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Helpful Resources for Owners of Cushing's Dogs Important information, including links to informative websites, relevant veterinary literature, how to find a Specialist and more

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Old 05-12-2009, 01:07 AM
k9cushings k9cushings is offline
Join Date: Apr 2009
Posts: 124
Arrow Trilostane/Vetoryl Information and Resources

Trilostane is the chemical name for a medication that effectively treats 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. Vetoryl is commonly used in the U.K. and Europe, and it is becoming more widely prescribed in the U.S. subsequent to FDA approval beginning in 2009.

All dosage strengths of brand name Vetoryl capsules are now sold in the U.S. by veterinarians and also via internet pharmacies. 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 regarding the ongoing availability of specific dosage strengths.

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 some especially helpful resources on Dechra's U.S. website, including direct contact information in the event that you or your vet have questions.

Diagnosis, Treatment and Monitoring of Hyperadrenocorticism

Vetoryl Client Brochure

Vetoryl Technical Brochure

"Contact Us"

Dechra's U.S. Product Insert***

Dechra's newly revised initial dosing protocol (as of July, 2014)***

Here is a link to Dechra's international homepage. Once there, you can click on information that is specific to your own country or part of the world. In order to convert laboratory values from international charts and literature (nmol/l) into U.S. lab units (ug/dl), divide the values reported on the international charts by 27.59.

Dechra's International Homepage***

Old 05-12-2009, 01:08 AM
k9cushings k9cushings is offline
Join Date: Apr 2009
Posts: 124
Default New, Lower Trilostane Dosing Recommendations (2015)

During the past decade since Vetoryl (trilostane) was first introduced as a Cushing’s treatment, recommendations re: the size of the initial starting dose have lowered. This revision is based on accumulated worldwide research and clinical experience, and reflects the current thinking of the majority of the specialists treating Cushing's here in the U.S. as well as elsewhere. It also reflects experiences we have seen here on our forum during this past decade. Put simply, dogs seem to experience fewer unwanted side effects when they are started at lower doses and adjusted upwards if need be, rather than vice versa.

Dechra (manufacturer of brandname Vetoryl) has a worldwide presence including a U.S. office. However, Vetoryl is made in the U.K. and to be legally sold there, Vetoryl must be properly registered with their "VMD" (Veterinary Medicines Directorate). To be legally sold in the U.S., Vetoryl is regulated by the FDA. Both regulatory bodies require their own specific filings and published literature re: medication. Until recently, the published initial dosing recommendations for Vetoryl were similar in both countries. However, in 2015 the official "Summary of Product Characteristics" for Vetoryl filed in the U.K. was revised to reflect this new initial dosing recommendation:

The starting dose for treatment is approximately 2 mg/kg, [or approx. 1 mg/lb] based on available combinations of capsule sizes.
This recommendation can be found here (just enter "Vetoryl" in the "Search" window, then click on the SPC for any dosage strength):

Likewise, it is this revised "SPC" recommedation that is discussed in the U.K. publication, "Vetsonline," that we often highlight for our members:

We believe it is unfortunate, but neither the U.K. Datasheets nor the U.S. Product Inserts that are actually packaged within boxes of Vetoryl yet reflect simplified dosing language identical to Dechra's revised "SPC." In the U.S., the original 1-3 mg/lb dosage range dating from 2009 remains published on the FDA-approved insert. However, please note that the range is immediately followed by this newer sentence added to the 2014 revision of the insert, "Start with the lowest possible dose based on body weight and available combinations of capsule sizes." So in truth, this is the same recommendation as that of the new SPC revision: start as closely as possible to the 1 mg/lb formula.

For any vet who has questions about the appropriateness of starting with a lower rather than a higher dose, we encourage the vet to call Dechra directly in order to discuss whether there are individual factors that make a higher dose more desirable for any given dog. However, to reinforce the general desirability of lower initial starting doses, here are quotes from several noted U.S. endocrinology specialists. Please note that 2.2 mg/kg translates into 1 mg/lb.

Dr. David Bruyette (2016):

Also, it is my recommendation when using the manufactured product [Vetoryl] to ignore the dosage recommended on the label, as it is too high. In fact, the manufacturer is in the process of trying to get the label dosage revised. I recommend a starting dosage of 1 to 2 mg/kg [.5 to 1 mg/lb] once a day in the morning with food.

Dr. Ellen Behrend (2011):

My recommended starting dose is either 2 mg/kg Q 24 H or 1 mg/kg Q 12 H, with adjustments made as needed based on adrenocorticotropic hormone (ACTH) stimulation testing.

Dr. Audrey Cook (2012):

In my experience, most dogs are acceptably controlled on 2-3 mg/kg daily, and I usually start with this range. If twice a day dosing is planned, this daily dose is simply divided in two.

Dr. Mark Peterson (2012):

My recommended starting dose is either 2 mg/kg given once daily or 1 mg/kg given twice daily… I would never start a dog on a dose at the higher end of the recommended dosage range (4-7 mg/kg)...

IDEXX Laboratory’s Trilostane Dosing and Monitoring Flowchart (2014):

Start trilostane treatment. Administer 2 mg/kg in morning or 1 mg/kg twice daily with food.

Dr. Edward Feldman advocates for the lowest starting dose of all (2010):

… trilostane at an initial dose of 0.5 mg/kg given twice daily…
Old 05-12-2009, 01:11 AM
k9cushings k9cushings is offline
Join Date: Apr 2009
Posts: 124
Default Compounded Trilostane in the U.S.

A decision regarding using a compounded version of trilostane is one that you must make in conjunction with your vet. Be aware that compounded versions of trilostane, while in widespread use, are not the equivalent of generics, and do not carry the same U.K./U.S. certifications as does Vetoryl. There are several pharmacies in the U.S. that are compounding and selling their own versions of trilostane for veterinary use. However, the FDA, various compounding pharmacies, and other interested parties are currently involved in ongoing litigation seeking to define the regulatory oversight associated with both human and veterinary compounding.

For more information regarding the use of compounded medications in the U.S., here is a recently revised brochure published by the American Veterinary Medical Association (AVMA). One section of particular interest is "Questions to Ask Your Pharmacist" in the event that a compounded drug is prescribed for your pet.

Included in the "Veterinary Compounding" brochure is the following explanation as to the difference between compounded and generic drugs:

Generic drug products are very different from compounded preparations. Generic drug products are FDA-approved, which requires a demonstration of bioequivalence of safety and efficacy with the pioneer drug product. Generic animal drug products are identified by an Abbreviated New Animal Drug Application (ANADA) number on their label or in FDA drug references. In contrast to generic drugs, compounded preparations lack FDA approval.
Additionally, here is the first of a series of articles that discuss current legal and regulatory issues associated with veterinary compounding in the U.S. All subsequent articles can be accessed from Part 1.

"Confounding Compounding" Part 1
November 23, 2009
By: Edie Lau
For The VIN News Service:
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