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Belviq
Overview
What is Belviq?
BELVIQ/BELVIQ XR (lorcaserin hydrochloride) is a serotonin 2C receptor agonist for oral administration used for chronic weight management. Lorcaserin hydrochloride is chemically designated as (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate. The empirical formula is CH
ClN·HCl·0.5HO, and the molecular weight of the hemihydrate form is 241.16 g/mol.The structural formula is:
Lorcaserin hydrochloride hemihydrate is a white to off-white powder with solubility in water greater than 400 mg/mL.
Each BELVIQ tablet contains 10.4 mg of crystalline lorcaserin hydrochloride hemihydrate, equivalent to 10.0 mg anhydrous lorcaserin hydrochloride, and the following 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.
Each BELVIQ XR extended-release tablet contains 20.8 mg of crystalline lorcaserin hydrochloride hemihydrate, equivalent to 20.0 mg anhydrous lorcaserin hydrochloride, and the following 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.
What does Belviq look like?
What are the available doses of Belviq?
Tablets: 10 mg film-coated ()
Extended-release Tablets: 20 mg film-coated ()
What should I talk to my health care provider before I take Belviq?
How should I use Belviq?
BELVIQ/BELVIQ XR 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:
[
]
Limitations of Use:
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.
Do not exceed recommended dose [
].
BELVIQ/BELVIQ XR can be taken with or without food.
Swallow BELVIQ XR tablets whole and do not chew, crush, or divide.
Response to therapy should be evaluated by week 12. If a patient has not lost at least 5% of baseline body weight, discontinue BELVIQ/BELVIQ XR, 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:
What interacts with Belviq?
Sorry No Records found
What are the warnings of Belviq?
Sorry No Records found
What are the precautions of Belviq?
Sorry No Records found
What are the side effects of Belviq?
Sorry No records found
What should I look out for while using Belviq?
● Pregnancy: Weight loss in a pregnant woman offers no benefit and may result in fetal harm [
].
● Hypersensitivity: BELVIQ/BELVIQ XR is contraindicated in patients with prior hypersensitivity reactions to lorcaserin or to any of the product components. Hypersensitivity reactions have been reported [see
].
What might happen if I take too much Belviq?
No experience with overdose of BELVIQ/BELVIQ XR is available. In clinical studies that used doses that were higher than the recommended dose, the most frequent adverse reactions associated with BELVIQ were headache, nausea, abdominal discomfort, and dizziness. Single 40- and 60-mg doses of BELVIQ caused euphoria, altered mood, and hallucination in some subjects. 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.
How should I store and handle Belviq?
Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. BELVIQ 10-mg tablets are blue-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “10” on the other side and are available as follows:• NDC 62856-529-60 Bottle of 60BELVIQ XR 20-mg extended-release tablets are orange-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “20” on the other side and are available as follows:Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].BELVIQ 10-mg tablets are blue-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “10” on the other side and are available as follows:• NDC 62856-529-60 Bottle of 60BELVIQ XR 20-mg extended-release tablets are orange-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “20” on the other side and are available as follows:Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].BELVIQ 10-mg tablets are blue-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “10” on the other side and are available as follows:• NDC 62856-529-60 Bottle of 60BELVIQ XR 20-mg extended-release tablets are orange-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “20” on the other side and are available as follows:Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].BELVIQ 10-mg tablets are blue-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “10” on the other side and are available as follows:• NDC 62856-529-60 Bottle of 60BELVIQ XR 20-mg extended-release tablets are orange-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “20” on the other side and are available as follows:Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Lorcaserin is believed to decrease food consumption and promote satiety by selectively activating 5-HT
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-HT
receptors as compared to 5-HT
and 5-HT
receptors (see Table 5), other 5-HT receptor subtypes, the 5-HT receptor transporter, and 5-HT reuptake sites.
Non-Clinical Toxicology
● Pregnancy: Weight loss in a pregnant woman offers no benefit and may result in fetal harm [ ].● Hypersensitivity: BELVIQ/BELVIQ XR is contraindicated in patients with prior hypersensitivity reactions to lorcaserin or to any of the product components. Hypersensitivity reactions have been reported [see ].
Drug Interactions
Effect of Concomitant Use of Benzodiazepines and Opioids:
In a study in which the 2 mg clonazepam orally disintegrating tablet was administered with and without propantheline (an anticholinergic agent with multiple effects on the GI tract) to healthy volunteers, the AUC of clonazepam was 10% lower and the C of clonazepam was 20% lower when the orally disintegrating tablet was given with propantheline compared to when it was given alone.
Fluoxetine does not affect the pharmacokinetics of clonazepam. Cytochrome P-450 inducers, such as phenytoin, carbamazepine and phenobarbital, induce clonazepam metabolism, causing an approximately 30% decrease in plasma clonazepam levels. Although clinical studies have not been performed, based on the involvement of the cytochrome P-450 3A family in clonazepam metabolism, inhibitors of this enzyme system, notably oral antifungal agents, should be used cautiously in patients receiving clonazepam.
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, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements such as St. John’s Wort and tryptophan, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs]), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists, particularly when used in combination [ ].
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g.,hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form, can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.
The safety of BELVIQ/BELVIQ XR when coadministered with other serotonergic or antidopaminergic agents, including antipsychotics, or drugs that impair metabolism of serotonin, including MAOIs, has not been systematically evaluated and has not been established.
If concomitant administration of BELVIQ/BELVIQ XR with an agent that affects the serotonergic neurotransmitter system is clinically warranted, extreme caution and careful observation of the patient is advised, particularly during treatment initiation and dose increases. Treatment with BELVIQ/BELVIQ XR and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated [ ].
The following important adverse reactions are described below and elsewhere in labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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