The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in the United States. Plenity is not a drug and is stimulant-free and non-habit forming. Rx Only. official website and that any information you provide is encrypted Usually, your doctor and pharmacist will have already done this with your prescription medications, but it's a good idea to double check and learn about these medications yourself. Create a FREE Epocrates Online account to access patient medication instructions. 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: MeSH Horn DB, Pash E, Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. JMIR Form Res. The result can be muscle pain, or even severe muscle injury known as rhabdomyolysis. Sign up to get the Blog newsletter featuring recent news, trending health topics and savings opportunities! We combine an FDA-cleared weight loss aid with science-backed resources from behavioral science, nutritional research, and psychology to help you take steps toward meaningful change. Plenity costs $98 for a 4-week supply ($1.75 per meal). The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). government site. The most common side effects were fullness, bloating, flatulence, and/or abdominal pain. Unauthorized use of these marks is strictly prohibited. However, as with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking PRISTIQ. *If a pre-meal dose is missed, take Plenity during or immediately after that meal. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. Or simply ask your doctor if Plenity is right for you and your weight loss goals. This series is coordinated by Allen F. Shaughnessy, PharmD, assistant medical editor. You can visit MyPlenity.com to start an online consultation where youll be asked to share your medical history and answer general health questions with a licensed physician. Selected from data included with permission and copyrighted by First Databank, Inc. Sign in to view your previously saved lists. The products discussed herein may have different product labeling in different countries. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Within 14 days of stopping an MAOI intended to treat psychiatric disorders. Inside Rx does not guarantee that the price you will pay at the pharmacy will be the same price displayed in advance of purchase. 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 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). Consult your doctor before breastfeeding. False positive test results may be expected for several days following discontinuation of desvenlafaxine therapy. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. OSH functions primarily through space occupancy in the stomach and small intestine. Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre Select al lado de I am a U.S. Because Plenity should not be used without food (it is meant to be taken 2030 minutes before a meal), this 2023 Gelesis, Inc. All rights reserved. Abstracts and posters were identified from relevant scientific congress archives and published supplements. 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). This is not a complete list of side effects and others may occur. Concomitant use of PRISTIQ is contraindicated: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. 2012 Dec 12;12(12):CD008650. Their average weight loss was 10% (about 22 pounds). If serotonin syndrome occurs, consider discontinuation of PRISTIQ and/or concomitant serotonergic drugs, other SNRIs, SSRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, tryptophan, and St. John's Wort. No in-person examination is required. Please change your Body weight management in overweight and obese breast cancer survivors. Author disclosure: No relevant financial relationships. Original dose should be taken when co-administered with PRISTIQ 100 mg or lower. Catch up on your Zs and rest better tonight with these tips from Dr. Ellen Albertson. WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. These medications may cause some risk when taken together. Plenity(Superabsorbent Hydrogel Particles in Capsules) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. It is We comply with the HONcode standard for trustworthy health information. Dosage form: Capsules handout addresses common concerns such as how to take the medication, and possible side effects. Watch the video below to learn more. from all oral drugs, esp. Disclaimer. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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. Get everything Plenity offers for just $1.75 per meal. $98/4-week supply. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish desvenlafaxine from PCP and amphetamine. 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 wasnt restrictive. As you continue to use it, you feel fuller throughout the day. Observed and potential adverse effects associated with the use of Plenity are listed below. Plenity costs $98 for a one-month supply. Last updated by Judith Stewart, BPharm on May 13, 2019. and height (in inches). doi: 10.1002/14651858.CD008650.pub2. 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. 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. Major drug interactions that are life-threatening are not common, but are of serious concern. 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. No serious adverse effects were observed in the patients taking Plenity.1 Hypersensitivity to any component of the formulation is a contraindication. However, as a medical device, Plenity has not been held to the same standard of testing as would be expected with medications. This content is intended for U.S. Healthcare Professionals. Concomitant use of PRISTIQ with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. 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. 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)]. of water during or immediately after your meal. Learn more about price differences between brand and generic drugs. To avoid impact on the absorption of medications: For all medications that should be taken with food, take them after starting a meal. For current full prescribing information, please visit www.pfizer.com. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com. The particles break down in the colon and are excreted in the stool without being absorbed. settings and refresh the page. 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 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. Cochrane Database Syst Rev. Brand name: Plenity monograph. Web7.3 Alcohol A clinical study has shown that PRISTIQ does not increase the impairment of mental and motor skills caused by ethanol. In fact, for some drugs, stopping the medication could also affect the levels of other drugs in your system. You do not need to meet with a physician in person to get Plenity! 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. Adverse events have been monitored in three (3) clinical trials, as noted in Section 8. sharing sensitive information, make sure youre on a federal To calculate your BMI, divide your weight in pounds (lb.) WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. The overall incidence of side effects with Plenity was no different than placebo. Contact a doctor right away if problems occur. 12/2021, https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_calculator/bmi_calculator.html, whether at least 35% of individuals receiving Plenity lost 5% of their body weight, in a clinical trial, 59% of Plenity responders lost on average 10% of their body weight (22 pounds) in six months, whether individuals receiving Plenity lost 3% more of their body weight than individuals receiving placebo. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. 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. Each independent review is provided by authors who have no financial association with the drug manufacturer. WebWhen you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Plenity helps you eat less, so you can lose weight. Please enable it to take advantage of the complete set of features! In comparison, phentermine costs about $15 per month, and generic topiramate costs $20 per month. Note that prescriptions can only be filled by GoGoMeds, a mail order pharmacy. Ask your pharmacist or doctor for advice if you are confused by the medical jargon. Any person under the age of 22 should not take Plenity. Weve made it easy to see if you qualify! 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. For a full list of Inside Rx program terms see full terms or call 800-722-8979. 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. 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. Objective: *Plenity (n=223) or placebo (n=213) was administered to 436 adults with excess weight or obesity, with or without type 2 diabetes. 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. Bethesda, MD 20894, Web Policies It is made from naturally derived building blockscellulose and citric acid. This Medication Guide has been approved by the U.S. Food and Drug Administration. 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. metformin, monitor glucose: combo may decr. Plenity should not be prescribed for pregnant patients or those with a history of strictures, esophageal anatomic anomalies, or complications from prior gastrointestinal surgery. With Plenity, you may find it easier to eat less and feel satisfied within weeks of starting your new routine. Yes, Plenity contains neither wheat nor gluten. Bookshelf Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. 2005 - 2023 WebMD LLC. The .gov means its official. Create a FREE Epocrates Online account to access full-color images of medications within the drug 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. Plenity may be an FDA approved weight loss aid, but it is not ideal. It's always best to ask your healthcare provider for the latest information on drug interactions. WebMD does not provide medical advice, diagnosis or treatment. Data synthesis: OSH is a first-in-class, nonsystemic agent for weight management. Drugs Comparison A-Z List. Keep an up-to-date list of your medications, over-the-counter products, vitamins, herbals, and medical conditions. 01/2022, Take three capsules with water 20 minutes before lunch and dinner.*. Plenity has been shown to be effective, safe and well-tolerated in clinical studies. Check for drug interactions and save your list for future reference. 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. There was no significant change in cardiovascular risk markers over six months of treatment compared with placebo. 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).*. Type a drug name in the box above to get started. False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. Inside Rx is administered by Inside Rx, LLC, 1 Express Way, St. Louis, MO 63121 . 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 miss a pre-meal dose, take Plenity with 16 oz. You should check with your insurance carrier to see if Plenity is covered for you. Plenity is not indicated for anyone under the age of 22. No gimmicks, just science-backed resources to help support your weight management journey. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. In a single clinical trial of 436 patients, there were no differences in rates of adverse effects between those taking Plenity (n = 223) and those taking placebo (n = 213). The overall incidence of side effects with Plenity was no different than placebo. Age restrictions may apply to the purchase of certain drugs. Before So when you speak with a health professional for your prescription, you can discuss the best times to take other meds. All rights reserved. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. Epub 2018 Nov 13. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. of water during or immediately after your meal. Company: Gelesis Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Plenitys potential side effects include gastrointestinal problems such as obstruction, diarrhea, constipation, and also dehydration and oddly enough weight gain. No deaths occurred during the trial. Reduce the dose of these drugs by up to one-half if co-administered with 400 mg of PRISTIQ. Many people begin to lose weight within the first four weeks of taking Plenity. Plenity is not recommended for use during pregnancy. Characteristics and Weight Loss Practices From a Cohort of 20,000 Patients Using Direct-to-Consumer Telehealth: Observational Cross-sectional Study. Please e-prescribe Plenity to GoGoMeds Pharmacy in Southgate, KY, or fax to (877) 766-0185. 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. This product's label may have been updated. BMI is calculated using your weight (in lb.) 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. Select one or more newsletters to continue. Contact a doctor right away if problems occur. Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity. STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. 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. If you miss a pre-meal dose, take Plenity with 16 oz. 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 However, if you can avoid a possible drug interaction by selecting a different medication, that is always your best bet. Treatment for: Weight Loss (Obesity/Overweight). cellulose/ citric acid hydrogel Concomitant use of PRISTIQ with other serotonergic drugs increases the risk of serotonin syndrome. 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 by your height in inches (in.) squared, and then multiply by a factor of 703. 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. This information might be about you, your preferences or your device. See additional information. To get Plenity, visit MyPlenity.com to start an online consultation. These studies did not show PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]. Save 15% when you purchase a 12-week supply ($249/$1.48 per meal). It is currently approved by the U.S. Food and Drug Administration. 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. To avoid impact on the absorption of medications: For all medications that should be taken with food, take them after starting a meal. Relevance to patient care and clinical practice: In this article, dietitian Nicole German Morgan dives into the scientific evidence. A clinical study has shown that PRISTIQ does not increase the impairment of mental and motor skills caused by ethanol. doi: 10.2196/40062. Plenity is NOT available at retail pharmacies. This is due to lack of specificity of the screening tests. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Obesity (Silver Spring). Patients should take three capsules twice per day with 500 mL of water 20 minutes before lunch and dinner. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with PRISTIQ. This site needs JavaScript to work properly. This action works to create increased bulk, thus signaling satiety. 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. It has been cleared by the FDA for adults. doi: 10.1002/14651858.CD012110.pub2. Or speak with your doctor to find out if Plenity is appropriate for you and your weight goals. An official website of the United States government. 2023 Pfizer Inc. All rights reserved. Accessibility However, PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Our scientific content is evidence-based, scientifically balanced and non-promotional. I could still eat the foods my family was eating, and still make progress toward my weight. How much weight can I expect to lose while taking Plenity? 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. Please e-prescribe Plenity to GoGoMeds Pharmacy in Southgate, KY, or fax to (877) 766-0185. Remember - drug interactions are usually preventable with your proactive efforts. Can I use my HSA/FSA/MSA to pay for Plenity? WebModerate Interactions. 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 is taken with water twice a day, 20 to 30 minutes before lunch and 20 to 30 minutes before dinner. 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. It is an FDA-cleared medical device available only by prescription. First, if you experience a severe or long-lasting side effect or a Plenity is NOT available at retail pharmacies. Plenity is a novel, oral, nonsystemic, superabsorbent hydrogel developed for the treatment of overweight and obesity ( 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). If you have a Take these 20 minutes to plan your meal and focus on you. And coming soon, community members will get access to even more exclusive content from medical experts and registered dietitians. Do I need to see a doctor in person to get Plenity? All Rights Reserved. Each individual blister pack holds a single dose of three (3) capsules, to be administered with water before lunch and dinner. For instance, a person who is 200 lb. To describe the mechanism, clinical trial data, adverse effects, and potential role in therapy of an oral superabsorbent hydrogel (OSH) for weight management. 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. PMC WebWhat does Plenity look like? The capsule for Plenity is made with gelatin, which is a porcine-derived product. Copyright 2022 by the American Academy of Family Physicians. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Plenity may interact with other oral medications taken at the same time. Each 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. The number of patients with any adverse event leading to study withdrawal was similar between groups. Instead, it is prescribed after patients complete an online form about their medical history. Common side effects include diarrhea, distended abdomen antihemophilic factor (factor VIII, human)/von Willebrand factor antihemophilic factor (factor VIII, recombinant). 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. Read the entire FDA prescribing information for Plenity (Superabsorbent Hydrogel Particles in Capsules). If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. ( 1) 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.
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