Type a drug name in the box above to get started. To calculate your BMI, divide your weight in pounds (lb.) Plenity is not absorbed into the bloodstream. This information is currently not available for this drug. It works by inducing a feeling of fullness so that patients eat less and lose weight. 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. Plenity prescriptions can ONLY be filled by GoGoMeds Pharmacy. Each individual blister pack holds a single dose of three (3) capsules, to be administered with water before lunch and dinner. In both treatment groups, most (>95%) adverse events were assessed by the investigator as mild or moderate in intensity. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Links to sites outside of Pfizer Medical Information are provided as a resource to the viewer. Peds dosing is currently unavailable or not applicable for this drug. WebPlenity reduces metformin absorption when taken without food. Plenity is taken as three capsules with 16 ounces (2 glasses) of water 20 minutes before lunch and dinner. 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. Rather, the hydro-gel capsule releases gel particles containing cellulose and citric acid that absorb water in the stomach and small intestine, expanding significantly in size. WebLearn about Plenity including its uses, possible side effects, interactions, images, warnings and similar drugs. Dosage form: Capsules See additional information. ( 1) The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Green tea for weight loss and weight maintenance in overweight or obese adults. The most Treatment for: Weight Loss (Obesity/Overweight). 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 Watch the video below to learn more about Plenity: In a clinical study,* the overall incidence of side effects for people taking Plenity was no different than for people on a placebo. Plenity is available for prescribing by all healthcare professionals who can write prescriptions. 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. Plenity has been shown to be effective, safe and well-tolerated in clinical studies. 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. The gel pieces increase the volume and elasticity of the stomach and small intestine contents, contributing to a feeling of fullness and inducing weight loss. This interaction can occur with the commonly used statins to lower cholesterol, like atorvastatin, lovastatin, or simvastatin. It is antihemophilic factor (factor VIII, human)/von Willebrand factor antihemophilic factor (factor VIII, recombinant). *If a pre-meal dose is missed, take Plenity during or immediately after that meal. 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 ). Ask your pharmacist or doctor for advice if you are confused by the medical jargon. PMC FDA Approved: Yes (First approved April 12, 2019) Author disclosure: No relevant financial relationships. Do I need to see a doctor in person to get Plenity? If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. However, if you can avoid a possible drug interaction by selecting a different medication, that is always your best bet. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Plenity is a prescription-only weight loss aid. This Medication Guide has been approved by the U.S. Food and Drug Administration. of water during or immediately after your meal. 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. 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). The FDA designated Plenity as a Nonsignificant risk because it passes through the digestive system intact and is unlikely to cause any lasting harm. 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). Most drug interactions are not serious, but because a few are, it is important to understand the possible outcome before you take your medications. 2020 Dec 11;12(12):CD012110. and height (in inches). Submit a medical question for Pfizer prescription products. desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine. Plenity is NOT available at retail pharmacies. Please enable it to take advantage of the complete set of features! To get Plenity, visit MyPlenity.com to start an online consultation. Youll have an answer within 24 hours. 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 Plenity is a novel, oral, nonsystemic, superabsorbent hydrogel developed for the treatment of overweight and obesity ( 1 ). 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 ). Horn DB, Pash E, Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. JMIR Form Res. individuals on Plenity lost on average 6% vs individuals on placebo, who lost on average 4%. WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. Learn How Genetics Make Some Fans of Fear, Dr. Whyte's Book: Take Control of Your Cancer Risk, How Breast Cancer Changed My Life and Me, Health News and Information, Delivered to Your Inbox. Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity. Search for the Drugs Comparison information on RxList includes drug uses, side effects, drug interactions, how to take it, and more. Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy & Cough Alka-Seltzer Plus Maximum Strength Sinus & Cold PowerMax, Alka-Seltzer Plus Maximum Strength Sinus & Cold PowerMax Night. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Our scientific content is evidence-based, scientifically balanced and non-promotional. 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. Drug interactions can also contribute to the cost of healthcare, as a serious drug interaction could result in injury, hospitalization, or rarely, death. Share this list with your doctor, pharmacist, and nurse at each visit so that they can also screen for drug interactions. The overall incidence of side effects with Plenity was no different than placebo. Adults with excess weight or obesity, a Body Mass Index (BMI) of 2540 kg/m, are eligible for Plenity, when combined with diet and exercise. Find your topic by using the A-Z list (select a letter). Clipboard, Search History, and several other advanced features are temporarily unavailable. Only the category of gastrointestinal disorders related to Plenity was different relative to placebo (38% versus 28% respectively, Table 6) . The products discussed herein may have different product labeling in different countries. sharing sensitive information, make sure youre on a federal of water during or immediately after your meal. Weve made it easy to see if you qualify! Can I use my HSA/FSA/MSA to pay for Plenity? Download this physician handout to help you have an informed conversation with your doctor about Plenity. Being proactive in your own health, checking for drug interactions, and discussing concerns with your healthcare provider can be a life-saving task. 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. 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. The .gov means its official. In this article, dietitian Nicole German Morgan dives into the scientific evidence. 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. This action works to create increased bulk, thus signaling satiety. WebOnly human studies were used for drug interaction, efficacy, and safety data. Before 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. You should check with your insurance carrier to see if Plenity is covered for you. 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)]. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Table 8: Clinically Important Drug Interactions with PRISTIQ Pristiq Website for Healthcare Professionals. Last updated by Judith Stewart, BPharm on May 13, 2019. Your patients and You may report side effects to FDA at 1-800-FDA-1088. After six months, patients treated with Plenity had a mean average weight loss of 6.4% compared with 4.4% in those receiving placebo. Is Plenity covered by my medical insurance? No gimmicks, just science-backed resources to help support your weight management journey. Reduce the dose of these drugs by up to one-half if co-administered with 400 mg of PRISTIQ. Federal government websites often end in .gov or .mil. Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity. Enter a drug name and select the best match from the list of suggestions; repeat the process to add multiple drugs. Characteristics and Weight Loss Practices From a Cohort of 20,000 Patients Using Direct-to-Consumer Telehealth: Observational Cross-sectional Study. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. You can either ask your healthcare provider about Plenity, or visit MyPlenity.com to start a telehealth experience with a licensed physician. Contact a doctor right away if problems occur. For instance, a person who is 200 lb. 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. The following adverse reactions are discussed in greater detail in other sections of the label. $98/4-week supply. Call your doctor for medical advice about side effects. Check for drug interactions and save your list for future reference. Plenity (cellulose and citric acid) is an oral capsule that promotes fullness and may help to increase satiety to help patients manage their weight and is indicated to aid in weight management in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise. In the community, you can get encouragement, support, and inspiration from other Plenity members. Note that prescriptions can only be filled by GoGoMeds, a mail order pharmacy. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is expelled in the feces. Plenity is administered in the form of capsules taken with water before lunch and dinner. Disclaimer. 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. Would you like to proceed? In a clinical study,* nearly 6 out of 10 people who took Plenity lost at least 5% of their body weight. Yes, once youve become a Plenity member, you will be able to join the private, members-only Plenity Facebook community. Tell your doctor all medications and supplements you use. If you miss a pre-meal dose, take Plenity with 16 oz. from all oral drugs, esp. Company: Gelesis National Library of Medicine In fact, for some drugs, stopping the medication could also affect the levels of other drugs in your system. US-PLEN-2000613 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. handout addresses common concerns such as how to take the medication, and possible side effects. Plenity may be an FDA approved weight loss aid, but it is not ideal. For a complete list of participating pharmacies, see pharmacies. 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. 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. Only FDA approved with a BMI from 25 to 40. Consult your doctor before breastfeeding. 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. 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. Most drug interactions listed in package labeling may be theoretical based on a drug's pharmacology. Developed, clinically tested, and manufactured by Gelesis. Create a FREE Epocrates Online account to access patient medication instructions. Manufactured by Gelesis package labeling may be able to join the private, members-only Plenity Facebook.. Both treatment groups, most ( > 95 % ) adverse events were assessed by the as... Online consultation human ) /von Willebrand factor antihemophilic factor ( factor VIII, human ) /von factor! 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