Version April 2023
Plecanatide is contraindicated in patients younger than 6 years; in nonclinical studies in young juvenile mice, administration of a single oral dose of plecanatide caused deaths due to dehydration. Avoid use of plecanatide in patients 6 years to younger than 18 years of age. The safety and effectiveness of plecanatide has not been established in patients younger than 18 years.
Chronic idiopathic constipation (CIC): Oral: 3 mg once daily.
Irritable bowel syndrome with constipation:
Note: Reserve for patients with persistent constipation despite osmotic laxatives (Wald 2022).
Oral: 3 mg once daily. Symptoms generally improve by day 7 (Black 2018; Brenner 2018; Menees 2020); some experts consider alternative therapy in patients without improvement by 4 weeks (Wald 2022).
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing; use with caution.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Trulance: 3 mg
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Trulance: 3 mg
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Trulance: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s007lbl.pdf#page=15
Administer with or without food. Swallow tablet whole.
For patients with swallowing difficulties, tablets can be crushed and administered orally either in applesauce or with water or administered with water via a nasogastric or gastric feeding tube. Mixing crushed tablets in other soft foods or in other liquids has not been tested.
Administration in applesauce: Crush tablet to a powder and mix with 1 teaspoonful (5 mL) of room temperature applesauce. Swallow entire mixture immediately. Do not store mixture for later use.
Administration in water: Combine tablet and ~30 mL of room temperature water into a cup and mix by gently swirling for at least 10 seconds; the tablet will fall apart in the water. Swallow the entire contents of the mixture immediately. If any portion of the tablet is left in the cup, add another 30 mL of water to the cup, swirl for at least 10 seconds, and swallow immediately. Do not store mixture for later use.
Administration via a nasogastric or gastric feeding tube: Combine tablet and 30 mL of room temperature water into a cup and mix by gently swirling for at least 15 seconds; the tablet will fall apart in the water. Flush the nasogastric or gastric feeding tube with 30 mL of water using an appropriate syringe. Draw up the mixture using the syringe and immediately administer via the nasogastric or gastric feeding tube. If any portion of the tablet is left in the cup, add another 30 mL of water to the cup, swirl for at least 15 seconds, and using the same syringe, administer via the nasogastric or gastric feeding tube. Using the same or a fresh syringe, flush the nasogastric or gastric feeding tube with at least 10 mL of water after administration. Do not store mixture for later use.
Chronic idiopathic constipation: Treatment of chronic idiopathic constipation (CIC) in adults
Irritable bowel syndrome with constipation: Treatment of irritable bowel syndrome with constipation (IBS-C) in adults
KIDs List: Plecanatide, when used in pediatric patients <6 years of age, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be avoided due to risk of death from dehydration (weak recommendation; very low quality of evidence) (PPA [Meyers 2020]).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Gastrointestinal: Abdominal distension (<2%), abdominal tenderness (<2%), diarrhea (4% to 5%; severe diarrhea: ≤1%), flatulence (<2%), nausea (1% to <2%)
Genitourinary: Urinary tract infection (1% to <2%)
Hepatic: Increased serum alanine aminotransferase (<2%), increased serum aspartate aminotransferase (<2%)
Nervous system: Dizziness (1% to <2%)
Respiratory: Nasopharyngitis (1% to <2%), sinusitis (<2%), upper respiratory tract infection (<2%)
Postmarketing:
Dermatologic: Pruritus, skin rash, urticaria
Gastrointestinal: Vomiting
Pediatric patients <6 years; mechanical gastrointestinal obstruction (known or suspected).
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to plecanatide or any component of the formulation.
Concerns related to adverse effects:
• Diarrhea: May cause diarrhea; may occur within the first month of treatment (severe diarrhea may occur within the first 3 days of treatment). Consider discontinuation of therapy and rehydration if severe diarrhea occurs.
Special populations:
• Pediatric patients: [US Boxed Warning]: Use is contraindicated in pediatric patients <6 years. Avoid use in pediatric patients 6 to 17 years of age. In studies in young juvenile mice, administration of a single oral dose of plecanatide caused deaths due to dehydration. The safety and effectiveness of plecanatide has not been established in patients <18 years.
None known.
There are no known significant interactions.
Plecanatide and its metabolite are generally not measurable in plasma when used at recommended doses. Maternal use is not expected to result in fetal exposure.
Plecanatide is not expected to be present in breast milk.
Plecanatide 3 mg was administered once daily for 2 weeks to lactating women. Plecanatide and the metabolite were not detected in breast milk sampled 2, 6, and 12 hours after the maternal dose. Plecanatide and its metabolite are generally not measurable in plasma when used at recommended doses. Maternal use is not expected to result in significant exposure via breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Frequency of straining during bowel movements; spontaneous bowel movement quality and frequency
Plecanatide and its active metabolite bind and agonize guanylate cyclase-C on the luminal surface of intestinal epithelium. Intracellular and extracellular cyclic guanosine monophosphate (cGMP) concentrations are subsequently increased resulting in chloride and bicarbonate secretion into the intestinal lumen. Intestinal fluid increases and GI transit time is accelerated.
Absorption: Minimal systemic availability; plasma concentrations are not measurable when used at recommended doses.
Distribution: Minimal tissue distribution is expected given immeasurable plasma concentrations when used at recommended doses.
Metabolism: Metabolized within GI tract to active metabolite; parent drug and metabolite undergo proteolytic degradation within the intestinal lumen to smaller peptides and amino acids
Tablets (Trulance Oral)
3 mg (per each): $21.55
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