Plenity
Plenity is an FDA-cleared medical device in pill form that's used for weight loss. It's taken by mouth along with a healthy diet and regular exercise through a weight management program that's supervised by a healthcare provider. Plenity is made up of natural ingredients (cellulose and citric acid). Since it works directly in your digestive tract, Plenity can help you feel full and eat less. But it might cause side effects like diarrhea, constipation, and bloating. Plenity is not a medication, and it might not be safe for people with stomach issues.
What is Plenity?
What is Plenity used for?
- Weight loss, used in addition to a healthy diet and regular exercise
How Plenity works
Plenity is a medical device in pill form that contains two natural ingredients called cellulose and citric acid. It works directly in your digestive tract. Once it's taken with water, the device absorbs the water in the stomach. Then, it mixes with the food that you eat.
After absorbing water and mixing with food, the device expands and physically takes up space in the stomach and small intestine. This makes you feel full. As you continue to use Plenity, you'll feel fuller throughout the day, which can lower your urge to eat.
Drug facts
Side effects of Plenity
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Diarrhea (13%)
- Bloating or swelling in the stomach area (12%)
- Common cold symptoms (12%)
- Passing gas (9%)
- Constipation or not having bowel movements often (5-9%)
- 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.
Less Common Side Effects
- Other upper respiratory infections
- Joint pain
Plenity serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reaction: trouble breathing; swelling of the body or lips
- Severe stomach pain
- Severe diarrhea
Pros and cons of Plenity
Pros
- Generally few side effects
- Is not a medication
Cons
- Need to take three pills for each dose
- Might need to avoid or use with caution if you have stomach issues or trouble swallowing
Pharmacist tips for Plenity
- Plenity comes packaged as pods. Each pod is a full dose and contains 3 pills.
- Take 3 capsules by mouth with 16 ounces (2 cups) of water 20 to 30 minutes before lunch and 20 to 30 minutes before dinner. Drink 2 more cups of water after you take your dose. Make sure to drink enough water each time you use the device, since it requires water to work.
- If you experience a severe or long-lasting side effect or a severe allergic reaction while using Plenity, stop using the device and contact your healthcare provider right away.
- If you miss a dose of Plenity before a meal, you can take it during or right after your meal.
- Don't use Plenity if the pod or the package is damaged. Don't take any Plenity capsules that are broken, crushed, or damaged. Throw them away.
- If you have medications that you typically take once daily, take them in the morning or at bedtime, as instructed by your healthcare provider. While it isn't completely known, it's possible that Plenity might change how medications are absorbed into the body. If you need to take the medication with food, take it after you've had your meal.
- Plenity works best when it's used together with a healthy diet and regular exercise. Work with your healthcare provider or nutritionist to create a diet and exercise plan that best fits your needs.
- Plenity is not a replacement for food. Your body doesn't absorb Plenity. And once the device works in your digestive tract, it gets removed from your body in your stool. Plenity doesn't provide any nutrition or calories for you.
- Keep Plenity pods closed at room temperature. Keep the pills in the original pods until you're ready to use it. This helps protect the pills from moisture so they don't start absorbing water before you take them.
Common questions about Plenity
In clinical studies, people who were overweight or obese with a body mass index (BMI) of 27 kg/m2 to 40 kg/m2 used Plenity in addition to following a low-calorie diet and exercise regimen. These participants lost an average of 6.4% of body weight in 6 months compared to 4.4% of body weight in those following diet and exercise regimens alone. In addition, about 6 in 10 people using the device were able to lose at least 5% of their body weight over those 6 months.
Talk to your healthcare provider before using Plenity if you have digestive tract problems, like gastroesophageal reflux disease (GERD)), ulcers, or Crohn's disease. Plenity works directly in your digestive tract, so your provider can help you decide whether this device is safe for you. In clinical studies, most people who used Plenity had mild-to-moderate side effects; few had severe side effects (e.g., diarrhea, stomach bloating, nausea). If you experience a severe or long-lasting side effect while using Plenity, stop using the device and contact your healthcare provider right away. They can check to see whether there's anything concerning going on.
Make sure to read the instructions carefully before using Plenity. Take 3 capsules by mouth with 16 ounces (2 cups) of water 20 to 30 minutes before lunch and 20 to 30 minutes before dinner. It's important to drink enough water each time you use the device, since it requires water to work. It's recommended to drink 2 more cups of water after you take your dose. Ask your healthcare provider if you have any questions about how to use Plenity.
Yes, you need a prescription from a healthcare provider to get Plenity. If you're interested in starting Plenity, talk to a provider to see whether this medical device is appropriate for you.
The FDA cleared Plenity for use as a medical device for weight management along with diet and exercise in 2019. "FDA clearance" is similar to "FDA approval." In both cases, the FDA evaluates the risks and benefits of the device. The main difference between using the two terms is how the FDA classifies the medical device depending on the extent of risk it has to the consumer. Plenity is classified as having the potential to have moderate risk to consumers.
The Plenity pills contain two natural ingredients: cellulose and citric acid. These are the active ingredients that work directly in your digestive tract to help you feel fuller. Other ingredients include gelatin, titanium dioxide, and sodium stearyl fumarate, which help with the formulation and manufacturing of the device.
Plenity and phentermine (Adipex-P, Lomaira) are both used for weight management along with diet and exercise. The biggest difference is that Plenity is a medical device and phentermine is a medication. Phentermine has several risks, like abuse and dependence potential, fast heart rate, and high blood pressure. On the other hand, people who used Plenity in clinical studies generally had mild stomach-related side effects, like diarrhea, bloating, and nausea. Phentermine is taken once daily, while Plenity is taken twice daily. If you're looking for weight management, speak with your provider about your options.
It's possible that Plenity might change how medications get absorbed into the body. Because of this, if you need to take medications once daily, take them in the morning or at bedtime, as instructed by your healthcare provider. So far, we only know that Plenity can be taken with metformin. Studies show that the device doesn't affect how metformin gets absorbed into the body when they're taken with a meal. If you take other medications, discuss with your provider about using Plenity before starting therapy.
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Risks and warnings for Plenity
Plenity can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Trouble swallowing Plenity
Since Plenity is a pill that's swallowed, you might have difficulty using this medical device if you have trouble swallowing. Talk to your provider whether it's safe for you to use Plenity based on your swallowing ability.
Caution in people with stomach issues
- Risk factors: Gastroesophageal reflux disease (GERD) | Stomach ulcers | Heartburn | Abnormal digestive tract anatomy | Diverticula | Narrowing in the intestines | Crohn's disease | Complications from surgery affecting digestive tract function
Talk to your provider before using Plenity if you have digestive tract problems, like gastroesophageal reflux disease (GERD), ulcers, or Crohn's disease. Also speak with your provider if you have complications from surgery that affect how your digestive system works. Plenity works directly in your digestive tract, so your provider can discuss with you whether this device is right for you.
Not a food substitute
Plenity isn't a food substitute. Plenity isn't absorbed by the body, and it gets removed through your stool, so it doesn't provide any nutrition or calories for you.
Plenity dosage
Typical dosage for Plenity
The typical dose is 3 capsules by mouth with 16 ounces (2 cups) of water 20 minutes before lunch and dinner.
Plenity contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Plenity will not be safe for you to take.
- Currently pregnant
- Allergy to ingredients (cellulose, citric acid, gelatin, titanium dioxide, or sodium stearyl fumarate)
