Consult your doctor before breastfeeding. 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 ). 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). The breadth of the label is interesting. This information is currently not available for this drug. 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. In fact, for some drugs, stopping the medication could also affect the levels of other drugs in your system. 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. by your height in inches (in.) Plenity prescriptions can ONLY be filled by GoGoMeds Pharmacy. The result can be muscle pain, or even severe muscle injury known as rhabdomyolysis. 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. Plenity may interfere with medication absorption and should not be taken at the same time as other medications. Concomitant use of PRISTIQ with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. Check for drug interactions and save your list for future reference. Being proactive in your own health, checking for drug interactions, and discussing concerns with your healthcare provider can be a life-saving task. oral superabsorbent hydrogel; preobesity; weight management. Copyright 2022 by the American Academy of Family Physicians. 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). If you have a Prescriptionrequired. This information might be about you, your preferences or your device. A few simple additions or swaps can help you feel fuller and more satisfied. Conclusions: and transmitted securely. Please e-prescribe Plenity to GoGoMeds Pharmacy in Southgate, KY, or fax to (877) 766-0185. Call your doctor for medical advice about side effects. Body weight management in overweight and obese breast cancer survivors. Do not stop your medication without talking to your healthcare provider first. Each 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 helps you eat less, so you can lose weight. A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps. OSH offers a nonsystemic approach to weight management for patients who are diagnosed with overweight or obesity. 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. If you miss a pre-meal dose, take Plenity with 16 oz. Rx Only. Instead, it is prescribed after patients complete an online form about their medical history. With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with PRISTIQ. doi: 10.1002/14651858.CD012110.pub2. Is it available in my area? No gimmicks, just science-backed resources to help support your weight management journey. You must drink 16 ounces of water for Plenity to work. The overall incidence of side effects with Plenity was no different than placebo. disable JavaScript, also known as "Active Scripting". Plenity (cellulose and citric acid) Consumer information. Observed and potential adverse effects associated with the use of Plenity are listed below. WebLearn about Plenity including its uses, possible side effects, interactions, images, warnings and similar drugs. Inside Rx does not guarantee that the price you will pay at the pharmacy will be the same price displayed in advance of purchase. OSH is a first-in-class, nonsystemic agent for weight management. 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. 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. caregivers will appreciate you printing these friendly handouts, available in English and Spanish. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. 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. The site is secure. However, you can also use our online drug interaction checker to learn more about possible drug interactions, too. Links to sites outside of Pfizer Medical Information are provided as a resource to the viewer. You may report side effects to FDA at 1-800-FDA-1088. 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: How can I get Plenity? 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). cellulose/ citric acid hydrogel WebThe most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. The most 2023 Gelesis, Inc. All rights reserved. Plenity is the first and only FDA-cleared weight management tool made from naturally derived building blockscellulose and citric acid. The particles break down in the colon and are excreted in the stool without being absorbed. 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. The capsule for Plenity is made with gelatin, which is a porcine-derived product. Affect how your medication works by changing levels of the drug in your blood, Put you at risk for side effects and toxicity. Or simply ask your doctor if Plenity is right for you and your weight loss goals. Data sources: Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity. If you miss a pre-meal dose, take Plenity with 16 oz. All Rights Reserved. Inside Rx cannot be used with any insurance benefit, copay assistance programs, or by persons covered by state-funded or federal-funded programs such as Medicare, Medicaid, or Tricare for purchases of certain medications, even if processed outside the benefit as an uninsured (cash-paying) patient. Recent advances in therapies utilizing superabsorbent hydrogel technology for weight management: A review. Plenity costs $98 for a one-month supply. PMC Relevance to patient care and clinical practice: Would you like to proceed? Some mixtures of medications can lead to serious and even fatal consequences. 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. 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. The following adverse reactions are discussed in greater detail in other sections of the label. Within 14 days of stopping an MAOI intended to treat psychiatric disorders. Given its nonsystemic mechanism of action and safety profile, OSH may help shift the focus of weight management toward patients with a lower BMI. 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. Bookshelf Review the Medication Guide, prescription information, warning labels, and Drug Facts Label with each new prescription or OTC product. 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. Inside Rx is administered by Inside Rx, LLC, 1 Express Way, St. Louis, MO 63121 . 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. It is currently approved by the U.S. Food and Drug Administration. Obesity (Silver Spring). official website and that any information you provide is encrypted However, if you discover you are at risk for a possible drug interaction, call your doctor or pharmacist as quickly as you can. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 2005 - 2023 WebMD LLC. Brand name: Plenity Monitor for symptoms of serotonin syndrome when PRISTIQ is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. The FDA designated Plenity as a Nonsignificant risk because it passes through the digestive system intact and is unlikely to cause any lasting harm. It's always best to ask your healthcare provider for the latest information on drug interactions. As you continue to use it, you feel fuller throughout the day. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor. 2019 Feb;27(2):205-216. doi: 10.1002/oby.22347. FDA Approved: Yes (First approved April 12, 2019) Plenity is taken with water twice a day, 20 to 30 minutes before lunch and 20 to 30 minutes before dinner. Patient / Caregiver. Share this list with your doctor, pharmacist, and nurse at each visit so that they can also screen for drug interactions. + Please e-prescribe Plenity to GoGoMeds Pharmacy in Southgate, KY, or fax to (877) 766-0185. It wasnt restrictive. Select one or more newsletters to continue. 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. Their average weight loss was 10% (about 22 pounds). This site needs JavaScript to work properly. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Gelesis Granted FDA Clearance to Market Plenity - a New Prescription Aid in Weight Management. Or speak with your doctor to find out if Plenity is appropriate for you and your weight goals. 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. Future reference, warning labels, and drug Administration drugs, stopping the medication also. A novel, oral, nonsystemic agent for weight management in overweight and obese cancer! 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