Canalevia-CA1 (Crofelemer): Chemotherapy-Induced Diarrhoea Support

crofelemer delayed-release tablets is covered as prescription antisecretory gastrointestinal medicine; supportive care, not antitumour treatment, with species, evidence, regulatory, safety, interaction and monitoring boundaries for a veterinarian-led decision.

Prescription antisecretory gastrointestinal medicine; supportive care, not antitumour treatment. Crofelemer.

Crofelemer.

Crofelemer is thought to reduce intestinal chloride and water secretion. The treatment target is chemotherapy-induced diarrhoea, not the tumour and not every cause of diarrhoea.

The US label is for chemotherapy-induced diarrhoea in dogs. Infectious, obstructive, dietary, pancreatic, inflammatory and other causes can look similar, so the veterinarian must identify the likely cause and assess hydration and systemic illness before applying the label.

The US label is for chemotherapy-induced diarrhoea in dogs. Infectious, obstructive, dietary, pancreatic, inflammatory and other causes can look similar, so the veterinarian must identify the likely cause and assess hydration and systemic illness before applying the label.

Oral delayed-release tablet prescribed for home administration under veterinary direction

FDA conditional approval was based on safety and manufacturing standards plus a reasonable expectation of effectiveness. The original evidence package was small and conditional approval is not the same as full approval based on substantial evidence. AAHA lists crofelemer-CA1 as one option while also emphasising modern antimicrobial stewardship and patient-specific supportive care.

FDA materials report abnormal faeces, appetite or activity change, vomiting and other gastrointestinal findings. Persistent diarrhoea can itself produce dehydration, electrolyte disturbance or treatment interruption. Blood, black stool, repeated vomiting, collapse, fever or marked lethargy needs urgent veterinary triage rather than repeated unsupervised dosing.

Delayed-release tablets must be treated as the labelled formulation; crushing or substituting another crofelemer product may alter delivery. The oncology team should review concurrent oral medicines, timing around vomiting, the chemotherapy agent and whether infection or neutropenia is possible.

The FDA Green Book report dated 7 July 2026 continued to list application 141-552 as Canalevia-CA1. It remains conditionally approved rather than fully approved. The CA1 suffix and conditional effectiveness standard must remain visible.

United States conditional approval for the labelled canine indication. This audit does not assert EMA, UK VMD or APVMA authorisation.

Before use, record stool pattern, onset relative to chemotherapy, appetite, drinking, vomiting, temperature if advised and signs of dehydration. The veterinarian decides whether faecal testing, blood work, fluids or hospital care are needed and defines when the anticancer protocol can continue. The page gives no dose or duration.