CYCLAVANCE: Product Information (Page 3 of 3)

Approved by FDA under ANADA # 200-689
Manufactured for:
Virbac AH, Inc.
P.O. Box 162059
Fort Worth, TX 76161

Information for Dog Owners

CYCLAVANCE is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. Dogs with atopic dermatitis scratch, lick and chew their skin which can cause red, raised crusty bumps, open sores and/or hair loss.

Atopic dermatitis is a common skin disease in dogs and is caused by allergens such as house dust mites or pollens which stimulate an exaggerated immune response. The disease is chronic, recurrent, and requires lifelong management.

This summary contains important information about CYCLAVANCE. You should read this information before starting your dog on CYCLAVANCE. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or you want to know more about CYCLAVANCE.

What is CYCLAVANCE?
CYCLAVANCE is an oral solution of cyclosporine that lowers the immune response.
CYCLAVANCE selectively acts on the immune cells involved in the allergic reaction.
CYCLAVANCE reduces the inflammation and itching associated with atopic dermatitis.


What kind of results can I expect when my dog takes CYCLAVANCE for the control of atopic dermatitis? CYCLAVANCE should be given daily until improvement is seen. This will generally be the case within 30 days. You should contact your veterinarian if you are not satisfied with your dog’s response. Once the signs of atopic dermatitis are satisfactorily controlled, your veterinarian may reduce the frequency of administration of the product. Dose adjustment should only be carried out in consultation with your veterinarian. Your veterinarian will perform a clinical assessment at regular intervals and adjust the frequency of administration up or down according to the clinical response obtained.

What dogs should not take CYCLAVANCE?
Your dog should not be given CYCLAVANCE if s/he:
• Has a history of cancer or may possibly have cancer.
• Has a history of seizures, diabetes mellitus, and infections.
• Is hypersensitive to cyclosporine.

What to discuss with your veterinarian before giving CYCLAVANCE to your dog.
Tell your veterinarian about:
• Any digestive upset (vomiting or diarrhea) your dog has had
• Any history of lack of appetite and/or weight loss your dog has had
• Any serious disease or health conditions your dog has had
• Any allergies that your dog has now or has had
• Any medications (specifically any azoles (e.g. ketoconazole and/or steroids) that you are giving your dog or plan to give your dog, including those you can get without prescription (over the counter) and any dietary supplements
• If you plan to breed your dog, or if your dog is pregnant or nursing

Talk to your veterinarian about:
• What tests might be done before CYCLAVANCE is prescribed
• The potential side effects your dog may experience while taking CYCLAVANCE
• How often your dog may need to be examined by your veterinarian
• The risks and benefits of using CYCLAVANCE

What are the possible side effects that may occur in my dog during therapy with CYCLAVANCE?
CYCLAVANCE, like all other drugs, may cause some side effects in individual dogs. These are normally mild, but serious side effects have been reported in dogs taking CYCLAVANCE. Serious side effects can, in rare situations, result in death. It is important to stop the medication and contact your veterinarian immediately if you think your dog may have a medical problem or side effect while on CYCLAVANCE. To report adverse effects, access medical information, or obtain additional product information call 1-800-338-3659.
In clinical studies, the most commonly reported side effect for cyclosporine was vomiting and diarrhea. In most cases, the vomiting and diarrhea stopped with continued use or dose modification. Persistent otitis externa, urinary tract infection, anorexia, lethargy, gingival hyperplasia and lymphadenopathy were the next most frequent side effects observed. Persistent, progressive weight loss may be associated with more serious side effects. You should monitor your dog’s appetite and body weight. If you think that your dog is losing weight, you should contact your veterinarian. CYCLAVANCE may increase susceptibility to infection and to the development of tumors.

CYCLAVANCE should only be given to dogs.
People should not take CYCLAVANCE. Keep CYCLAVANCE and all medication out of reach of children. Call your physician immediately if you accidentally swallow CYCLAVANCE.

How to give CYCLAVANCE to your dog.
CYCLAVANCE should be given according to your veterinarian’s instructions. Your veterinarian will tell you what amount of CYCLAVANCE is right for your dog. CYCLAVANCE should be given at least one hour before or two hours after a meal. Do not change the way you give CYCLAVANCE to your dog without first speaking with your veterinarian. 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. Do not rinse or clean the oral dosing syringe between uses.

Advice on Correct Administration.
See Instructions for Assembling the Dispensing System and Preparing a Dose of CYCLAVANCE. If your veterinarian has already assembled the dispensing system, skip the instructions for assembling the dispensing system and follow the instructions for preparing a dose of medicine.

How to Store CYCLAVANCE.
CYCLAVANCE should be stored and dispensed in the original container at temperatures between 68-86°F (20-30°C). Do not refrigerate because a precipitate may be observed below 68°F (20°C). Once opened, use contents within 12 weeks.

Special precautions to be taken when administering CYCLAVANCE.
Wear gloves during administration. Do not eat, drink, smoke, or use smokeless tobacco while handling CYCLAVANCE. Wash hands after administration. In case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician.
People with known hypersensitivity to cyclosporine should avoid contact with CYCLAVANCE.

Can CYCLAVANCE be given with other medications?
CYCLAVANCE should not be given with other drugs that may lower the immune response. Cyclosporine has been safely used in conjunction with other common medications. However, interactions with certain medications are possible. Therefore, always tell your veterinarian about all medications that you have given your dog in the past and all medications that you are planning to give with CYCLAVANCE.

What can I do in case my dog gets more than the prescribed amount of CYCLAVANCE?
Contact your veterinarian immediately if your dog gets more than the prescribed amount of CYCLAVANCE.

What else should I know about CYCLAVANCE?
If your dog becomes seriously ill, consult your veterinarian who will recommend the appropriate treatment.This sheet provides a summary of information about CYCLAVANCE. If you have any questions or concerns about CYCLAVANCE or atopic dermatitis in dogs, talk to your veterinarian. As with all prescribed medications, CYCLAVANCE should only be given to the dog for which it was prescribed. It should be given to your dog only for the condition for which it was prescribed, at the prescribed dose, and as directed by your veterinarian.

Approved by FDA under ANADA # 200-689

Principal Display 15 mL

15 mL
(click image for full-size original)

Principal Display 50 mL

50 mL
(click image for full-size original)

CYCLAVANCE cyclosporine oral solution solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-994
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
cyclosporine (CYCLOSPORINE) cyclosporine 100 mg in 1 mL
Product Characteristics
Color white (colorless to yellow solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-994-15 15 mL in 1 VIAL, MULTI-DOSE None
2 NDC:51311-994-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200692 12/18/2020
Labeler — Virbac AH Inc (131568396)
Establishment
Name Address ID/FEI Operations
Pegasus Laboratories, Inc. 108454760 manufacture, analysis
Establishment
Name Address ID/FEI Operations
Microbac Laboratories 178463126 analysis
Establishment
Name Address ID/FEI Operations
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd 654019884 api manufacture, analysis
Establishment
Name Address ID/FEI Operations
Concord Biotech, Limited 916708337 api manufacture, analysis
Establishment
Name Address ID/FEI Operations
Alcami Carolinas Corporation 831351445 analysis

Revised: 02/2021 Virbac AH Inc

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