Atopica: Product Information

ATOPICA- cyclosporine capsule, gelatin coated
Elanco US Inc.

(cyclosporine capsules) USP MODIFIED

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of reach of children.

Description:

ATOPICA (cyclosporine capsules) USP MODIFIED is an oral form of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active ingredient in ATOPICA, is a cyclic polypeptide, immune modulating agent consisting of 11 amino acids. It is produced as a metabolite by the fungal species Beauveria nivea.

Chemically, cyclosporine A is designated Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-Nmethyl-L-leucyl-L-alanyl-D-ananyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl].

The structural formula is:

Structural Formula

Indications:

ATOPICA is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.

Dosage and Administration:

The initial dose of ATOPICA is 5 mg/kg/day (3.3-6.7 mg/kg/day) as a single daily dose for 30 days. Following this initial daily treatment period, the dose of ATOPICA may be tapered by decreasing the frequency of dosing to every other day or twice weekly, until a minimum frequency is reached which will maintain the desired therapeutic effect. ATOPICA should be given at least one hour before or two hours after a meal. If a dose is missed, the next dose should be administered (without doubling) as soon as possible, but dosing should be no more frequent than once daily.

Dose Administration
Dog body weight (lbs) Dog body weight (kg) Dose 5 mg/kg
4 – 6.5 lbs 2 – 2.9 kg 10 mg capsule
6.6 – 9 lbs 3 – 3.9 kg 2 x 10 mg capsules
9.1 – 16 lbs 4 – 7.9 kg 25 mg capsule
16.1 – 33 lbs 8 – 14.9 kg 50 mg capsule
33.1 – 64 lbs 15 – 28.9 kg 100 mg capsule
64.1 – 79 lbs 29 – 35.9 kg 100 mg capsule
+50 mg capsule
79.1 – 121 lbs 36 – 55.9 kg 2 x 100 mg capsules

Contraindications:

ATOPICA is contraindicated for use in dogs with a history of neoplasia. Do not use in dogs with a hypersensitivity to cyclosporine.

Warnings:

ATOPICA (cyclosporine) is a systemic immunosuppressant that may increase the susceptibility to infection and the development of neoplasia.

Human Warnings:

Not for human use. Keep this and all drugs out of reach of children.

For use only in dogs.

Capsules should not be broken or opened. Wear gloves during administration.

Wash hands after administration. In case of accidental ingestion, seek medical advice immediately and provide the package insert or the label to the physician.

Precautions:

The safety and effectiveness of ATOPICA has not been established in dogs less than 6 months of age or less than 4 lbs body weight. ATOPICA is not for use in breeding dogs, pregnant or lactating bitches.

As with any immunomodulation regimen, exacerbation of sub-clinical neoplastic and infectious conditions may occur.

Gastrointestinal problems and gingival hyperplasia may occur at the initial recommended dose (See Animal Safety).

ATOPICA may cause elevated levels of serum glucose, and should be used with caution in cases with diabetes mellitus. If signs of diabetes mellitus develop following the use of ATOPICA, consideration should be given to tapering or discontinuing the dose.

ATOPICA should be used with caution with drugs that affect the P-450 enzyme system. Simultaneous administration of ATOPICA with drugs that suppress the P-450 enzyme system, such as azoles (e.g. ketoconazole), may lead to increased plasma levels of cyclosporine.

Since the effect of cyclosporine use on dogs with compromised renal function has not been studied, ATOPICA should be used with caution in dogs with renal insufficiency.

There have been reports of convulsions in human adult and pediatric patients receiving cyclosporine, particularly in combination with high dose methylprednisolone (See Animal Safety).

Killed vaccines are recommended for dogs receiving ATOPICA because the impact of cyclosporine on the immune response to modified live vaccines is unknown (See Animal Safety).

Adverse Reactions:

A total of 265 dogs were included in the field study safety analysis. One hundred and eleven (111) dogs were treated with placebo for the first 30 days. For the remainder of the study, all dogs received ATOPICA capsules.

Fourteen dogs withdrew from the study due to adverse reactions. Four dogs withdrew from the study after vomiting. One dog each withdrew from the study after diarrhea; vomiting, diarrhea and pruritus; vomiting, depression and lethargy; lethargy, anorexia and hepatitis; gingival hyperplasia, lethargy, polyuria/polydipsia and soft stool; seizure; sebaceous cyst; pruritus; erythema; or otitis externa.

Vomiting and diarrhea were the most common adverse reactions occurring during the study. In most cases, signs spontaneously resolved with continued dosing. In other cases, temporary dose modifications (brief interruption in dosing, divided dosing, or administration with a small amount of food) were employed to resolve signs.

Persistent otitis externa, urinary tract infections, anorexia, gingival hyperplasia, lymphadenopathy and lethargy were the next most frequent adverse events observed. Gingival hyperplasia regressed with dose tapering. Owners of four dogs reported seizures while dogs were receiving ATOPICA. In one dog, seizures were the result of a brain tumor diagnosed one month into the study. Another dog experienced seizures before and after the study.

Otitis externa, allergic otitis, or pinna erythema, with or without exudates, commonly accompanies atopy. Many dogs entered the study with otitis externa, which did not resolve without otic treatment. New cases of otitis externa, allergic otitis, or pinna erythema developed while dogs were receiving ATOPICA. However, the incidence rate was lower with ATOPICA compared to placebo. A change in the dose frequency was not necessary when new cases occurred.

Number of Dogs Displaying Each Clinical Observation in the Field Study
Clinical Sign % out of 265
Vomiting 30.9%
Diarrhea 20.0%
Persistent Otitis Externa 6.8%
Urinary Tract Infection 3.8%
Anorexia 3.0%
Lethargy 2.3%
Gingival Hyperplasia 2.3%
Lymphadenopathy 2.3%

The following clinical signs were reported in less than 2% of dogs treated with ATOPICA in the field study: constipation, flatulence, Clostridial organisms in the feces, nausea, regurgitation, polyuria/polydipsia, strong urine odor, proteinuria, pruritus, erythema/flushed appearance, pyoderma, sebaceous adenitis, crusty dermatitis, excessive shedding, coarse coat, alopecia, papillomas, histiocytoma, granulomatous mass or lesion, cutaneous cyst, epulis, benign epithelial tumor, multiple hemangioma, raised nodule on pinna, seizure, shaking/trembling, hind limb twitch, panting, depression, irritability, hyperactivity, quieter, increased light sensitivity, reluctance to go outside, weight loss, hepatitis.

The following clinical signs were observed in 1.5-4.5% of dogs while receiving the placebo: vomiting, diarrhea and urinary tract infection. The following clinical signs were observed in less than 1% of dogs receiving the placebo: anorexia, otitis externa, cutaneous cysts, corneal opacity, lymphadenopathy, erythema/flushed appearance.

Clinical Pathology Changes: During the study, some dogs experienced changes in clinical chemistry parameters while receiving ATOPICA, as described in the following table:

Clinical Chemistry % Affected (out of 265)
Elevated Creatinine 7.8%
Hyperglobulinemia 6.4%
Hyperphosphatemia 5.3%
Hyperproteinemia 3.4%
Hypercholesterolemia 2.6%
Hypoalbuminemia 2.3%
Hypocalcemia 2.3%
Elevated BUN 2.3%

In addition, the following changes in clinical chemistry parameters were noted in less than 2% of dogs: hypernatremia; hyperkalemia, elevated ALT, elevated ALP, hypercalcemia and hyperchloremia. These clinical pathology changes were generally not associated with clinical signs.

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