What are the contraindications for Trulance (plecanatide)?

Contraindications for Trulance (Plecanatide)

Trulance (plecanatide) is contraindicated in patients less than 6 years of age due to risk of serious dehydration and in patients with known or suspected mechanical gastrointestinal obstruction. 1

Primary Contraindications

Trulance has two absolute contraindications:

1. Age restriction:

   • Contraindicated in children less than 6 years of age
   • This is due to the risk of serious dehydration observed in nonclinical studies with young juvenile mice 1
   • A boxed warning emphasizes this contraindication due to deaths caused by dehydration in young animal models

2. Mechanical gastrointestinal obstruction:

   • Contraindicated in patients with known or suspected mechanical GI obstruction 1, 2
   • This includes any physical blockage of the gastrointestinal tract that would prevent normal passage of intestinal contents

Special Populations and Precautions

Pediatric Patients

• While contraindicated in children under 6 years, the FDA also recommends avoiding use in patients 6 years to less than 18 years of age 1
• Safety and effectiveness have not been established in patients less than 18 years of age

Pregnancy Considerations

• No specific contraindication is listed for pregnancy in the FDA label for Trulance
• However, clinicians should exercise caution as with any medication during pregnancy

Administration Considerations

• Trulance can be taken with or without food
• For patients with swallowing difficulties, tablets can be crushed and administered orally with applesauce or water, or via nasogastric/gastric feeding tube 1

Mechanism of Action and Clinical Context

Trulance is a guanylate cyclase-C agonist that:

• Increases cyclic guanosine monophosphate concentrations
• Results in luminal chloride and bicarbonate secretion
• Increases intestinal fluid and accelerates GI transit 2

This mechanism explains why mechanical GI obstruction is a contraindication, as increased fluid secretion in an obstructed bowel could worsen the clinical situation.

Adverse Effects to Consider

While not contraindications, clinicians should be aware of potential adverse effects:

• Diarrhea is the most common side effect, with higher rates compared to placebo (RR 5.39) 2
• Approximately 27 more patients per 1,000 may experience diarrhea leading to treatment discontinuation compared to placebo 2

Clinical Application

When considering Trulance for chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C):

1. Confirm patient is ≥18 years of age (contraindicated <6 years, avoid 6-17 years)
2. Rule out mechanical GI obstruction
3. Prescribe at recommended dose of 3 mg taken orally once daily 1
4. Monitor for diarrhea, which may necessitate dose adjustment or discontinuation

Trulance has demonstrated efficacy in increasing complete spontaneous bowel movements and improving stool consistency in adults with CIC and IBS-C 2.