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Plecanatide

Medically reviewed by Drugs.com. Last updated on Aug 9, 2020.

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 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.

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

Contraindications

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

Dosing: Adult

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

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

Dosing: Geriatric

Refer to adult dosing; use with caution.

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%:

Central nervous system: Dizziness (1% to <2%)

Gastrointestinal: Diarrhea (4% to 5%), abdominal distension (<2%), abdominal tenderness (<2%), flatulence (<2%), nausea (1% to <2%), severe diarrhea (≤1%)

Genitourinary: Urinary tract infection (1% to <2%)

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

Respiratory: Sinusitis (<2%), upper respiratory tract infection (<2%), nasopharyngitis (1% to <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; 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.

Monitoring Parameters

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

What is this drug used for?

• It is used to treat constipation.

• It is used to treat irritable bowel syndrome.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe or persistent diarrhea

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.