Cyclavance USP Modified for Dogs

How to Order Prescriptions

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Description

CYCLAVANCE is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs (1.8 kg) body weight. CYCLAVANCE™ (cyclosporine oral solution) USP MODIFIED is an oral form of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active ingredient in CYCLAVANCE, is a cyclic polypeptide, immune modulating agent consisting of 11 amino acids. It is produced as a metabolite by the fungal species Beauveria nivea.

Dosage and Administration

Always Provide the Instructions for Assembling the Dispensing System and Preparing a Dose of CYCLAVANCE and the Information for Dog Owners with the prescription. The initial dose of CYCLAVANCE is 5 mg/kg/day as a single daily dose for 30 days. Following this initial daily treatment period, the dose of CYCLAVANCE 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. CYCLAVANCE 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. The dispensing system for the 5 and 15 mL vial sizes includes a 1 mL oral dosing syringe graduated in 0.05 mL increments. To dose the dog, administer 0.05 mL of CYCLAVANCE per 2.2 lbs of body weight. The dispensing system for the 30 and 50 mL vial sizes includes both a 1 mL oral dosing syringe graduated in 0.05 mL increments, and a 3 mL oral dosing syringe graduated in 0.1 mL increments. To dose the dog, administer 0.1 mL of CYCLAVANCE per 4.4 lbs of body weight. Do not rinse or clean the oral dosing syringe between uses. (See Instructions for Assembling the Dispensing System and Preparing a Dose of CYCLAVANCE.)

Assembling the Dispensing System

The dispensing system consists of three parts:

1. A vial containing the medicine sealed with a rubber stopper
2. A plastic adapter (dispensing system) that you will push onto the top of the vial. The adapter must always remain on the vial after first use.
3. An oral dosing syringe that fits into the top of the plastic adapter to withdraw the prescribed dose of medicine from the vial. (1 mL syringe with the 5 and 15 mL vial sizes; 1 and 3 mL syringes with the 30 and 50 mL vial sizes) 

Preparing a Dose of Medicine

1. Check that the plunger of the oral dosing syringe is pushed all the way down.
2. Keep the vial upright and push the oral dosing syringe firmly into the plastic adapter while turning the syringe clockwise to secure the dispensing system.
3. Turn the vial with the attached dosing syringe upside down and slowly pull the plunger up so that the oral dosing syringe fills with the medicine.
4. Expel any large bubbles by pushing and pulling the plunger a few times. The presence of a few tiny bubbles is not important for dosing accuracy.
5. Withdraw the dose of medicine prescribed by your veterinarian. Note: If the prescribed dose is more than the maximum volume marked on the oral dosing syringe, you will need to reload the syringe to withdraw the full dose.
6. Return the vial to its upright position and remove the oral dosing syringe by twisting it counterclockwise out of the plastic dispenser.

Contraindications

CYCLAVANCE is contraindicated for use in dogs with a history of neoplasia. Do not use in dogs with a hypersensitivity to cyclosporine. WARNINGS: CYCLAVANCE (cyclosporine oral solution) 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. Special precautions to be taken when administering CYCLAVANCE in dogs: Do not eat, drink, smoke, or use smokeless tobacco while handling CYCLAVANCE. 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. People with known hypersensitivity to cyclosporine should avoid contact with CYCLAVANCE.

Precautions

The safety and effectiveness of cyclosporine has not been established in dogs less than 6 months of age or less than 4 lbs body weight. CYCLAVANCE 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).

CYCLAVANCE 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 CYCLAVANCE, consideration should be given to tapering or discontinuing the dose.

CYCLAVANCE should be used with caution with drugs that affect the P-450 enzyme system. Simultaneous administration of CYCLAVANCE 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, CYCLAVANCE 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 CYCLAVANCE because the impact of cyclosporine on the immune response to modified live vaccines is unknown (See Animal Safety).