Crofelemer (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET, DELAYED RELEASE.
Routes of administration: ORAL.
Brand Names
- MYTESI
Indications and Usage
CANALEVIA-CA1 is indicated for the treatment of chemotherapy-induced diarrhea in dogs.
Dosage and Administration
Administer 1 tablet orally twice daily for 3 days for dogs weighing ≤ 140 pounds. Administer 2 tablets orally twice daily for 3 days for dogs weighing >140 pounds. Tablets should not be broken, crushed, or chewed. If the tablet is chewed, one additional dose may be administered. Give with or without food.
Contraindications
Do not use in patients with a known hypersensitivity to crofelemer.
Adverse Reactions
In a masked, randomized study to support a reasonable expectation of effectiveness (CANA-001a) there was similar incidence of adverse events in dogs administered Crofelemer (not commercial formulation) compared to control dogs administered a vehicle control. Crofelemer was administered orally twice a day for three days as enteric-coated beads containing 40 mg of the active ingredient. The vehicle control was enteric-coated beads without the active ingredient. The dogs had daily assessments for changes in attitude, hydration, appetite, and abdominal palpation. Table 1 shows the adverse reactions during CANA-001a study. Table 1. Adverse Reactions in CANA-001a Study to Support Reasonable Expectation of Effectiveness Adverse Reaction1 Crofelemer N = 29 Vehicle Control N = 32 Appetite decreased 7 (24%) 9 (28%) Attitude depressed 5 (17%) 5 (16%) Activity decreased 4 (14%) 4 (13%) Dehydration2 4 (14%) 5 (16%) Abdominal palpation indicated pain3 3 (10%) 5 (16%) Vomiting 1 (3%) 2 (6%) 1 Dogs may have experienced more than one occurrence and more than one type of abnormal assessment during the study 2 Two crofelemer treated dogs and one vehicle control dog were administered fluid therapy 3 One of the vehicle control dogs was reported to not allow abdominal palpation at one timepoint on Day 2 In an open-label pilot study (CANA-001b) 48 dogs were administered crofelemer (not commercial formulation) orally twice a day for three days. The adverse reactions included decreased appetite in 16/48 (33%) dogs, vomiting in 3 (6%) dogs, decreased activity in 3 dogs (6%), abdominal pain in 1 (2%) dog, and 1 (2%) dog had blood in feces. In a separate pilot clinical field study (CANA-003), dogs with acute diarrhea were randomized to receive crofelemer or placebo tablets. The study included 22 dogs administered crofelemer (not commercial formulation) tablets and 112 dogs administered 125 mg CANALEVIA-CA1 tablets. There were 66 dogs who received placebo tablets. Dogs were administered tablets