of BELVIQ is 10 mg administered orally twice daily. Do not exceed recommended dose.

BELVIQ can be taken with or without food.

Response to therapy should be evaluated by week 12. If a patient has not lost at least 5% of baseline body weight, discontinue BELVIQ, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

BMI is calculated by dividing weight (in kg) by height (in meters) squared.

A BMI chart for height in inches and weight in pounds is provided below:

Table 1: BMI Conversion Chart

SIDE EFFECTS

The following important adverse reactions are described below and elsewhere in labeling:

• Serotonin Syndrome or NMS-like Reactions
• Valvular Heart Disease
• Cognitive Impairment
• Psychiatric Disorders
• Hypoglycemia
• Heart Rate Decreases
• Hematological Changes
• Prolactin Elevation

Clinical Trials Experience

In the BELVIQ placebo-controlled clinical database of trials of at least one year in duration, of 6888 patients (3451 BELVIQ vs. 3437 placebo; age range 18-66 years, 79.3% women, 66.6% Caucasians, 19.2% Blacks, 11.8% Hispanics, 2.4% other, 7.4% type 2 diabetics), a total of 1969 patients were exposed to BELVIQ 10 mg twice daily for 1 year and 426 patients were exposed for 2 years.

In clinical trials of at least one year in duration, 8.6% of patients treated with BELVIQ prematurely discontinued treatment due to adverse reactions, compared with 6.7% of placebo-treated patients. The most common adverse reactions leading to discontinuation more often among BELVIQ treated patients than placebo were headache (1.3% vs. 0.8%), depression (0.9% vs. 0.5%) and dizziness (0.7% vs. 0.2%).

Most Common Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reactions for non-diabetic patients (greater than 5% and more commonly than placebo) treated with BELVIQ compared to placebo were headache, dizziness, fatigue, nausea, dry mouth, and constipation. The most common adverse reactions for diabetic patients were hypoglycemia, headache, back pain, cough, and fatigue. Adverse reactions that were reported by greater than or equal to 2% of patients and were more frequently reported by patients taking BELVIQ compared to placebo are summarized in Table 2 (non-diabetic subjects) and Table 3 (subjects with type 2 diabetes mellitus).

Table 2: Adverse Reactions Reported by Greater Than or Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients without Diabetes Mellitus

Table 3: Adverse Reactions Reported by Greater Than or Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients with Type 2 Diabetes Mellitus

PATIENT INFORMATION

BELVIQ®
(BEL-VEEK)
(lorcaserin hydrochloride) Tablets

Read the Patient Information that comes with BELVIQ before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about BELVIQ, talk to your doctor or pharmacist.

What is BELVIQ?

BELVIQ is a prescription medicine that may help some obese adults or overweight adults who also have weight related medical problems lose weight and keep the weight off.

BELVIQ should be used with a reduced calorie diet and increased physical activity.

It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.

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

It is not known if BELVIQ is safe when taken with some other medicines that treat depression, migraines, mental problems, or the common cold (serotonergic or antidopaminergic agents).

It is not known if BELVIQ is safe and effective in children under 18 years old.

BELVIQ is a federally controlled substance (CIV) because it contains lorcaserin hydrochloride and may be abused or lead to drug dependence. Keep your BELVIQ in a safe place, to protect it from theft. Never give your BELVIQ to anyone else, because it may cause harm to them. Selling or giving away this medicine is against the law.

Who should not take BELVIQ?

Do not take BELVIQ if you:

• are pregnant or planning to become pregnant. BELVIQ may harm your unborn baby.
• are allergic to lorcaserin hydrochloride or any of the ingredients in BELVIQ. See the end of this leaflet for a complete list of ingredients in BELVIQ.

What should I tell my healthcare provider before taking BELVIQ?

Before you take BELVIQ, tell your doctor if you:

• have or have had heart problems including:
  • congestive heart failure
  • heart valve problems
  • slow heart beat or heart block
• have diabetes
• have a condition such as sickle cell anemia, multiple myeloma, or leukemia
• have a deformed penis, Peyronie’s disease, or ever had an erection that lasted more than 4 hours
• have kidney problems
• have liver problems
• are pregnant or plan to become pregnant.
• are breast feeding or plan to breastfeed. It is not known if BELVIQ passes into your breastmilk. You
• and your doctor should decide if you will take BELVIQ or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

BELVIQ may affect the way other medicines work, and other medicines may affect how BELVIQ works.

Especially tell your doctor if you take medicines for depression, migraines or other medical conditions such as:

• triptans, used to treat migraine headache
• medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin uptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or antipsychotics
• cabergoline
• linezolid, an antibiotic
• tramadol
• dextromethorphan, an over-the-counter medicine used to treat the common cold or cough
• over-the-counter supplements such as tryptophan or St. John’s Wort
• medicines to treat erectile dysfunction

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know all the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take BELVIQ?

• Take BELVIQ exactly as your doctor tells you to take it.
• Your doctor will tell you how much BELVIQ to take and when to take it.
  • Take 1 tablet 2 times each day.
  • Do not increase your dose of BELVIQ.
  • BELVIQ can be taken with or without food.
• Your doctor should start you on a diet and exercise program when you start taking BELVIQ. Stay on this program while you are taking BELVIQ.
• Your doctor should tell you to stop taking BELVIQ if you do not lose a certain amount of weight within the first 12 weeks of treatment.
• If you take too much BELVIQ or overdose, call your doctor or go to the nearest emergency room right away.

What should I avoid while taking BELVIQ?

• Do not drive a car or operate heavy machinery until you know how BELVIQ affects you. BELVIQ can slow your thinking.

What are the possible side effects of BELVIQ?

BELVIQ may cause serious side effects, including:

• Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions.

BELVIQ and certain medicines for depression, migraine, the common cold, or other medical problems may affect each other causing serious or life-threatening side effects. Call your doctor right away if you start to have any of the following symptoms while taking BELVIQ:

• mental changes such as agitation, hallucinations, confusion, or other changes in mental status
• coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes)
• restlessness
• racing or fast heart beat, high or low blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle rigidity (stiff muscles)
  • Valvular heart disease. Some people taking medicines like BELVIQ have had problems with the valves in their heart. Call your doctor right away if you have any of the following symptoms while taking BELVIQ:
  • trouble breathing
  • swelling of the arms, legs, ankles, or feet
  • dizziness, fatigue, or weakness that will not go away
  • fast or irregular heartbeat
• Changes in your attention or memory.
• Mental problems. Taking BELVIQ in high doses may cause psychiatric problems such as:
  • hallucinations
  • feeling high or in a very good mood (euphoria)
  • feelings of standing next to yourself or out of your body (disassociation)
• Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings.
• Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas).
• Painful erections (priapism). The medicine in BELVIQ can cause painful erections that last more than 6 hours.
• Slow heart beat. BELVIQ may cause your heart to beat slower.
• Decreases in your blood cell count. BELVIQ may cause your red and white blood cell count to decrease.
• Increase in prolactin. The medicine in BELVIQ may increase the amount of a certain hormone your body makes called prolactin.

The most common side effects of BELVIQ include:

• • headache

• dizziness
• fatigue
• nausea
• dry mouth
• constipation
• cough
• low blood sugar (hypoglycemia) in patients with diabetes
• back pain

Call your doctor for medical advice about side effects. You may report side effects to FDA at ….

How do I store BELVIQ?

Store BELVIQ at room temperature between 59°F to 86°F (15°C to 30°C).

Safely throw away medicine that is out of date or no longer needed.

Keep BELVIQ and all medicines out of the reach of children.

General information about the safe and effective use of BELVIQ.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

What are the ingredients in BELVIQ?

Active Ingredient: lorcaserin hydrochloride

Inactive Ingredients : silicified microcrystalline cellulose; hydroxypropyl cellulose NF; croscarmellose sodium NF; colloidal silicon dioxide NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP; FD&C Blue #2 aluminum lake; and magnesium stearate NF.