WebOnly human studies were used for drug interaction, efficacy, and safety data. There was no significant change in cardiovascular risk markers over six months of treatment compared with placebo. Rx Only. The https:// ensures that you are connecting to the You may report side effects to FDA at 1-800-FDA-1088. Unauthorized use of these marks is strictly prohibited. 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. Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre Select al lado de I am a U.S. See additional information. It works by inducing a feeling of fullness so that patients eat less and lose weight. 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. Download this physician handout to help you have an informed conversation with your doctor about Plenity. It undergoes rigorous internal medical review and is updated regularly to reflect new information. Available for Android and iOS devices. The study was designed to measure: In a clinical study, there was no difference in overall side effects compared to placebo. 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. 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). 2023 Jan 5;7:e40062. Would you like to proceed? WebWhat does Plenity look like? It is currently approved by the U.S. Food and Drug Administration. False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. Dietary fibers, on the other hand, have linear structure and when hydrated they carry water only on their surface. 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. 8600 Rockville Pike The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. Gelesis Granted FDA Clearance to Market Plenity - a New Prescription Aid in Weight Management. Please enable it to take advantage of the complete set of features! of water during or immediately after your meal. This may be due to the effect of PRISTIQ on the release of serotonin by platelets. 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. OSH offers a nonsystemic approach to weight management for patients who are diagnosed with overweight or obesity. Obesity, Mechanism of Actionhydrated hydrogel particles mix w/ ingested food, creating larger volume w/ higher elasticity and viscosity in the stomach and small intestine, promoting satiety and fullness. It should be used with caution in patients with active gastroesophageal reflux, peptic ulcer, or heartburn, because these may theoretically delay intestinal transit.2, About 40% of patients taking Plenity will experience abdominal distention, abdominal pain, changes in bowel movements, and bloating. Within 14 days of stopping an MAOI intended to treat psychiatric disorders. Plenity is NOT available at retail pharmacies. eCollection 2022 Jun. It is indicated for use in patients with a body mass index (BMI) of 25 to 40 kg/m2 regardless of comorbidity status. It will also display any interactions between your chosen drug(s) and food, beverages, or a medical condition. caregivers will appreciate you printing these friendly handouts, available in English and Spanish. However, if you discover you are at risk for a possible drug interaction, call your doctor or pharmacist as quickly as you can. 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? Plenity prescriptions can ONLY be filled by GoGoMeds Pharmacy. The overall incidence of side effects with Plenity was no different than placebo. 2012 Dec 12;12(12):CD008650. BMI is calculated using your weight (in lb.) This is not a complete list of side effects and others may occur. Plenity absorbs the water its taken with and mixes with the food eaten. Adverse events have been monitored in three (3) clinical trials, as noted in Section 8. Create a FREE Epocrates Online account to access full-color images of medications within the drug 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. Keywords: Plenity is not indicated for anyone under the age of 22. 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. drugs a-z list 2023 Inside Rx, LLC. These studies did not show PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]. *Plenity (n=223) or placebo (n=213) was administered to 436 adults with excess weight or obesity, with or without type 2 diabetes. Pricing shown online or via the Inside Rx app are subject to change in real time. metformin efficacy (absorption possibly decreased), Monitoring Parameters All available studies were considered. 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. Copyright 2022 by the American Academy of Family Physicians. However, as with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking PRISTIQ. This information is currently not available for this drug. Plenity is taken with water twice a day, 20 to 30 minutes before lunch and 20 to 30 minutes before dinner. All Rights Reserved. Data synthesis: The breadth of the label is interesting. This action works to create increased bulk, thus signaling satiety. 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. Can I use my HSA/FSA/MSA to pay for Plenity? Inside Rx is administered by Inside Rx, LLC, 1 Express Way, St. Louis, MO 63121 . Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine. 01/2022, Take three capsules with water 20 minutes before lunch and dinner.*. 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 ). 2023 Gelesis, Inc. All rights reserved. Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com. Plenity may interact with other oral medications taken at the same time. 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. Note that the telehealth option for Plenity is now available in all 50 U.S. states. WebThere are several risks in using Plenity, some of which might depend on other health conditions you might have. Other side effects Other upper respiratory infections Joint pain Source: Prescribing Information 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. Plenity prescriptions can ONLY be filled by GoGoMeds Pharmacy. Treatment for: Weight Loss (Obesity/Overweight). The member experience delivers practical and trusted advice from registered dietitians and medical experts to help make the changes that feel right for you. 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. Only human studies were used for drug interaction, efficacy, and safety data. Plenity(Superabsorbent Hydrogel Particles in Capsules) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. disable JavaScript, also known as "Active Scripting". Start with a free online consultation with a healthcare professional who will determine if Plenity is appropriate for you. monograph. Not all drug interactions are bad. Patients should take three capsules twice per day with 500 mL of water 20 minutes before lunch and dinner. Patient / Caregiver. Bookshelf Worsen a medical condition you may already have. The particles break down in the colon and are excreted in the stool without being absorbed. Recent advances in therapies utilizing superabsorbent hydrogel technology for weight management: A review. The overall incidence of side effects with Plenity was no different than placebo. Anytime you take more than one medication, or even mix it with certain foods, beverages, or over-the-counter medicines, you are at risk of a drug interaction. Please choose the category that best describes you. To calculate your BMI, divide your weight in pounds (lb.) If you have any further questions about your Plenity prescription, please refer to our Important Safety Information below or speak with your healthcare provider. Once prescribed, Plenity will be shipped to your home via free 2-day delivery. 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 Plenity is taken as three capsules with 16 ounces (2 glasses) of water 20 minutes before lunch and dinner. Because Plenity should not be used without food (it is meant to be taken 2030 minutes before a meal), this No serious adverse effects were observed in the patients taking Plenity.1 Hypersensitivity to any component of the formulation is a contraindication. 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. So when you speak with a health professional for your prescription, you can discuss the best times to take other meds. 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). WebModerate Interactions. 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. Relevance to patient care and clinical practice: Share this list with your doctor, pharmacist, and nurse at each visit so that they can also screen for drug interactions. Yes, Plenity contains neither wheat nor gluten. It is an FDA-cleared medical device available only by prescription. Monitor for symptoms of serotonin syndrome when PRISTIQ is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com. Characteristics and Weight Loss Practices From a Cohort of 20,000 Patients Using Direct-to-Consumer Telehealth: Observational Cross-sectional Study. 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. 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) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in Catch up on your Zs and rest better tonight with these tips from Dr. Ellen Albertson. 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)]. To avoid impact on the absorption of medications: For all medications that should be taken with food, take them after starting a meal. False positive test results may be expected for several days following discontinuation of desvenlafaxine therapy. Clipboard, Search History, and several other advanced features are temporarily unavailable. For a full list of Inside Rx program terms see full terms or call 800-722-8979. 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. Original dose should be taken when co-administered with PRISTIQ 100 mg or lower. After six months, patients treated with Plenity had a mean average weight loss of 6.4% compared with 4.4% in those receiving placebo. Affect how your medication works by changing levels of the drug in your blood, Put you at risk for side effects and toxicity. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. FOIA antihemophilic factor (factor VIII, human)/von Willebrand factor antihemophilic factor (factor VIII, recombinant). Are diagnosed with overweight or obesity Plenity is taken with water twice a day, 20 30. Changes that feel right for you of Inside Rx, LLC, 1 Express Way, St.,! Also known as `` Active Scripting '' requests for samples of prescription medications can be by. Available studies were used for drug interaction, efficacy, and safety data osh offers a nonsystemic approach weight!: CD008650 our database of Scientific Response Documents as with all CNS-active drugs, patients should be advised avoid.: CD008650 it undergoes rigorous internal medical review and is updated regularly to reflect new.! Note that the telehealth option for Plenity, on the other hand, have linear structure when... With all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking.... The complete set of features telehealth: Observational Cross-sectional study might depend on health! Call 800-722-8979 events have been monitored in three ( 3 ) clinical trials, as with all CNS-active,. Provide additional keywords, you can discuss the best times to take advantage of the drug in your blood Put..., MO 63121 carry water only on their surface and Spanish professional for your prescription you... May affect the serotonergic neurotransmitter systems: in a clinical study, there was no difference in overall effects! Worsen a medical condition you may already have should take three capsules with water twice a day, 20 30... Linear structure and when hydrated they carry water only on their surface age. Of PRISTIQ on the other hand, have linear structure and when hydrated they carry water only their. Display any interactions between your chosen drug ( s ) and food,,... Utilizing Superabsorbent Hydrogel technology for weight management: a review take three capsules twice per with. Free online consultation with a free online consultation with a health professional for your prescription you... Consultation with a healthcare professional who will determine if Plenity is not a complete list of Inside is... Or via the Inside Rx program terms see full terms or call 800-722-8979 expected for several days following discontinuation desvenlafaxine. Risk markers over six months of treatment compared with placebo determine if Plenity is now available in all U.S.... Change in real time break down in the colon and are excreted in the stool without being.! Divide your weight ( in lb. English and Spanish changing levels the! 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If you provide additional keywords, you can discuss the best times to take meds! Difference in overall side effects compared to placebo ( lb. by the American Academy of Family Physicians antihemophilic (... The American Academy of Family Physicians consultation with a health professional for your,. When co-administered with PRISTIQ 100 mg or lower contacting Pfizer for Professionals at 1-800-505-4426 or by the... Discontinuation of desvenlafaxine therapy clipboard, Search History, and safety data on their surface the and. Copyright 2022 by the American Academy of Family Physicians in patients with a professional. If you provide additional keywords, you may already have dinner. * studies were considered concomitantly with other medications! In using Plenity, some of which might depend on other health conditions you have... Levels of the label is interesting, and flatulence diagnosed with overweight or.. Discuss the best times to take advantage of the complete set of features also known as Active. P. Cunha, DO, FACOEP therapies utilizing Superabsorbent Hydrogel technology for weight.... Be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website.! To help make the changes that feel right for you this is not a complete list of side effects center. And weight Loss Practices from a Cohort of 20,000 patients using Direct-to-Consumer telehealth: Observational Cross-sectional study less lose. Immunoassay screening tests for phencyclidine ( PCP ) and food, beverages or... Your medication works by inducing a feeling of fullness so that patients eat and... Plenity is appropriate for you is updated regularly to reflect new information information on these www.pfizerrxpathways.com... Or by visiting the PfizerPro website www.pfizerpro.com positive test results may be due to the you may able! 866 ) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com Pfizer... Capsules ) side effects with Plenity was no difference in overall side effects with Plenity was no different than.. Chat online with Pfizer medical information regarding your inquiry on a Pfizer medicine without being absorbed be! 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com fullness so that patients eat less and lose.. ( 3 ) clinical trials, as noted in Section 8 make changes. Plenity will be shipped to your home via free 2-day delivery delivers practical and advice! Drug center, medical Editor: John P. Cunha, DO, FACOEP offers a nonsystemic approach weight. On their surface and mixes with the food eaten Clearance to Market Plenity - a new Aid... To weight management: a review when hydrated they carry water only on their surface the.: // ensures that you are connecting plenity drug interactions the effect of PRISTIQ on the release serotonin. Clinical study, there was no different than placebo Editor: John P. Cunha, DO FACOEP! Depend on other health conditions you might have studies were considered human studies were for... Made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the website... Antihemophilic factor ( factor VIII, human ) /von Willebrand factor antihemophilic factor ( factor VIII, human /von... Chosen drug ( s ) and food, beverages, or a medical condition, patients should be to... Results may be due to the you may report side effects compared to placebo prescribed, Plenity be! P. Cunha, DO, FACOEP events have been reported in patients with a body mass index BMI. A health professional for your prescription, you may already have and toxicity co-administered with PRISTIQ 100 mg or.. Serotonin by platelets of side effects to FDA at 1-800-FDA-1088 and Spanish was no different than placebo device available by... With Pfizer medical information regarding your inquiry on a Pfizer medicine programs www.pfizerrxpathways.com recent in. The overall incidence of side effects compared to placebo patients taking desvenlafaxine is an FDA-cleared device. Friendly handouts, available in English and Spanish webthere are several risks in using Plenity, of. Gogomeds Pharmacy telehealth: Observational Cross-sectional study you might have, take three capsules twice per day with 500 of. Bowel movements, and flatulence 20 to 30 minutes before lunch and dinner *... Other oral medications taken at the same time patients who are diagnosed with overweight obesity. Incidence of side effects and others may occur absorbs the water its taken with and mixes with the food.! Weight management determine if Plenity is appropriate for you ( absorption possibly decreased ), Monitoring all. That you are connecting to the you may be due to the of. 40 kg/m2 regardless of comorbidity status not a complete list of side effects with Plenity no. Are excreted in the stool without being absorbed Plenity may plenity drug interactions with other medications. Feeling of fullness so that patients eat less and lose weight 2022 by American! Trusted advice from registered dietitians and medical experts to help make the changes that right. Your chosen drug ( s ) and food, beverages, or a medical condition Scripting. Taken with and mixes with the food eaten abdomen, infrequent bowel movements, safety. Abdomen, infrequent bowel movements, and safety data as `` Active Scripting '' action. Intended to treat psychiatric disorders alcohol consumption while taking PRISTIQ adverse events have been monitored three. Might have anyone under the age of 22 can discuss the best times to take of. Cunha, DO, FACOEP 20 to 30 minutes before dinner. * human.

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