Now with Motegrity, it's possible to take adult


Chronic Idiopathic Constipation (CIC) patients from

Stasis to peristalsis

Now with Motegrity, it's possible


to take adult Chronic Idiopathic


Constipation (CIC) patients from

Stasis to peristalsis

Enhanced colonic peristalsis is now possible with Motegrity,
the only FDA-approved selective serotonin type 4 (5-HT4) receptor
agonist for adults with CIC.1-4

Discover the Motegrity difference

Select Important Safety Information

Contraindications

  • Hypersensitivity to Motegrity. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed.
  • Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum

Motegrity is a GI prokinetic that enhances colonic peristalsis (i.e. HAPCs), which increases bowel motility

In a pharmacodynamic study in patients with CIC, a single 2 mg dose of Motegrity increased the number of high amplitude propagating contractions (HAPCs) during the first 12 hours vs. an osmotic laxative treatment.1

Treatment with Motegrity 4 mg once daily (2X max recommended dose of 2 mg) for 7 days increased the amplitude of HAPCs in healthy subjects without affecting colonic phasic activity vs. placebo.1

See mechanism of action

Clinical efficacy

View the results established in 6 clinical trials in 2484 patients with CIC.1

See trial data

Savings & support

Eligible patients can pay as little
as $15* per 30-day fill.

See patient savings

*Up to $90 max benefit per 30-day
prescription. Terms and Conditions
apply. See link below for details.

Motegrity savings card
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IMPORTANT SAFETY INFORMATION

Contraindications

  • Hypersensitivity to Motegrity. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed.
  • Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum

Warnings and Precautions

Suicidal Ideation and Behavior: In clinical trials, suicides, suicide attempts and suicidal ideation have been reported. A causal association between treatment with Motegrity and an increased risk of suicidal ideation and behavior has not been established. Monitor patients for persistent worsening of depression and emergence of suicidal thoughts and behavior. Instruct patients to discontinue Motegrity immediately and contact their healthcare provider if their depression is persistently worse, or they experience emerging suicidal thoughts or behaviors.

Adverse Reactions

Most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.

Use in Specific Populations

  • Lactation: Motegrity is present in breast milk. Consider risks and benefits of breastfeeding
  • Pediatric: Safety and effectiveness in pediatric patients have not been established
  • Renal Impairment: A decreased dosage is recommended in patients with severe renal impairment. Avoid Motegrity in patients with end-stage renal disease requiring dialysis

Indication

Motegrity is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Please click here for full Prescribing Information.

References:

1. Motegrity (prucalopride) Prescribing Information. Lexington, MA: Shire LLC. 2. Emmanuel A, Cools M, Vandeplassche L, Kerstens R. Am J Gastroenterol. 2014;109(6):887-894. 3. Miner PB, Camilleri M, Burton D, et al. Neurogastroenterol Motil. 2016;28(9):1341-1348. 4. Enterostasis. Stedman's Online. https://stedmansonline.com/‌content.aspx‌?term=‌ENTEROSTASIS. Accessed February 25, 2019.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Hypersensitivity to Motegrity. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed.
  • Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum

Warnings and Precautions

Suicidal Ideation and Behavior: In clinical trials, suicides, suicide attempts and suicidal ideation have been reported. A causal association between treatment with Motegrity and an increased risk of suicidal ideation and behavior has not been established. Monitor patients for persistent worsening of depression and emergence of suicidal thoughts and behavior. Instruct patients to discontinue Motegrity immediately and contact their healthcare provider if their depression is persistently worse, or they experience emerging suicidal thoughts or behaviors.

Adverse Reactions

Most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.

Use in Specific Populations

  • Lactation: Motegrity is present in breast milk. Consider risks and benefits of breastfeeding
  • Pediatric: Safety and effectiveness in pediatric patients have not been established
  • Renal Impairment: A decreased dosage is recommended in patients with severe renal impairment. Avoid Motegrity in patients with end-stage renal disease requiring dialysis

Indication

Motegrity is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Please click here for full Prescribing Information.

Continue

Study Design details1

In Studies 2 and 6, geriatric patients (≥65 years) started at 1 mg of Motegrity once daily and, if necessary, the dose was increased to Motegrity 2 mg after 2 or 4 weeks of treatment if response was insufficient at 1 mg. Of these patients, 81% (n=93/115) increased to 2 mg.1

Inclusion Criteria1
  • History of chronic constipation defined as having <3 SBMs per week that resulted in a feeling of complete evacuation (complete spontaneous bowel movement; CSBM)
  • 1 or more of the following symptoms for >25% of BMs in the preceding 3 months, with symptoms onset >6 months prior to screening:
    • Lumpy or hard stool
    • Sensation of incomplete evacuation
    • Straining at defecation
  • Patients who never had SBMs were eligible
  • In Study 1, eligibility also included sensation of ano-rectal obstruction or blockade or the need for digital manipulation in more than 25% of BMs
Exclusion Criteria1
  • Constipation was due to secondary causes
  • Suspected drug-induced constipation

BM=bowel movement; SBM=spontaneous bowel movement

Reference:
1. Motegrity (prucalopride) Prescribing Information. Lexington, MA: Shire LLC.

Key patient demographics & baseline characteristics1,2*

Study design infographic Study design infographic

*Characteristics for placebo and Motegrity ≤2 mg groups. For more demographics and baseline characteristics see Camilleri et al. 2016.
BMI=body mass index; SBM=spontaneous bowel movement

References:
1. Motegrity (prucalopride) Prescribing Information. Lexington, MA: Shire LLC. 2. Camilleri M, Piessevaux H, Yiannakou Y, et al. Dig Dis Sci. 2016;61(8):2357-2372.

Alternative Endpoint Study Results1

Efficacy responder rates in placebo-controlled studies of CIC: Proportion of patients with an average of ≥3 CSBMs/week and an increase of ≥1 CSBM/week for at least 9 out of the 12 weeks, including 3 of the last 4 weeks (ITT population)1

Study Motegrity
1 or 2 mg Once Daily		 placebo Treatment Difference
N n (%) N n (%) (95% CI)
Study 1 249 65 (26) 252 22 (9) 17 (11, 24)
Study 2 177 57 (32) 181 25 (14) 18 (10, 27)
Study 3 236 30 (13) 240 13 (5) 8 (2, 12)
Study 4 190 37 (19) 193 15 (8) 11 (5, 18)
Study 5 214 34 (16) 212 11 (5) 11 (5, 16)
Study 6 171 29 (17) 169 22 (13) 4 (-4, 12)

CSBM=complete spontaneous bowel movement; N=number of patients per treatment group; n=number of responders

Select Important Safety Information

Contraindications

  • Hypersensitivity to Motegrity. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed.
  • Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum

Reference:
1. Motegrity (prucalopride) Prescribing Information. Lexington, MA: Shire LLC.

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