Jaguar Animal Health’s crofelemer product has conditional approval from the FDA
Crofelemer delayed-release tablets (Canalevia-CA1; Jaguar Animal Health) for the treatment of chemotherapy-induced diarrhea (CID) in dogs, is now available by prescription from multiple leading veterinary distributors in the United States.1
This drug product is a tablet that can be given orally twice a day and can be used for home treatment of CID. It received conditional approval from the FDA on December 21, 2021.
“Canalevia-CA1 is an important prescription drug introduction for the veterinary community and the thousands of dogs experiencing CID. Canalevia-CA1 can help support the comfort and quality of life of dogs, while being treated with chemotherapy, which may help keep them compliant with their life-saving treatment,” said Chip Whitlow, sales and marketing director of the Jaguar Health’s animal health commercial portfolio, in an organizational press release.
Chemotherapy is quickly becoming a widely used oncology modality in veterinary medicine because of the increasing number of chemotherapeutic agents being adopted by veterinary oncologists and general practice veterinarians, according to Jaguar Animal Health. Studies have found the incidence of CID to be 1 of the 3 most prevalent adverse effects in dogs undergoing treatment for cancer. Managing adverse effects such as CID can be important to maintain successful cancer treatment. More than half of US veterinarians who responded to a recent Jaguar-sponsored survey reported that CID interferes with their patients’ chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID.
Crofelemer is a novel, oral plant-based medicine extracted and purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest. Jaguar Health’s subsidiary, Napo Pharmaceuticals, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for local and Indigenous communities.
The most reported adverse reactions include decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting, according to Jaguar Animal Health. Infectious etiologies of diarrhea should be ruled out prior to using crofelemer delayed-release tablets. Jaguar’s drug product is intended only for oral use in dogs, and not for human use. Crofelemer delayed-release tablets should be kept in a secure location, out of reach of children and other animals.
Jaguar Animal Health launched a website in December 2021 that provides veterinarians with prescribing information about crofelemer delayed-release tablets, data on the pharmacological properties and novel mechanism of action of the product’s active pharmaceutical ingredient, and a listing of upcoming veterinary conferences the company plans to attend. For dog owners, the site provides an overview of CID and its negative effects on dogs undergoing chemotherapy.
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