SporimuneSporimune™ (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: Sporimune (cyclosporine capsules) USP MODIFIED, the active ingredient in Sporimune is a cyclic polypeptide, cyclosporine A. It is produced as a metabolite by the fungal species Beauveria nivea.

Chemical Formula: 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-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl].

Indications: Sporimune 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 Sporimune is 5 mg/kg (3.3-6.7 mg/kg/day) as a single daily dose for 30 days.

• Following this initial treatment period, the dose of Sporimune may be tapered by decreasing the frequency of dosing to every other day or twice weekly, until a minimum frequency is reached which maintains the desired therapeutic effect. Sporimune 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.

Contraindications:

• Sporimune is contraindicated for use in dogs with a history of neoplasia.

• Do not use in dogs with a hypersensitivity to cyclosporine.

Warnings:

• Sporimune is a systemic immunosuppressant that may increase the susceptibility to infection and the development of neoplasia.

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

Human Warnings:

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

• Gastrointestinal problems and gingival hyperplasia may occur at the initial recommended dose (See Animal Safety). Sporimune may cause elevated levels of serum glucose, and should be used with caution in cases with diabetes mellitus.

• Concurrent administration of drugs that suppress the P-450 enzyme system, such as azoles (e.g. ketoconazole), should be used with caution in dogs.

• Sporimune should be used with caution with drugs that affect the P-glycoprotein system. Simultaneous administration of Sporimune with cyclosporin doses with compromised renal function has not been studied. Sporimune may increase blood levels of cyclosporine.

• Since the effect of cyclosporine use on 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 Sporimune because the impact of cyclosporine on 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 dogs were treated with placebo for the first 30 days. For the remainder of the study, all dogs received cyclosporine capsules.

• Fourteen dogs withdrew from the study due to adverse reactions. Four dogs withdrew from the study during the placebo phase of the study for vomiting, lethargy, increased appetite, and polyuria/polydipsia.

• One dog each withdrew from the study after diarrhea, vomiting, diarrhea and pruritis, vomiting, depression and vomiting, lethargy, anorexia and hepatitis, gingival hyperplasia, lethargy, polyuria/polydipsia and soft stool, seizures, lethargy, and diarrhea, and seizures, respectively.

• 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.

• The most frequent adverse events observed anorexia, gingival hyperplasia, lymphadenopathy and lethargy were present at exit in treatment groups were treated with cyclosporine capsules for a total of 4 months.

Animal Safety:

• In a 52-week oral study with dose levels of 0, 1, 3, and 9 times the target initial daily dose, emesis, diarrhea and weight loss were seen in all dose groups with increasing frequency as the dose increased.

• Other findings in the mid and high dose animals included: swollen gums due to chronic gingivitis and periodontitis and mild hyperplasia of the lymphoid tissues, mild atrophy of the seminiferous tubules of the testes, and slight increases in liver serum albumin and cholesterol and triglycerides.

• Decreased leukocyte counts in a few high dose animals were observed in a dose dependent fashion. Notable histopathological renal tubular epithelial rates were increased at all dose levels in a dose dependent fashion.

Storage Conditions:

Sporimune should be stored and dispensed in the original unit-dose container at controlled room temperature, 68-77°F (20-25°C).

How Supplied:

Sporimune is supplied in packages of 15 unit-dose blisters as follows:

• 10 mg, oval, off-white capsules imprinted with black “10” (NDC 17033-260-15).

• 25 mg, oblong, gray capsules imprinted with black “25” (NDC 17033-261-15).

• 50 mg, oblong, gray capsules imprinted with black “50” (NDC 17033-262-15).

• 100 mg, oblong, gray capsules imprinted with black “D 100” (NDC 17033-263-15).

Manufactured for:

Dechra Veterinary Products

7015 College Boulevard, Suite 525

Overland Park, KS 66211 USA

Sporimune is a trademark of Dechra Veterinary Products, LLC

Rev. August 2022

P10464

This information sheet provides a comprehensive overview of Sporimune, including its description, indications, dosage, contraindications, warnings, precautions, adverse reactions, animal safety, storage conditions, and how it’s supplied.

Note: This information is intended for educational purposes only and should not be considered a substitute for professional veterinary advice. Always consult with your veterinarian before starting or changing any medication for your pet.