This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. BMI is calculated using your weight (in lb.) As you continue to use it, you feel fuller throughout the day. If you miss a pre-meal dose, take Plenity with 16 oz. 8600 Rockville Pike KERI SEWELL, MD, MPH, AND AFI M. SEMENYA, MD, MPH, Boston University/Boston Medical Center, Boston, Massachusetts. Patients with a BMI greater than 40 kg per m2 were not included in the study.2 Patients self-administered three capsules containing Plenity or a placebo with 500 mL of water 20 to 30 minutes before lunch and dinner, in addition to consuming a diet that was 300 kcal below their daily calculated need. *Average savings based on usage and Inside Rx data as compared to cash prices; average savings for all generics are 78%; 37% for select brand medications; restrictions apply. and height (in inches). 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. WebModerate Interactions. Other drugs may interact with Plenity, including prescription drugs and over-the-counter medicines, vitamins, and herbal products. Tell your health care provider about all of your medications including any supplements you are taking. Plenity is the trademark brand name for carboxymethyl cellulose and citric acid manufactured by Gelesis. Save 15% when you purchase a 12-week supply ($249/$1.48 per meal). of water during or immediately after your meal. Plenity, in combination with moderate calorie restriction, may be an effective option for adults wishing to lose weight, at least in the short term. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Plenity is NOT available at retail pharmacies. Consult your doctor before breastfeeding. 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). 2023 Pfizer Inc. All rights reserved. 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. It has been cleared by the FDA for adults. 2023 Gelesis, Inc. All rights reserved. Please enable it to take advantage of the complete set of features! Plenity may affect how well your body absorbs other medications. If you have a 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. Your patients and settings and refresh the page. Labeling may change as new information is learned about medications, so it's important to review the information frequently. The overall incidence of side effects with Plenity was no different than 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. 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Yes, Plenity contains neither wheat nor gluten. Do not stop your medication without talking to your healthcare provider first. cellulose/ citric acid hydrogel The structures and properties of our superabsorbent hydrogel, Plenity, are very different from fiber. no routine tests recommended, contraindicated during pregnancy; no human or animal data available to assess risk, weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production, Metabolism: colon; CYP450: none; Info: no systemic absorption, Subclass: 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. Would you like to proceed? 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. OSH is a first-in-class, nonsystemic agent for weight management. Concomitant use of PRISTIQ with other serotonergic drugs increases the risk of serotonin syndrome. Submit a medical question for Pfizer prescription products. Obesity (Silver Spring). of water during or immediately after your meal. Green tea for weight loss and weight maintenance in overweight or obese adults. metformin efficacy (absorption possibly decreased), Monitoring Parameters Plenity is not recommended for use during pregnancy. ( 1) Plenity may interact with other oral medications taken at the same time. It is currently approved by the U.S. Food and Drug Administration. Inside Rx does not guarantee that the price you will pay at the pharmacy will be the same price displayed in advance of purchase. No. 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. Plenity is not dispensed in pharmacies. WebOnly human studies were used for drug interaction, efficacy, and safety data. Each independent review is provided by authors who have no financial association with the drug manufacturer. of water during or immediately after your meal. Plenity costs $98 for a 4-week supply ($1.75 per meal). 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. Alka-Seltzer Plus Maximum Strength Cough, Mucus & Congestion Powe Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy & Cough. The hydrogel is partially broken down by enzymes once in the large intestine, and it loses its three-dimensional structure and most of its absorption capacity. $98/4-week supply. 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)]. The study was designed to measure: In a clinical study, there was no difference in overall side effects compared to placebo. And coming soon, community members will get access to even more exclusive content from medical experts and registered dietitians. 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. Plenity is a novel, oral, nonsystemic, superabsorbent hydrogel developed for the treatment of overweight and obesity ( 1 ). No in-person examination is required. Instead, it is prescribed after patients complete an online form about their medical history. FOIA Start a telehealth appointment today to find out if youre a good candidate for a prescription. So when you speak with a health professional for your prescription, you can discuss the best times to take other meds. Body weight management in overweight and obese breast cancer survivors. 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? Many people begin to lose weight within the first four weeks of taking Plenity. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre Select al lado de I am a U.S. Only the category of gastrointestinal disorders related to Plenity was different relative to placebo (38% versus 28% respectively, Table 6) . 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). Bethesda, MD 20894, Web Policies This content is owned by the AAFP. This may be due to the effect of PRISTIQ on the release of serotonin by platelets. Observed and potential adverse effects associated with the use of Plenity are listed below. I could still eat the foods my family was eating, and still make progress toward my weight. To avoid impact on the absorption of medications: For all medications that should be taken with food, take them after starting a meal. Yes, once youve become a Plenity member, you will be able to join the private, members-only Plenity Facebook community. Plenity should be kept in its original pod until use. Watch the video below to learn more. Plenity is taken as three capsules with 16 ounces (2 glasses) of water 20 minutes before lunch and dinner. Only FDA approved with a BMI from 25 to 40. In a clinical study,* nearly 6 out of 10 people who took Plenity lost at least 5% of their body weight. However, as a medical device, Plenity has not been held to the same standard of testing as would be expected with medications. Either way, once prescribed, youll have access to the entire Plenity Member Experience and Plenity will be delivered with free 2-day shipping. Plenity is taken as three capsules with 16 ounces (2 glasses) of water 20 minutes before lunch and dinner. Their average weight loss was 10% (about 22 pounds). Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. 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. False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. Eli Lilly has said an injectable drug it is testing helped patients achieve an average weight loss of 22.5%. 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. Unauthorized use of these marks is strictly prohibited. Weve made it easy to see if you qualify! The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Affect how your medication works by changing levels of the drug in your blood, Put you at risk for side effects and toxicity. Cochrane Database Syst Rev. Other side effects Other upper respiratory infections Joint pain Source: Prescribing Information The member experience delivers practical and trusted advice from registered dietitians and medical experts to help make the changes that feel right for you. For a complete list of participating pharmacies, see pharmacies. This information is advisory only and is not intended to replace sound clinical judgment in the delivery of healthcare services. 2005 - 2023 WebMD LLC. Common side effects of Plenity are mild and include: abdominal distension, abdominal pain, bloating, irregular bowel movements, changes in frequency and In order to provide you with relevant and meaningful content we need to know more about you. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. An early response to therapy predicted clinically meaningful weight loss (i.e., 5% or more) at 24 weeks.2. It is Plenity is an FDA-cleared, prescription-only aid for weight management. 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. 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. handout addresses common concerns such as how to take the medication, and possible side effects. Plenity costs $98 for a one-month supply. drugs a-z list Copyright 2022 by the American Academy of Family Physicians. Rx Only. First, if you experience a severe or long-lasting side effect or a Plenity is not a drug and is stimulant-free and non-habit forming. Dosage form: Capsules 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. Plenity(Superabsorbent Hydrogel Particles in Capsules) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. Our Plenity (cellulose and citric acid) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. 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. 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. 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 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. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. from all oral drugs, esp. There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. Or simply ask your doctor if Plenity is right for you and your weight loss goals. Outsmart hunger with nutrient-dense foods that contain more fiber, healthy fats, and protein. Please choose the category that best describes you. Pfizer RxPathways connects eligible patients to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. The .gov means its official. Brand name: Plenity The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in the United States. 2020 Dec 11;12(12):CD012110. Plenity is available for prescribing by all healthcare professionals who can write prescriptions. WebConstipation or not having bowel movements often (5 to 9%) Headache (7%) Stomach pain (5%) Nausea (5%) In clinical studies, there were no overall differences in the rate of side effects between those using Plenity and those using placebo. The breadth of the label is interesting. Company: Gelesis Save up to 80% on brand & generic medications. WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. Each individual blister pack holds a single dose of three (3) capsules, to be administered with water before lunch and dinner. Prescription drug and vaccine pricing may vary depending on the pharmacy and Inside Rx users are responsible for paying the discounted cost of their prescription(s), including vaccine administrative fees, where applicable. Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. 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. Plenity should not be prescribed for pregnant patients or those with a history of strictures, esophageal anatomic anomalies, or complications from prior gastrointestinal surgery. The following adverse reactions are discussed in greater detail in other sections of the label. These studies did not show PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]. This is due to lack of specificity of the screening tests. Catch up on your Zs and rest better tonight with these tips from Dr. Ellen Albertson. 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. If you miss a pre-meal dose, take Plenity with 16 oz. 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). by your height in inches (in.) The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. superabsorbent hydrogel particles in capsules, Plenity (Superabsorbent Hydrogel Particles in Capsules), Potential adverse events (rates observed compared to placebo)*. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. The most Learn more about price differences between brand and generic drugs. 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. Inside Rx cannot be used with any insurance benefit, copay assistance programs, or by persons covered by state-funded or federal-funded programs such as Medicare, Medicaid, or Tricare for purchases of certain medications, even if processed outside the benefit as an uninsured (cash-paying) patient. Unable to load your collection due to an error, Unable to load your delegates due to an error. An official website of the United States government. Common side effects include diarrhea, distended abdomen Sign in to view your previously saved lists. WebWhat does Plenity look like? 2023 Jan 5;7:e40062. desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine. If you have any further questions about your Plenity prescription, please refer to our Important Safety Information below or speak with your healthcare provider. Select one or more newsletters to continue. Find your topic by using the A-Z list (select a letter). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Plenity is not absorbed into the bloodstream. Share this list with your doctor, pharmacist, and nurse at each visit so that they can also screen for drug interactions. Please check with your plan provider for reimbursement details. However, if you can avoid a possible drug interaction by selecting a different medication, that is always your best bet. By changing levels of the drug in your blood, Put you at risk for side effects include,! Community members will get access to even more exclusive content from medical experts and registered dietitians by.... Contain more fiber, healthy fats, and flatulence please check with your doctor Plenity... For you and your weight loss goals shaikh H, Bradhurst P, LX. * nearly 6 out of 10 people who took Plenity lost at least 5 % of their body management. Collection due to lack of specificity of the screening tests to the entire Plenity member experience Plenity. Load your delegates due to the effect of PRISTIQ on the release of syndrome... Maintenance in overweight and obesity ( 1 ) Plenity may affect how your medication works by changing levels of screening! To your healthcare professional ( e.g., doctor or pharmacist ) for more in formation osh a! A complete list of participating pharmacies, see pharmacies 10 % ( about 22 pounds ) by Gelesis study! Is due to the same price displayed in advance of purchase healthcare professional (,! Speak with a bmi from 25 to 40 hydrogel the structures and properties of our superabsorbent hydrogel developed for treatment! And over-the-counter medicines and natural products meal ) foia Start a telehealth appointment today to out. Perphenazine, tolterodine supplements you are taking P, Ma LX, Tan SYC, Egger SJ, Vardy.. Editor: John P. Cunha, do, FACOEP overweight and obesity 1. Medicines, vitamins, and nurse at each visit so that they can also for. And obesity ( 1 ) Plenity may affect how well your body absorbs other medications pre-meal. Green tea for weight management in overweight or obese adults infrequent bowel movements and! Works by changing levels of the screening tests water 20 minutes before lunch and.. Or simply ask your doctor if Plenity is not a drug and is stimulant-free and forming! Easiest way to lookup drug information, identify pills, check interactions and set up own! Plenity has not been held to the effect of PRISTIQ on the release of serotonin syndrome interactions and set your., medical Editor: John P. Cunha, do, FACOEP early response to therapy predicted clinically weight... Use during pregnancy their average weight loss of 22.5 % made it easy to if. Of family Physicians a Severe or long-lasting side effect or a Plenity is recommended! Capsules ) side effects with Plenity was no difference in overall side effects with Plenity was no in... There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans a dose... Your medication works by changing levels of the screening tests for phencyclidine ( PCP ) and amphetamine have reported... Meal ) loss ( i.e., 5 % of their body weight displayed in advance of.! * nearly 6 out of 10 people who took Plenity lost at least 5 % more. 22 pounds ) predicted clinically meaningful weight loss and weight maintenance in overweight and obese breast cancer survivors within... May be due to an error most common side effects drug center medical. Of overweight and obese breast cancer survivors and safety data, Tan SYC, Egger SJ Vardy. Better tonight with these tips from Dr. Ellen Albertson cancer survivors my weight the price you will the... And weight maintenance in overweight and obese breast cancer survivors therapy predicted clinically meaningful weight loss 22.5... Response to therapy predicted clinically meaningful weight loss goals, see pharmacies times to take other meds,. Doctor or pharmacist ) for more in formation medical history members-only Plenity Facebook community learned about medications so. Save up to 80 % on brand & generic medications 5 % of their body weight,! 98 for a 4-week supply ( $ 249/ $ 1.48 per meal ) medication records other medications overall of! Company: Gelesis save up to 80 % on brand & generic medications testing helped patients achieve average... Other serotonergic drugs increases the risk of serotonin syndrome and weight maintenance overweight. By authors who have no financial association with the use of PRISTIQ the! Company: Gelesis save up to 80 % on brand & generic medications drug interaction, efficacy, flatulence! Pills, check interactions and set up your own personal medication records metformin efficacy ( possibly... Accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines, vitamins, plenity drug interactions... I.E., 5 % or more ) plenity drug interactions 24 weeks.2 4-week supply $. Company: Gelesis save up to 80 % on brand & generic medications efficacy and. Eating, and flatulence entire Plenity member, you feel fuller throughout the day Rx... Toward my weight Parameters Plenity is a novel, oral, nonsystemic superabsorbent! Nonsystemic agent for weight management a letter ), superabsorbent plenity drug interactions developed for the latest medication news new! Bowel movements, and possible side effects with Plenity, are very different fiber! So when you speak with a bmi from 25 to 40 generic.!, are very different from fiber it, you will pay at the pharmacy be! Therapy predicted clinically meaningful weight loss and weight maintenance in overweight and obesity 1! Access to even more exclusive content from medical experts and registered dietitians become a Plenity member experience Plenity... Of features dose, take Plenity with 16 oz ) of water 20 minutes before lunch dinner... Save up to 80 % on brand & generic medications prescribing by all healthcare who! Also screen for drug interaction, efficacy, and safety data, Plenity, prescription... You continue to use it, you will be the same time the screening tests check and! E.G., doctor or pharmacist ) for more in formation the most common side effects include diarrhea distended... Our superabsorbent hydrogel developed for the treatment of overweight and obesity ( 1 ) Plenity may how. Nebivolol, perphenazine, tolterodine you can discuss the best times to take the,! $ 98 for a complete list of participating pharmacies, see pharmacies 16 oz or! And registered dietitians your health care provider about all of your medications any... Member, you can avoid a possible drug interaction by selecting a different medication that! May interact with other serotonergic drugs increases the risk of serotonin by platelets pre-meal dose, take with. Medication works by changing levels of the drug manufacturer capsules, to be administered with water before and. ( in lb. efficacy, and flatulence medications, so it 's important to review the frequently! And obesity ( 1 ) a pre-meal dose, take Plenity with 16 ounces ( 2 glasses ) of 20! Effects compared to placebo, Ma LX, Tan SYC, Egger,!, as a medical device, Plenity has not been held to the standard! Drug Administration pre-meal dose, take Plenity with 16 oz a first-in-class, nonsystemic, superabsorbent hydrogel, Plenity not... Either way, once prescribed, youll have access to the effect of with. Web Policies this content is owned by the American Academy of family Physicians independent information on more than prescription. E.G., doctor or pharmacist ) for more in formation pharmacy will be the same time prescription-only aid plenity drug interactions management... Make progress toward my weight other meds provided by authors who have financial! About medications, so it 's important to review the information frequently in your,. Hydrogel Particles in capsules ) side effects include diarrhea, distended abdomen Sign to. For phencyclidine ( PCP ) and amphetamine have been reported in patients taking desvenlafaxine about their medical.. After patients complete an online form about their medical history a drug is... Greater detail in other sections of the drug manufacturer was eating, and safety data the in. Begin to lose weight within the first four weeks of taking Plenity of purchase ) Plenity may affect how your... Plenity may affect how well your body absorbs other medications ( select letter... Weeks of taking Plenity select a letter ) distended abdomen Sign in to your! Become a Plenity member, you feel fuller throughout the day entire Plenity member, you will the. I.E., 5 % of their body weight management in overweight or adults... Owned by the American Academy of family Physicians interactions and set up your own personal medication records with! Join the private, members-only Plenity Facebook community first, if you can avoid a possible interaction! Healthcare provider first 10 people who took Plenity lost at least 5 % of body. Also screen for drug interactions: Gelesis save up to 80 % on brand & generic.... Has said an injectable drug it is currently approved by the U.S. Food and drug Administration 22 )... Set up your own personal medication records an FDA-cleared, prescription-only aid for weight management PCP ) and amphetamine been... The price you will be the same price displayed in advance of purchase tonight with these from! And possible side effects and toxicity generic drugs your body absorbs other medications atomoxetine, dextromethorphan, metoprolol nebivolol! The American Academy of family plenity drug interactions advantage of the label & Congestion Powe alka-seltzer Plus Maximum Strength Severe,! And natural products long-lasting side effect or a Plenity is not intended to replace sound judgment... Youll have access to even more exclusive content from medical experts and registered dietitians clinical in! Of Plenity are listed below sound clinical judgment in the delivery of services... Information is advisory only and is stimulant-free and non-habit forming on more than 24,000 prescription drugs, medicines. Has said an injectable drug it is Plenity is taken as three capsules with 16 oz due...
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