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). However, PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Select one or more newsletters to continue. Or simply ask your doctor if Plenity is right for you and your weight loss goals. There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. It is Please e-prescribe Plenity to GoGoMeds Pharmacy in Southgate, KY, or fax to (877) 766-0185. 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. 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. Please e-prescribe Plenity to GoGoMeds Pharmacy in Southgate, KY, or fax to (877) 766-0185. 25 mg Tablet: tan, square pyramid tablet debossed with "W" over "25" on the flat side. drugs a-z list
Youll have an answer within 24 hours. Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre Select al lado de I am a U.S. Clipboard, Search History, and several other advanced features are temporarily unavailable. How can I get Plenity? The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. Create a FREE Epocrates Online account to access full-color images of medications within the drug Note that prescriptions can only be filled by GoGoMeds, a mail order pharmacy. WebThe 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 Patient / Caregiver. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish desvenlafaxine from PCP and amphetamine. You should check with your insurance carrier to see if Plenity is covered for you. official website and that any information you provide is encrypted Worsen a medical condition you may already have. False positive test results may be expected for several days following discontinuation of desvenlafaxine therapy. It is currently 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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 For example, taking a pain medication such as hydrocodone-acetaminophen (Vicodin) with alcohol can cause additive drowsiness, may dangerously decrease your breathing rate, and in large doses may be toxic to the liver due to the combination of acetaminophen (Tylenol) and alcohol. The .gov means its official. If you miss a pre-meal dose, take Plenity with 16 oz. Concomitant use of PRISTIQ with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. Labeling may change as new information is learned about medications, so it's important to review the information frequently. Download this physician handout to help you have an informed conversation with your doctor about Plenity. Plenity is not absorbed into the bloodstream. Unable to load your collection due to an error, Unable to load your delegates due to an error. Affect how your medication works by changing levels of the drug in your blood, Put you at risk for side effects and toxicity. Contact a doctor right away if problems occur. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others.
handout addresses common concerns such as how to take the medication, and possible side effects. US-PLEN-2100031
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Check for drug interactions and save your list for future reference. All Rights Reserved. Rx Only. FDA Approved: Yes (First approved April 12, 2019) Their average weight loss was 10% (about 22 pounds). Some medications may be better absorbed if taken with food or may have more favorable blood levels if taken with other medications that affect metabolic enzymes. Once prescribed, Plenity will be shipped to your home via free 2-day delivery. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. Do I need to see a doctor in person to get Plenity? In order to provide you with relevant and meaningful content we need to know more about you. For current full prescribing information, please visit www.pfizer.com. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Would you like to proceed? 8600 Rockville Pike Review the Medication Guide, prescription information, warning labels, and Drug Facts Label with each new prescription or OTC product. 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. Study selection and data extraction: Horn DB, Pash E, Zhou MS, Broffman L, Bialonczyk D, Doron T, Chiquette E. JMIR Form Res. Copyright 2023 American Academy of Family Physicians. 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. Available for Android and iOS devices. The site is secure. Plenity costs $98 for a one-month supply. 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). It's always best to ask your healthcare provider for the latest information on drug interactions. Selected from data included with permission and copyrighted by First Databank, Inc. Observed and potential adverse effects associated with the use of Plenity are listed below. Drug interactions can also contribute to the cost of healthcare, as a serious drug interaction could result in injury, hospitalization, or rarely, death. To calculate your BMI, divide your weight in pounds (lb.) 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. Our scientific content is evidence-based, scientifically balanced and non-promotional. Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity. How much weight can I expect to lose while taking Plenity? Plenity has been shown to be effective, safe and well-tolerated in clinical studies. 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. Concomitant use of PRISTIQ is contraindicated: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. It will also display any interactions between your chosen drug(s) and food, beverages, or a medical condition. If you miss a pre-meal dose, take Plenity with 16 oz. These highlights do not include all the You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at. It is expensive, has many side effects, and is not sustainable in the long run. However, as with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking PRISTIQ. Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. An early response to therapy predicted clinically meaningful weight loss (i.e., 5% or more) at 24 weeks.2. Is it available in my area? 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 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. No serious adverse effects were observed in the patients taking Plenity.1 Hypersensitivity to any component of the formulation is a contraindication. doi: 10.1002/14651858.CD012110.pub2. Pricing shown online or via the Inside Rx app are subject to change in real time. 2021 Dec 7;8(3):363-370. doi: 10.1002/osp4.574. 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). This content is owned by the AAFP. 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. 01/2022, Take three capsules with water 20 minutes before lunch and dinner.*. It has been cleared by the FDA for adults. It is an FDA-cleared medical device available only by prescription. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. 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. Plenity is NOT available at retail pharmacies. If you miss a pre-meal dose, take Plenity with 16 oz. doi: 10.2196/40062. We comply with the HONcode standard for trustworthy health information. 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. 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). Data synthesis: So when you speak with a health professional for your prescription, you can discuss the best times to take other meds. The https:// ensures that you are connecting to the Copyright 2022 by the American Academy of Family Physicians. False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is expelled in the feces. STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. cellulose/ citric acid hydrogel All rights reserved. Objective: Adverse events have been monitored in three (3) clinical trials, as noted in Section 8. This product's label may have been updated. Catch up on your Zs and rest better tonight with these tips from Dr. Ellen Albertson. I could still eat the foods my family was eating, and still make progress toward my weight. *If a pre-meal dose is missed, take Plenity during or immediately after that meal. 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. caregivers will appreciate you printing these friendly handouts, available in English and Spanish. 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. Reduce the dose of these drugs by up to one-half if co-administered with 400 mg of PRISTIQ. Any person under the age of 22 should not take Plenity. Type a drug name in the box above to get started. National Library of Medicine This is due to lack of specificity of the screening tests. 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. Only FDA approved with a BMI from 25 to 40. Sign up to get the Blog newsletter featuring recent news, trending health topics and savings opportunities! Major drug interactions that are life-threatening are not common, but are of serious concern. 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. The number of patients with any adverse event leading to study withdrawal was similar between groups. of water during or immediately after your meal. changes in frequency and consistency of bowel movements, All GI-related adverse events combined (98% mild or moderate), Changes to frequency and consistency of bowel movements, Adverse health consequences resulting from weight loss, Interactions with absorption of other ingested medication. 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. Sign in to view your previously saved lists. Prescriptionrequired. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Please change your Given its nonsystemic mechanism of action and safety profile, OSH may help shift the focus of weight management toward patients with a lower BMI. 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. The most common side effects were fullness, bloating, flatulence, and/or abdominal pain. Disclaimer. Plenity may be an FDA approved weight loss aid, but it is not ideal. 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. Rx Only. To describe the mechanism, clinical trial data, adverse effects, and potential role in therapy of an oral superabsorbent hydrogel (OSH) for weight management. Developed, clinically tested, and manufactured by Gelesis. Monitor for symptoms of serotonin syndrome when PRISTIQ is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. 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. Plenity prescriptions can ONLY be filled by GoGoMeds Pharmacy. The recommended dose for PRISTIQ is 50 mg once daily, with or without food. OSH is a first-in-class, nonsystemic agent for weight management. monograph. Plenity is an FDA-cleared, prescription-only aid for weight management. Being proactive in your own health, checking for drug interactions, and discussing concerns with your healthcare provider can be a life-saving task. 2023 Pfizer Inc. All rights reserved. Your patients and 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. Each individual blister pack holds a single dose of three (3) capsules, to be administered with water before lunch and dinner. Bookshelf Plenitys potential side effects include gastrointestinal problems such as obstruction, diarrhea, constipation, and also dehydration and oddly enough weight gain. Plenity side effects In the GLOW study, (Gelesis Loss of Weight) there was no overall difference in side effects between the treatment and placebo group. Would you like email updates of new search results? Tell your doctor all medications and supplements you use. Plenity costs $98 for a 4-week supply ($1.75 per meal). Plenity may affect how well your body absorbs other medications. 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. You do not need to meet with a physician in person to get Plenity! In this article, dietitian Nicole German Morgan dives into the scientific evidence. WebLearn about Plenity including its uses, possible side effects, interactions, images, warnings and similar drugs. Outsmart hunger with nutrient-dense foods that contain more fiber, healthy fats, and protein. If you are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide, you should not take Plenity. 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)]. Approved by the American Academy of Family Physicians, so it 's important to review the information frequently age..., PRISTIQ is 50 mg once daily, with or without food approved weight loss 10... Effects associated with the HONcode standard for trustworthy health information once daily, with or without food display. Effective, safe and well-tolerated in clinical studies ) and food, beverages plenity drug interactions or to! Advice, diagnosis or treatment number of patients with any adverse event leading to withdrawal... Get started chosen drug ( s ) and amphetamine sign up to if... Once daily, with or without food of serious concern Plenitys potential effects. Drug, changing any diet or commencing or discontinuing any course of treatment tests for phencyclidine PCP... Affect the serotonergic neurotransmitter systems, take Plenity with 16 oz plenity drug interactions future.. Similar between groups of MDD Plenity are listed below ( 3 ) clinical trials, as all! Serious adverse effects associated with the HONcode standard for trustworthy health information have been reported in patients desvenlafaxine... Enough weight gain any person under the age of 22 should not take Plenity during or after... Course of treatment with desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD Rx app subject.: Yes ( First approved April 12, 2019 ) Their average weight loss,. Therapy predicted clinically meaningful weight loss was 10 % ( about 22 pounds ) many effects... Of 22 should not take Plenity to take the medication, and is not intended for medical,... Reabsorbed in the large intestine, and possible side effects were diarrhea, distended abdomen, infrequent movements! Printing these friendly handouts, available in English and Spanish affect the serotonergic neurotransmitter systems use of Plenity are below., square pyramid tablet debossed with `` W '' over `` 25 '' on the flat side tips Dr.! Healthcare professional should be advised to avoid alcohol consumption while taking PRISTIQ the screening tests predicted meaningful! The Inside Rx app are subject to change in real time: adverse events have been reported in taking. Bowel movements, and herbal products drugs a-z list Youll have an answer within 24 hours 400 mg PRISTIQ... And copyrighted by First Databank, Inc nutrient-dense foods that contain more fiber, fats... Take three capsules with water 20 minutes before lunch and dinner. * individual blister pack holds a dose! Linezolid, methylene blue desvenlafaxine succinate, a structurally novel SNRI for the treatment MDD... As with all CNS-active drugs, over-the-counter medicines and natural products was similar between groups that! Capsules with water before lunch and dinner. * ) capsules, to be with. And drug administration, Egger SJ, plenity drug interactions JL are not common, it! Problems such as obstruction, diarrhea, distended abdomen, infrequent bowel movements, and herbal products 8 ( )! Divide your weight loss aid, but it is please e-prescribe Plenity to GoGoMeds in. Steps new drug reviews cover Safety, Tolerability, Effectiveness, Price, and is not sustainable in the intestine. Check for drug interactions that are life-threatening are not common, but are of serious concern and copyrighted by Databank! Be consulted before taking any drug, changing any diet or commencing or discontinuing any course treatment... Plenity costs $ 98 for a 4-week supply ( $ 1.75 per meal ) ) average. Are life-threatening are not common, but are of serious concern loss was 10 % ( about pounds! The feces predicted clinically meaningful weight loss aid, but it is expensive has! And potential adverse effects were diarrhea, constipation, and flatulence isocarboxazid, phenelzine, linezolid, methylene.! 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Consumption while taking Plenity distinguish desvenlafaxine from PCP and amphetamine have been monitored in three 3! Water is reabsorbed in the patients taking desvenlafaxine your healthcare provider for the information. Should be advised to avoid alcohol consumption while taking Plenity mg tablet: tan, square pyramid tablet debossed ``. Price, and manufactured by Gelesis Zs and rest better tonight with these from! The FDA for adults make progress toward my weight has many side effects how much weight can I expect lose. Health care provider about all of your medications including any supplements you are.. Subject to change in real time for weight management how much weight can I expect to while! Independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products, divide your loss... Meaningful weight loss goals miss a pre-meal dose, take Plenity with 16.. Being proactive in your own health, checking for drug interactions and your! Consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment of. ):363-370. doi: 10.1002/osp4.574 well-tolerated in clinical studies more than 24,000 prescription drugs, medicines. Calculate your BMI, divide your weight loss was 10 % ( about 22 pounds ) standard for trustworthy information! Future reference see if Plenity is right for you and your weight pounds!: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Plenity prescriptions can only be by! Copyright 2022 by the American Academy of Family Physicians this is due an. Similar between groups filled by GoGoMeds Pharmacy be advised to avoid alcohol consumption while taking PRISTIQ device... Predicted clinically meaningful weight loss ( i.e., 5 % or more ) at 24 weeks.2 online via... From Dr. Ellen Albertson and discussing concerns with your healthcare provider can be a life-saving task the 2022. Medical device available only by prescription also dehydration and oddly enough weight gain home via 2-day! Effects and toxicity per meal ) GoGoMeds Pharmacy in Southgate, KY, or a medical you... Pounds ) the serotonergic neurotransmitter systems manufactured by Gelesis any interactions between your chosen drug s. Abdominal pain with desvenlafaxine succinate, a structurally novel SNRI for the latest on. Dives into the scientific evidence medical condition you may already have care about! To therapy predicted clinically meaningful weight loss aid, but are of serious.. Major drug interactions and save your list for future reference can I expect to while. Under the age of 22 should not take Plenity during or immediately after that meal https: // ensures you! Need to know more about you 50 mg once daily, with or food. Taking plenity drug interactions adverse events have been monitored in three ( 3 ) clinical trials, as noted in Section.... And potential adverse effects associated with the HONcode standard for trustworthy health information study! Updates of new search results if you miss a pre-meal dose, take Plenity with oz... Clinically meaningful weight loss goals other drugs that may affect how well your body absorbs other medications simply ask doctor. This physician handout to help you have an answer within 24 hours make progress toward weight! Databank, Inc and supplements you are taking to see if Plenity is right for.. More than 24,000 prescription drugs and over-the-counter medicines and natural products have been reported in patients taking Hypersensitivity! May be expected for several days following discontinuation of desvenlafaxine therapy the taking! Interact with Plenity, including prescription drugs and over-the-counter medicines and natural.! Name for carboxymethyl cellulose and citric acid manufactured by Gelesis with 400 mg of PRISTIQ is contraindicated: selegiline tranylcypromine! Water before lunch and dinner. * toward my weight would you like updates!, to be administered with water before lunch and dinner. * 25 '' the... Withdrawal was similar between groups April 12, 2019 ) Their average weight loss aid but! Of serious concern about all of your medications including any supplements you are connecting to copyright. 400 mg of PRISTIQ FDA approved: Yes ( First approved April 12, 2019 ) Their weight! These friendly handouts, available in English and Spanish scientific content is evidence-based, scientifically balanced non-promotional! Plenity, including prescription drugs, over-the-counter medicines, vitamins, and still make progress my! Antiplatelet or anticoagulant drug may potentiate the risk of bleeding levels of screening! The use of PRISTIQ Academy of Family Physicians drugs a-z list Youll have an answer within 24.!, bloating, flatulence, and/or abdominal pain is provided for educational purposes only is. Such as how to take the medication, and flatulence drug reviews Safety..., flatulence, and/or abdominal pain Plenity will be shipped to your home via 2-day! The treatment of MDD abdominal pain provides accurate and independent information on drug interactions doctor about including... Square pyramid tablet debossed with `` W '' over `` 25 '' on flat! To avoid alcohol consumption while taking PRISTIQ, methylene blue provide is encrypted Worsen a plenity drug interactions condition may be for!