Plecanatide

Plecanatide is used in adults to treat chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C).

Plecanatide is available under the following different brand names: Trulance.

Dosages of Plecanatide:

Dosage Forms and Strengths

Tablets

• 3 mg

Dosage Considerations – Should be Given as Follows:

Chronic Idiopathic Constipation

• Indicated for chronic idiopathic constipation in adults
• 3 mg orally once daily

Irritable Bowel Syndrome

• Indicated for irritable bowel syndrome with constipation (IBS-C) in adults
• 3 mg orally once daily

Geriatric use:

• Clinical studies did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently
• In general, dose selection in elderly patients should be cautious

Pediatric use:

• Children under 18 years: Safety and efficacy not established
• Avoid use in patients aged 6 years to under 18 years
• Contraindicated in children under 6 years; single oral dose caused deaths owing to dehydration in nonclinical studies

Common side effects of plecanatide include:

• Diarrhea
• Sinusitis
• Upper respiratory tract infection
• Abdominal distension
• Gas (flatulence)
• Abdominal tenderness
• Increased ALT and AST

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Plecanatide has no listed severe interactions with other drugs.
• Plecanatide has no listed serious interactions with other drugs.
• Plecanatide has no listed moderate interactions with other drugs.
• Plecanatide has no listed mild interactions with other drugs.

Warnings

• This medication contains plecanatide. Do not take Trulance if you are allergic to plecanatide or any ingredients contained in this drug.

Black Box Warnings

• Contraindicated in children aged under 6 years; in nonclinical studies in young juvenile mice, administration of a single oral dose caused deaths owing to dehydration
• Avoid use in children 6 years to under18 years
• Safety and effectiveness have not been established in children aged under 18 years

Contraindications

• Children under 6 years
• Known or suspected mechanical gastrointestinal obstruction

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Plecanatide?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Plecanatide?"

Cautions

• Diarrhea may occur; however, severe diarrhea is infrequent; if severe diarrhea occurs, suspend dosing and rehydrate the patient
• Risk of serious dehydration in pediatric patients
  • Contraindicated in children aged under 6 years
  • In young juvenile mice (human age equivalent of approximately 1 month to under 2 years), the drug increased fluid secretion into the intestines as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently owing to dehydration
  • Because of increased intestinal expression of GC-C, patients aged under 6 years may be more likely than older children to develop severe diarrhea and its potentially serious consequences
  • Safety and efficacy have not been established in children aged under 18 years

Pregnancy and Lactation

• Data are insufficient regarding the use of plecanatide during pregnancy to assess drug-associated risks for major birth defects and miscarriage in humans. Plecanatide and its active metabolite are negligibly absorbed systemically, and maternal use is not expected to result in fetal exposure to the drug. Consult your doctor.
• It is unknown if plecanatide is distributed in human breast milk. Plecanatide and its active metabolite are negligibly absorbed systemically, and maternal use is not expected to result in fetal exposure to the drug. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for plecanatide, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.