Belviq

Name: Belviq

Is lorcaserin HCL (Belviq) available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for lorcaserin HCL (Belviq)?

Yes

What else should I know about lorcaserin HCL (Belviq)?

What preparations of lorcaserin HCL (Belviq) are available?

Oral film coated tablets: 10 mg

How should I keep lorcaserin HCL (Belviq) stored?

Tablets should be stored at room temperature, between 15 C to 30 C (59 F to 86 F).

Reviewed on 4/16/2015 References Reference: FDA Prescribing Information

Uses of Belviq

Belviq is a prescription medication used to help adults who are obese or who are overweight and have weight-related medical problems to lose weight and keep from gaining back that weight. Belviq must be used along with a reduced-calorie diet and an exercise plan.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Eisai, Inc

Side Effects of Belviq

Serious side effects have been reported with Belviq. See the “Belviq Precautions” section.

Common side effects of Belviq include the following:

In non-diabetic patients:

  • headache
  • dizziness
  • fatigue
  • nausea
  • dry mouth
  • constipation

In Diabetic patients:

  • low blood sugar (hypoglycemia)
  • headache
  • back pain
  • cough
  • fatigue

This is not a complete list of Belviq side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Lorcaserin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using lorcaserin and call your doctor at once if you have:

  • unusual changes in mood or behavior, thoughts of suicide or hurting yourself;

  • feelings of standing next to yourself or being outside of your body;

  • memory problems, trouble concentrating;

  • breast swelling (in women or men), nipple discharge;

  • penis erection that is painful or lasts longer than 4 hours;

  • heart problems--fast heart rate, trouble breathing, dizziness, ongoing weakness, or swelling in your arms, hands, legs, or feet;

  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

  • headache, dizziness, feeling tired;

  • dry mouth, cough;

  • nausea, constipation;

  • back pain; or

  • low blood sugar (in people with diabetes).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Dosage forms and strengths

  • Belviq 10 mg tablets: blue, film-coated, round, biconvex, debossed with “A” on one side and “10” on the other side.
  • Belviq XR 20 mg extended-release tablets: orange, film-coated, round, biconvex, debossed with “A” on one side and “20” on the other side.

Drug abuse and dependence

9.1       Controlled Substance

Belviq/Belviq XR is listed in Schedule IV of the Controlled Substances Act.

9.2       Abuse

In a human abuse potential study in recreational drug abusers, supratherapeutic oral doses of Belviq (40 and 60 mg) produced up to two- to six-fold increases on measures of “High”, “Good Drug Effects”, “Hallucinations” and “Sedation” compared to placebo. These responses were similar to those produced by oral administration of the positive control drugs, zolpidem (15 and 30 mg) and ketamine (100 mg). In this study, the incidence of the adverse reaction of euphoria following lorcaserin administration (40 and 60 mg; 19%) is similar to the incidence following zolpidem administration (13-16%), but less than the incidence following ketamine administration (50%). The duration of euphoria following lorcaserin administration persisted longer (> 9 hours) than that following zolpidem (1.5 hours) or ketamine (2.5 hours) administration.

Overall, in short-term studies with healthy individuals, the rate of euphoria following oral administration of lorcaserin was 16% following 40 mg (n = 11 of 70) and 19% following 60 mg (n = 6 of 31). However, in clinical studies with obese patients with durations of 4 weeks to 2 years, the incidence of euphoria and hallucinations following oral doses of lorcaserin up to 40 mg was low (< 1.0%).

9.3       Dependence

There are no data from well-conducted animal or human studies that evaluate whether lorcaserin can induce physical dependence, as evidenced by a withdrawal syndrome. However, the ability of lorcaserin to produce hallucinations, euphoria, and positive subjective responses at supratherapeutic doses suggests that lorcaserin may produce psychic dependence.

Clinical pharmacology

12.1       Mechanism of Action

Lorcaserin is believed to decrease food consumption and promote satiety by selectively activating 5-HT2C receptors on anorexigenic pro-opiomelanocortin neurons located in the hypothalamus. The exact mechanism of action is not known.

Lorcaserin at the recommended daily dose selectively interacts with 5-HT2C receptors as compared to 5-HT2A and 5-HT2B receptors (see Table 5), other 5-HT receptor subtypes, the 5-HT receptor transporter, and 5-HT reuptake sites.

Table 5.       Lorcaserin Potency (EC50) and Binding Affinity (Ki) to Human 5-HT2A, 5-HT2B, and 5-HT2C Receptor Subtypes
Serotonin Receptor Subtype EC50, nM Ki, nM
5HT2C 39 13
5HT2B 2380 147
5HT2A 553 92

12.2       Pharmacodynamics

Cardiac Electrophysiology. The effect of multiple oral doses of lorcaserin 15 mg and 40 mg once daily on QTc interval was evaluated in a randomized, placebo- and active- (moxifloxacin 400 mg) controlled four-treatment arm parallel thorough QT study in 244 healthy subjects. In a study with demonstrated ability to detect small effects, the upper bound of the one-sided 95% confidence interval for the largest placebo adjusted, baseline-corrected QTc based on individual correction method (QTcI) was below 10 ms, the threshold for regulatory concern.

12.3       Pharmacokinetics

Absorption

Belviq
Lorcaserin is absorbed from the gastrointestinal tract with peak plasma concentration occurring 1.5 - 2 hours after oral dosing. The absolute bioavailability of lorcaserin has not been determined. Steady state is reached within 3 days after twice daily dosing, and accumulation is estimated to be approximately 70%.

Effect of Food. Twelve adult volunteers (6 men and 6 women) were given a single 10 mg oral dose of Belviq in a fasted state and after administration of a high fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800–1000 calories) meal. The Cmax increased approximately 9% and exposure (AUC) increased approximately 5% under fed conditions. Tmax was delayed approximately 1 hour in the fed state. Belviq can be administered with or without food.

Belviq XR
In an open label, randomized, crossover clinical trial, single dose and steady state pharmacokinetics of Belviq XR 20 mg administered once daily were compared with Belviq 10 mg tablet administered twice daily under fasted conditions in 34 healthy subjects. At steady state, the time to reach peak plasma concentrations of lorcaserin (tmax) following Belviq XR 20 mg once daily was approximately 10 hours compared with 1.5 hours for Belviq 10 mg tablet twice daily. A single dose administration of Belviq XR 20 mg resulted in comparable total plasma exposure (AUC0-∞), but approximately 25% lower peak exposures (Cmax) relative to two doses of Belviq tablets administered 12 hours apart. At steady state, however, both Cmax,ss and area under the plasma concentration versus time curve (AUC0-24,ss) of Belviq XR 20 mg administered once daily were bioequivalent to Belviq 10 mg tablets administered twice daily under fasted conditions.

Effect of Food. Intake of high fat, high calorie breakfast before a single 20 mg oral dose of Belviq XR resulted in approximately 46% increase in Cmax and 17% increase in AUC0-∞ but no change in tmax.  At steady state, however, there was no significant food effect on the rate or extent of absorption of Belviq XR.

      Distribution

Lorcaserin distributes to the cerebrospinal fluid and central nervous system in humans. Lorcaserin hydrochloride is moderately bound (~70%) to human plasma proteins.

     Metabolism

Lorcaserin is extensively metabolized in the liver by multiple enzymatic pathways.  After oral administration of lorcaserin the major circulating metabolite is lorcaserin sulfamate (M1), with a plasma Cmax that exceeds lorcaserin Cmax by 1- to 5-fold. N-carbamoyl glucuronide lorcaserin (M5) is the major metabolite in urine; M1 is a minor metabolite in urine, representing approximately 3% of dose. Other minor metabolites excreted in urine were identified as glucuronide or sulfate conjugates of oxidative metabolites. The principal metabolites exert no pharmacological activity at serotonin receptors.

     Elimination

Lorcaserin is extensively metabolized by the liver and the metabolites are excreted in the urine.  In a human mass balance study in which healthy subjects ingested radiolabeled lorcaserin, 94.5% of radiolabeled material was recovered, with 92.3% and 2.2% recovered from urine and feces, respectively. The terminal phase half-life for Belviq/ Belviq XR is approximately 11 to 12 hours.

     Specific Populations

Renal Impairment. The pharmacokinetics of lorcaserin was studied in patients with varying degrees of renal function. Creatinine clearance (CLcr) was calculated by Cockcroft-Gault equation based on ideal body weight (IBW). Impaired renal function decreased Cmax of lorcaserin, with no change in AUC.

Exposure of lorcaserin sulfamate metabolite (M1) was increased in patients with impaired renal function by approximately 1.7-fold in mild (CLcr = 50-80 mL/min), 2.3-fold in moderate (CLcr = 30-50 mL/min) and 10.5-fold in severe renal impairment (CLcr = <30 mL/min) compared to normal subjects (CLcr >80 mL/min).

Exposure of the N-carbamoyl-glucuronide metabolite (M5) was increased in patients with impaired renal function by approximately 1.5-fold in mild (CLcr = 50-80 mL/min), 2.5-fold in moderate (CLcr = 30-50 mL/min) and 5.1-fold in severe renal impairment (CLcr = <30 mL/min) compared to normal subjects (CLcr >80 mL/min).

The terminal half-life of M1 is prolonged by 26%, 96%, and 508% in mild, moderate, and severe renal impairment, respectively.  The terminal half-life of M5 is prolonged by 0%, 26%, and 22% in mild, moderate, and severe renal impairment, respectively. The metabolites M1 and M5 accumulate in patients with severely impaired renal function.

Approximately 18% of metabolite M5 in the body was cleared from the body during a standard 4-hour hemodialysis procedure.  Lorcaserin and M1 were not cleared by hemodialysis.  Lorcaserin is not recommended for patients with severe renal impairment (CLcr <30 mL/min) or patients with end stage renal disease [see Use in Specific Populations (8.6)].

Estimate Ideal Body Weight (IBW) in (kg)

Males: IBW = 50 kg + 2.3 kg for each inch over 5 feet.

Females: IBW = 45.5 kg + 2.3 kg for each inch over 5 feet.

The Cockcroft-Gault calculation using the IBW:

female:

GFR (mL/min) = 0.85 x (140-age) x   ideal body weight (kg)

                                         72 x serum creatinine (mg/dL)

male:

GFR (mL/min) = (140-age) x     ideal body weight (kg)

                              72 x serum creatinine (mg/dL)

Hepatic Impairment. The pharmacokinetics of lorcaserin was evaluated in patients with hepatic impairment and subjects with normal hepatic function. Lorcaserin Cmax was 7.8% and 14.3% lower, in subjects with mild (Child-Pugh score 5-6) and moderate (Child-Pugh score 7-9) hepatic impairment, respectively, than that in subjects with normal hepatic function. The half-life of lorcaserin is prolonged by 59% to 19 hours in patients with moderate hepatic impairment.  Lorcaserin exposure (AUC) is approximately 22% and 30% higher in patients with mild and moderate hepatic impairment, respectively. Dose adjustment is not required for patients with mild to moderate hepatic impairment. The effect of severe hepatic impairment on lorcaserin was not evaluated [see Use in Specific Populations (8.7)].

Gender. No dosage adjustment based on gender is necessary. Gender did not meaningfully affect the pharmacokinetics of lorcaserin.

Geriatric. No dosage adjustment is required based on age alone.  In a clinical trial of 12 healthy elderly (age greater than 65 years) subjects and 12 matched adult patients, lorcaserin exposure (AUC and Cmax) was equivalent in the two groups. Cmax was approximately 18% lower in the elderly group, and Tmax was increased from 2 hours to 2.5 hours in the elderly group as compared to the non-elderly adult group.

Race. No dosage adjustment based on race is necessary. Race did not meaningfully affect the pharmacokinetics of lorcaserin.

Drug-Drug Interactions

Lorcaserin inhibits CYP 2D6-mediated metabolism.  In a clinical trial in 21 CYP 2D6 extensive metabolizers, concomitant administration of lorcaserin (10 mg BID for 4 days) increased dextromethorphan peak concentrations (Cmax) by approximately 76% and exposure (AUC) by approximately 2-fold [see Drug Interactions (7.2)].

Nonclinical toxicology

13.1       Carcinogenesis, Mutagenesis, Impairment of Fertility

     Mutagenesis

Lorcaserin was not mutagenic in an in vitro bacterial mutation assay (Ames test), was not clastogenic in an in vitro chromosome aberration assay in Chinese hamster ovary cells, and was not genotoxic in an in vivo micronucleus assay in rat bone marrow.

     Carcinogenesis

The carcinogenic potential of lorcaserin was assessed in two-year carcinogenicity studies in mice and rats. CD-1 mice received doses of 5, 25 and 50 mg/kg. There were no treatment-related increases in the incidence of any tumor in mice at doses that produced plasma exposure in males and females of 8 and 4-times the daily human clinical dose, respectively.

In the rat carcinogenicity study, male and female Sprague-Dawley rats received 10, 30, and 100 mg/kg lorcaserin hydrochloride.  In females, mammary adenocarcinoma increased at 100 mg/kg, which was associated with plasma exposures that were 87-times the daily human clinical dose. The incidence of mammary fibroadenoma was increased in female rats at all doses with no safety margin to the clinical dose. The increases in adenocarcinomas and fibroadenomas may be associated with lorcaserin-induced changes in prolactin homeostasis in rats. The relevance of the increased incidence of mammary adenocarcinomas and fibroadenomas in rats to humans is unknown.

In male rats, treatment-related neoplastic changes were observed in the subcutis (fibroma, Schwannoma), the skin (squamous cell carcinoma), mammary gland (adenocarcinoma and fibroadenoma), and the brain (astrocytoma) at greater than or equal to 30 mg/kg (plasma exposure 17-times human clinical dose).  At higher exposure, liver adenoma and thyroid follicular cell adenoma were increased but were considered secondary to liver enzyme induction in rats and are not considered relevant to humans.  Human brain exposure (AUC24h,ss) to lorcaserin at the clinical dose is estimated to be 70-fold lower than brain exposure in rats at the dose at which no increased incidence of astrocytoma was observed. Excluding the liver and thyroid tumors, these neoplastic findings in male rats are of unknown relevance to humans.

     Impairment of Fertility

Potential effects on fertility were assessed in Sprague-Dawley rats in which males were dosed with lorcaserin hydrochloride for 4 weeks prior to and through the mating period, and females were dosed for 2 weeks prior to mating and through gestation day 7. Lorcaserin had no effects on fertility in rats at exposures up to 29 times the human clinical dose.

Patient counseling information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • Inform patients that Belviq/Belviq XR is indicated for chronic weight management only in conjunction with a reduced-calorie diet and increased physical activity.
  • Caution patients not to increase their dose of Belviq/Belviq XR.
  • Instruct patients to discontinue use of Belviq/Belviq XR if they have not achieved 5% weight loss by 12 weeks of treatment.
  • Instruct patients to tell their healthcare provider about all the medications, nutritional supplements and vitamins (including any weight loss products) that they may take while taking Belviq/Belviq XR.
  • Inform patients of the possibility of serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions with the combined use of Belviq/Belviq XR with other serotonergic drugs, including selective serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), triptans, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs]), dietary supplements such as St. John’s Wort and tryptophan, tramadol, or antipsychotics or other dopamine antagonists.
  • Inform patients who develop signs or symptoms of valvular heart disease, including dyspnea or dependent edema to seek medical attention.
  • Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that Belviq/Belviq XR therapy does not affect them adversely.
  • Instruct patients to seek medical attention in the event of emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
  • Instruct men who have an erection lasting greater than 4 hours, whether painful or not, to immediately discontinue the drug and seek emergency medical attention.
  • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider with a known or suspected pregnancy [see Contraindications (4), Use in Specific Populations (8.1)].
  • Advise women to avoid use of Belviq/Belviq XR while breastfeeding [see Use in Specific Populations (8.2)]. 

     

Belviq® and Belviq XR® are registered trademarks of Arena Pharmaceuticals GmbH, Zofingen, Switzerland

Manufactured by Arena Pharmaceuticals GmbH, Untere Brühlstrasse 4, CH-4800, Zofingen, Switzerland

Distributed by Eisai Inc., Woodcliff Lake, NJ 07677

© 2016

PATIENT INFORMATION
     
Belviq® (BEL-VEEK)
(lorcaserin hydrochloride)
tablets, CIV
Belviq XR® (BEL-VEEK Eks-Are)
(lorcaserin hydrochloride)
extended release tablets, CIV
What is Belviq?
Belviq is a prescription medicine that may help adults with obesity, or some adults who are overweight and 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.
Do not take Belviq if you:
  • are pregnant or planning to become pregnant. Belviq may harm your unborn baby.
  • are allergic to lorcaserin or any of the ingredients in Belviq or Belviq XR. See the end of this leaflet for a complete list of ingredients in Belviq and Belviq XR.
Before you take Belviq, tell your healthcare provider about all of your medical conditions, including 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 breastfeeding or plan to breastfeed. It is not known if Belviq passes into your breast milk. You and your healthcare provider should decide if you will take Belviq or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Belviq may affect the way other medicines work, and other medicines may affect how Belviq works.
Especially tell your healthcare provider 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 healthcare provider 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 healthcare provider and pharmacist when you get a new medicine.
How should I take Belviq?
  • Take Belviq exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much Belviq to take and when to take it.
  • Belviq comes in 2 different dose forms. Your doctor will prescribe the form of Belviq that is right for you.
    ○ Belviq: Take one tablet 2 times each day.
    ○ Belviq XR: Take one tablet 1 time each day. 
  • Do not increase your dose of Belviq.
    ○ Belviq can be taken with or without food.
    ○ Take the whole Belviq XR extended release tablet. Do not chew, crush, or divide the tablet.
  • Your healthcare provider should start you on a diet and exercise program when you start taking Belviq. Stay on this program while you are taking Belviq.
  • Your healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
  • 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). You should check your blood sugar before you start taking Belviq and while you take Belviq.
  • Painful erections (priapism). The medicine in Belviq can cause painful erections that last more than 6 hours. If you have an erection lasting more than 4 hours whether it is painful or not, stop using Belviq and call your healthcare provider or go to the nearest emergency room right away.
  • Slow heart beat. Belviq may cause your heart to beat slower. Tell your healthcare provider if you have a history of your heart beating slow or heart block.
  • Decreases in your blood cell count. Belviq may cause your red and white blood cell count to decrease. Your healthcare provider may do tests to check your blood cell count while you are taking Belviq.
  • Increase in prolactin. The medicine in Belviq may increase the amount of a certain hormone your body makes called prolactin. Tell your healthcare provider if your breasts begin to make milk or a milky discharge or if you are a male and your breasts begin to increase in size.
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
These are not all the possible side effects of Belviq.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should 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. Do not use Belviq for a condition for which it was not prescribed. Do not give Belviq to other people, even if they have the same symptoms you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about Belviq that is written for health professionals.
What are the ingredients in Belviq and Belviq XR?
Belviq tablets
Active ingredient:  lorcaserin hydrochloride hemihydrate
Inactive ingredients:  silicified microcrystalline cellulose NF; hydroxypropyl cellulose NF; croscarmellose sodium NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP; FD&C blue #2/indigo carmine aluminum lake; and magnesium stearate NF

Belviq XR extended-release tablets
Active ingredient:  lorcaserin hydrochloride hemihydrate
Inactive ingredients:  microcrystalline cellulose NF; mannitol USP; hypromellose USP; ethylcellulose dispersion Type B NF; colloidal silicon dioxide NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP; FD&C yellow #6/sunset yellow FCF aluminum lake; iron oxide yellow NF; iron oxide red NF; and magnesium stearate NF

Manufactured by Arena Pharmaceuticals GmbH, Untere Brϋhlstrasse 4, CH-4800, Zofingen, Switzerland. Distributed by Eisai Inc., Woodcliff Lake, NJ 07677  For more information, go to www.Belviq.com or call 1-888-274-2378.

This Patient Information has been approved by the U.S. Food and Drug Administration       Revised: 5/2017

Important information

Do not use Belviq if you are pregnant. Weight loss during pregnancy can harm an unborn baby, even if you are overweight.

Serious drug interactions can occur when certain medicines are used together with lorcaserin. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Before you take Belviq, tell your doctor if you have diabetes, congestive heart failure, a heart valve disorder, sickle cell anemia, leukemia or myeloma, kidney or liver disease, or a physical deformity of the penis (such as Peyronie's disease).

Belviq may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Tell your doctor if you do not lose at least 5% of your starting weight after taking the medication for 12 weeks.

Belviq is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly testing your blood sugar.

In Summary

Common side effects of Belviq include: headache, hypoglycemia, decreased hemoglobin, euphoria, and lymphocytopenia. Other side effects include: constipation, dizziness, fatigue, increased serum prolactin, nausea, and xerostomia. See below for a comprehensive list of adverse effects.

Dosing & Uses

FDA Safety Communication

February 13, 2020: FDA requests lorcaserin be withdrawn from the market owing to a potential risk of cancer

For more information, see FDA Drug Safety Communication

Dosage Forms & Strengths

tablet: Schedule IV

  • 10mg

extended-release tablet: Schedule IV

  • 20mg

FDA Safety Communication

February 13, 2020: FDA requests lorcaserin be withdrawn from the market owing to a potential risk of cancer

For more information, see FDA Drug Safety Communication

Health care professionals should stop prescribing and dispensing lorcaserin to patients

Contact patients currently taking lorcaserin, inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine

Discuss alternative weight-loss medicines or strategies

Obesity

Indicated as an adjunct to a reduced-calorie diet and exercise for chronic weight management with initial BMI ≥30 kg/m² (obese) or ≥27 kg/m² (overweight) with 1 weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes mellitus)

Tablets: 10 mg PO q12hr, OR

Extended-release tablets: 20 mg PO qDay

Dosage Modifications

Renal impairment

  • Mild (CrCl >50 mL/min): No dosage adjustment required
  • Moderate (CrCl 30-50 mL/min): Use caution
  • Severe (CrCl

Hepatic impairment

  • Mild-to-moderate (Child-Pugh score 5-9): No dosage adjustment required
  • Severe (Child-Pugh score >9): Use caution

Dravet Syndrome (Orphan)

Orphan designation for treatment of Dravet syndrome

Sponsor

  • Epygenix Therapeutics, Inc; 140 East Ridgewood Avenue, Suite 415 South Tower; Paramus, New Jersey 07652

Safety and efficacy not established

Administration

Oral Administration

May take with or without food

Discontinue if 5% weight loss not achieved by week 12

Do not exceed recommended dose

Extended-release tablets

  • Swallow whole; do not chew, crush, or divide
(web3)