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ONCOVET TL - CHEMOVET 

Trilostane 10 mg, 30 mg, 60 and 120 mg - Tablets

Indicated for the treatment of pituitary-dependent hyperadrenocorticism in dogs and the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs.

    

DESCRIPTION: ONCOVET® TL tablets are available in 4 sizes (10, 30, 60 and 120 mg) for oral administration based on body weight. 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, mineralocorticoids and sex hormones while steroid precursor levels increase. The structural formula is:  

 

 

 

 

INDICATIONS: ONCOVET® TL tablets are indicated for the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs. 

 

DOSAGE AND ADMINISTRATION: 

  1. Starting dose: The starting dose for the treatment of hyperadrenocorticism in dogs is 1-3 mg/lb (2,2-6,7 mg/kg) once a day. Start with the lowest possible dose based on body weight and available combinations of capsule sizes. ONCOVET® TL tablets should be administered with food (Table 1). 

 

Table 1: Dosage

 

Weight

Tablet amount

1,7 a 4,5 Kg.

1 tablet 10 mg

4,5 a 10 Kg.

1 tablet 30 mg

10 a 20 Kg.

1 tablet 60 mg

20 a 40 Kg.

1 tablet 120 mg

40 a 60 Kg.

1 tablet 120 mg + 1 tablet 60 mg

 

 

 

2. Action at 10-14 day evaluation (Table 2) 

After approximately 10-14 days at this dose, re-examine the dog and conduct a 4-6 hour post-dosing 

ACTH stimulation test and serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function). If physical examination is acceptable, take action according to Table 2. 

Owners should be instructed to stop therapy and contact their veterinarian immediately in the event of adverse reactions such as vomiting, diarrhea, lethargy, poor/reduced appetite, weakness, collapse or any other unusual developments. If these clinical signs are observed, conduct an ACTH stimulation test and serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function). 

 

 

Table 2: Action at 10-14 day evaluation 

 

 

Post-ACTH serum cortisol 

 

μg/dL                nmol/L 

Action

< 1,45

< 40

Stop treatment. Re-start at a decreased dose 

1,45 - 5,4

40 - 150

Continue on same dose 

5,4 - 9,1

150 - 250

EITHER: Continue on current dose if clinical signs are well controlled 

OR: Increase dose if clinical signs of hyperadrenocorticism are still evident* 

> 9,1

> 250

Increase initial dose 

 

 

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

 

 

3. Individual dose adjustments and close monitoring are essential 

Re-examine and conduct an ACTH stimulation test and serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function) 10-14 days after every dose alteration. Care must be taken during dose increases to monitor the dog's clinical signs. 

Once daily administration is recommended. However, if clinical signs are not controlled for the full day, twice daily dosing may be needed. To switch from a once daily dose to a twice daily dose, the total daily dose should be divided into 2 portions given 12 hours apart. It is not necessary for the portions to be equal. If applicable, the larger dose should be administered in the morning and the smaller dose in the evening. For example, a dog receiving 90 mg would receive 60 mg in the morning, and 30 mg in evening. 

 

4. Long term monitoring 

Once an optimum dose of ONCOVET® TL tablets 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.
An ACTH stimulation test (conducted 4-6 hours after ONCOVET® TL tablets administration) - a post-ACTH stimulation test resulting in a cortisol of < 1,45 μg/dL (< 40 nmol/L), with or without electrolyte abnormalities, may precede the development of clinical signs of hypoadrenocorticism. Serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function). 

Good control is indicated by favorable clinical signs as well as post-ACTH serum cortisol of 1,45-9,1 μg/dL (40-250 nmol/L). 

If the ACTH stimulation test is < 1,45 μg/dL (< 40 nmol/L) and/or if electrolyte imbalances characteristic of hypoadrenocorticism (hyperkalemia and hyponatremia) are found, ONCOVET® TL tablets should be temporarily discontinued until recurrence of clinical signs consistent with hyperadrenocorticism and ACTH stimulation test results return to normal (1,45-9,1 μg/dL or 40- 250 nmol/L). ONCOVET® TL tablets may then be re-introduced at a lower dose. 

   

CONTRAINDICATIONS: The use of ONCOVET® TL tablets is contraindicated in dogs that have demonstrated hypersensitivity to trilostane. Do not use ONCOVET® TL tablets in animals with primary hepatic disease or renal insufficiency (See WARNINGS and PRECAUTIONS). Do not use in pregnant dogs. Studies conducted with trilostane in laboratory animals have shown teratogenic effects and early pregnancy loss. 

 

WARNINGS: Hypoadrenocorticism can develop at any dose of ONCOVET® TL tablets. In some cases, it may take months for adrenal function to return and some dogs never regain adequate adrenal function. 

All dogs should undergo a thorough history and physical examination before initiation of therapy with ONCOVET® TL tablets. Other conditions, such as primary hepatic and/or renal disease should be considered when the patient is exhibiting signs of illness in addition to signs of hyperadrenocorticism (e.g. vomiting, diarrhea, poor/reduced appetite, weight loss, and lethargy). Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of ONCOVET® TL tablets should be considered. Owners should be advised to discontinue therapy immediately and contact their veterinarian if signs of potential drug toxicity are observed (see INFORMATION FOR DOG OWNERS, DOSAGE AND ADMINISTRATION, 

 

PRECAUTIONS, ADVERSE REACTIONS: In case of overdosage, symptomatic treatment of hypoadrenocorticism with corticosteroids, mineralocorticoids and intravenous fluids may be required. 

Angiotensin converting enzyme (ACE) inhibitors should be used with caution with ONCOVET® TL tablets, 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 ONCOVET® TL tablets 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. 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: 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 ONCOVET® TL tablets. 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 ONCOVET® TL tablets is initiated. Close monitoring of adrenal function is advised, as dogs previously treated with mitotane may be more responsive to the effects of ONCOVET® TL tablets. The use of ONCOVET® TL tablets 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 drug has not been evaluated in lactating dogs and males intended for breeding. 

 

ADVERSE REACTIONS: The most common adverse reactions reported are poor/reduced appetite, vomiting, lethargy/dullness, diarrhea, and weakness. Occasionally, more serious reactions, including severe depression, hemorrhagic diarrhea, collapse, electrolyte alterations, azotemia, renal failure, diabetes mellitus, pancreatitis, autoimmune hemolytic anemia, skin reactions (rash, erythematous skin eruptions), hind limb paresis, seizures, neurological signs from growth of macroadenomas, oral ulceration, muscle tremors and hypoadrenocortical crisis or adrenal necrosis/rupture may occur, and may result in death.

 

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 should result in resolution of polyphagia, polyuria and polydipsia. Serious adverse reactions associated with this drug can occur without warning and in some cases result in death (see ADVERSE REACTIONS). Owners should be advised to discontinue ONCOVET® TL tablets and contact their veterinarian immediately if signs of intolerance such as vomiting, diarrhea, lethargy, poor/reduced appetite, weakness, or collapse are observed. Owners should be advised of the importance of periodic follow-up for all dogs during administration of ONCOVET® TL tablets. 

 

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: Treatment with ONCOVET® TL tablets resulted in an improvement in clinical signs (decreased thirst, decreased frequency of urination, decreased panting, and improvement of appetite and activity). 

 

STORAGE INFORMATION: Store at controlled room temperature between 15°- 30°C.

 

HOW SUPPLIED: ONCOVET® TL tablets are available in 10, 30, 60 and 120 mg tablets, packaged in aluminum/PVC blister of 10 tablet, with ONCOVET® TL tablet 10 mg, ONCOVET® TL tablet 30 mg, ONCOVET® TL tablet, 60 mg ONCOVET® TL tablet 120 mg  with 3 blisters per carton. 

 

 

 

TAKE TIME OBSERVE LABEL DIRECTIONS 

 

Manufactured for SENASA Nº 8.473

Medicine product SENASA Nº 20-040
LABORATORIO FARMACÉUTICO VETERINARIO CHEMOVET

9 de Julio 3875, Lanús, Buenos Aires, Argentina.

SENASA Nº:12.197

+54-011-4220-3594

www.chemovet.org  

ONCOVET® is a trademark of CHEMOVET®

Rev. April 2020 

 

    

                        Easy to eat in dogs and cats !!

                                        In Tablets !!

                                         Slotted

                                         Sweets

    

9 de Julio 3875, Lanús, Buenos Aires, Argentina

Contact: chemovet@chemovet.org

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