These highlights do not include all the You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at. Create a FREE Epocrates Online account to access full-color images of medications within the drug Plenity (cellulose and citric acid) Consumer information. In this article, dietitian Nicole German Morgan dives into the scientific evidence. official website and that any information you provide is encrypted Metabolic enzymes in your body and your genetics. It is made from naturally derived building blockscellulose and citric acid. oral superabsorbent hydrogel; preobesity; weight management. Select one or more newsletters to continue. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. Plenity has been shown to be effective, safe and well-tolerated in clinical studies. 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). Copyright 2022 by the American Academy of Family Physicians. Learn How Genetics Make Some Fans of Fear, Dr. Whyte's Book: Take Control of Your Cancer Risk, How Breast Cancer Changed My Life and Me, Health News and Information, Delivered to Your Inbox. Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine. Data sources: If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088. For current full prescribing information, please visit www.pfizer.com. Plenity prescriptions can ONLY be filled by GoGoMeds Pharmacy. 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)]. Age restrictions may apply to the purchase of certain drugs. Either way, once prescribed, youll have access to the entire Plenity Member Experience and Plenity will be delivered with free 2-day shipping. 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. Only the category of gastrointestinal disorders related to Plenity was different relative to placebo (38% versus 28% respectively, Table 6) . Greenway FL, Aronne LJ, Raben A, Astrup A, Apovian CM, Hill JO, Kaplan LM, Fujioka K, Matejkova E, Svacina S, Luzi L, Gnessi L, Navas-Carretero S, Alfredo Martinez J, Still CD, Sannino A, Saponaro C, Demitri C, Urban LE, Leider H, Chiquette E, Ron ES, Zohar Y, Heshmati HM. It is indicated for use in patients with a body mass index (BMI) of 25 to 40 kg/m2 regardless of comorbidity status. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. In fact, most people will feel fuller after meals and between themhelping you eat and snack less. These medications may cause some risk when taken together. 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? If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. WebWhen you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. Ask your pharmacist or doctor for advice if you are confused by the medical jargon. Plenity is not absorbed into the bloodstream. 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 This may be due to the effect of PRISTIQ on the release of serotonin by platelets. 2005 - 2023 WebMD LLC. In the community, you can get encouragement, support, and inspiration from other Plenity members. Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in adults who are overweight or obese. Download this physician handout to help you have an informed conversation with your doctor about Plenity. If you are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide, you should not take Plenity. *Plenity (n=223) or placebo (n=213) was administered to 436 adults with excess weight or obesity, with or without type 2 diabetes. These side effects include: Stomach pain or upset stomach Oily discharge from the anus Gas with oily anal discharge Oily stools More-frequent bowel movements Urgent or hard-to-control bowel movements Other possible side effects include: Headache Back pain Common cold 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. Learn more about price differences between brand and generic drugs. Treatment for: Weight Loss (Obesity/Overweight). Three capsules taken orally twice daily before lunch and dinner, Immediate, unlimited access to all AFP content, Immediate, unlimited access to this issue's content. Most drug interactions are not serious, but because a few are, it is important to understand the possible outcome before you take your medications. Plenity is available for prescribing by all healthcare professionals who can write prescriptions. Table 8: Clinically Important Drug Interactions with PRISTIQ, Report an adverse event or concern about the quality of a Pfizer product, Assistance programs (for eligible patients). Company: Gelesis 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. Review the Medication Guide, prescription information, warning labels, and Drug Facts Label with each new prescription or OTC product. 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. Plenity may be an FDA approved weight loss aid, but it is not ideal. 2020 Dec 11;12(12):CD012110. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Alka-Seltzer Plus Maximum Strength Cough, Mucus & Congestion Powe Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy & Cough. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. It's always best to ask your healthcare provider for the latest information on drug interactions. 2023 Inside Rx, LLC. Developed, clinically tested, and manufactured by Gelesis. Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. Data synthesis: OSH is a first-in-class, nonsystemic agent for weight management. It works by inducing a feeling of fullness so that patients eat less and lose weight. Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in Bethesda, MD 20894, Web Policies No serious adverse effects were observed in the patients taking Plenity.1 Hypersensitivity to any component of the formulation is a contraindication. Plenity is not a drug and is stimulant-free and non-habit forming. of water during or immediately after your meal. Plenity is a prescription-only weight loss aid. This interaction can occur with the commonly used statins to lower cholesterol, like atorvastatin, lovastatin, or simvastatin. 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And be sure to keep an eye out for an updated member experience filled with even more science-backed resources to help guide your weight management journey. 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. WebMD does not provide medical advice, diagnosis or treatment. Last updated by Judith Stewart, BPharm on May 13, 2019. A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. 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. This product's label may have been updated. The particles break down in the colon and are excreted in the stool without being absorbed. Horn DB, Pash E, Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. JMIR Form Res. 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. To describe the mechanism, clinical trial data, adverse effects, and potential role in therapy of an oral superabsorbent hydrogel (OSH) for weight management. Plenity is not indicated for anyone under the age of 22. Studies have demonstrated that OSH has modest weight loss efficacy and a favorable safety profile, with no significant difference in overall adverse events compared with placebo. 2023 Pfizer Inc. All rights reserved. sharing sensitive information, make sure youre on a federal These studies did not show PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]. Plenity is the first and only FDA-cleared weight management tool made from naturally derived building blockscellulose and citric acid. Patients should take three capsules twice per day with 500 mL of water 20 minutes before lunch and dinner. Original dose should be taken when co-administered with PRISTIQ 100 mg or lower. It is currently approved by the U.S. Food and Drug Administration. Plenity is administered in the form of capsules taken with water before lunch and dinner. Each However, as with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking PRISTIQ. 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. 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. WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. This Medication Guide has been approved by the U.S. Food and Drug Administration. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Do I need to see a doctor in person to get Plenity? and transmitted securely. Concomitant use of PRISTIQ with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. Plenity passes through the digestive system, maintaining its three-dimensional structure in the stomach and small intestine before breaking down in the colon. WebBlood levels of an interacting drug may rise, leading to toxicity. Please choose the category that best describes you. Prescriptionrequired. As with other treatments, weight loss with Plenity can vary widely, Leider noted. National Library of Medicine Anytime you take more than one medication, or even mix it with certain foods, beverages, or over-the-counter medicines, you are at risk of a drug interaction. Some mixtures of medications can lead to serious and even fatal consequences. Free Epocrates Online account to access full-color images of medications within the drug (! This page applies to your personal circumstances taking PRISTIQ FDA approved weight loss aid, but it is from! Being absorbed potentiate the risk of bleeding 40 kg/m2 regardless of comorbidity status and fatal. 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