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. MOTEGRITY tablets containing 1 mg prucalopride are white to off-white, round, biconvex film-coated tablets debossed with "PRU 1" on one side and no debossing on the other side. They are supplied as:
NDC 54092-546-01: HDPE bottle of 30 tablets, with child-resistant closure.
MOTEGRITY tablets containing 2 mg prucalopride are pink, round, biconvex film-coated tablets debossed with "PRU 2" on one side and no debossing on the other side. They are supplied as:
NDC 54092-547-01: HDPE bottle of 30 tablets, with child-resistant closure.
Store MOTEGRITY at 20�C to 25�C (68�F to 77�F); excursions permitted between 15�C to 30�C (between 59�F to 86�F) [see USP Controlled Room Temperature].
Store MOTEGRITY in the original container to protect from moisture. These highlights do not include all the information needed to use MOTEGRITY safely and effectively. See full prescribing information for MOTEGRITY.
MOTEGRITY (prucalopride) tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
MOTEGRITY� is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. (1.1)
DOSAGE AND ADMINISTRATION
Take with or without food. (2)
Recommended dosage by patient population:
Population with CIC Recommended Oral Dose Regimen
Adults 2 mg once daily. (2)
Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min 1 mg once daily. (2, 8.5, 8.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg of prucalopride (3)
CONTRAINDICATIONS
Hypersensitivity to MOTEGRITY(4)
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. (4)
WARNINGS AND PRECAUTIONS
Suicidal Ideation and Behavior: 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. (5.1)
ADVERSE REACTIONS
Most common adverse reactions (?2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Shire at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2018
