Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
Absorption
Oral: Not systemically absorbed
Onset of Action
Oral: Satiety: 20 to 30 minutes
Use: Labeled Indications
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.
Contraindications
Hypersensitivity to cellulose, citric acid, sodium stearyl fumarate, gelatin, titanium oxide, or any component of the formulation; pregnancy.
Dosage and Administration
Dosing: Adult
Weight management: Oral: 2.25 g (3 capsules) twice daily (before lunch and dinner).
Dosing: Geriatric
Refer to adult dosing.
Administration
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.
Storage
Store in original blister packs at 5°C to 30°C (41°F to 86°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
>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%)
Warnings/Precautions
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.
Monitoring Parameters
BMI; weight; blood glucose in diabetic patients.
Pregnancy
Pregnancy Considerations
The cellulose and citric acid matrix contained in Plenity capsules are not systemically absorbed.
An increased risk of adverse maternal and fetal outcomes is associated with obesity. However, moderate weight gain based on prepregnancy BMI is required for positive fetal outcomes. Therefore, medications for weight loss therapy are not recommended at conception or during pregnancy (ACOG 156 2015; Stang 2016). Use of this product is contraindicated in pregnant females.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience bloating, abdominal pain, diarrhea, constipation, passing gas, nausea, stuffy nose, sore throat, or headache. Have patient report immediately to prescriber signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, fast heartbeat, confusion, increased hunger, or sweating) (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
