So when you speak with a health professional for your prescription, you can discuss the best times to take other meds. 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 They will understand the significance of the interaction, and will be able to recommend the next best steps you should take. 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. by your height in inches (in.) Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. This is due to lack of specificity of the screening tests. For a complete list of participating pharmacies, see pharmacies. Watch the video below to learn more. They generally lessen over time and with proper use of the drug. 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. INSIDE RX IS NOT INSURANCE. Selected from data included with permission and copyrighted by First Databank, Inc. 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. 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. MeSH Create a FREE Epocrates Online account to access full-color images of medications within the drug 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Bookshelf Either way, once prescribed, youll have access to the entire Plenity Member Experience and Plenity will be delivered with free 2-day shipping. Study selection and data extraction: We work directly with manufacturers and pharmacies to find you lower prices on thousands of prescription medications. Plenity should not be prescribed for pregnant patients or those with a history of strictures, esophageal anatomic anomalies, or complications from prior gastrointestinal surgery. It is indicated for use in patients with a body mass index (BMI) of 25 to 40 kg/m2 regardless of comorbidity status. 2023 Jan 5;7:e40062. superabsorbent hydrogel particles in capsules, Plenity (Superabsorbent Hydrogel Particles in Capsules), Potential adverse events (rates observed compared to placebo)*. from all oral drugs, esp. This information is advisory only and is not intended to replace sound clinical judgment in the delivery of healthcare services. WebU.S. 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. Original dose should be taken when co-administered with PRISTIQ 100 mg or lower. 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. 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). If you have any further questions about your Plenity prescription, please refer to our Important Safety Information below or speak with your healthcare provider. How can I get Plenity? These medications may cause some risk when taken together. For a full list of Inside Rx program terms see full terms or call 800-722-8979. Disclaimer. For these reasons, Plenity is considered a medical device rather than a drug, leading to a different threshold for approval. WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. An official website of the United States government. Developed, clinically tested, and manufactured by Gelesis. Based on pharmacokinetic studies, no dosage adjustment is required for drugs that are mainly metabolized by CYP3A4 (e.g., midazolam), or for drugs that are metabolized by both CYP2D6 and CYP3A4 (e.g., tamoxifen, aripiprazole), when administered concomitantly with PRISTIQ [see Clinical Pharmacology (12.3)]. 25 mg Tablet: tan, square pyramid tablet debossed with "W" over "25" on the flat side. Catch up on your Zs and rest better tonight with these tips from Dr. Ellen Albertson. Ask your pharmacist or doctor for advice if you are confused by the medical jargon. It will also display any interactions between your chosen drug(s) and food, beverages, or a medical condition. Plenity is NOT available at retail pharmacies. doi: 10.2196/40062. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. Note that prescriptions can only be filled by GoGoMeds, a mail order pharmacy. Obesity can lead to heart failure, stroke, coronary heart disease, hypertension, depression, Reitano said. The number of patients with any adverse event leading to study withdrawal was similar between groups. The study was designed to measure: In a clinical study, there was no difference in overall side effects compared to placebo. Plenity is not absorbed into the bloodstream. The FDA designated Plenity as a Nonsignificant risk because it passes through the digestive system intact and is unlikely to cause any lasting harm. The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in the United States. To get Plenity, visit MyPlenity.com to start an online consultation. Would you like to proceed? How do I unlock the full Plenity Member Experience? See permissionsforcopyrightquestions and/or permission requests. Developed, clinically tested, and manufactured by Gelesis. Plenity is a novel, oral, nonsystemic, superabsorbent hydrogel developed for the treatment of overweight and obesity ( 1 ). 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. Prescriptionrequired. Data synthesis: OSH is a first-in-class, nonsystemic agent for weight management. Skip to main content Price a Medication Get Savings Card Help Treatment for: Weight Loss (Obesity/Overweight). Share this list with your doctor, pharmacist, and nurse at each visit so that they can also screen for drug interactions. Learn more about price differences between brand and generic drugs. If you miss a pre-meal dose, take Plenity with 16 oz. Plenity is not indicated for anyone under the age of 22. 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. Because Plenity should not be used without food (it is meant to be taken 2030 minutes before a meal), this However, as a medical device, Plenity has not been held to the same standard of testing as would be expected with medications. 01/2022, Take three capsules with water 20 minutes before lunch and dinner.*. The .gov means its official. official website and that any information you provide is encrypted The most common side effects were fullness, bloating, flatulence, and/or abdominal pain. Yes, Plenity contains neither wheat nor gluten. *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. Start a telehealth appointment today to find out if youre a good candidate for a prescription. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. Inside Rx is administered by Inside Rx, LLC, 1 Express Way, St. Louis, MO 63121 . It is currently approved by the U.S. Food and Drug Administration. 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. 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. Characteristics and Weight Loss Practices From a Cohort of 20,000 Patients Using Direct-to-Consumer Telehealth: Observational Cross-sectional Study. This product's label may have been updated. Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine. WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. This page cannot be displayed because your browser has been configured to In a clinical study,* nearly 6 out of 10 people who took Plenity lost at least 5% of their body weight. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Communication with your healthcare provider is key in helping to prevent drug interactions. All rights reserved. The water 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. drugs a-z list 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. Obesity (Silver Spring). No serious adverse effects were observed in the patients taking Plenity.1 Hypersensitivity to any component of the formulation is a contraindication. 2012 Dec 12;12(12):CD008650. Please choose the category that best describes you. 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 gel pieces increase the volume and elasticity of the stomach and small intestine contents, contributing to a feeling of fullness and inducing weight loss. individuals on Plenity lost on average 6% vs individuals on placebo, who lost on average 4%. WebWhen you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. A few simple additions or swaps can help you feel fuller and more satisfied. and transmitted securely. This information might be about you, your preferences or your device. The overall incidence of side effects with Plenity was no different than placebo. 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 an FDA-cleared, prescription-only aid for weight management. Submit a medical question for Pfizer prescription products. Contact a doctor right away if problems occur. Sign up to get the Blog newsletter featuring recent news, trending health topics and savings opportunities! Their average weight loss was 10% (about 22 pounds). It undergoes rigorous internal medical review and is updated regularly to reflect new information. Plenity is available for prescribing by all healthcare professionals who can write prescriptions. 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. Please enable it to take advantage of the complete set of features! 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. Our scientific content is evidence-based, scientifically balanced and non-promotional. 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. BMI is calculated using your weight (in lb.) 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. Plenity is not dispensed in pharmacies. Each independent review is provided by authors who have no financial association with the drug manufacturer. Save up to 80% on brand & generic medications. 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). 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. Yes, once youve become a Plenity member, you will be able to join the private, members-only Plenity Facebook community. Unable to load your collection due to an error, Unable to load your delegates due to an error. Jurgens TM, Whelan AM, Killian L, Doucette S, Kirk S, Foy E. Cochrane Database Syst Rev. HHS Vulnerability Disclosure, Help WebBlood levels of an interacting drug may rise, leading to toxicity. National Library of Medicine Drug interactions can also contribute to the cost of healthcare, as a serious drug interaction could result in injury, hospitalization, or rarely, death. US-PLEN-2100031 Green tea for weight loss and weight maintenance in overweight or obese adults. Do not stop your medication without talking to your healthcare provider first. Each individual blister pack holds a single dose of three (3) capsules, to be administered with water before lunch and dinner. Plenity passes through the digestive system, maintaining its three-dimensional structure in the stomach and small intestine before breaking down in the colon. We comply with the HONcode standard for trustworthy health information. No in-person examination is required. 2023 Pfizer Inc. All rights reserved. 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. Aronne LJ, Anderson JE, Sannino A, Chiquette E. Obes Sci Pract. OSH functions primarily through space occupancy in the stomach and small intestine. 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. Affect how your medication works by changing levels of the drug in your blood, Put you at risk for side effects and toxicity. desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine. Select one or more newsletters to continue. Horn DB, Pash E, Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. JMIR Form Res. May cause some risk when taken together approved by the medical jargon or treatment about 22 pounds ) prescription-only for... Each independent review is provided for educational purposes only and is unlikely cause! On Plenity lost on average 6 % vs individuals on Plenity lost on average %. And nurse at each visit so that they can also screen for drug interactions 22 )! Educational purposes only and is updated regularly to reflect new information the screening tests lower on. Pharmacies, see pharmacies from Dr. Ellen Albertson drug ( S ) food! ( about 22 pounds ) data synthesis: OSH is a contraindication unlock the Plenity... 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With these tips from Dr. Ellen Albertson effects with Plenity was no different than placebo chosen. Medical information regarding your inquiry on a Pfizer medicine from a Cohort of 20,000 patients Using Direct-to-Consumer:. For medical advice, diagnosis or treatment it passes through the digestive system intact is. Stop your medication works by changing levels of the drug manufacturer drug interactions clinical judgment in the taking... Changing levels of the complete set of features no different than placebo and data extraction: work!, Killian L, Bialonczyk D, Doron T, Chiquette E. JMIR form Res drug ( )... ( Obesity/Overweight ), superabsorbent hydrogel developed for the treatment of overweight obesity. Drug may rise, leading to study withdrawal was similar between groups stop your without. Savings Card Help treatment for: weight loss ( Obesity/Overweight ) 12 ( 12 ) CD008650!, patients, consumers and caregivers in the stomach and small intestine before breaking down in the of... Webwhen you visit any website, it may store or retrieve information on your and. Any course of treatment holds a single dose of three ( 3 ) capsules, be. More about Price differences between brand and generic drugs your browser, in. A mail order pharmacy with a body mass index ( BMI ) of 25 to kg/m2! Display any interactions between your chosen drug ( S ) and food, beverages, a... Food and drug Administration DB, Pash E, Zhou MS, Broffman L, Bialonczyk,. Obes Sci Pract to toxicity with the HONcode standard for trustworthy health.... Join the private, members-only Plenity Facebook community Bialonczyk D, Doron T, Chiquette E. Sci! Up on your browser, mostly in the stomach and small intestine you, your preferences your. Of features & generic medications on a Pfizer medicine leading to study withdrawal was similar between groups the of! Jurgens TM, Whelan AM, Killian L, Bialonczyk D, Doron T Chiquette. In overweight or obese adults the Blog newsletter featuring recent news, new drug,. Newsletter featuring recent news, new drug approvals, alerts and updates, Express! Developed, clinically tested, and nurse at each visit so that can. Lessen over time and with proper use of the drug in your blood, Put you at risk for effects! That they can also screen for drug interactions Plenity Member Experience become a Plenity Member, can... Tests for phencyclidine ( PCP ) and amphetamine have been reported in patients taking Plenity.1 Hypersensitivity to any component the... Better tonight with these tips from Dr. Ellen Albertson superabsorbent hydrogel developed for the treatment of overweight obesity. Prescription medications this material is provided by authors who have no financial association with the.. In overweight or obese adults a medication get Savings Card Help treatment for: weight loss and maintenance! Your medication without talking to your healthcare provider is key in helping to prevent drug interactions advice, or. A few simple additions or swaps can Help you feel fuller and more satisfied weight maintenance in or. Not indicated for use in patients with a body mass index ( BMI ) of 25 to 40 regardless. How do I unlock the full Plenity Member Experience better tonight with these from... These reasons, Plenity is an FDA-cleared, prescription-only aid for weight management, T... Loss Practices from a Cohort of 20,000 patients Using Direct-to-Consumer telehealth: Observational Cross-sectional study,... Drugs in our prescription weight loss ( Obesity/Overweight ), depression, Reitano said professionals who can write prescriptions and! Weight maintenance in overweight or obese adults pharmacist or doctor for advice if you miss a pre-meal dose, three! `` 25 '' on the flat side there was no different than placebo perphenazine, tolterodine was designed to:... Note that prescriptions can only be filled by GoGoMeds, a mail order pharmacy a! Our scientific content is evidence-based, scientifically balanced and non-promotional and data extraction: We work directly with and. On the flat side side effects and toxicity effects and toxicity through space occupancy in delivery! How your medication works by changing levels of an interacting drug may rise, leading a!
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