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Safety and Tolerability Profile

Nonsystemic aid with proven safety and tolerability profile.1,2

No difference in overall incidence of adverse events (AEs) vs. placebo.1,2

95%

AEs were mild or moderate1,2

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Occurred within the first 3 months2

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Most AEs resolved within 2 weeks2

More than 1 out of 3 patients did experience GI AEs, so it is important to manage expectations with your patients.1

Overview of treatment-related adverse events.1-3

The dropout rate was lower in the Plenity group (23%) than the placebo group (29%)2

 

Parameter Plenity (n=223) Placebo (n=211) Difference (95% CI)² P value²
Related AEs 39.5% (88) 30.3% (64) 9.1 (-0.2, 18.2) 0.06
Eye disorders 0% (0) 0.5% (1) -0.5 (-3.0, 1.7) 0.49
GI disorders 37.7% (84) 27.5% (58) 10.2 (1.0, 19.1) 0.02
General disorders 0.4% (1) 0.5% (1) -0.0 (-2.6, 2.4) 1.00
Infection/infestations 0.9% (2) 0.5% (1) 0.4 (-2.2, 3.1) 1.00
Investigations 1.3% (3) 1.4% (3) -0.1 (-3.3, 3.0) 1.00
Metabolism/nutrition 0% (0) 1.9% (4) -1.9 (-5.1, 0.6) 0.06
MSK/connective tissue 0.9% (2) 0% (0) 0.9 (-1.5, 3.5) 0.50
Nervous system 1.8% (4) 0.9% (2) 0.8 (-2.2, 4.0) 0.69
Renal/urinary 0.4% (1) 0% (0) 0.4 (-1.8, 2.9) 1.00
Reproductive 0% (0) 0.5% (1) -0.5 (-3.0, 1.7) 0.49
Respiratory/thoracic 0.4% (1) 0.5% (1) -0.0 (-2.6, 2.4) 1.00
Skin/subcutaneos 0.4% (1) 1.4% (3) -1.0 (-4,0, 1.7) 0.36
The overall incidence of all AEs in the Plenity group was no different than the placebo group.1,2

Only the category of GI disorders related to Plenity was different relative to Placebo (p=0.02488).1,2

Treatment-related GI AEs as assessed by investigators.1,2

Parameter Plenity % (n) Placebo % (n)
GI-related AEs* 37.7% (84) 27.5% (58)
Abdominal distension 10.8% (24) 5.7% (12)
Diarrhea 10.3% (23) 7.6% (16)
Infrequent bowel movements 9.0% (20) 4.7% (10)
Flatulence 8.5% (19) 4.7% (10)
Abdominal pain 4.9% (11) 2.8% (6)
Constipation 4.5% (10) 4.7% (10)
The most common (>5%) GI AEs in the Plenity group were diarrhea, abdominal distension, infrequent bowel movements, flatulence, constipation, abdominal pain, and nausea.1,2

75% (119 out of 158) of GI AEs in the Plenity group and 79% (83 of 105) in the placebo group were assessed as mild.1

 

 


 

 

Incidence of treatment-related GI AEs.

In the trial, 37.7% of Plenity patients experienced GI AEs - these occurred within the first 2 weeks and the majority resolved within 2 weeks of onset.2,4

GI AEs Graph

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Intended Use

Plenity® is indicated to aid weight management in adults with excess weight or obesity, a Body Mass Index (BMI) of 25–40 kg/m², when used in conjunction with diet and exercise.

 

Important Safety Information

  • Plenity is contraindicated in patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide
  • Plenity may alter the absorption of medications. Read Sections 6 and 8.3 of the Instructions for Use carefully
  • Avoid use in patients with: esophageal anatomic anomalies, including webs, diverticuli, and rings; suspected strictures (such as patients with Crohn’s disease); and complications from prior gastrointestinal (GI) surgery that could affect GI transit and motility
  • Use with caution in patients with active gastrointestinal conditions such as gastro-esophageal reflux disease (GERD), ulcers, or heartburn
  • The overall incidence of AEs in the Plenity group was no different than the placebo group
  • The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence

Rx Only. For the safe and proper use of Plenity, refer to the Healthcare Professional Instructions for Use.

References:
  1. Plenity (Instructions for Use). Boston, MA: Gelesis, Inc.; 2021.
  2. Greenway FL, Aronne LJ, RabenA, et al. A randomized, double-blind, placebo-controlled study of Gelesis100: a novel nonsystemicoral hydrogel for weight loss. Obesity. 2019;27(2):205–216.
  3. Data on file. Gelesis, Inc.
  4. Luzi L, Raben A, Astrup A, et al. Comprehensive analysis of safety and tolerability of Gelesis100 in overweight and obesity in the pivotal GLOW study. Poster presented at: European and International Congress on Obesity; September 1–4, 2020; virtual meeting.

AE=adverse event; CI=confidence interval; GI=gastrointestinal; MSK=musculoskeletal