FDA Approves Canalevia-CA1 to Treat Diarrhea from Chemotherapy in Dogs
Key takeaways:
The FDA conditionally approved Canalevia-CA1 (crofelemer) in December 2021. It's an oral medication that treats chemotherapy-induced diarrhea (CID) in dogs.
The active ingredient in Canalevia-CA1 is crofelemer, which works as an antidiarrheal.
Canalevia-CA1 is available in the U.S. as of January 2022.
According to the FDA, about 1% of dogs in the U.S. are diagnosed with cancer every year. Cancer in dogs often resembles cancer types in humans. This can include lymphoma, bone cancer, and prostate cancer. And, like chemotherapy medications available to treat people living with cancer, several chemotherapies can treat certain cancers in dogs.
But while chemotherapy can be effective at treating cancer, it can also cause unwanted side effects. Diarrhea from chemotherapy is one of these side effects. It can be intense and make your dog uncomfortable.
To help combat this, the FDA approved Canalevia-CA1 (crofelemer) in December 2021. It’s the first medication approved to treat dogs with diarrhea caused by chemotherapy.
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Here, we’ll discuss Canalevia-CA1 — how it works, how effective it is, and how to get it for your dog.
What is Canalevia-CA1?
Canalevia-CA1 (crofelemer) is an oral medication for dogs that treats chemotherapy-induced diarrhea (CID). It’s a tablet that your dog can swallow. Canalevia-CA1 is available only with a prescription, and it’s prescribed by veterinarians.
Canalevia-CA1’s approval is noteworthy for the world of veterinary medicine. It’s the first and only medication that has been conditionally approved for CID in dogs. Conditional approval information is discussed more below.
How does Canalevia-CA1 work to treat chemotherapy-induced diarrhea in dogs?
Chemotherapy often disrupts the digestive tract in dogs and humans. This can lead to side effects like diarrhea. CID is a type of diarrhea that’s caused by chemotherapy. It happens when too much water enters the digestive tract, leading to watery stools. Serious diarrhea can also lead to other complications, like dehydration.
Canalevia-CA1 helps fight this process. It works as an antidiarrheal that can lower the frequency of watery stools.
More specifically, Canalevia-CA1 helps by influencing chloride channels. These channels are pathways in the gut that control water secretion. Canalevia-CA1 targets and modifies chloride channels in the lining of the intestines to improve water flow in the gut. This causes less water to enter the gut, resulting in less diarrhea.
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Diarrhea may affect you and your dog's quality of life and raise the amount of accidents at home. But Canalevia-CA1 helps manage diarrhea caused by chemotherapy.
How is Canalevia-CA1 dosed?
Canalevia-CA1’s dosing depends on your dog’s body weight.
If your dog weighs 140 pounds or less, they’ll typically take 1 tablet (125 mg) by mouth twice daily for 3 days. But if your dog weighs more than 140 pounds, it’s recommended that they receive 2 tablets (250 mg) by mouth twice daily for 3 days.
Canalevia-CA1 tablets should be swallowed whole. They shouldn't be crushed or chewed. Canalevia-CA1 is a delayed-release tablet, meaning that small amounts of the medication are released into the body over time. Crushing or chewing the tablet may disrupt this timed-release effect.
You can give Canalevia-CA to your dog at home. And if your dog doesn’t like swallowing pills, your veterinarian can give you tips on how to help your furry friend swallow the medication.
Is crofelemer used in humans?
Yes. Crofelemer is also approved to treat diarrhea in adults with HIV/AIDS who take antiretroviral medications. In humans, crofelemer is a prescription-only tablet medication called Mytesi. Crofelemer is thought to work similarly in humans as it does in dogs.
But Canalevia-CA1 is for canine use only. People should never take Canalevia-CA1.
How effective is Canalevia-CA1?
What we currently know about Canalevia-CA1’s effectiveness comes from a small study of 24 dogs with diarrhea. In total, 12 dogs received Canalevia-CA1, and 12 dogs received placebo (a tablet with no medication in it).
In the study, Canalevia-CA1 was successful if a dog's diarrhea got better and didn’t come back within 3 days. On day 3 of the study, 75% of the dogs who received Canalevia-CA1 were treated successfully, compared to 25% that received placebo.
And even though this is one small study, this data suggests that Canalevia-CA1 is effective in dogs with CID. This led to its conditional FDA approval.
What is a conditional approval?
Canalevia-CA1 has been conditionally approved by the FDA. This means Canalevia-CA1 can be marketed and sold in the U.S., but the manufacturer of the medication (Jaguar Animal Health) needs to collect more evidence that Canalevia-CA1 is effective.
This extra effectiveness data is needed for a full FDA approval. Jaguar Animal Health also has to further prove that Canalevia-CA1 is safe and is made in high-quality conditions.
If Jaguar Animal Health gathers this type of data, Canalevia-CA1 may be able to achieve full FDA approval status. But if Jaguar Animal Health can't provide more safety and effectiveness data to the FDA, its approval status may be revoked. This means the medication would be removed from the market.
What are the known side effects of Canalevia-CA1?
Canalevia-CA1 works locally in the gut. It’s not absorbed into the bloodstream, so it doesn’t work throughout your dog’s entire body. It’s usually well-tolerated by dogs, but some side effects have been reported in studies, including:
Abnormal feces (soft, watery, and/or discolored stool)
Smaller appetite
Less activity than normal
Depressed mood
Vomiting
If your dog experiences severe side effects from Canalevia-CA1, notify your veterinarian as soon as possible. It may be necessary to stop taking Canalevia-CA1.
How much will Canalevia-CA1 cost?
The cost of Canalevia-CA1 hasn’t been announced yet. Check back with us soon for cost information and how to save on Canalevia-CA1.
When will Canalevia-CA1 be available?
Canalevia-CA1 is now available for order by your veterinarian. It comes from many authorized veterinary distributors.
Canalevia-CA1 is only available by prescription from a licensed veterinarian. Speak to your veterinarian if you have questions about accessing Canalevia-CA1 for your dog.
The bottom line
Diarrhea can happen in dogs who receive chemotherapy. Canalevia-CA1 is a new treatment option for dogs with chemotherapy-induced diarrhea, and it can help improve your dog's comfort and quality of life during chemotherapy treatment. To determine if Canalevia-CA1 would be beneficial for your dog, it’s recommended to talk with your veterinarian.
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References
American Kennel Club. (2019). Chemotherapy for dogs with cancer: Common questions.
Food and Drug Administration. (2020). Conditional approval explained: A resource for veterinarians.
Food and Drug Administration. (2021). FDA conditionally approves first oral tablet to treat chemotherapy-induced diarrhea in dogs.
Gardner, H. L., et al. (2016). Dogs as a model for cancer. Annual Review of Animal Biosciences.
Jaguar Animal Health. (2021). Canalevia-CA1 [package insert].
Jaguar Animal Health. (2021). What is Canalevia-CA1?
Jaguar Animal Health. (2022). Canalevia-CA1.
Franklin, G. B., et al. (2017). Chemotherapy-induced diarrhea. Jaguar Health.
Napo Pharmaceuticals Inc. (2020). Mytesi [package insert].
