Version May 2024
Weight management: Oral: 2.25 g (3 capsules) twice daily (before lunch and dinner).
No dosage adjustment necessary; not systemically absorbed.
No dosage adjustment necessary; not systemically absorbed.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Gastrointestinal: GI adverse effects (38%), diarrhea (13%), abdominal distention (12%)
1% to 10%:
Gastrointestinal: Change in bowel habits (infrequent: 9%), flatulence (9%), abdominal pain (5%)
Hypersensitivity to cellulose, citric acid, sodium stearyl fumarate, gelatin, titanium oxide, or any component of the formulation; pregnancy.
Concerns related to adverse effects:
• GI: Severe abdominal pain or diarrhea may occur; discontinue use.
Disease-related concerns:
• Dysphagia: Use with caution in patients with dysphagia; may affect ability to swallow capsules.
• GI disease: Use with caution in patients with active GI disease, such as gastroesophageal reflux disease, heartburn, or ulcers. Avoid use in patients with esophageal anatomic anomalies (eg, diverticuli, rings, webs), suspected strictures (eg, Crohn disease), and complications from prior GI surgery that may affect mobility and transit.
Concurrent drug therapy issues:
• Altered medication absorption: May affect absorption of other medications; monitor for safety and effectiveness. Avoid concurrent administration when possible. For oral medications scheduled to be administered at lunch or dinner, the manufacturer's labeling recommends administering the concomitant medication after the meal has started.
Dosage form specific issues:
• Packaging: Do not use if blister package is damaged or capsules are broken, crushed, or damaged.
Other warnings/precautions:
• Appropriate use: Should be taken under supervision of a health care provider as part of a structured weight loss program. Not a food substitute.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Plenity: 0.75 g per capsule [42s] [contains carboxymethylcellulose]
Plenity Welcome Kit: 0.75 g per capsule [168s] [contains carboxymethylcellulose]
Oral: Administer capsules with water 20 to 30 minutes before lunch and dinner. Following administration, immediately consume an additional 16 ounces of water. If a premeal dose is missed, may be administered during or immediately after the meal.
Weight management: Management of weight in overweight and obese adults with a BMI of 25 to 40 kg/m2, when used in conjunction with diet and exercise.
None known.
There are no known significant interactions.
Obesity increases the risk of infertility. Optimal weight control prior to conception improves pregnancy outcomes. However, medications for weight loss are not recommended prior to pregnancy due to safety issues and adverse events. Weight loss medications should be discontinued prior to conception (ACOG 2021; Wharton 2020).
The cellulose and citric acid matrix contained in Plenity capsules are not systemically absorbed.
An increased risk of adverse maternal and fetal events is associated with obesity. However, moderate gestational weight gain based on pre-pregnancy BMI is required for positive fetal outcomes in all pregnancies, including patients who are overweight or obese. Therefore, medications for weight loss therapy are not recommended during pregnancy (ACOG 2021; Wharton 2020).
Use of this product is contraindicated in pregnant patients.
The cellulose and citric acid matrix contained in Plenity capsules are not systemically absorbed.
Due to safety concerns, medications for weight loss therapy are not recommended for patients who are breastfeeding (Wharton 2020).
BMI; weight; blood glucose in diabetic patients.
Cellulose and citric acid form a three-dimensional matrix that occupies volume in the stomach and small intestine to create a sensation of fullness and increase satiety.
Onset: Oral: Satiety: 20 to 30 minutes
Absorption: Oral: Not systemically absorbed
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