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Vetoryl (Rx)

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Product Description

Vetoryl (10mg, 30 Capsule Bottle) is an adrenocortical suppressant for oral use in dogs only.

VETORYL Capsules for dogs by Dechra Veterinary Products are available in 4 sizes (10, 30, 60 mg and 120 mg) for oral administration based on body weight. It is indicated for the treatment of pituitary-dependent hyperadrenocorticism in dogs and hyperadrenocorticism due to adrenocortical tumor in dogs. This product helps control the excess cortisol production caused by either pituitary-dependent and adrenal-dependent cases of Canine Cushing’s Disease.

The key ingredient, trilostane (4α, 5α-epoxy-17β-hydroxy-3-oxoandrostane-2α-carbonitrile) is an orally active synthetic steroid analogue that selectively inhibits 3 β-hydroxysteroid dehydrogenase in the adrenal cortex, thereby inhibiting the conversion of pregnenolone to progesterone. This inhibition blocks production of glucocorticoids and to a lesser extent, mineral corticoids and sex hormones while steroid precursor levels increase. This helps to treat Cushing’s disease in dogs.

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For

Dogs

CAUTION:

Federal (USA) law restricts this pet medicine to use by or on the order of a licensed veterinarian.

INDICATIONS:

VETORYL Capsules for dogs are indicated for the treatment of pituitary-dependent hyperadrenocorticism in dogs.

VETORYL Capsules are indicated for the treatment of hyperadrenocorticism in dogs due to adrenocortical tumor in dogs.

DOSAGE AND ADMINISTRATION:

Always provide the Client Information Sheet with prescription.

The starting dose for the treatment of hyperadrenocorticism in dogs is 1.0-3.0 mg/lb (2.2-6.7mg/kg) once a day based on body weight and capsule size (see Table 1). VETORYL Capsules for dogs should be administered with food.

Table 1: Starting dose

Weight range (pounds)Weight range (kg)Starting dose (mg) ONCE DAILY
≥ 3.8 to < 10≥ 1.7 to < 4.510
≥ 10 to < 22≥ 4.5 to < 1030
≥ 22 to < 44≥ 10 to < 2060
≥ 44 to < 88≥ 20 to < 40120
≥ 88 to < 132*≥ 40 to < 60*180 (1 x 120 mg and 1 x 60 mg)

* Dogs over 132 pounds (60 kg) should be administered the appropriate combination of capsules.

After approximately 10-14 days at this dose, re-examine the dog and conduct a 4-6 hour post-dosing ACTH stimulation test. If physical examination is acceptable, take action according to Table 2.

Table 2: Action at 10-14 day evaluation

Post-ACTH serum cortisolAction
μg/dLnmol/L
< 1.45< 40Stop treatment. Re start at a decreased dose
1.45 to 5.440 to 150Continue on same dose
> 5.4 to 9.1> 150 to 250EITHER: Continue on current dose if clinical signs are well controlled
OR: Increase dose if clinical signs of hyperadrenocorticism are still evident*
> 9.1> 250Increase initial dose

* Combinations of capsule sizes should be used to slowly increase the once daily dose.

Individual dose adjustments and close monitoring are essential after administration of this pet medicine. Re-examine and conduct an ACTH stimulation test 10-14 days after every dose alteration. Care must be taken during dose increases to monitor the dog’s clinical signs and serum electrolyte concentrations. Once daily administration of this pet med is recommended. However, if clinical signs are not controlled for the full day, twice daily dosing may be needed. To switch from once daily to twice daily dosing of this pet medicine, increase the total daily dose by 1/3 to 1/2 and divide the total amount into two doses given 12 hours apart.

Long Term Monitoring

Once an optimum dose of VETORYL Capsules for dogs has been reached, re-examine the dog at 30 days, 90 days and every 3 months thereafter. At a minimum, this monitoring should include a thorough history and physical examination, ACTH stimulation test (conducted 4-6 hours after VETORYL Capsule administration), and serum biochemical tests (with particular attention to electrolytes, renal and hepatic function). A post-ACTH stimulation test resulting in a cortisol of

If the ACTH stimulation test is

Owners should be instructed to stop therapy and contact their veterinarian immediately in the event of adverse reactions or unusual developments.

CONTRAINDICATIONS:

The use of VETORYL Capsules for dogs is contraindicated in dogs that have demonstrated hypersensitivity to trilostane.

Do not use VETORYL Capsules in animals with primary hepatic disease or renal insufficiency.

Do not use this dog medicine in pregnant dogs. Studies conducted with trilostane in laboratory animals have shown teratogenic effects and early pregnancy loss.

WARNINGS:

In case of over dosage, symptomatic treatment of hypoadrenocorticism in dogs with corticosteroids, mineralocorticoids and intravenous fluids may be required.

Angiotensin converting enzyme (ACE) inhibitors should be used with caution with VETORYL Capsules, as both drugs have aldosterone-lowering effects which may be additive, impairing the patient’s ability to maintain normal electrolytes, blood volume and renal perfusion. Potassium sparing diuretics (e.g. spironolactone) should not be used with VETORYL Capsules for dogs as both drugs have the potential to inhibit aldosterone, increasing the likelihood of hyperkalemia.

HUMAN WARNINGS:

Keep out of reach of children. Not for human use.

Wash hands after use. Do not empty capsule contents and do not attempt to divide the capsules for dogs. Do not handle the capsules if pregnant or if trying to conceive. Trilostane is associated with teratogenic effects and early pregnancy loss in laboratory animals. In the event of accidental ingestion/overdose, seek medical advice immediately and take the labeled container with you.

PRECAUTIONS:

Hypoadrenocorticism in dogs can develop at any dose of VETORYL Capsules. In some cases, it may take months for adrenal function to return and some dogs never regain adequate adrenal function.

A small percentage of dogs may develop corticosteroid withdrawal syndrome within 10 days of starting treatment with this dog medicine. This phenomenon results from acute withdrawal of circulating glucocorticoids; clinical signs include weakness, lethargy, anorexia, and weight loss. These clinical signs should be differentiated from an early hypoadrenocortical crisis by measurement of serum electrolyte concentrations and performance of an ACTH stimulation test. Corticosteroid withdrawal syndrome should respond to cessation of VETORYL Capsules (duration of discontinuation based on the severity of the clinical signs) and restarting at a lower dose.

Mitotane (o,p’-DDD) treatment will reduce adrenal function. Experience in foreign markets suggests that when mitotane therapy is stopped, an interval of at least one month should elapse before the introduction of VETORYL Capsules for dogs. It is important to wait for both the recurrence of clinical signs consistent with hyperadrenocorticism, and a post-ACTH cortisol level of >9.1 μg/dL (>250 nmol/L) before treatment with VETORYL Capsules is initiated. Close monitoring of adrenal function is advised, as dogs previously treated with mitotane may be more responsive to the effects of VETORYL Capsules.

The use of VETORYL Capsules for dogs will not affect the adrenal tumor itself. Adrenalectomy should be considered as an option for cases that are good surgical candidates.

The safe use of this dog medicine has not been evaluated in lactating dogs and males intended for breeding.

ADVERSE REACTIONS:

The most common adverse reactions after using this pet prescription medication reported are poor/reduced appetite, vomiting, lethargy/dullness, diarrhea, and weakness. Occasionally, more serious reactions, including severe depression, hemorrhagic diarrhea, collapse, hypoadrenocortical crisis or adrenal necrosis/rupture may occur, and may result in death.

In a US field study with 107 dogs, adrenal necrosis/rupture (two dogs) and hypoadrenocorticism (two dogs) were the most severe adverse reactions in the study. One dog died suddenly of adrenal necrosis, approximately one week after starting trilostane therapy. One dog developed an adrenal rupture, believed to be secondary to adrenal necrosis, approximately six weeks after starting trilostane therapy. This dog responded to trilostane discontinuation and supportive care.

Two dogs developed hypoadrenocorticism during the study. These two dogs had clinical signs consistent with hypoadrenocorticism (lethargy, anorexia, collapse) and post-ACTH cortisol levels ≤0.3 μg/dL. Both dogs responded to trilostane discontinuation and supportive care, and one dog required continued treatment for hypoadrenocorticism (glucocorticoids and mineralocorticoids) after the acute presentation.

Additional adverse reactions were observed in 93 dogs treated with this dog medicine. The most common of these included diarrhea (31 dogs), lethargy (30 dogs), inappetence/anorexia (27 dogs), vomiting (28dogs), musculoskeletal signs (lameness, worsening of degenerative joint disease) (25 dogs), urinary tract infection (UTI)/hematuria (17 dogs), shaking/shivering (10 dogs), otitis externa (8 dogs), respiratory signs (coughing, congestion) (7 dogs), and skin/coat abnormality (seborrhea, pruritus) (8 dogs).

Five dogs died or were euthanized during the study (one dog secondary to adrenal necrosis, discussed above, two dogs due to progression of pre-existing congestive heart failure, one dog due to progressive central nervous system signs, and one dog due to cognitive decline leading to inappropriate elimination). In addition to the two dogs with adrenal necrosis/rupture and the two dogs with hypoadrenocorticism, an additional four dogs were removed from the study as a result of possible trilostane-related adverse reactions, including collapse, lethargy, inappetence, and trembling.

Complete blood counts conducted pre-and post-treatment revealed a statistically significant (p<0.005) reduction in red cell variables (HCT, HGB, and RBC), but the mean values remained within the normal range.

Additionally, approximately 10% of the dogs had elevated BUN values (≥40 mg/dL) in the absence of concurrent creatinine elevations. In general, these dogs were clinically normal at the time of the elevated BUN.

In a long term follow-up study of dogs in the US effectiveness study, the adverse reactions were similar to the short-term study. Vomiting, diarrhea and general gastrointestinal signs were most commonly observed.

Lethargy, inappetence/anorexia, heart murmur or cardiopulmonary signs, inappropriate urination/incontinence, urinary tract infections or genitourinary disease, and neurological signs were reported. Included in the US follow-up study were 14 deaths, three of which were possibly related to trilostane. Eleven dogs died or were euthanized during the study for a variety of conditions considered to be unrelated to or to have an unknown relationship with administration of trilostane.

In two UK field studies with 75 dogs, the most common adverse reactions seen were vomiting, lethargy, diarrhea/loose stools, and anorexia. Other adverse reactions included: nocturia, corneal ulcer, cough, persistent estrus, vaginal discharge and vulvar swelling in a spayed female, hypoadrenocorticism, electrolyte imbalance (elevated potassium with or without decreased sodium), collapse and seizure, shaking, muscle tremors, constipation, scratching, weight gain, and weight loss. One dog died of congestive heart failure and another died of pulmonary thromboembolism. Three dogs were euthanized during the study. Two dogs had renal failure and another had worsening arthritis and deterioration of appetite after the use of this pet medicine.

In a long term follow-up of dogs included in the UK field studies, the following adverse reactions were seen: hypoadrenocortical episode (including syncope, tremor, weakness, and vomiting) hypoadrenocortical crisis or renal failure (including azotemia, vomiting, dehydration, and collapse), chronic intermittent vaginal discharge, hemorrhagic diarrhea, occasional vomiting, and distal limb edema. Signs of hypoadrenocorticism were usually reversible after withdrawal of this pet med, but may be permanent. One subject discontinued VETORYL Capsules and continued to have hypoadrenocorticism when evaluated a year later. Included in the follow-up were reports of deaths, at least 5 of which were possibly related to use of VETORYL Capsules for dogs. These included dogs that died or were euthanized because of renal failure, hypoadrenocortical crisis, hemorrhagic diarrhea, and hemorrhagic gastroenteritis.

Foreign Market Experience: The following events were reported voluntarily during post-approval use of VETORYL Capsules for dogs in foreign markets. The most serious adverse events were death, adrenal necrosis, hypoadrenocorticism (electrolyte alterations, weakness, collapse, anorexia, lethargy, vomiting, diarrhea, and azotemia), and corticosteroid withdrawal syndrome (weakness, lethargy, anorexia, and weight loss). Additional adverse events included: renal failure, diabetes mellitus, pancreatitis, autoimmune hemolytic anemia, vomiting, diarrhea, anorexia, skin reactions (rash, erythematous skin eruptions), hind limb paresis, seizures, and neurological signs from growth of macroadenomas, oral ulceration, and muscle tremors.

For a copy of the Material Safety Data Sheet (MSDS), or to report adverse reactions, call Dechra Veterinary Products at (866) 933-2472.

INFORMATION FOR DOG OWNERS:

Owners should be aware that the most common adverse reactions may include: an unexpected decrease in appetite, vomiting, diarrhea, or lethargy and should receive the Client Information Sheet with the prescription.

Owners should be informed that control of hyperadrenocorticism in dogs should result in resolution of polyphagia, polyuria and polydipsia.
Serious adverse reactions associated with this pet med can occur without warning and in rare situations result in death. Owners should be advised to discontinue VETORYL Capsules for dogs and contact their veterinarian immediately if signs of intolerance are observed.

Owners should be advised of the importance of periodic follow-up for all dogs during administration of VETORYL 10 mg Capsules.

CLINICAL PHARMACOLOGY:

Trilostane absorption is enhanced by administration with food. In healthy dogs, maximal plasma levels of trilostane occur within 1.5 hours, returning to baseline levels within twelve hours, although large inter-dog variation occurs. There is no accumulation of trilostane or its metabolites over time.

EFFECTIVENESS:

Eighty-three dogs with hyperadrenocorticism were enrolled in a multi-center US field study. Additionally, 30 dogs with hyperadrenocorticism were enrolled in two UK field studies. Results from these studies demonstrated that treatment with VETORYL 10 mg Capsules resulted in an improvement in clinical signs (decreased thirst, decreased frequency of urination, decreased panting, and improvement of appetite and activity). Improvement in post-ACTH cortisol levels occurred in most cases within 14 days of starting VETORYL Capsules therapy.

In these three studies, there were a total of 10 dogs diagnosed with hyperadrenocorticism in dogs due to an adrenal tumor in dogs or due to concurrent pituitary and adrenal tumors. Evaluation of these cases failed to demonstrate a difference in clinical, endocrine, or biochemical response when compared to cases of pituitary-dependent hyperadrenocorticism in dogs.

ANIMAL SAFETY:

In a laboratory study, VETORYL Capsules for dogs were administered to 8 healthy 6 month old Beagles per group at 0X (empty capsules), 1X, 3X, and 5X the maximum starting dose of 6.7 mg/kg twice daily for 90 days. Three animals in the 3X group (receiving 20.1mg/kg twice daily) and five animals in the 5X group (receiving 33.5 mg/kg twice daily) died between Days 23 and 46. They showed one or more of the following clinical signs: decreased appetite, decreased activity, weight loss, dehydration, soft stool, slight muscle tremors, diarrhea, lateral recumbency, and staggering gait. Blood work showed hyponatremia, hyperkalemia, and azotemia, consistent with hypoadrenocortical crisis. Post-mortem findings included epithelial necrosis or cystic dilation of duodenal mucosal crypts, gastric mucosal or thymic hemorrhage, atrial thrombosis, pyelitis and cystitis, and inflammation of the lungs.

ACTH stimulated cortisol release was reduced in all dogs treated with VETORYL 10 mg Capsules. The dogs in the 3X and 5X groups had decreased activity. The 5X dogs had less weight gain than the other groups. The 3X and 5X dogs had lower sodium, albumin, total protein, and cholesterol compared to the control dogs. The 5X dogs had lower mean corpuscular volume than the controls. There was a dose dependent increase in amylase. Post-mortem findings included dose dependent adrenal cortical hypertrophy.

STORAGE INFORMATION:

Store this prescribed medicines for dogs at controlled room temperature 25°C (77°F) with excursions between 15°-30°C (59°-86°F) permitted.

HOW SUPPLIED:

VETORYL Capsules for dogs are available in 10, 30, 60 and 120 mg strengths, packaged in aluminum foil blister cards of 10 capsules, with 3 cards per carton.

VETORYL Capsules 10 mg NDC 17033-110-30

VETORYL Capsules 30 mg NDC 17033-130-30

VETORYL Capsules 60 mg NDC 17033-160-30

VETORYL Capsules 120 mg NDC 17033-112-3

Distributed by: Dechra Veterinary Products, 7015 College Boulevard, Suite 525, Overland Park, KS 66211

VETORYL is a trademark of Dechra Ltd

Additional Information

Bottle Size

10mg, 30 Capsule Bottle), 120mg, 30 Capsule Bottle, 30mg, 30 Capsule Bottle, 60mg, 30 Capsule Bottle

Product Type

Nutrition Medicine, OTC Medicine, Rx Medicine

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