Product Name:Sirolimus Delayed-Release Tablets
Active Ingredient: Sirolimus – A macrocyclic lactone compound with antiproliferative properties
Indications: (sirolimus delayed-release tablets) is indicated for the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM) .
Subclinical HCM refers to cats with left ventricular (LV) hypertrophy (LV wall thickness of ≥6 mm at end diastole by 2D or M-mode assessment) in the absence of :
Systemic hypertension
Other causes of compensatory myocardial hypertrophy
Current or historic symptoms of congestive heart failure
Arterial thromboembolism
Severe LV outflow tract obstruction
Usage and Dosage:
For Cats
|
|
Number of Tablets
|
|
Body Weight (kg)
|
0.4 mg
|
1.2 mg
|
2.4 mg
|
|
2.5-3.2
|
2
|
0
|
0
|
|
3.3-4.8
|
0
|
1
|
0
|
|
4.9-6.4
|
1
|
1
|
0
|
|
6.5-9.6
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0
|
0
|
1
|
|
>9.6
|
0
|
1
|
1
|
Administration Instructions:
1.Administer once weekly on the same day each week
2.Tablets should be swallowed whole and not chewed
3.Do not split or crush tablets
4.Administer in conjunction with a meal
5.Always store tablets in the original packaging and only remove required tablets at the time of dosing
Contraindications:
Do not use in cats with :
Diabetes mellitus – Discontinue immediately if a cat receiving treatment is diagnosed with diabetes mellitus. Administration to a cat that
developed diabetes mellitus was associated with the development of diabetic ketoacidosis and death.
Pre-existing liver disease
Notes:
Before Treatment :
A diagnosis of subclinical HCM should be made by comprehensive physical examination including blood pressure measurement and echocardiography
Conduct screening bloodwork including a serum biochemical profile to rule out pre-existing liver dysfunction
During Treatment :
Bloodwork should be repeated 1 to 2 months following initiation of treatment, and every 6 to 12 months thereafter
Treatment with FELYCIN®-CA1 has been associated with elevation of ALT and AST
Adverse reactions:
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Adverse Event
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Notes
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|
Transaminase elevation (ALT/AST)
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Most common; up to 2X ULN
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|
Diabetic ketoacidosis and death
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In cats that developed diabetes mellitus
|
|
Gastrointestinal effects
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Possible
|
|
Immunosuppression
|
Available information does not indicate immunosuppression at the doses administered
|
Storage conditions:
Store at controlled room temperature; protect from light and moisture. Keep in original packaging.
Package:
Blister packaging – store tablets in original packaging until use
For animal use only.