These highlights do not include all the information needed to use TRULANCE safely and effectively. See full prescribing information for TRULANCE.
TRULANCE (plecanatide) tablets, for oral use
Initial U.S. Approval: 2017
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
See full prescribing information for complete boxed warning.
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TRULANCE is contraindicated in patients less than 6 years of age; in young juvenile mice, plecanatide caused death due to dehydration. (4, 8.4)
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Avoid use of TRULANCE in patients 6 years to less than 18 years of age. (5.1, 8.4)
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The safety and effectiveness of TRULANCE have not been established in patients less than 18 years of age. (8.4)
INDICATIONS AND USAGE
TRULANCE is a guanylate cyclase-C agonist indicated in adults for treatment of chronic idiopathic constipation (CIC). (1)DOSAGE AND ADMINISTRATION
The recommended adult dosage of TRULANCE is 3 mg taken orally once daily. (2.1)
Administration Instructions (2.2):
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Take with or without food.
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Swallow tablets whole.
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For patients who have difficulty swallowing tablets whole or those with a nasogastric or gastric feeding tube, see full prescribing information with instructions for crushing the tablet and administering with applesauce or water.
DOSAGE FORMS AND STRENGTHS
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Patients less than 6 years of age due to the risk of serious dehydration. (4, 5.1, 8.4)
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Patients with known or suspected mechanical gastrointestinal obstruction. (4)
WARNINGS AND PRECAUTIONS
Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate the patient. (5.2)
ADVERSE REACTIONS
Most common adverse reaction (≥2%) is diarrhea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Synergy Pharmaceuticals at 1-888-869-8869 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 1/2017
