Trulance (plecanatide) Mechanism Of Action, Cost, Side Effects, And Prescribing Information For Chronic Idiopathic Constipation (CIC) | Joseph Han, PharmD Intern | RxEconsult
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Trulance (plecanatide) Cost, Side Effects, And Prescribing Information For Chronic Idiopathic Constipation Category: GI (Ulcers, Crohn's, Ulcerative Colitis) by - January 27, 2017 | Views: 22909 | Likes: 2 | Comment: 0  

Chronic constipation

Brand Name: Trulance 
Generic Nameplecanatide
Medication Class: Guanylate cyclase C (GC-C) agonist
Similar Drugs: Linzess (linaclotide)
Manufacturer: Synergy Pharmaceuticals Inc.
FDA Approval Date: January 19, 2017

What is Trulance and its mechanism of action?

Trulance (plecanatide) is an oral medication used for reducing symptoms of chronic idiopathic constipation (CIC). Trulance changes stool consistency by increasing the amount of water into the GI lumen and increases gastrointestinal movement. Trulance is a 16-amino acid peptide similar to uroguanylin. Uroguanylin is a peptide released by the small intestine and is involved in normal bowel function. 

Trulance works by increasing the activity of guanylate cyclase-C enzyme. Once in the intestine, plecanatide binds to guanylate Cyclase-C, increasing cellular levels of guanosine monophosphate (cGMP). This leads to the activation of cystic fibrosis transmembrane conductance regulator (CFTR). CFTR increases chloride and bicarbonate secretion in the intestinal lumen. All these biochemical changes increase the amount of fluid in the GI lumen. Water in the GI lumen softens stool and promotes stool movement through the GI tract.

What is Trulance used to treat?

Trulance is used for the treatment of chronic idiopathic constipation (CIC) in adults.

How effective is Trulance?

Trulance was studied in two 12-week clinical trials involving 1,775 adult patients. Patients were randomly given the placebo or 3 mg oral dose of Trulance once daily. All patients were diagnosed with constipation at least six months prior to the study. Patients receiving Trulance began to see an improvement in the frequency of complete spontaneous bowel movements (CSBM) within the first week of treatment. The difference between the Trulance group and placebo group was a mean improvement of 1.1 CSBMs/week from baseline. 

What are the side effects of Trulance?

The most common side effect of Trulance is diarrhea. Patients reported diarrhea within 4 weeks of treatment and 2% of treated patients withdrew from the clinical trials due to diarrhea. Severe diarrhea was reported in 0.6% of patients treated with Trulance compared to 0.3% of placebo-treated patients.

Other reported side effects include: 

  • flatulence
  • abdominal tenderness
  • sinusitis
  • upper respiratory infection 
  • an increase in the level of liver biochemical tests [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]
  • dehydration

What is the dosage of Trulance?

Trulance is offered in a 3 mg off-white round tablet. The recommended dosage is 3 mg taken orally once daily, with or without food. The tablet should be swallowed whole.

Adult patients with swallowing difficulties may crush the tablets and administer Trulance orally either in applesauce or with water. It may also be administered with water via a nasogastric or gastric feeding tube. Mixing Trulance crushed tablets in other soft foods or in other liquids has not been studied.

What are Trulance drug interactions?

The manufacturer did not list drugs that interact with Trulance. However, drugs that increase GI movement or cause diarrhea may increase the incidence of diarrhea if they are combined with Trulance.

What are warnings and precautions for Trulance?

Trulance is not indicated for patients less than six years of age due to the risk of serious dehydration.  

Patients between 6 and 18 years of age should also avoid taking Trulance because the safety and efficacy of Trulance have not yet been established in this patient population.  

Patients with known or suspected mechanical obstruction in their GI should also avoid using Trulance until the obstruction is resolved.  

Trulance may cause severe diarrhea. Trulance should be stopped if severe diarrhea occurs and the patient should be hydrated.

What is the cost of Trulance

The retail cost of Trulance is not available because Trulance was recently approved by the FDA,.  

Resources

Trulance FDA Prescribing Information

Also ReadReview Of Irritable Bowel Syndrome (IBS) Treatment

 

Image courtesy of Ohmega1982 at FreeDigitalPhotos.net.


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