Vetoryl (Trilostane) FAQs

Trilostane is the chemical name for a medication that is being used successfully to treat Canine Cushing's Disease. Worldwide, the only licensed veterinary version of trilostane is manufactured in the U.K. by the Dechra Group under the brand name of "Vetoryl." Vetoryl is marketed in four dosage strengths: 10 mg., 30 mg., 60 mg., and 120 mg. capsules. It is widely prescribed in the U.K. and Europe, and Dechra has recently announced that 30 mg. and 60 mg. Vetoryl capsules have been approved by the FDA for distribution in the U.S. beginning January 2009. Dechra anticipates that 10 mg. and 120 mg. capsules will also receive FDA approval later this year.

It is our current understanding that 30 mg. and 60 mg. Vetoryl capsules are being sold in the U.S. by veterinarians. Also, through March 2009, it appears as though American residents with existing prescription refills are still able to import all four Vetoryl capsule strengths from a U.K. internet pharmacy named Masters Marketing (http://www.mastersmarketing.com). (Please see Post #4 below for the FDA's current policy regarding the importation of unapproved drugs for personal use). However, Masters is no longer accepting new prescriptions for 30 mg. or 60 mg. capsules from U.S. residents.

Additionally, several pharmacies in the U.S. are compounding and selling their own versions of trilostane for veterinary use. For members who obtain compounded trilostane, we encourage you to contact your pharmacy directly in order to determine the effect that FDA approval of Vetoryl may have upon the future availability of your compounded product. (Please see Post #5 below for additional discussion regarding compounded trilostane.)

Dechra's Recommendations Regarding Treatment and Monitoring

Dechra provides published information about Vetoryl, as well as guidelines for its use. For U.S. pet owners, here are links to Dechra's U.S. website and several very helpful diagnostic, treatment, and monitoring resources, as well as contact information in the event that you or your vet have questions.

Dechra's U.S. Website Homepage

Index of Resource Information for Veterinarians

Diagnostic Brochure

Treatment and Monitoring Flowchart

Technical Brochure

Dechra's U.S. Product Insert

Because these resources are in the form of "pdf" files, you'll need Adobe Acrobat reader on your computer to view them. Here is a free version of Adobe Reader to download if you don't already have it on your computer:

www.adobe.com/products/ac...dstep.html

However, if you still have difficulty downloading or viewing these "pdf" files, there are additional resources listed in subsequent posts that contain similar treatment and dosing information, so just keep scrolling down to find them .

Treatment and Monitoring Recommended by University of California at Davis

Based on their clinical experience with trilostane, the Veterinary School at the University of California at Davis ("UC Davis") has modified some of Dechra's specific treatment and monitoring guidelines. Since there are differences in the two approaches, we suggest you ask your vet whether he/she will be following the guidelines of Dechra, or those of UC Davis. If your vet is following UC Davis protocol, here is a summary of their recommendations. These recommendations are found on page 3 of the following article (special thanks to Glynda ["LulusMom"] for providing it):

http://www.dvmnews.com/dvm/Small+ani.../detail/460965

The UC-Davis current recommendation is to initiate trilostane therapy at 1 mg/kg once daily. That dose is continued for about one week until a veterinary re-check can be completed.

Owners are instructed to collect a small urine sample from their dog before leaving home the morning of the scheduled re-check prior to trilostane administration. Trilostane should then be given and the dog should be seen by the veterinarian two to three hours later.

The goal of therapy is an owner who is completely pleased with the response. As aids in achieving this goal, both urine and blood tests are indicated. The urine should be checked, at a minimum, for specific gravity, glucose and urine cortisol-to-creatinine ratio (UCCR). An ACTH stimulation test should be started at the time the dog is seen, again about two to three hours after trilostane administration.

The UCCR result should be within the reference interval and the post-ACTH serum cortisol concentration should be between 1.5 and 5.5 mcg/dl.
If the serum-cortisol concentration is within that goal and the UCCR is abnormal, the medication should be given BID [twice daily].
If the serum-cortisol concentration is too high, the trilostane dose should be increased. But if the serum-cortisol concentration is too low, the dose should be decreased.

This approach should be used at each re-check until the dog is doing well.