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Thread: Trilostane Questions for Dr. Bruyette

  1. #21

    Default Re: Trilostane Questions for Dr. Bruyette

    Hi,

    In general with adrenal tumors if we want to treat the cancer and not just the elevated cortisols then op-DDD would be preferred.

    There is no data on liquid formulations of trilostane so we cant really make any scientific comments.

    Dave

  2. #22

    Default Re: Trilostane Questions for Dr. Bruyette

    This also brings up the issues of compounding medications and not using the veterinary approved products. A couple of facts/comments that might help -

    · Compounding pharmacies are not purchasing trilostane from Dechra. Dechra has an exclusive supply arrangement with the Italian company that holds the MDF (Master Drug File). This European company is the only manufacturer approved by FDA. That means the probable source of compounders bulk trilostane is an uninspected manufacturing facility in China or India.


    Sources of Problems w/ Compounded Drugs

    o Reformulation of any drug product into a compounded drug product alters the behavior of the finished version of the drug.
    o Compounded drugs are not equivalent to generic drugs.
    o Compounded drugs are not subject to external quality control measures with regard to consistency of the manufacturing process, amount/potency of drug, consistency of formulation, lack of contaminants, and evaluation of inactive ingredients or incipients.
    o The stability, bioavailability and bioequivalence of compounded drugs has not been evaluated.
    o Several samples of US compounded trilostane products were analyzed by Dechra and contained <90% of the labeled content.

    · Key Points from the AVMA Position Statement on Compounding (Available on the AVMA website)

    o Compounding is the manipulation of a drug, other than in accordance with the FDA approved label, to make a different formulation of the drug to meet the needs of a specific patient.
    o Compounding may impact the absorption of a drug. The use of a compounded drug may result in drug concentrations that lead to the development of an adverse event, including therapeutic failure.
    o Use of a compounded drug should be limited to those drugs for which both safety and efficacy have been demonstrated in the compounded form in the targeted species.

    · According to the AVMA PLIT if a veterinarian uses a compounded drug where there is an FDA approved animal drug, their professional liability (malpractice) insurance coverage may be voided.

    Dave Bruyette

  3. #23
    Join Date
    Jul 2011
    Posts
    8

    Default Re: Trilostane Questions for Dr. Bruyette

    Hi Dr. Bruyette,
    My dog, Mugsy, a 10 yr old Brussels Griffon was just diagnosed with Cushings on Friday. The vet told me I did not have to treat him, that it was very expensive! I do not accept that advise and will talk to the other vet in the clinic for better advise.

    I have been reading about compounded Trilostane as having a lot more precise dosing choices and also less expensive than the commercially available but also read that compounded meds are not approved by the AVMA. Please comment on this.

    Thank you!

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