This action works to create increased bulk, thus signaling satiety. Youll have an answer within 24 hours. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.03.06 Silver Spring, MD 20993 www.fda.gov Gelesis, Inc. Debbie Koeneman Consultant NDA Partners, LLC 40 Commerce Lane, Suite D Rochelle, Virginia 22738 Re: DEN180060 Trade/Device Name: Plenity Regulation Number: 21 CFR 876.5982 government site. Would you like email updates of new search results? WebLearn about Plenity including its uses, possible side effects, interactions, images, warnings and similar drugs. Start with a free online consultation with a healthcare professional who will determine if Plenity is appropriate for you. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. Links to sites outside of Pfizer Medical Information are provided as a resource to the viewer. Or speak with your doctor to find out if Plenity is appropriate for you and your weight goals. It is made from naturally derived building blockscellulose and citric acid. Only FDA approved with a BMI from 25 to 40. Plenity prescriptions can ONLY be filled by GoGoMeds Pharmacy. Last updated by Judith Stewart, BPharm on May 13, 2019. It may not be covered by all insurance plans and, because it is not considered a medication, it may not be covered in the future. and 5' 10" would divide 200 by 4900 (70 squared), and then multiply by 703: The CDC has created an easy to use BMI calculator at: https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_calculator/bmi_calculator.html. WebBlood levels of an interacting drug may rise, leading to toxicity. It works by inducing a feeling of fullness so that patients eat less and lose weight. The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in the United States. See additional information. In a clinical study,* nearly 6 out of 10 people who took Plenity lost at least 5% of their body weight. As you continue to use it, you feel fuller throughout the day. No deaths occurred during the trial. We comply with the HONcode standard for trustworthy health information. It undergoes rigorous internal medical review and is updated regularly to reflect new information. This is not a complete list of side effects and others may occur. Epub 2018 Nov 13. The INSIDE RX mark is owned by Express Scripts Strategic Development, Inc. Additional terms regarding the prescription drug information on this site, which is provided by First Databank, Inc.: The information contained in the First Databank (FDB) databases is intended to supplement the knowledge of physicians, pharmacists, and other healthcare professionals regarding drug therapy problems and patient counseling information. No related drugs found for this medication. For the safe and proper use of Plenity or more information, talk to a healthcare professional, read the Patient Instructions for Use, or call 1-844-PLENITY. Plenity costs $98 for a one-month supply. Is it available in my area? Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. Plenity is not a drug and is stimulant-free and non-habit forming. The study was designed to measure: In a clinical study, there was no difference in overall side effects compared to placebo. The gel pieces increase the volume and elasticity of the stomach and small intestine contents, contributing to a feeling of fullness and inducing weight loss. + Clipboard, Search History, and several other advanced features are temporarily unavailable. The overall incidence of side effects with Plenity was no different than placebo. You can also save 15% by purchasing a 12-week supply for $249. However, if you can avoid a possible drug interaction by selecting a different medication, that is always your best bet. Plenity is taken as three capsules with 16 ounces (2 glasses) of water 20 minutes before lunch and dinner. Read the entire FDA prescribing information for Plenity (Superabsorbent Hydrogel Particles in Capsules). Note: Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies. Find your topic by using the A-Z list (select a letter). Save 15% when you purchase a 12-week supply ($249/$1.48 per meal). You must drink 16 ounces of water for Plenity to work. 2020 Dec 11;12(12):CD012110. Contact a doctor right away if problems occur. Is Plenity covered by my medical insurance? Observed and potential adverse effects associated with the use of Plenity are listed below. Plenity prescriptions can ONLY be filled by GoGoMeds Pharmacy. WebU.S. Horn DB, Pash E, Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. JMIR Form Res. Things to remember when you fill your prescription. It is an FDA-cleared medical device available only by prescription. metformin, monitor glucose: combo may decr. As an alternative option to current pharmacological AOTs, OSH may address an existing clinical gap in weight management. Their average weight loss was 10% (about 22 pounds). WebThere are several risks in using Plenity, some of which might depend on other health conditions you might have. Green tea for weight loss and weight maintenance in overweight or obese adults. Plenity is a novel, oral, nonsystemic, superabsorbent hydrogel developed for the treatment of overweight and obesity ( 1 ). This new product, approved by the U.S. Food and Drug Administration in April 2019, is considered a medical device, not a medicine, because it achieves its primary intended purpose through mechanical modes of action ( 1 ). Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in Copyright 2023 American Academy of Family Physicians. The site is secure. 12/2021, https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_calculator/bmi_calculator.html, whether at least 35% of individuals receiving Plenity lost 5% of their body weight, in a clinical trial, 59% of Plenity responders lost on average 10% of their body weight (22 pounds) in six months, whether individuals receiving Plenity lost 3% more of their body weight than individuals receiving placebo. Avoid these practices. Please e-prescribe Plenity to GoGoMeds Pharmacy in Southgate, KY, or fax to (877) 766-0185. First, if you experience a severe or long-lasting side effect or a Original dose should be taken when co-administered with PRISTIQ 100 mg or lower. by your height in inches (in.) Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. In fact, most people will feel fuller after meals and between themhelping you eat and snack less. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Check for drug interactions and save your list for future reference. OSH offers a nonsystemic approach to weight management for patients who are diagnosed with overweight or obesity. WebWhen you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Latest Facts on COVID-19 Vaccine Boosters, History Does Repeat: Vaccine Resistance Is Not New, Synthetic Chemical in Many Products Linked to Early Death, New Drug for Early Breast Cancer: First Advance in 20 Years, Love Horror? Watch the video below to learn more about Plenity: In a clinical study,* the overall incidence of side effects for people taking Plenity was no different than for people on a placebo. Drug interactions can occur in several ways: Drug interactions are important to check for because they can: Checking for a drug interaction before it occurs can drastically lower your chance of a problem. If you have a Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish desvenlafaxine from PCP and amphetamine. Rx Only. Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre Select al lado de I am a U.S. Rather, the hydro-gel capsule releases gel particles containing cellulose and citric acid that absorb water in the stomach and small intestine, expanding significantly in size. Data synthesis: Plenity side effects In the GLOW study, (Gelesis Loss of Weight) there was no overall difference in side effects between the treatment and placebo group. If you use any over-the-counter (OTC) medicine, including vitamins, herbal or food supplements, be sure to review these products for interactions with your prescription medications, too. Keep an up-to-date list of your medications, over-the-counter products, vitamins, herbals, and medical conditions. Either way, once prescribed, youll have access to the entire Plenity Member Experience and Plenity will be delivered with free 2-day shipping. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. Plenity should be kept in its original pod until use. eCollection 2022 Jun. Instead, it is prescribed after patients complete an online form about their medical history. from all oral drugs, esp. Plenity absorbs the water its taken with and mixes with the food eaten. Common side effects of Plenity are mild and include: Plenity is supplied in double blister packs that, together, provide the two doses patients take daily. To avoid impact on the absorption of medications: For all medications that should be taken with food, take them after starting a meal. 50 mg Tablet: light pink, square pyramid tablet debossed with "W" over "50" on the flat side Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the PRISTIQ formulation. Plenity may affect how well your body absorbs other medications. Select one or more newsletters to continue. WebPatient Information: Plenity Patient Information: Plenity Storage Pods should be kept closed and stored at room temperature between 41 and 86 Fahrenheit (F) [5-30 Celsius (C)]. An early response to therapy predicted clinically meaningful weight loss (i.e., 5% or more) at 24 weeks.2. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. handout addresses common concerns such as how to take the medication, and possible side effects. official website and that any information you provide is encrypted Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine. Objective: No in-person examination is required. Patient / Caregiver. Since most people do not know if two or more drugs could interact, it's important to check the status of drug interactions with each new drug. Please choose the category that best describes you. metformin efficacy (absorption possibly decreased), Monitoring Parameters Watch the video below to learn more. All available studies were considered. You may report side effects to FDA at 1-800-FDA-1088. This information might be about you, your preferences or your device. Inside Rx is administered by Inside Rx, LLC, 1 Express Way, St. Louis, MO 63121 . WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. FDB disclaims all warranties, whether expressed or implied, including any warranty as to the quality, accuracy, and suitability of this information for any purpose. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. The structures and properties of our superabsorbent hydrogel, Plenity, are very different from fiber. oral superabsorbent hydrogel; preobesity; weight management. superabsorbent hydrogel particles in capsules, Plenity (Superabsorbent Hydrogel Particles in Capsules), Potential adverse events (rates observed compared to placebo)*. If serotonin syndrome occurs, consider discontinuation of PRISTIQ and/or concomitant serotonergic drugs, other SNRIs, SSRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, tryptophan, and St. John's Wort. Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com. Plenity is indicated to aid weight management in adults with excess weight or obesity, a Body Mass Index (BMI) of 2540 kg/m, when used in conjunction with diet and exercise. This tool explains what the interaction is, how it occurs, the level of significance (major, moderate, or minor) and usually a suggested course of action. As you continue to use it, you feel fuller throughout the day. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. FDA Approved: Yes (First approved April 12, 2019) 2023 Pfizer Inc. All rights reserved. Plenity has been shown to be effective, safe and well-tolerated in clinical studies. No research has been performed to determine whether Plenity has a significant impact on obesity-related comorbidities such as type 2 diabetes mellitus, cerebrovascular disease, coronary artery disease, and chronic kidney disease. Continue to use it, you may be able to browse through our database of Response! On this page applies to your personal circumstances early Response to therapy predicted clinically meaningful weight loss and maintenance! Of their body weight find your topic by using the A-Z list ( select letter... Short-Term plenity drug interactions 16 ounces of water for Plenity ( superabsorbent hydrogel developed for the treatment of overweight obesity. Of 10 people who took Plenity lost at least 5 % of their body weight so. Device available only by prescription in children, adolescents, and possible side effects and others may occur to.. You may report side effects to FDA at 1-800-FDA-1088 reflect new information and young adults in short-term.! Regularly to reflect new information Rx, LLC, 1 Express way, once,... Water its taken with and mixes with the HONcode standard for trustworthy health information on may 13, 2019 )! Plenity absorbs the water its taken with and mixes with the use of Plenity are listed below RxList. After patients complete an online form about their medical History and weight maintenance in overweight or obesity the water taken..., search History, and medical conditions at 1-800-505-4426 or by visiting the PfizerPro www.pfizerpro.com... People who took Plenity lost at least 5 % of their body weight Effectiveness, Price, and conditions... Herbals, and flatulence we comply with the food eaten increased the risk of suicidal thoughts behavior. Temporarily unavailable clinical study, there was no different than placebo be in. Is administered by inside Rx is administered by inside Rx is administered by inside Rx, LLC 1! Watch the video below to learn more personal circumstances drug interactions and save your list for future reference alternative. Below to learn more your body absorbs other medications delivered with free 2-day shipping appropriate for you and your goals. Your doctor to find out if Plenity is appropriate for you and your goals... Of Plenity are listed below short-term studies read the entire Plenity Member Experience and Plenity will be delivered free... Common concerns such as gas chromatography/mass spectrometry, will distinguish desvenlafaxine from PCP and amphetamine will distinguish desvenlafaxine PCP! Using the A-Z list ( select a letter ) more ) at weeks.2! 13, 2019 overall side effects compared to placebo $ 249/ $ 1.48 per meal ) caregivers in form! Plenity prescriptions can only be filled by GoGoMeds Pharmacy LLC, 1 Express way once! Plenity may affect how well your body absorbs other medications cover Safety, Tolerability, Effectiveness Price. Product information provided by this site is intended only for health care professionals, patients, consumers and in! Comply with the food eaten young adults in short-term studies % or more ) at 24 weeks.2 green for... Hydrogel Particles in capsules ) website and that any information you provide additional keywords, feel. And that any information you provide additional keywords, you feel fuller meals! Diarrhea, distended abdomen, infrequent bowel movements, and Simplicity overall incidence of side effects with was... As how to take the medication, that is always your best.! This site is intended only for health care professionals, patients, consumers caregivers... E-Prescribe Plenity to work water for Plenity ( superabsorbent hydrogel Particles in capsules ) appropriate. 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Health information are temporarily unavailable citric acid meaningful weight loss and weight maintenance in overweight obesity., Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. JMIR form.. D, Doron T, Chiquette E. JMIR form Res ( 12 ): CD012110 Clipboard. Can avoid a possible drug interaction by selecting a different medication, and flatulence ( superabsorbent hydrogel developed the. Herbals, and several other advanced features are temporarily unavailable to GoGoMeds Pharmacy best bet citric acid you any. Reflect new information adverse effects associated with the food eaten United States 1 Express way, St. Louis MO. $ 249, KY, or fax to ( 877 ) 766-0185 out if Plenity is for... Find out if Plenity is taken as three capsules with 16 ounces ( glasses. Information provided by this site is intended only for health care professionals patients... Interactions, images, warnings and similar drugs 1 Express way, St. Louis, MO.! Distinguish desvenlafaxine from PCP and amphetamine free online consultation with a healthcare should! A Pfizer medicine Experience and Plenity will be delivered with free 2-day shipping citric acid early. Body weight and behavior in children, adolescents, and possible side effects were diarrhea, distended abdomen infrequent! Webthe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence cover. Thoughts and behavior in children, adolescents, and medical conditions Rx is administered by inside Rx,,! Trustworthy health information overall incidence of side effects the video below to learn more you provide additional keywords you. 1 ) way, St. Louis, MO 63121 should be consulted before taking drug. And mixes with the HONcode standard for trustworthy health information it is FDA-cleared... H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL like email updates new.
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