Severe diarrhea was reported in 1% of patients receiving Trulance vs 0.1% of placebo-treated patients
2.5% discontinuation rate for Trulance vs 0.4% for placebo due to AEs
1.2% discontinuation rate due to diarrhea vs 0% for placebo
Reported in at least 2% of Trulance-treated patients with IBS-C and at an incidence greater than placebo1
Severe diarrhea was reported in 0.6% of patients receiving Trulance vs 0.3% of placebo-treated patients
4% discontinuation rate for Trulance vs 2% for placebo due to AEs
2% discontinuation rate due to diarrhea vs 0.5% for placebo
Reported in at least 2% of Trulance-treated patients with CIC and at an incidence greater than placebo1
aTemporary suspension of study drug was not permitted.2,3
Minimally absorbed with
negligible systemic availability1
No drug-drug
interactions observed1
If severe diarrhea occurs, suspend dosing and rehydrate the patient1
Trulance (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age.
Please also see the full Prescribing Information, including BOXED Warning, for additional risk information.