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Plecanatide: Drug information

Plecanatide: Drug information
(For additional information see "Plecanatide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Risk of serious dehydration in pediatric patients:

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.

Brand Names: US
  • Trulance
Brand Names: Canada
  • Trulance
Pharmacologic Category
  • Gastrointestinal Agent, Miscellaneous;
  • Guanylate Cyclase-C (GC-C) Agonist
Dosing: Adult
Chronic idiopathic constipation

Chronic idiopathic constipation (CIC): Oral: 3 mg once daily.

Irritable bowel syndrome with constipation

Irritable bowel syndrome with constipation (IBS-C): Oral: 3 mg once daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing; use with caution.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Trulance: 3 mg

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Trulance: 3 mg

Medication Guide and/or Vaccine Information Statement (VIS)

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

Administration: Adult

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.

Use: Labeled Indications

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

Medication Safety Issues
Pediatric patients: High-risk medication:

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]).

Adverse Reactions

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

Contraindications

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.

Warnings/Precautions

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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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.

Breastfeeding Considerations

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.

Monitoring Parameters

Frequency of straining during bowel movements; spontaneous bowel movement quality and frequency

Mechanism of Action

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.

Pharmacokinetics

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

Pricing: US

Tablets (Trulance Oral)

3 mg (per each): $20.33

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Trulance (IN)


For country abbreviations used in Lexicomp (show table)
  1. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  2. Trulance (plecanatide) [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals, a division of Bausch Health US, LLC; April 2021.
  3. Trulance (plecanatide) [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals, a division of Bausch Health US, LLC; February 2021.
  4. Trulance (plecanatide) [product monograph]. Laval, Quebec, Canada; Bausch Health Canada Inc; March 2021.
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