Frequently Asked Questions - CA.Atopica.com - Intended for Canadian Residents only

Atopic dermatitis is an allergic skin disease caused by common allergens such as pollens, molds and dust mites. It causes itching and can be so severe that the dog’s scratching can lead to complications such as skin lesions, hair loss, and secondary infections. Atopic dermatitis usually occurs seasonally at first, but eventually can become a year-round problem. The disease is chronic and lasts a lifetime. It’s almost impossible to completely avoid allergens, so most atopic dogs need long-term treatment.

How common is atopic dermatitis in dogs?

Atopic dermatitis is the most common allergic skin disease in dogs. Veterinarians estimate that 14.4 percent of dogs are affected and about two-thirds of these affected dogs are chronic cases.*

*Veterinarian market research, Burke Marketing Research, 2001. Data on file. Novartis Animal Health Canada, Inc.

What are the symptoms of atopic dermatitis?

Itchiness is the main symptom. Initial lesions or sores can appear as reddish patches or small, cone-shaped bumps where the dog has scratched. Atopic dermatitis has a characteristic distribution pattern. The itchiness and sores usually occur on what are referred to as the Five F’s of AD: the face—especially the ears, the feet, folds of skin, friction points, and flexure spots like the patch of skin over the elbow.

Atopic dogs scratch, bite, lick and rub until they lose hair and irritate the skin. Over time, the skin may thicken and produce higher levels of oils, often producing an odour. Inflamed ears are common and may be the owner’s primary concern. A high percentage of dogs with atopic dermatitis also develop secondary bacterial and yeast infections in their skin.

What are the other types of canine allergic dermatitis?

Dogs can also be affected by food allergies, flea allergies and contact dermatitis. It’s important for your veterinarian to rule out these other potential causes of your dog’s itching.

Is there a cure for atopic dermatitis?

Like human allergies, atopic dermatitis is a lifelong condition that can be controlled but not "cured." However, the condition can be successfully managed so the dog can live in comfort. The first signs usually appear between the ages of 6 months and 3 years, after a dog has developed sensitivities to common allergens like house dust, mites, pollens and molds.

What is ATOPICA^TM (Cyclosporine capsules, USP)?

ATOPICA is an oral medication specifically approved for the control of the clinical signs of atopic dermatitis. Unlike steroids, which are the most frequently prescribed drugs for atopic dermatitis, ATOPICA selectively targets specific immune cells responsible for the dog’s allergic response. ATOPICA comes in soft gelatin capsules in four different sizes.

Based on results from several studies, ATOPICA was generally well tolerated in dogs. As with all drugs, side effects may occur. In a field study, the most common side effects were gastrointestinal signs. Gingival hyperplasia and papillomas may also occur during the initial dosing phase. ATOPICA is not for use in dogs with a history of malignant neoplasia, or with a demonstrated hypersenstivity to Cyclosporine A. See product insert for prescribing information.

What other products are available to treat atopic dermatitis?

The options for controlling atopic dermatitis include avoiding allergens, using topical products like shampoos, sprays and creams to reduce allergen exposure or reduce localized inflammation, and administering various medications like steroids, antihistamines, essential fatty acids and antibiotics to help control the itching and treat secondary infections.

How does ATOPICA compare to corticosteroids?

Steroids provide quick relief of symptoms, but they can cause serious side effects if given for an extended period of time. These side effects develop because steroids affect virtually every system in the body. Steroids also become less effective over time, so higher doses are required to achieve the same result. ATOPICA, on the other hand, inhibits activation of specific immune cells involved in the allergic reaction.

What are the risks of long-term steroid use for atopic dogs?

Some common side effects include excessive urination, thirst and overeating. When given for long periods of time, steroids can affect vital organs, leading to problems such as Cushing’s syndrome, muscle breakdown, compromised kidney function and type 2 diabetes mellitus. Because of these side effects, many pet owners want to avoid giving steroids to their dogs. In a recent survey of veterinarians, they stated that 11 percent of their clients refused to give steroids to their dogs and 24 percent requested steroid use be minimized.**

Based on results from several studies, ATOPICA was generally well tolerated in dogs. As with all drugs, side effects may occur. In a field study, the most common side effects were gastrointestinal signs.Gingival hyperplasia and papillomas may also occur during the initial dosing phase. ATOPICA is not for use in dogs with a history of malignant neoplasia or with a demonstrated hypersensitivity to Cyclosporine A. See product insert for prescribing information.

**Veterinarian Survey, Burke Market Research, May 2001.

How does ATOPICA work?

ATOPICA selectively targets specific immune cells that cause the dog’s scratching, chewing and other responses to allergens. By targeting these cells, the allergic response is blocked.

How quickly does ATOPICA work?

When ATOPICA was tested in clinical trials, significant improvement was seen in 76% of the dogs within the first four weeks. Individual results may vary with some patients responding quickly to treatment, while others require longer for ATOPICA to control the clincal signs of atopic dermatis.

Based on results from several studies, ATOPICA was generally well tolerated in dogs. As with all drugs, side effects may occur. In a field study, the most common side effects were gastrointestinal signs. Gingival hyperplasia and papillomas may also occur during the initial dosing phase. ATOPICA is not for use in dogs with a history of malignant neoplasia, or with a demonstrated hypersensitivity to Cyclosporine A . See product insert for prescribing information.

***ATOPICA Data on File Novartis Animal Health Canada Inc.

What are the side effects of ATOPICA?

As with all drugs, side effects may occur. In a field study, the most common side effects were gastrointestinal signs. Gingival hyperplasia and papillomas may also occur during the initial dosing phase. ATOPICA is not for use in dogs with a history of malignant neoplasia or with a demonstrated hypersensitivity to Cyclosporine A . See product insert for prescribing information.

How is ATOPICA administered?

Available in soft gelatin capsules, ATOPICA is given orally as a daily dose for the first 30 days. At that point, depending on the response to therapy, your veterinarian may reduce the dose by decreasing frequency to every other day, and eventually to twice a week until a dose frequency that maintains your dog’s comfort is reached.

Based on results from several studies, ATOPICA was generally well tolerated in dogs. As with all drugs, side effects may occur. In a field study, the most common side effects were gastrointestinal signs. Gingival hyperplasia and papillomas may also occur during the initial dosing phase. ATOPICA is not for use in dogs with a history of malignant neoplasia, or with a demonstrated hypersensitivity to Cyclosporine A . See product insert for prescribing information.

Can ATOPICA be prescribed for any size of dog?

No, ATOPICA can be prescribed only for dogs that are 6 months of age or older and at least 2 kg in weight .

Based on results from several studies, ATOPICA was generally well tolerated in dogs. As with all drugs, side effects may occur. In a field study, the most common side effects were gastrointestinal signs. Gingival hyperplasia and papillomas may also occur during the initial dosing phase. ATOPICA is not for use in dogs with a history of malignant neoplasia, or with a demonstrated hypersensitivity to Cyclosporine A . See product insert for prescribing information.

Is ATOPICA safe?

A number of laboratory safety studies evaluated the tolerance of cyclosporine at various dose levels, including up to nine times the label dose. In these studies CsA, the active ingredient in ATOPICA, was not associated with long-term health issues related to major organs or systems (including liver and kidney). Possible side effects are transient vomiting, abnormal stools, oral papillomas, and gingival hyperplasia. These effects are typically reversed when the dose is tapered or the drug is withdrawn.***, +

Based on results from several studies, ATOPICA was generally well tolerated in dogs. As with all drugs, side effects may occur. In a field study, the most common side effects were gastrointestinal signs. Gingival hyperplasia and papillomas may also occur during the initial dosing phase. ATOPICA is not for use in dogs with a history of malignant neoplasia, or with a demonstrated hypersensitivity to Cyclosporine A . See product insert for prescribing information.

***ATOPICA Freedom of Information Summary, NADA 141-218, 2003.

+ Ryfell B, Donatch P, Madorin M, et al. Toxicological evaluation of cyclosporin A. Arch Toxicol 1983; 53:107-141.

What kinds of studies have been done on ATOPICA?

The safety and efficacy of ATOPICA has been extensively tested in laboratory trials and in the real world. The results of these studies confirm that ATOPICA is highly effective in controlling the clinical signs of atopic dermatitis in the majority of dogs.

ATOPICA is not for use in dogs with a history of malignant neoplasia, or with a demonstrated hypersensitivity to Cyclosporine A. See product insert for prescribing information.

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