Read the entire FDA prescribing information for Plenity (Superabsorbent Hydrogel Particles in Capsules). Adults with excess weight or obesity, a Body Mass Index (BMI) of 2540 kg/m, are eligible for Plenity, when combined with diet and exercise. The breadth of the label is interesting. In fact, for some drugs, stopping the medication could also affect the levels of other drugs in your system. Plenity is administered in the form of capsules taken with water before lunch and dinner. Available for Android and iOS devices. Accessibility WebLearn about Plenity including its uses, possible side effects, interactions, images, warnings and similar drugs. Being proactive in your own health, checking for drug interactions, and discussing concerns with your healthcare provider can be a life-saving task. No in-person examination is required. See permissionsforcopyrightquestions and/or permission requests. OSH offers a nonsystemic approach to weight management for patients who are diagnosed with overweight or obesity. Aronne LJ, Anderson JE, Sannino A, Chiquette E. Obes Sci Pract. Data sources: Author disclosure: No relevant financial relationships. For these reasons, Plenity is considered a medical device rather than a drug, leading to a different threshold for approval. Observed and potential adverse effects associated with the use of Plenity are listed below. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. In the community, you can get encouragement, support, and inspiration from other Plenity members. WebThere are 6 disease interactions with Wegovy (semaglutide) which include: suicidal behavior and ideation thyroid cancer GI adverse events hypoglycemia pancreatitis retinopathy Report options Share by QR Code More about Wegovy (semaglutide) Wegovy consumer information Check interactions Pricing & coupons Reviews (129) Side effects Taken with water 20 minutes before lunch and dinner, Plenity helps you feel full, eat less, and lose weight. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. However, PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is expelled in the feces. If you have a MeSH Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. In the GLOW pivotal trial, during the 24-week assessment period, the overall incidence of adverse events in the Plenity treatment group was no different than placebo (71% in both groups). If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. antihemophilic factor (factor VIII, recombinant), Fc fusion prote antihemophilic factor (factor VIII, recombinant), glycopegylated, antihemophilic factor (factor VIII, recombinant), pegylated, antihemophilic factor (factor VIII, recombinant), porcine, antihemophilic factor (factor VIII, recombinant), single chain, antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein, asparaginase erwinia chrysanthemi (recombinant), Aspercreme Lidocaine Pain Relieving Creme, aspirin/chlorpheniramine/dextromethorphan/phenylephrine, aspirin/doxylamine/dextromethorphan/phenylephrine, Aveeno Baby Eczema Therapy Moisturizing Cream, Aveeno Baby Eczema Therapy Nighttime Balm, Aveeno Baby Eczema Therapy Soothing Bath Treatment, Aveeno Baby Soothing Hydration Creamy Oil, Aveeno Baby Soothing Multi-Purpose Ointment, Aveeno Restorative Skin Therapy Itch Relief Balm, separate admin. The https:// ensures that you are connecting to the It will also display any interactions between your chosen drug(s) and food, beverages, or a medical condition. The capsules contain particles that rapidly absorb water in the stomach, creating small individual gel pieces with the texture of plant-based foods such as vegetables, without having any caloric value. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: *If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site. The number of patients with any adverse event leading to study withdrawal was similar between groups. Unauthorized use of these marks is strictly prohibited. squared, and then multiply by a factor of 703. FDA Approved: Yes (First approved April 12, 2019) US-PLEN-2100031 How can I get Plenity? In fact, most people will feel fuller after meals and between themhelping you eat and snack less. Plenity may be an FDA approved weight loss aid, but it is not ideal. superabsorbent hydrogel particles in capsules, Plenity (Superabsorbent Hydrogel Particles in Capsules), Potential adverse events (rates observed compared to placebo)*. Plenitys potential side effects include gastrointestinal problems such as obstruction, diarrhea, constipation, and also dehydration and oddly enough weight gain. Search for the Drugs Comparison information on RxList includes drug uses, side effects, drug interactions, how to take it, and more. WebSignificantly more patients treated with Plenity (59% vs. 42% with placebo) achieved a weight loss of at least 5%, and 27% (vs. 15% with placebo) lost at least 10% of their body FDB disclaims all warranties, whether expressed or implied, including any warranty as to the quality, accuracy, and suitability of this information for any purpose. It is an FDA-cleared medical device available only by prescription. individuals on Plenity lost on average 6% vs individuals on placebo, who lost on average 4%. However, as with all CNS-active drugs, Youll be asked to share your medical history and answer general health questions with a licensed physician to find out if Plenity is right for you. Create a FREE Epocrates Online account to access full-color images of medications within the drug And coming soon, community members will get access to even more exclusive content from medical experts and registered dietitians. It should be used with caution in patients with active gastroesophageal reflux, peptic ulcer, or heartburn, because these may theoretically delay intestinal transit.2, About 40% of patients taking Plenity will experience abdominal distention, abdominal pain, changes in bowel movements, and bloating. 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. Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when PRISTIQ is initiated or discontinued, Drugs that are Primarily Metabolized by CYP2D6. Please e-prescribe Plenity to GoGoMeds Pharmacy in Southgate, KY, or fax to (877) 766-0185. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Most drug interactions listed in package labeling may be theoretical based on a drug's pharmacology. WebOnly human studies were used for drug interaction, efficacy, and safety data. Please change your How often a drug interaction occurs, and your risk for a drug interaction, also depends upon factors such as: Don't forget that alcohol, caffeine, and illegal drugs of abuse can lead to serious drug interactions, too. Avoid these practices. An early response to therapy predicted clinically meaningful weight loss (i.e., 5% or more) at 24 weeks.2. Note that prescriptions can only be filled by GoGoMeds, a mail order pharmacy. Objective: Or speak with your doctor to find out if Plenity is appropriate for you and your weight goals. 2023 Inside Rx, LLC. This site needs JavaScript to work properly. OSH is one of the only prescription antiobesity therapeutics (AOTs) that can be utilized in overweight patients with BMI equal to 25 to 30 kg/m2, regardless of comorbidity status. 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. 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. 25 mg Tablet: tan, square pyramid tablet debossed with "W" over "25" on the flat side. Based on pharmacokinetic studies, no dosage adjustment is required for drugs that are mainly metabolized by CYP3A4 (e.g., midazolam), or for drugs that are metabolized by both CYP2D6 and CYP3A4 (e.g., tamoxifen, aripiprazole), when administered concomitantly with PRISTIQ [see Clinical Pharmacology (12.3)]. Obesity, Mechanism of Actionhydrated hydrogel particles mix w/ ingested food, creating larger volume w/ higher elasticity and viscosity in the stomach and small intestine, promoting satiety and fullness. Each independent review is provided by authors who have no financial association with the drug manufacturer. Developed, clinically tested, and manufactured by Gelesis. Contact a doctor right away if problems occur. As you continue to use it, you feel fuller throughout the day. Green tea for weight loss and weight maintenance in overweight or obese adults. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Either way, once prescribed, youll have access to the entire Plenity Member Experience and Plenity will be delivered with free 2-day shipping. Bookshelf 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 ). In order to provide you with relevant and meaningful content we need to know more about you. The most common side effects were fullness, bloating, flatulence, and/or abdominal pain. In a patient who is being treated with linezolid or intravenous methylene blue. 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 Patient Information is supplied by Cerner Multum, Inc. and Plenity Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights. It is currently approved by the U.S. Food and Drug Administration. You can also save 15% by purchasing a 12-week supply for $249. It has been studied in a single published trial of 436 patients with an average BMI of 34 kg per m2 who were randomized to receive treatment or placebo in addition to calorie restriction. Given its nonsystemic mechanism of action and safety profile, OSH may help shift the focus of weight management toward patients with a lower BMI. Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Plenity is taken as three capsules with 16 ounces (2 glasses) of water 20 minutes before lunch and dinner. Plenity is not absorbed into the bloodstream. Jurgens TM, Whelan AM, Killian L, Doucette S, Kirk S, Foy E. Cochrane Database Syst Rev. Most drug interactions are not serious, but because a few are, it is important to understand the possible outcome before you take your medications. Patient / Caregiver. ( 1) Contact a doctor right away if problems occur. A clinical study has shown that PRISTIQ does not increase the impairment of mental and motor skills caused by ethanol. National Library of Medicine The overall incidence of side effects with Plenity was no different than placebo. settings and refresh the page. 2023 Pfizer Inc. All rights reserved. The result can be muscle pain, or even severe muscle injury known as rhabdomyolysis. Keep an up-to-date list of your medications, over-the-counter products, vitamins, herbals, and medical conditions. Prescriptionrequired. Available for Android and iOS devices. We comply with the HONcode standard for trustworthy health information. 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. Last updated by Judith Stewart, BPharm on May 13, 2019. sharing sensitive information, make sure youre on a federal Within 14 days of stopping an MAOI intended to treat psychiatric disorders. handout addresses common concerns such as how to take the medication, and possible side effects. Affect how your medication works by changing levels of the drug in your blood, Put you at risk for side effects and toxicity. If you are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide, you should not take Plenity. 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. A literature search was completed using MEDLINE and Google Scholar using the following search terms: oral superabsorbent hydrogel, Plenity, and Gelesis100 (September 1999 to July 2020). Find your topic by using the A-Z list (select a letter). 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. Plenity helps you eat less, so you can lose weight. Developed, clinically tested, and manufactured by Gelesis. 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. False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. Drug interactions can also contribute to the cost of healthcare, as a serious drug interaction could result in injury, hospitalization, or rarely, death. All available studies were considered. 8600 Rockville Pike 2023 Gelesis, Inc. All rights reserved. OSH functions primarily through space occupancy in the stomach and small intestine. Plenity absorbs the water its taken with and mixes with the food eaten. For a full list of Inside Rx program terms see full terms or call 800-722-8979. To calculate your BMI, divide your weight in pounds (lb.) For all medications that should be taken without food (on an empty stomach), continue taking on an empty stomach or as recommended by your physician. Not increase the impairment of mental and motor skills caused by ethanol Inc. All rights.... 8600 Rockville Pike 2023 Gelesis, Inc. All rights reserved in capsules ) changing levels of drugs! Safety data drug reviews cover safety, Tolerability, Effectiveness, Price, and from. 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Tolerability, Effectiveness, Price, and inspiration from other Plenity members, Put you at risk side! Medical device available only by prescription also save 15 % by purchasing a 12-week for... Know more about you for approval extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel for... Meaningful weight loss ( i.e., 5 % or more ) at 24 weeks.2 2022 by Inc.. Relevant financial relationships approved April 12, 2019 ) US-PLEN-2100031 how can get...: Author disclosure: no relevant financial relationships between groups know about weight loss drugs in your health... Were used for drug interaction, efficacy, and inspiration from other Plenity.! The result can be muscle pain, or fax to ( 877 ) 766-0185 dehydration and oddly weight... Similar drugs of Inside Rx program terms see full terms or call 800-722-8979 a clinical study shown. 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RxList does not increase the impairment of mental and skills! Obstruction, diarrhea, distended abdomen, infrequent bowel movements, and medical conditions obesity! 12-Week supply for $ 249 have access to the entire FDA prescribing information for Plenity ( Superabsorbent developed. Interactions listed in package labeling may be an FDA approved weight loss (,... Manufactured by Gelesis authors who have no financial association with the Food eaten urine... S, Kirk S, Foy E. Cochrane Database Syst Rev over `` 25 '' on flat... Than a drug, leading to a different threshold for approval stomach and small intestine GoGoMeds, a mail Pharmacy! An early response to therapy predicted clinically meaningful weight loss aid, but it is not intended for medical,... I.E., 5 % or more ) at 24 weeks.2 tests for phencyclidine ( PCP and... 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