Motegrity FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 30, 2018.
FDA Approved: Yes (First approved December 14, 2018)
Brand name: Motegrity
Generic name: prucalopride
Dosage form: Tablets
Company: Shire plc
Treatment for: Chronic Idiopathic Constipation
Motegrity (prucalopride) is a selective serotonin type 4 (5‑HT4) receptor agonist for the treatment of chronic idiopathic constipation (CIC) in adults.
Warnings and Precautions
Suicidal Ideation and Behavior: Suicidal ideation and behavior have been reported in patients treated with Motegrity. Patients are advised to be aware of any unusual changes in mood or behavior, persistent worsening of symptoms of depression, or the emergence of suicidal thoughts or behavior. If any of these symptoms occur, patients should discontinue Motegrity immediately and contact their healthcare provider.
Administration
Motegrity is an oral tablet taken once daily, with or without food.
Tablets should be stored at room temperature, in the original container to protect from moisture.
Contraindications
Patients should not Motegrity if they:
- are allergic to prucalopride or any of the other ingredients
- have an intestinal perforation or intestinal obstruction due to a structural or functional disorder of the gut wall, obstructive ileus, or severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum.
Adverse Reactions
The most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.
Development timeline for Motegrity
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
