Trulance Side effects are primarily confined to the gastrointestinal tract. Trulance is the brand name of Plecanatide, marketed and manufactured by Synergy Pharmaceuticals. It has got FDA approval in 2017 for the treatment of patients with chronic idiopathic constipation (CIC) and Irritable Bowel Syndrome with predominant symptoms of constipation (IBS-C).
Trulance contains Plecanatide as the active ingredient and magnesium stearate and microcrystalline cellulose as inactive ingredients.
Trulance MOA (Mechanism of action of Plecanatide):
Trulance acts on the luminal epithelial surface of the small intestines. It increases the intestinal fluid by causing the secretion of fluid from inside the cells into the intestine. The fluid that is added to soften the stools is rich in bicarbonate and chloride.
Trulance also increases gastrointestinal motility propelling the food forward and relieving constipation. It has been observed to modulate the visceral pain sensation arising from the GI tract.
The primary mechanism of action of relieving constipation is the activation of guanylate cyclase inside and outside the cells.
Trulance Side effects:
Trulance (plecanatide) acts locally on the luminal surface of gastrointestinal tract. It does not get absorbed so it has minimal systemic side effects. Most of the systemic side effects are related to the fluid and electrolyte imbalance that occur as a result of the diarrheal effect of Trulance.
Gastrointestinal Side effects of Trulance (Plecanatide):
The most common side effects of the plecanatide are related to the gastrointestinal tract. Plecanatide is contraindicated in children younger than six years of age and should be used with caution in patients who are 18 years of age or younger.
Individuals in these age groups are very sensitive to the drug because of the increased expression of guanlylate cylcase in the intestinal luminal epithelial cells. The use of plecanatide in younger age groups can result in severe diarrhea and life-threatening dehydration.
Diarrhea is the most common Side effects of the Trulance:
Since the drug is used to relieve constipation, it can cause diarrhea in sensitive individuals. Diarrhea can be especially severe in case of overdose. Although, not very common, in clinical trials 2% of the patients treated with plecanatide developed diarrhea including 0.6% (5 patients out of 863) of the patients who developed severe diarrhea compared to 0.1% (1 patients out of 870) in the placebo group [Ref].
Diarrhea was common in the first four weeks of treatment initiation. Severe diarrhea occurred during the first three days of treatment initiation. 4% of the patients in the treatment group and 2% of the placebo treated patients discontinued plecanatide due to the diarrhea.
Other Side effects of Trulance (Plecanatide):
Most of the side effects of trulance are related to the gastrointestinal tract. Patients may report excessive abdominal gases, abdominal distension, nausea, and abdominal pain.
Patients may report dizziness, vertigo, weakness, and symptoms and signs suggestive of fluid depletion such as hypotension (low blood pressure).
Respiratory and genitourinary infections were observed in the plecanatide-treated patients compared to placebo-treated patients. These included sinusitis, nasopharyngitis, upper respiratory tract infections, and urinary tract infections.
2 patients develop raised liver enzymes exceeding 5 – 15 times the upper limits of normal while 3 patients developed raised liver enzymes exceeding 5 times the upper limits of normal in clincal trials.
Lastly, Before treatment initiation, assess the patient for the symptoms and signs suggestive of intestinal obstruction. Avoid using Trulance in patients with intestinal obstruction.
Avoid Trulance in Children < 6 years of age and suspected Intestinal Obstruction