Plenity

Plenity is a prescription-only, weight management device approved for use in adults with excess weight or obesity to be combined with diet and exercise. Plenity is made with 2 ingredients, cellulose and citric acid.

Plenity works by releasing gel particles in the stomach when taken with water. The particles absorb water and mix with food, leading to a feeling of fullness. That helps patients eat less.

Plenity is supplied in pods. Within each pod is a single dose of 3 capsules. Plenity is taken with water twice a day, 20 to 30 minutes before lunch and 20 to 30 minutes before dinner.

Common side effects include diarrhea, distended abdomen (swollen belly), infrequent bowel movements, and flatulence (passing gas).

Serious side effects may occur. See "Precautions" section.

The most common side effects in clinical studies were:

• diarrhea
• distended abdomen (swollen belly)
• infrequent bowel movements
• flatulence (gas)

This is not a complete list of Plenity side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

On an empty stomach, Plenity can affect how your body absorbs medications you take at the same time.

To avoid impact on the absorption of medications:

• For all medications that should be taken with food, take them after starting a meal.
• 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.

Contact a doctor right away if problems occur. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak with your doctor.

• If you have a medical condition that makes it hard to swallow, you may have trouble swallowing Plenity.

• Use Plenity with caution if you:

  • have problems with your esophagus, including webs and/or rings.

  • have diverticula.

  • are likely to have strictures (a narrowing in the intestines, such as patients with Crohn’s disease may have).

  • have had gastrointestinal surgery with complications (for example, obstruction and/or adhesive peritonitis or known abdominal adhesions).

  • have active gastrointestinal conditions such as gastroesophageal reflux disease (GERD), ulcers, or heartburn.

• Do not consume Plenity if pod or package is damaged.

• Do not take any capsules which are broken, crushed, or damaged. Discard those capsules.

• Plenity is NOT a food substitute. It is not absorbed by the body and therefore has no nutritional value.

• Plenity should be taken under the direction of a healthcare provider as part of a structured weight loss program. Failure
  to adhere to prescribed dietary and exercise instructions may result in failure to lose weight.

You cannot take Plenity if you:

• are pregnant

• have had allergic reactions to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide.

Plenity should be taken with water twice a day, 20 to 30 minutes before lunch and 20 to 30 minutes before dinner. Each dose includes 3 capsules of Plenity provided in a single pod.

For each dose, follow these steps:

• Check that the capsules are not broken, crushed, or damaged. (Throw away any damaged capsules.)
• Swallow the 3 capsules with water.
• After you take the capsules, drink 2 more glasses of water (8 fl oz/250 mL each). 
• After taking Plenity, wait 20 to 30 minutes before starting your meal.
• If a pre-meal dose is missed, take Plenity during or immediately after that meal.

To avoid impact on the absorption of medications:

• For all medications that should be taken with food, take them after starting a meal.
• 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.

Keep out of the reach of children.

Pods should be kept closed and stored at room temperature between 41° and 86° Fahrenheit (F) [5°-30° Celsius (C)].

Plenity should be kept in its original pod until use.