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DrugMotegrity™ (prucalopride) [Shire US Manufacturing Inc.]

July 2019

Therapeutic area - Gastrointestinal (GI) Motility, Chronic

Approval criteria

Patient must:

  • Be ≥ 18 years old AND
  • Have diagnosis of chronic idiopathic constipation (CIC) AND
  • Not have any of the following:
    • hypersensitivity to prucalopride OR
    • intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus OR
    • severe inflammatory conditions of the intestinal tract (e.g., Crohn’s disease, ulcerative colitis, toxic megacolon/megarectum) OR
    • history of QT prolongation AND
  • Have a trial and failure of or inadequate response to ≥ 2 preferred traditional laxative therapies (e.g., polyethylene glycol, lactulose) AND
  • Have a trial and failure of ≥ 1 newer products indicated for CIC (e.g., linaclotide, lubiprostone)

Renewal criteria

  • Patient must continue to meet the above criteria AND
  • Patient must have documented efficacy/prescriber is able to provide verification of clinical improvement AND
  • Patient has not experienced any treatment-restricting adverse effects (e.g., hypersensitivity, suicidal ideation)

Quantity limits

  • 30 tablets per 30 days


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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