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Plecanatide

Pronunciation

(ple KAN a tide)

Dosage Forms

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

Tablet, Oral:

Trulance: 3 mg

Brand Names: U.S.

  • Trulance

Pharmacologic Category

  • Gastrointestinal Agent, Miscellaneous
  • Guanylate Cyclase-C (GC-C) Agonist

Pharmacology

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 increased.

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.

Use: Labeled Indications

Chronic idiopathic constipation: Treatment of chronic idiopathic constipation (CIC) in adults

Contraindications

Pediatric patients <6 years; mechanical gastrointestinal obstruction (known or suspected).

Dosing: Adult

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

Dosing: Geriatric

Refer to adult dosing; use with caution.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

Administration

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.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not subdivide or repackage; protect from moisture.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

1% to 10%:

Gastrointestinal: Diarrhea (5%), abdominal distension (<2%), abdominal tenderness (<2%), flatulence (<2%)

Hepatic: Increased serum ALT (<2%), increased serum AST (<2%)

Respiratory: Sinusitis (<2%), upper respiratory tract infection (<2%)

ALERT: U.S. 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.

Warnings/Precautions

Concerns related to adverse effects:

• Diarrhea: May cause diarrhea; 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.

Monitoring Parameters

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

Pregnancy Considerations

Plecanatide and its metabolite are not measurable in plasma when used at recommended doses. Maternal use is not expected to result in fetal exposure.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe diarrhea (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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