Plenity is not dispensed in pharmacies. Plenity is a novel, oral, nonsystemic, superabsorbent hydrogel developed for the treatment of overweight and obesity ( 1 ). In a premarketing study of 436 people, dropout rates from adverse effects (4%) were similar in the treatment and placebo groups.1, Data are limited about the effectiveness of Plenity. OSH offers a nonsystemic approach to weight management for patients who are diagnosed with overweight or obesity. Consult your doctor before breastfeeding. 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. For current full prescribing information, please visit www.pfizer.com. Contact a doctor right away if problems occur. It undergoes rigorous internal medical review and is updated regularly to reflect new information. *If a pre-meal dose is missed, take Plenity during or immediately after that meal. 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. Relevance to patient care and clinical practice: This series is coordinated by Allen F. Shaughnessy, PharmD, assistant medical editor. To calculate your BMI, divide your weight in pounds (lb.) It is indicated for use in patients with a body mass index (BMI) of 25 to 40 kg/m2 regardless of comorbidity status. Careers. Plenity has been shown to be effective, safe and well-tolerated in clinical studies. 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. Inside Rx is administered by Inside Rx, LLC, 1 Express Way, St. Louis, MO 63121 . Their average weight loss was 10% (about 22 pounds). and transmitted securely. How do I unlock the full Plenity Member Experience? 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. This content is intended for U.S. Healthcare Professionals. Youll have an answer within 24 hours. No related drugs found for this medication. 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. Save up to 80% on brand & generic medications. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. 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. 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. These studies did not show PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]. metformin efficacy (absorption possibly decreased), Monitoring Parameters However, as with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking PRISTIQ. Plenity is the first and only FDA-cleared weight management tool made from naturally derived building blockscellulose and citric acid. The water There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Type a drug name in the box above to get started. How can I get Plenity? It will also display any interactions between your chosen drug(s) and food, beverages, or a medical condition. oral superabsorbent hydrogel; preobesity; weight management. Contact a doctor right away if problems occur. US-PLEN-2100031
Enter a drug name and select the best match from the list of suggestions; repeat the process to add multiple drugs. MeSH Watch the video below to learn more. 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 NCI CPTC Antibody Characterization Program. Plenity Patient Information is supplied by Cerner Multum, Inc. and Plenity Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights. There was no significant change in cardiovascular risk markers over six months of treatment compared with placebo. This is not a complete list of side effects and others may occur. Aronne LJ, Anderson JE, Sannino A, Chiquette E. Obes Sci Pract. Plenity helps you eat less, so you can lose weight. of water during or immediately after your meal. Rx Only. As you continue to use it, you feel fuller throughout the day. Check for drug interactions and save your list for future reference. and height (in inches). We work directly with manufacturers and pharmacies to find you lower prices on thousands of prescription medications. 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: 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. The capsule for Plenity is made with gelatin, which is a porcine-derived product. All Rights Reserved. For a complete list of participating pharmacies, see pharmacies. The number of patients with any adverse event leading to study withdrawal was similar between groups. Our scientific content is evidence-based, scientifically balanced and non-promotional. 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. However, as a medical device, Plenity has not been held to the same standard of testing as would be expected with medications. WebBlood levels of an interacting drug may rise, leading to toxicity. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. Most drug interactions listed in package labeling may be theoretical based on a drug's pharmacology. Avoid these practices. WebPlenity reduces metformin absorption when taken without food. doi: 10.1002/14651858.CD008650.pub2. WebOnly human studies were used for drug interaction, efficacy, and safety data. To avoid impact on the absorption of medications: For all medications that should be taken with food, take them after starting a meal. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine. desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine. Alka-Seltzer Plus Maximum Strength Sinus Congestion & Pain PowerF Alka-Seltzer Plus Severe Cold & Cough PowerFast Fizz, Alka-Seltzer Plus Severe Cold & Flu Night, Alka-Seltzer Plus Severe Cold & Flu PowerFast Fizz, Alka-Seltzer Plus Severe Cold PowerFast Fizz, Alka-Seltzer Plus Severe Cold PowerFast Fizz Night, Alka-Seltzer Plus Severe Cold PowerFast Fizz Non-Drowsy, Alka-Seltzer Plus Severe Sinus, Cold & Cough, aluminum acetate topical (modified Burow's solution), aluminum hydroxide/magnesium hydroxide/simethicone, amyl nitrite/sodium nitrite/sodium thiosulfate, antihemophilic factor (factor VIII, human). Clipboard, Search History, and several other advanced features are temporarily unavailable. Plenity(Superabsorbent Hydrogel Particles in Capsules) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in 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 We comply with the HONcode standard for trustworthy health information. BMI is calculated using your weight (in lb.) Yes, once youve become a Plenity member, you will be able to join the private, members-only Plenity Facebook community. WebU.S. Accessibility 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. Plenity may interfere with medication absorption and should not be taken at the same time as other medications. 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. They generally lessen over time and with proper use of the drug. 2019 Feb;27(2):205-216. doi: 10.1002/oby.22347. Create a FREE Epocrates Online account to access full-color images of medications within the drug If you use any over-the-counter (OTC) medicine, including vitamins, herbal or food supplements, be sure to review these products for interactions with your prescription medications, too. How much weight can I expect to lose while taking Plenity? It wasnt restrictive. FDA Approved: Yes (First approved April 12, 2019) Federal government websites often end in .gov or .mil. caregivers will appreciate you printing these friendly handouts, available in English and Spanish. Plenity is not indicated for anyone under the age of 22. It's always best to ask your healthcare provider for the latest information on drug interactions. Any person under the age of 22 should not take Plenity. Please e-prescribe Plenity to GoGoMeds Pharmacy in Southgate, KY, or fax to (877) 766-0185. Plenity costs $98 for a one-month supply. Brand name: Plenity 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. Concomitant use of PRISTIQ is contraindicated: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. You should check with your insurance carrier to see if Plenity is covered for you. The overall incidence of side effects with Plenity was no different than placebo. Plenity is available for prescribing by all healthcare professionals who can write prescriptions. 25 mg Tablet: tan, square pyramid tablet debossed with "W" over "25" on the flat side. If you are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide, you should not take Plenity. Plenity (cellulose and citric acid) Consumer information. Your patients and However, you can also use our online drug interaction checker to learn more about possible drug interactions, too. Please check with your plan provider for reimbursement details. As with other treatments, weight loss with Plenity can vary widely, Leider noted. Find your topic by using the A-Z list (select a letter). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. Review the Medication Guide, prescription information, warning labels, and Drug Facts Label with each new prescription or OTC product. 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