Lorcaserin hydrochloride

WITHDRAWAL FROM THE MARKET

On February 13, 2020 the United States FDA requested that the manufacturer of Belviq and Belviq XR (active ingredient lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer and the manufacturer, subsequently withdrew this medication from the US market.

What is Lorcaserin hydrochloride?

• Lorcaserin hydrochloride (BELVIQ/BELVIQ XR) is a serotonin 2C receptor agonist used as a weight-loss drug.

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Lorcaserin

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What are the uses of this medicine?

This medicine is used 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:

• 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.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• 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.

What drug interactions can this medicine cause?

• Use with extreme caution in combination with other drugs that may affect the serotonergic neurotransmitter systems, including, but not limited to, triptans, monoamine oxidase inhibitors (MAOIs, including linezolid, an antibiotic which is a reversible non-selective MAOI), selective serotonin reuptake inhibitors (SSRIs), selective serotonin- norepinephrine reuptake inhibitors (SNRIs), dextromethorphan, tricyclic antidepressants (TCAs), bupropion, lithium, tramadol, tryptophan, and St. John’s Wort.

Is this medicine FDA approved?

• On 27 June 2012, the FDA approved lorcaserin for use in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia)

How should this medicine be used?

Recommended dosage:

• The recommended dose for BELVIQ is one 10 mg tablet administered orally twice daily.
• The recommended dose for BELVIQ XR is one 20 mg tablet administered orally once daily.

Administration:

• 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 10 mg film-coated
• Extended-release Tablets: 20 mg film-coated

This medicine is available in fallowing brand namesː

• BELVIQ
• BELVIQ XR

What side effects can this medication cause?

The most common side effects of this medicine include:

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

BELVIQ/BELVIQ XR may cause serious side effects, including:

• Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions
• Valvular heart disease
• Changes in your attention or memory
• Mental problems
• Depression or thoughts of suicide
• Painful erections (priapism)
• Slow heart beat
• Decreases in your blood cell count
• Increase in prolactin

What special precautions should I follow?

• Do not drive a car or operate heavy machinery until you know how BELVIQ affects you. BELVIQ can slow your thinking.
• BELVIQ/BELVIQ XR is a serotonergic drug. The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported during use of serotonergic drugs. The safety of coadministration with other serotonergic or antidopaminergic agents has not been established. Manage with immediate BELVIQ/BELVIQ XR discontinuation and provide supportive treatment.
• Regurgitant cardiac valvular disease, primarily affecting the mitral and/or aortic valves, has been reported in patients who took serotonergic drugs. If signs or symptoms develop consider BELVIQ/BELVIQ XR discontinuation and evaluate the patient for possible valvulopathy.
• BELVIQ/BELVIQ XR May cause disturbances in attention or memory. Caution with use of hazardous machinery when starting BELVIQ/BELVIQ XR treatment.
• Events of euphoria, hallucination, and dissociation were seen with BELVIQ. Do not exceed recommended dose of BELVIQ 10 mg twice daily or BELVIQ XR 20 mg once daily.
• Monitor for depression or suicidal thoughts. Discontinue if symptoms develop.
• weight loss may cause hypoglycemia with the use of Antidiabetic Medications. Monitor blood glucose. BELVIQ/BELVIQ XR has not been studied in patients taking insulin.
• BELVIQ/BELVIQ XR should be used with caution in men who have conditions that might predispose them to priapism. Patients should seek emergency treatment if an erection lasts >4 hours. Use BELVIQ/BELVIQ XR with caution in patients predisposed to priapism.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• headache
• nausea
• abdominal discomfort
• dizziness
• euphoria
• altered mood
• hallucination

Treatment of overdosage:

• Treatment of overdose should consist of BELVIQ/BELVIQ XR discontinuation and general supportive measures in the management of overdosage.
• Lorcaserin is not eliminated to a therapeutically significant degree by hemodialysis.

Can this medicine be used in pregnancy?

• BELVIQ/BELVIQ XR is contraindicated during pregnancy, because weight loss offers no benefit to a pregnant woman and may result in fetal harm.

Can this medicine be used in children?

• The safety and effectiveness of BELVIQ/BELVIQ XR in pediatric patients below the age of 18 have not been established and the use of BELVIQ/BELVIQ XR is not recommended in pediatric patients.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

• Distributed by Eisai Inc., Woodcliff Lake, NJ

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Lorcaserin hydrochloride
• FDA Lorcaserin hydrochloride

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