Plecanatide

Name: Plecanatide

Adverse Effects

1-10%

Diarrhea 5%

Frequency Not Defined

Sinusitis

Upper respiratory tract infection

Abdominal distension

Flatulence

Abdominal tenderness

Increased ALT and AST

Brand names

  • Trulance®

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Plecanatide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Diarrhea is a common side effect of plecanatide.

Stop using plecanatide and call your doctor at once if you have severe diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Plecanatide Dosage and Administration

Administration

Oral Administration

Administer orally without regard to food.1 Administration with meals may result in looser stools.1

Swallow tablets whole.1

If patient cannot swallow whole tablet, crush tablet and mix in applesauce and administer orally or disperse tablet in water and administer orally or via a nasogastric or gastric feeding tube.1 Use these mixtures immediately; do not store for later use.1 Administration in other soft foods or liquids not studied.1

If a dose is missed, do not double the dose.1 Administer the next dose at the regularly scheduled time.1

Oral Administration in Applesauce

Crush 3-mg tablet to a powder and mix with 1 teaspoonful of room-temperature applesauce.1 Administer entire mixture immediately.1

Oral Administration as Aqueous Dispersion

Place 3-mg tablet in a cup, add approximately 30 mL of room-temperature water, gently swirl for ≥10 seconds to disperse the disintegrating tablet, then administer immediately.1

Disperse any residue remaining in the cup in an additional 30 mL of water, gently swirl for ≥10 seconds, then administer immediately.1

Administration via Nasogastric or Gastric Tube

Place 3-mg tablet in a cup, add approximately 30 mL of room-temperature water, gently swirl for ≥15 seconds to disperse the disintegrating tablet.1 Flush the nasogastric or gastric feeding tube with 30 mL of water, then draw up entire contents of the plecanatide dispersion into a syringe and administer immediately.1

Disperse any residue remaining in the cup in an additional 30 mL of water, gently swirl for ≥15 seconds, and administer using the same syringe.1 Then use the same syringe or a new syringe to flush the nasogastric or gastric feeding tube with ≥10 mL of water.1

Dosage

Adults

Chronic Idiopathic Constipation Oral

3 mg once daily.1

Higher dosage (6 mg daily) not recommended; provides no additional clinical benefit but may increase adverse effects.1 13

Special Populations

Hepatic Impairment

Manufacturer makes no specific dosage recommendations.1

Renal Impairment

Manufacturer makes no specific dosage recommendations.1

Geriatric Patients

Manufacturer makes no specific dosage recommendations.1

Uses of Plecanatide

  • It is used to treat hard stools (constipation).

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.

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.

In Summary

More frequently reported side effects include: diarrhea. See below for a comprehensive list of adverse effects.

Usual Adult Dose for Chronic Idiopathic Constipation

3 mg orally once a day

Use: Treatment of chronic idiopathic constipation (CIC)

Dialysis

Data not available.

Other Comments

Administration Advice:
-Administer this drug with or without food.
-Advise patients to swallow a drug tablet whole for each dose.
-Consult the manufacturer product information for instructions on administering a crushed tablet in either applesauce or water or administering it with water via a nasogastric or gastric feeding tube to patients with swallowing difficulties; mixing this drug in other soft foods and liquids has not been tested.

Storage Requirements:
-Store this drug at room temperature (20 to 25 Celsius/68 to 77 Fahrenheit).
-Keep this drug in its original bottle; do not subdivide or repackage.
-Keep this drug in a dry place and protect from moisture; do not remove the desiccant from the drug bottle.


Patient Advice:
-If you miss a dose, skip it and take the next dose at the regular time. Do not take two doses at the same time.
-If you experience severe diarrhea during treatment, stop taking this drug and contact your healthcare provider.

(web3)