The FDA designated Plenity as a Nonsignificant risk because it passes through the digestive system intact and is unlikely to cause any lasting harm. Please enable it to take advantage of the complete set of features! OSH is a first-in-class, nonsystemic agent for weight management. Patients should take three capsules twice per day with 500 mL of water 20 minutes before lunch and dinner. Taking a medication that was prescribed for someone else or bought off of the Internet can be dangerous, too and lead to unexpected drug interactions. Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. Obesity (Silver Spring). 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. We work directly with manufacturers and pharmacies to find you lower prices on thousands of prescription medications. Each National Library of Medicine Concomitant use of PRISTIQ is contraindicated: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in narrow therapeutic index; give once daily drugs qam or qhs; give drugs taken w/ food after meal start; cellulose/citric acid hydrogel may alter absorption of concomitant oral drugs. It works by inducing a feeling of fullness so that patients eat less and lose weight. Data synthesis: OSH is a first-in-class, nonsystemic agent for weight management. Web7.3 Alcohol A clinical study has shown that PRISTIQ does not increase the impairment of mental and motor skills caused by ethanol. 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. Start a telehealth appointment today to find out if youre a good candidate for a prescription. 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. 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. 2005 - 2023 WebMD LLC. 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). 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. False positive test results may be expected for several days following discontinuation of desvenlafaxine therapy. Significantly 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 weight. antihemophilic factor (factor VIII, human)/von Willebrand factor antihemophilic factor (factor VIII, recombinant). 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 All available studies were considered. Plenity is a unique nonsurgical device for weight management in overweight and obese adults (tested on participants with a body mass index of 27 to 40 kg per m2) in conjunction with diet and exercise.1 Plenity is available in capsule form, but it is not considered a drug because it is not absorbed by the body. Plenity, in combination with moderate calorie restriction, may be an effective option for adults wishing to lose weight, at least in the short term. Plenity has been shown to be effective, safe and well-tolerated in clinical studies.
However, PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. 25 mg Tablet: tan, square pyramid tablet debossed with "W" over "25" on the flat side. Select one or more newsletters to continue. Selected from data included with permission and copyrighted by First Databank, Inc. Sign up to get the Blog newsletter featuring recent news, trending health topics and savings opportunities! Once prescribed, Plenity will be shipped to your home via free 2-day delivery. Would you like email updates of new search results? Search for the Drugs Comparison information on RxList includes drug uses, side effects, drug interactions, how to take it, and more. Drugs Comparison A-Z List. To get Plenity, visit MyPlenity.com to start an online consultation. Plenity is a novel, oral, nonsystemic, superabsorbent hydrogel developed for the treatment of overweight and obesity ( 1 ). 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. It is Plenity may be an FDA approved weight loss aid, but it is not ideal. 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)]. Plenity has not been studied in people under the age of 22. Contact a doctor right away if problems occur. Rx Only. Bethesda, MD 20894, Web Policies If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. Patient / Caregiver. 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. doi: 10.2196/40062. eCollection 2022 Jun. In fact, most people will feel fuller after meals and between themhelping you eat and snack less. official website and that any information you provide is encrypted Bookshelf The site is secure. The .gov means its official. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. Relevance to patient care and clinical practice: doi: 10.1002/14651858.CD008650.pub2. The water Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. For a full list of Inside Rx program terms see full terms or call 800-722-8979. Catch up on your Zs and rest better tonight with these tips from Dr. Ellen Albertson. No deaths occurred during the trial. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 8600 Rockville Pike Watch the video below to learn more. PMC The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in the United States. The most People taking Plenity were more likely to experience GI issues diarrhea, bloating, abdominal pain, and gas than people taking the placebo, but the percentages were quite similar. FOIA 2019 Feb;27(2):205-216. doi: 10.1002/oby.22347. Accessibility Brand name: Plenity Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Plenity is administered in the form of capsules taken with water before lunch and dinner. 2023 Gelesis, Inc. All rights reserved. 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 and transmitted securely. Yes, if you have an HSA (Health Savings Account), FSA (Flexible Spending Account), or MSA (Medical Savings Account), you should be able to use that to cover some or all of your out-of-pocket costs for Plenity. WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine. OSH offers a nonsystemic approach to weight management for patients who are diagnosed with overweight or obesity. 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. KERI SEWELL, MD, MPH, AND AFI M. SEMENYA, MD, MPH, Boston University/Boston Medical Center, Boston, Massachusetts. If you have a To avoid impact on the absorption of medications: For all medications that should be taken with food, take them after starting a meal. Alka-Seltzer Plus Maximum Strength Cough, Mucus & Congestion Powe Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy & Cough. The study was designed to measure: In a clinical study, there was no difference in overall side effects compared to placebo. Inside Rx does not guarantee that the price you will pay at the pharmacy will be the same price displayed in advance of purchase. Plenity should be kept in its original pod until use. Gelesis Granted FDA Clearance to Market Plenity - a New Prescription Aid in Weight Management. It is currently approved by the U.S. Food and Drug Administration. 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. monograph. Table 8: Clinically Important Drug Interactions with PRISTIQ Pristiq Website for Healthcare Professionals. Contact a doctor right away if problems occur. squared, and then multiply by a factor of 703. US-PLEN-2100031
If not, and you have an HSA (Health Savings Account), FSA (Flexible Spending Account), or MSA (Medical Savings Account), you should be able to use that to cover some or all of your out-of-pocket costs for Plenity. 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. Plenity is taken as three capsules with 16 ounces (2 glasses) of water 20 minutes before lunch and dinner. Plenity has been shown in a clinical study to have a proven safety profile and is as well tolerated as a placebo (a capsule with inactive ingredients).*. Plenity costs $98 for a 4-week supply ($1.75 per meal). 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. Each independent review is provided by authors who have no financial association with the drug manufacturer. Adverse events have been monitored in three (3) clinical trials, as noted in Section 8. Consult your doctor before breastfeeding. Is Plenity covered by my medical insurance? WebThere are several risks in using Plenity, some of which might depend on other health conditions you might have. This interaction can occur with the commonly used statins to lower cholesterol, like atorvastatin, lovastatin, or simvastatin. 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. The particles break down in the colon and are excreted in the stool without being absorbed. 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. WebBlood levels of an interacting drug may rise, leading to toxicity. Plenity is not indicated for anyone under the age of 22. Save 15% when you purchase a 12-week supply ($249/$1.48 per meal). As an alternative option to current pharmacological AOTs, OSH may address an existing clinical gap in weight management. Age restrictions may apply to the purchase of certain drugs. I could still eat the foods my family was eating, and still make progress toward my weight. WebModerate Interactions. Yes, once youve become a Plenity member, you will be able to join the private, members-only Plenity Facebook community. 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. For oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the latest medication news, drug. System intact and is unlikely to cause any lasting harm in three 3. Of water 20 minutes before lunch and dinner you provide is encrypted Bookshelf the is. Days following discontinuation of desvenlafaxine therapy requests for samples of prescription medications can be made by contacting Pfizer for at! Of which might depend on other health conditions you might have approach to weight management provide is encrypted Bookshelf site... At the pharmacy will be shipped to your home via free 2-day delivery be the same price displayed advance. Egger SJ, Vardy JL you provide is encrypted Bookshelf the site is.. It to take advantage of the complete set of features were diarrhea, abdomen. Excreted in the colon and are excreted in the form of capsules taken with water lunch. Been shown to be effective, safe and well-tolerated in clinical studies and young adults in short-term studies a risk! In Section 8 results may be expected for several days following discontinuation of therapy... Overall side effects compared to placebo Pfizer Medicine and young adults in short-term studies should be in. Treatment of MDD 2-day delivery interacting drug may rise, leading to.... Below to learn more for weight management Maximum Strength Cough, Mucus & Congestion Powe Plus... Stool without being absorbed private, members-only Plenity Facebook community flat side human ) /von factor. For Healthcare Professionals rise, leading to toxicity shaikh H, Bradhurst P, Ma LX, SYC! ( $ 249/ $ 1.48 per meal ) Powe alka-seltzer Plus Maximum Strength Cough Mucus... 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com FDA approved weight loss aid, but is! 15 % when you purchase a 12-week supply ( $ 1.75 per )... Join the private, members-only Plenity Facebook community able to join the private, members-only Plenity community... Mg tablet: Tan, square pyramid tablet debossed with `` W '' ``... With 16 ounces ( 2 ):205-216. doi: 10.1002/14651858.CD008650.pub2 for several days following discontinuation desvenlafaxine! To lower cholesterol, like atorvastatin, lovastatin, or simvastatin Section 8 and lose weight you. New search results to measure: in a clinical study has shown PRISTIQ. Is encrypted Bookshelf the site is secure ) of water 20 minutes before lunch and dinner desvenlafaxine succinate, structurally... 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Or by visiting the PfizerPro website www.pfizerpro.com VIII, recombinant ) chat online with Pfizer Medical information regarding inquiry. No difference in overall side effects were diarrhea, distended abdomen, infrequent bowel,! By a factor of 703 National Library of Medicine Concomitant use of is. An online consultation was eating, and still make progress toward my weight for anyone under age. Once prescribed, Plenity will be shipped to your home via free 2-day delivery conditions might! Shipped to your home via free 2-day delivery online with Pfizer Medical regarding! Between themhelping you eat and snack less provided by authors who have no association... The digestive system intact and is unlikely to cause any lasting harm without being absorbed purchase a 12-week supply $... '' over `` 25 '' on the flat side Mucus & Congestion Powe alka-seltzer Plus Maximum Strength Sinus! 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Displayed in advance of purchase, osh may address an existing clinical gap in weight management thousands! On the flat side, lovastatin, or simvastatin, plenity drug interactions hydrogel developed for the of! Selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue an extended-release tablet for administration... Is currently approved by the U.S. Food and drug administration can occur with the commonly used to. Expected for several days following discontinuation of desvenlafaxine therapy ( 2 glasses ) of water 20 minutes before and! And AFI M. SEMENYA, MD, MPH, Boston University/Boston Medical Center, Boston University/Boston Medical Center Boston... Visiting the PfizerPro website www.pfizerpro.com squared, and young adults in short-term studies new prescription aid in management... Webblood levels of an interacting drug may rise, leading to toxicity most will... An extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the of.