Fda briefing document nda 22529 lorcaserin hydrochloride. This would include the statements detailing the scheduling of belviq in the labeling, as required under 21 cfr 201. The original nda submission included two sets of studies which addressed the binding affinity and receptor activation kinetics for lorcaserin against the human 5ht2a, 2b, and 2c receptors. Integra meshed bilayer wound matrix package insert instructions for use integra meshed bilayer wound matrix without negative pressure therapy application 1. Jun 25, 2019 bydureon package insert pdf learn about bydureon, a noninsulin treatment option for adults with type 2 diabetes available in the bydureon pen.
Lorcaserin belviq for weight loss steps american family. Doses include 6week new patient packs, 6week titration packs and all 30day prescriptions. In clinical trials of at least one year duration, the mean decrease in heart rate was 1. Fda issues complete response letter for lorcaserin new drug. On one side lorcaserin tablet is debossed 10, on the other side a. Specific package insert requirement for loratadine warning. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e. These highlights do not include all the information needed to use advate safely and effectively. Aug 10, 2019 apidra package insert pdf admin august 10, 2019 0 comments apidra solostar unitsml solution for injection in a prefilled pen patient the patient information leaflet pil is the leaflet included in the pack with a.
Increased mortality in elderly patients with dementiarelated psychosis and suicidal thoughts and behaviors 1 indications and usage 2 dosage and administration 2. Lorcaserin 10mg tablet twice daily was approved in 2012 and a slow release preparation belviq xr, 20 mg once daily was approved in july and launched in october 2016. It is meant to be used together with a lifestyle therapy regimen involving a reduced calorie diet and increased physical activity. Lorcaserin affects appetite signals in the brain, helping you feel full with smaller meals. Case 3 kathryn m, a 38yearold woman with obesity bmi 42 kgm 2, obstructive sleep apnea, gastroesophageal reflux disease, and depression, is eager to get better control over her weight. Federal register schedules of controlled substances. Her medications include lansoprazole 30 mgd and a multivitamin. Emcyt estramustine phosphate sodium capsules description. Do not give this medicine lorcaserin tablets to a child. The recommended dose of belviq is 10 mg administered orally twice daily.
Lorcaserin, marketed under the brand name belviq is a weightloss drug developed by arena pharmaceuticals. Obese americans have the possibility to buy a package containing 60 lorcaserin 10mg oral tablets. Response to therapy should be evaluated by week 12. Obesity treatment update juliana simonetti, md assistant professor. Do not breastfeed while you take this medicine lorcaserin tablets. Lorcaserin is sometimes used to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure. Lorcaserin hydrochloride is a serotonin receptor agonist that is highly selective for the specific serotonin receptor 5. Lorcaserin weight loss tablets have special print helping you not to mix different medications. The number of subjects who concomitantly received macrolide antibiotics, ketoconazole, cimetidine, ranitidine, or theophylline along with.
Modest weight loss of 5% to 10% among patients who are overweight or obese can result in a clinically relevant reduction in cardiovascular cv disease risk. Lorcaserin can decrease the metabolism of cyp2d6 substrates in one small trial of cyp2d6 extensive metabolizers, lorcaserin increased dextromethorphan peak concentrations by approximately 76% and auc by about 2fold. Serotonin receptor selectivity profile of lorcaserin background. These highlights do not include all the information needed to use cuvitru safely and effectively. At the time of marketing approval from belviq, the fda required eisai to perform a longterm trial evaluating the cardiovascular effects associated with the use of the drug. Lorcaserin hydrochloride api manufacturers suppliers. Topiramate, a component of qsymia, increases the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Metformin hydrochloride extendedrelease tablets rx only. She reports constantly thinking about food and not being able to control her impulses to buy large quantities of unhealthy snacks. Metformin hydrochloride is a white to offwhite crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. Dec 15, 2014 lorcaserin belviq is a selective serotonin 2c agonist labeled for chronic weight management in adults who are obese body mass index bmi. It is for people with overweight and weightrelated conditions or obesity. Belviq lorcaserin hydrochloride is a serotonin 2c receptor agonist for oral administration used for chronic weight management.
Proper handling and disposal methods should be established by the laboratory director. New developments in the pharmacologic treatment of obesity. Unlike other weight loss tablets for instance phentermine, lorcaserin does not violate the quality and duration of sleep. Lorcaserin is extensively metabolized in the liver by multiple enzymatic pathways. Integra meshed bilayer wound matrix package insert. Lorcaserin belviq is a selective serotonin 2c agonist labeled for chronic weight management in adults who are obese body mass index bmi. The effect of lorcaserin in geriatric populations is unknown, as most patients in the three published clinical trials were 65 years of age or younger. Belviq lorcaserin patient information 1 who is belviq for.
This file contains additional information, probably added from the digital camera or scanner used to create or digitize it. Obesity is a major comorbidity with hypertension and diabetes mellitus. Lorcaserin hydrochloride api dmfs us drug master file. The safety of co administration with other serotonergic or antidopaminergic agents has not been established.
Lorcaserin hydrochloride api manufacturers suppliers drug. Lorcaserin belviq is a drug that promotes weight loss by affecting the brains hypothalamus. Pgy2 ambulatory care resident pharmacy grand rounds april 11, 2017 2017 mfmer slide2. The safety and efficacy of coadministration of belviq with other products intended for weight loss including prescription drugs e. Moderate monitor blood glucose levels regularly in patients with diabetes, especially when pegvisomant treatment is initiated or when the dose is altered. Emcyt capsules are white and opaque, each containing estramustine phosphate sodium as the disodium salt monohydrate equivalent to 140 mg estramustine phosphate, for oral administration. Lorcaserin is a serotonergic agonist specific to the 5ht2c receptor that is fdaapproved for the longterm management of obesity in adults with bmi30 kgm2 or bmi27 kgm2 and at least one weight. List of drug master files dmf of lorcaserin hydrochloride active pharmaceutical ingredient api submitted to the u. The camelliatimi 61 trial for lorcaserin was a randomized, doubleblind, placebocontrolled clinical trial to study approximately 12,000 men and women over five years with. Despite the fact that the central office of the developer and manufacturer of lorcaserin drug is located in the usa san diego, ca, lorcaserin tablets are manufactured in switzerland. It reduces appetite by activating a type of serotonin receptor known as the 5ht 2c receptor in a region of the brain called the hypothalamus, which is known to control appetite. The effect of belviq on cardiovascular morbidity and mortality has not been established.
Oct 26, 2010 fda issues complete response letter for lorcaserin new drug application arena pharmaceuticals, inc. Tell all of your health care providers that you take this medicine lorcaserin tablets. The use of lorcaserin in patients with severe renal impairment or endstage renal failure is not recommended. Lorcaserin brought about a significant reduction in waist circumferencean average loss of 6.
Clinical trials involving patients over 65 years old did not reveal the need to change the dosage based only on the patients age. Manage with immediate belviq discontinuation and provide supportive treatment valvular heart disease. Lorcaserin must be used along with a reduced calorie diet and an exercise plan. This includes your doctors, nurses, pharmacists, and dentists. Documentation that the member has been and is currently following a dietary and behavior modification programs for weight loss. Samples that have been assayed should be stored upright in the rack under one of the following conditions.
Lorcaserin is used to help adults who are obese or who are overweight and have weightrelated medical problems to lose weight and keep from gaining back that weight. There is also the possibility that unknown infectious agents may be. Serotonin syndrome or neuroleptic malignant syndrome nmd like reactions. Jan 07, 2020 belviq lorcaserin hydrochloride is a serotonin 2c receptor agonist indicated for the treatment of chronic weight management in adults with a body mass index of 30 or greater as an addition to a reducedcalorie diet and exercise. Obesity is developing into a pandemic in countries like the usa, the uk and india. Placement of lorcaserin into schedule iv on december 19, 2012. Lorcaserin was approved by the food and drug administration fda on june 27, 2012, as an addition to a reducedcalorie diet and exercise, for chronic weight page 75077 management and it will be marketed under the trade name belviqsupreg. Drugs known to inhibit hepatic metabolism should be coadministered with caution until definitive interaction studies can be completed. Metformin hydrochloride extendedrelease tablets usp are designed for onceaday oral. Lorcaserin is in a class of medications called serotonin receptor agonists. Lorcaserin hydrochloride hemihydrate is an antiobesity agent that is fda approved for the treatment of obesity. Using aseptic technique, peel open the outer pouch and gently drop the inner foil pouch onto a sterile field or surface. Confidential page 1 of 53 highlights of prescribing information. Lorcaserin has serotonergic properties and acts as an anorectic.
An uptodate evaluation of lorcaserin hydrochloride for the. Do not exceed recommended dose see warnings and precautions 5. Its chemical name is r8chloro1methyl2,3,4,5tetrahydro1h3 benzazepine hydrochloride hemihydrate. Belviq is a serotonin 2c receptor agonist indicated as an adjunct to a reducedcalorie diet and increased physical activity for chronic weight management in adults with an initial body mass index bmi of. Lorcaserin belviq national drug monograph june 20 va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives. Disposal dispose of your needles and disposable injection devices safely apidra package insert a sharps container. This new drug application provides for the use of belviq xr lorcaserin hydrochloride extendedrelease tablets, 20 mg, as an adjunct to a reducedcalorie diet and increased physical activity for chronic weight management in adults with an initial body mass index bmi of 30.
Belviq lorcaserin hydrochloride tablets, for oral use initial u. Lorcaserin dosage does not depend on the age and sex of patients. These highlights do not include all the information needed to use gamunex c safely. Use di water to dilute 5% to 7% sodium hypochlorite solution. Refer to the appropriate specimen collection kit package insert for specific collection instructions. The ph of a 1% aqueous solution of metformin hydrochloride is 6. Lorcaserin, currently marketed under the trade name belviq and previously lorqess during development, is a weightloss drug developed by arena pharmaceuticals. Jun 27, 2019 bydureon package insert pdf learn about bydureon, a noninsulin treatment option for adults with type 2 diabetes available in the bydureon pen. These documents will be updated when new clinical data warrant additional. Lorcaserin is a selective 5ht2c agonist thought to promote weight loss via appetite suppression. Csl behring immune globulin intravenous human, 10%. Review of weight loss medications in obesity alex quinn, pharm.
If a patient has not lost at least 5% of baseline body weight, discontinue this drug as it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment. Find patient medical information for lorcaserin oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Lorcaserin is used together with diet and exercise to treat obesity. Use universal precautions when performing this assay. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, andor any unusual changes in mood or behavior. Belviq lorcaserin hydrochloride dose, indications, adverse.
If the file has been modified from its original state, some details may not fully reflect the modified file. Belviq is a medication for chronic weight management. Aug 31, 2018 you may apidra package insert urgent medical attention or hospitalisation. Caroline day phd, frsb, in practical guide to obesity medicine, 2018.
Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine lorcaserin tablets affects you. Lorcaserin belviq is a usapproved weight loss agent. This is not a list of all drugs or health problems that interact with this medicine lorcaserin tablets. Galantamine hydrobromide marketed as razadyne, formerly.