TRULANCE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRULANCE (TRULANCE).
Guanylate cyclase-C receptor agonist; increases intracellular cGMP, leading to chloride and water secretion into intestinal lumen and accelerated transit.
| Metabolism | Metabolized by hydrolysis and reduction, not via cytochrome P450; converted to active and inactive metabolites. |
| Excretion | Primarily excreted in feces as unchanged drug (approximately 60%) and as metabolites; renal excretion is minimal (<3%). |
| Half-life | Terminal elimination half-life is approximately 16 hours, supporting once-daily dosing. |
| Protein binding | Approximately 95% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 2.3 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Absolute bioavailability is approximately 19% after oral administration due to first-pass metabolism. |
| Onset of Action | Oral: Onset within 24 hours of first dose; clinical effect on bowel movements observed within the first week. |
| Duration of Action | Duration is approximately 24 hours with once-daily dosing; sustained increase in spontaneous bowel movements over 12 weeks in clinical trials. |
| Molecular Weight | 587.65 |
3 mg orally once daily.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for any degree of renal impairment, including end-stage renal disease. |
| Liver impairment | No dose adjustment required for mild or moderate hepatic impairment (Child-Pugh class A or B). Not studied in severe hepatic impairment (Child-Pugh class C); use not recommended. |
| Pediatric use | Safety and efficacy not established in pediatric patients below 18 years of age. |
| Geriatric use | No specific dose adjustment recommended; however, consider potential increased sensitivity and monitor renal function due to age-related decline. |
| 1st trimester | Insufficient human data; animal studies show no teratogenicity at clinically relevant doses. Use only if benefit outweighs risk. |
| 2nd trimester | Insufficient human data; no known fetal harm. Caution advised. |
| 3rd trimester | Insufficient human data; risk of fetal harm unknown. Avoid unless necessary. |
Clinical note
Comprehensive clinical and safety monograph for TRULANCE (TRULANCE).
| Placental transfer | Predicted to cross placenta based on molecular weight and pharmacokinetics; no human data. |
| Breastfeeding | Not recommended due to potential for adverse effects in nursing infants. Excretion into human milk unknown. |
| Lactation Rating |
■ FDA Black Box Warning
Not applicable.
| Serious Effects |
Known hypersensitivity to plecanatide or any excipientGastrointestinal obstruction (including mechanical obstruction)Abdominal surgery within the past 6 months
| Precautions | Risk of diarrhea, sometimes severe; avoid in patients with suspected or known mechanical gastrointestinal obstruction; caution in patients with severe hepatic impairment. |
| Food/Dietary | No significant food interactions; can be taken with or without food. |
| Clinical Pearls |
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| L4 |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. Animal studies show no evidence of harm at clinically relevant exposures. Risk cannot be ruled out; use only if clearly needed. |
| Fetal Monitoring | No specific monitoring requirements beyond routine prenatal care. Monitor for gastrointestinal adverse effects (e.g., diarrhea) and maternal hydration status. |
| Fertility Effects | No human data on fertility. Animal studies show no impairment of fertility at clinically relevant exposures. |
| Trulance (plecanatide) is a guanylate cyclase-C agonist indicated for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). It increases intestinal fluid and transit. Avoid use in patients younger than 6 years due to risk of severe dehydration. Dose is 3 mg once daily; no adjustment for renal or hepatic impairment. Onset may take days to weeks. Titration not needed. |
| Patient Advice | Take Trulance once daily with or without food. · Swallow tablet whole; do not crush or chew. · Diarrhea is the most common side effect; report severe or persistent diarrhea. · May cause dehydration; drink adequate fluids. · Not recommended in children under 6 years. · Store at room temperature; keep out of reach of children. |