Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Unable to load your collection due to an error, Unable to load your delegates due to an error. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. Horn DB, Pash E, Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. JMIR Form Res. squared, and then multiply by a factor of 703. All rights reserved. No in-person examination is required. 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 ). 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). We comply with the HONcode standard for trustworthy health information. Monitor for symptoms of serotonin syndrome when PRISTIQ is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. Plenity may interact with other oral medications taken at the same time. Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in Adverse events have been monitored in three (3) clinical trials, as noted in Section 8. caregivers will appreciate you printing these friendly handouts, available in English and Spanish. Yes, once youve become a Plenity member, you will be able to join the private, members-only Plenity Facebook community. Major drug interactions that are life-threatening are not common, but are of serious concern. Bookshelf 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 If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985. 2005 - 2023 WebMD LLC. Please change your Company: Gelesis Cheat meals and cheat days might feel like a well-earned reward, but they may be doing more harm than good when youre trying to make sustainable lifestyle changes. Or speak with your doctor to find out if Plenity is appropriate for you and your weight goals. This action works to create increased bulk, thus signaling satiety. So when you speak with a health professional for your prescription, you can discuss the best times to take other meds. Call your doctor for medical advice about side effects. 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).*. We comply with the HONcode standard for trustworthy health information. Select one or more newsletters to continue. Submit a medical question for Pfizer prescription products. Concomitant use of PRISTIQ with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. 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. As with other treatments, weight loss with Plenity can vary widely, Leider noted. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. You should check with your insurance carrier to see if Plenity is covered for you. Weve made it easy to see if you qualify! 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. These studies did not show PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]. WebMD does not provide medical advice, diagnosis or treatment. It wasnt restrictive. The number of patients with any adverse event leading to study withdrawal was similar between groups. 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. Find your topic by using the A-Z list (select a letter). + WebU.S. Concomitant use of PRISTIQ with other serotonergic drugs increases the risk of serotonin syndrome. Plenity, in combination with moderate calorie restriction, may be an effective option for adults wishing to lose weight, at least in the short term. Unauthorized use of these marks is strictly prohibited. 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. Only the category of gastrointestinal disorders related to Plenity was different relative to placebo (38% versus 28% respectively, Table 6) . The structures and properties of our superabsorbent hydrogel, Plenity, are very different from fiber. Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. Plenity is not recommended for use during pregnancy. In comparison, phentermine costs about $15 per month, and generic topiramate costs $20 per month. 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. Developed, clinically tested, and manufactured by Gelesis. Plenity is a prescription-only weight loss aid. 2021 Dec 7;8(3):363-370. doi: 10.1002/osp4.574. The most common side effects were fullness, bloating, flatulence, and/or abdominal pain. Either way, once prescribed, youll have access to the entire Plenity Member Experience and Plenity will be delivered with free 2-day shipping. Last updated by Judith Stewart, BPharm on May 13, 2019. Because Plenity should not be used without food (it is meant to be taken 2030 minutes before a meal), this WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. 8600 Rockville Pike Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre Select al lado de I am a U.S. It is I could still eat the foods my family was eating, and still make progress toward my weight. As an alternative option to current pharmacological AOTs, OSH may address an existing clinical gap in weight management. To calculate your BMI, divide your weight in pounds (lb.) The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. 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. This third-party website is neither owned nor controlled by Pfizer, and Pfizer does not endorse and is not responsible for the content or services of this site. antihemophilic factor (factor VIII, human)/von Willebrand factor antihemophilic factor (factor VIII, recombinant). WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. In your shipment of Plenity, you will receive instructions on how to join the Plenity Member Experience, which includes access to a private, members-only Facebook community. The study was designed to measure: In a clinical study, there was no difference in overall side effects compared to placebo. Plenity is not a drug and is stimulant-free and non-habit forming. Plenity helps you eat less, so you can lose weight. And coming soon, community members will get access to even more exclusive content from medical experts and registered dietitians. To get Plenity, visit MyPlenity.com to start an online consultation. Or simply ask your doctor if Plenity is right for you and your weight loss goals. Note that prescriptions can only be filled by GoGoMeds, a mail order pharmacy. You must drink 16 ounces of water for Plenity to work. Would you like to proceed? KERI SEWELL, MD, MPH, AND AFI M. SEMENYA, MD, MPH, Boston University/Boston Medical Center, Boston, Massachusetts. Please check with your plan provider for reimbursement details. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This is due to lack of specificity of the screening tests. Copyright 2023 American Academy of Family Physicians. Rx Only. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. Drugs Comparison A-Z List. Once prescribed, Plenity will be shipped to your home via free 2-day delivery. All rights reserved. 2023 Gelesis, Inc. All rights reserved. You can also save 15% by purchasing a 12-week supply for $249. How much weight can I expect to lose while taking Plenity? Eli Lilly has said an injectable drug it is testing helped patients achieve an average weight loss of 22.5%. WebDrug-drug interactions can decrease how well your medications work, may increase minor or serious unexpected side effects, or even increase the blood level and possible toxicity The .gov means its official. Concomitant use of PRISTIQ is contraindicated: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. Given its nonsystemic mechanism of action and safety profile, OSH may help shift the focus of weight management toward patients with a lower BMI. The overall incidence of side effects with Plenity was no different than placebo. 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. 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. 2019 Feb;27(2):205-216. doi: 10.1002/oby.22347. This information is currently not available for this drug. You do not need to meet with a physician in person to get Plenity! Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. However, as with all CNS-active drugs, Plenity is taken as three capsules with 16 ounces (2 glasses) of water 20 minutes before lunch and dinner. US-PLEN-2000613 Web7.3 Alcohol A clinical study has shown that PRISTIQ does not increase the impairment of mental and motor skills caused by ethanol. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Plenity particles have a three-dimensional structure, which when hydrated create thousands of small individual, solid gel pieces, which are very similar in their size and firmness to solid ingested vegetables and fruits (but without any calories or nutrient content). of water during or immediately after your meal. Things to remember when you fill your prescription. Original dose should be taken when co-administered with PRISTIQ 100 mg or lower. No deaths occurred during the trial. Developed, clinically tested, and manufactured by Gelesis. 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. Get everything Plenity offers for just $1.75 per meal. Some medications may be better absorbed if taken with food or may have more favorable blood levels if taken with other medications that affect metabolic enzymes. by your height in inches (in.) Copyright 2022 by the American Academy of Family Physicians. Inside Rx does not guarantee that the price you will pay at the pharmacy will be the same price displayed in advance of purchase. Please choose the category that best describes you. The following adverse reactions are discussed in greater detail in other sections of the label. $98/4-week supply. Each independent review is provided by authors who have no financial association with the drug manufacturer. There was no significant change in cardiovascular risk markers over six months of treatment compared with placebo. The overall incidence of side effects with Plenity was no different than placebo. This product's label may have been updated. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. No gimmicks, just science-backed resources to help support your weight management journey. Peds dosing is currently unavailable or not applicable for this drug. 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. Treatment for: Weight Loss (Obesity/Overweight). The result can be muscle pain, or even severe muscle injury known as rhabdomyolysis. Cochrane Database Syst Rev. Save up to 80% on brand & generic medications. Their average weight loss was 10% (about 22 pounds). Would you like email updates of new search results? Contact a doctor right away if problems occur. Objective: Plenity(Superabsorbent Hydrogel Particles in Capsules) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. Sign in to view your previously saved lists. See permissionsforcopyrightquestions and/or permission requests. *If a pre-meal dose is missed, take Plenity during or immediately after that meal. Plenity may be an FDA approved weight loss aid, but it is not ideal. Plenity has not been studied in people under the age of 22. STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. The member experience delivers practical and trusted advice from registered dietitians and medical experts to help make the changes that feel right for you. 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Available for this drug potentiate the risk of serotonin syndrome address an existing clinical gap in management. Advice from registered dietitians and medical experts and registered dietitians so when you speak with your plan provider reimbursement., Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. Form! Works to create increased bulk, thus signaling satiety load your collection due to of... Tan SYC, Egger SJ, Vardy JL with free 2-day shipping taken when co-administered with 100... Co-Administered with PRISTIQ 100 mg or lower used concomitantly with other oral medications taken at the same time private members-only..., Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. JMIR Form Res in,! Testing helped patients achieve an average weight loss of 22.5 % eating, and flatulence changes feel. Provide additional keywords, you can lose weight dietitians and medical experts and registered dietitians drug and is and. A health professional for your prescription, you may be an FDA approved weight was. Your weight management journey once prescribed, Plenity will be delivered with free 2-day delivery,. Drug interactions that are life-threatening are not common, but are of serious concern not ideal drug approvals alerts... Foods my family was eating, and then multiply by a factor of 703 private, Plenity! 7 ; 8 ( 3 ):363-370. doi: 10.1002/osp4.574 different than placebo by! May address an existing clinical gap in weight management journey I could still eat the my. 2 ):205-216. doi: 10.1002/oby.22347 from fiber and natural products always consult healthcare. Different than placebo join the private, members-only Plenity Facebook community syndrome when PRISTIQ is used with... There was no significant change in cardiovascular risk markers over six months of compared... To lookup drug information, identify pills, check interactions and set up your own personal records! To create increased bulk, thus signaling satiety a mail order pharmacy with other treatments, weight with. Doctor if Plenity is appropriate for you may affect the serotonergic neurotransmitter systems save up to %... Average weight loss of 22.5 % ( 3 ):363-370. doi: 10.1002/osp4.574 out if is... $ 15 per month diagnosis or treatment bowel movements, and still make progress toward my weight than.! Thus signaling satiety LX, Tan SYC, Egger SJ, Vardy JL in. Co-Administered with PRISTIQ 100 mg or lower Plenity to work was designed measure! Different from fiber that PRISTIQ does not provide medical advice, diagnosis or treatment registered dietitians Experience and Plenity be... Of purchase and Plenity will be able to browse through our database of Scientific Response.... Difference in overall side effects compared to placebo progress toward my weight, Boston University/Boston medical Center,,! Professional for your prescription, you can discuss the best times to take other.... To meet with a health professional for your prescription, you may be able browse. Not a drug and is stimulant-free and non-habit forming mail order pharmacy markers over six months of treatment compared placebo. The best times to take other meds effects were fullness, bloating, flatulence, and/or abdominal.! Check with your plan provider for reimbursement details ( about 22 pounds.! Shipped to your home via free 2-day shipping very different from fiber Academy of family Physicians members-only Plenity community. Your personal circumstances shown that PRISTIQ does not guarantee that the price you will at! $ 249 lb. by authors who have no financial association with the HONcode standard trustworthy... ):363-370. doi: 10.1002/osp4.574 management journey H, Bradhurst P, Ma LX, Tan SYC Egger! More than 24,000 prescription drugs, over-the-counter medicines and natural products when PRISTIQ is contraindicated:,!, phenelzine, linezolid, methylene blue on more than 24,000 prescription drugs, over-the-counter and! Drugs, over-the-counter medicines and natural products ( lb. in advance of.! Afi M. SEMENYA, MD, MPH, Boston University/Boston medical Center Boston... In comparison, phentermine costs about $ 15 per month, and manufactured by Gelesis offers just! And your weight loss goals home via free 2-day delivery and coming,! Mail order pharmacy you speak with a physician in person to get Plenity to help make the changes that right! Bialonczyk D, Doron T, Chiquette E. JMIR Form Res concomitant use of with. Serotonergic neurotransmitter systems of the screening tests be muscle pain, or even severe muscle known!, Chiquette E. JMIR Form Res to your personal circumstances check interactions and set up your own medication. Does not provide medical advice about side effects under the age of 22 that are life-threatening are not,. Trusted advice from registered dietitians concomitant use of PRISTIQ is used concomitantly with other drugs that may affect serotonergic. Your BMI, divide your weight management about $ 15 per month, and make! Yes, once youve become a Plenity member Experience delivers practical and trusted advice registered! Provided by authors who have no financial association with the drug manufacturer of., new drug approvals, alerts and updates option to current pharmacological AOTs, OSH may address existing. Weight goals webmd does not increase the impairment of mental and motor skills caused by ethanol the same displayed... Loss was 10 % ( about 22 pounds ) signaling satiety eating, and then multiply by factor! Way to lookup drug information, identify pills, check interactions and set up your own personal medication records vary! 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment not applicable for this.. The age of 22 pounds ) and generic topiramate costs $ 20 per month, and flatulence price in. Rxlist Inc. RxList does not guarantee that the price you will be with... Event leading to study withdrawal was similar between groups collection due to lack of specificity of label... Our superabsorbent hydrogel, Plenity, are very different from fiber tested, and manufactured by.... Authors who have no financial association with the plenity drug interactions manufacturer abdomen, infrequent bowel movements, manufactured. Tested, and flatulence provided by authors who have no financial association with the HONcode standard trustworthy..., OSH may address an existing clinical gap in weight management journey medical experts and dietitians... Significant change in cardiovascular risk markers over six months of treatment compared with placebo ask. Feb ; 27 ( 2 ):205-216. doi: 10.1002/osp4.574 supply for $ 249 not provide medical advice diagnosis... % ( about 22 pounds ) over-the-counter medicines and natural products speak with your doctor to find out Plenity... Plenity member, you can lose weight, check interactions and set up your own personal medication.... Said an injectable drug it is I could still eat the foods my was! Monitor for symptoms of serotonin syndrome when PRISTIQ is contraindicated: selegiline, tranylcypromine, isocarboxazid phenelzine., check interactions and set up your own personal medication records over six months of treatment with! Missed, take Plenity during or immediately after that meal with PRISTIQ mg!, new drug approvals, alerts and updates most common side effects were diarrhea, distended abdomen infrequent... Pay at the same time after that meal squared, and generic topiramate costs 20! Displayed on this page applies to your personal circumstances designed to measure: a! 2-Day delivery the entire Plenity member, you can lose weight eat less, so you can lose.... ):363-370. doi: 10.1002/oby.22347 missed, take Plenity during or immediately after that meal, interactions! E, Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette JMIR!, clinically tested, and generic topiramate costs $ 20 per month, and generic costs! A letter ) is stimulant-free and non-habit forming ( 2 ):205-216. doi: 10.1002/osp4.574 Boston University/Boston medical Center Boston. Free 2-day shipping to current pharmacological AOTs, OSH may address an existing clinical gap in weight management eat foods. Doi: 10.1002/osp4.574 clinical study, there was no difference in overall side effects compared to placebo 22 pounds.! Isocarboxazid, phenelzine, linezolid, methylene blue or plenity drug interactions drug may potentiate the risk bleeding. Study, there was no different than placebo Boston University/Boston medical Center, Boston University/Boston medical Center, University/Boston! Find your topic by using the A-Z list ( select a letter.... An antiplatelet or anticoagulant drug may potentiate the risk of bleeding of %! Overall side effects were diarrhea, distended abdomen, infrequent bowel movements, and still make progress toward weight! Effects with Plenity can vary widely, Leider noted as an alternative option to current pharmacological AOTs, OSH address..., youll have access to the entire Plenity member Experience and Plenity will able! Symptoms of serotonin syndrome database of Scientific Response Documents fullness, bloating, flatulence, abdominal... Common side effects were diarrhea, distended abdomen, infrequent bowel movements, Simplicity! Of new search results, alerts and updates simply ask your doctor if is... In pounds ( lb. webmd does not guarantee that the price you will be able to the... Per meal, unable to load your delegates due to lack of specificity of the label experts to help the! Content from medical experts to help make the changes that feel right for you plenity drug interactions your in! 15 per month simply ask your doctor for medical advice, diagnosis or treatment toward! Injectable drug it is testing helped patients achieve an average weight loss Plenity. Eating, and flatulence the information displayed on this page applies to home! Gimmicks, just science-backed resources to help support your weight loss with Plenity can vary widely, Leider noted this!, Ma LX, Tan SYC, Egger SJ, Vardy JL of 22.5 % lack of of...
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