Q. How does ATOPICA® (Cyclosporine capsules, USP) MODIFIED work?
A. Unlike steroids that affect every system in the body, ATOPICA targets only the specific cells in the immune system that cause the allergic reaction. Cyclosporine inhibits production of interleukin-2 and works to suppress T-helper and T-suppressor cells.
Q. How efficacious is ATOPICA? When will the client typically start to see results?
A. Every atopic dermatitis case is different, but in two dose characterization studies, dogs showed improvements in clinical signs (lesions and pruritus) at day 10 to the end of the study at 6 weeks. In clinical trials, dogs were examined 30 days after starting ATOPICA. At 30 days, 74% of dogs showed some improvement12 and by 90 days, 90% of dogs on daily dosing showed improvement.
Q. If my patient has a flare-up, can I use steroids or other modalities for short-term symptom relief?
A. Atopic dermatitis is a dynamic disease condition and, depending on the individual patient, short-term relief therapies may be needed. It is important to reassess atopic patients regularly and especially during a flare-up. While ATOPICA has not been specifically evaluated with various topical agents (shampoos, conditioners, otic preparations) or oral antihistamines/essential fatty acids, a safety study12 was conducted with methylprednisolone. In this study, dogs were administered methylprednisolone for 14 days, followed by ATOPICA and methylprednisolone for an additional 14 days. There was no evidence of seizures or other neurological signs. One may consider a tapering course of a short-acting corticosteroid for immediate relief during a seasonal flare-up.
Q. What is the long-term safety with ATOPICA?
A. Cyclosporine has been used in both human and veterinary medicine for decades. ATOPICA was FDA-approved for the control of canine atopic dermatitis in August 2003 and has been administered to thousands of dogs.7 A retrospective study (Radowicz/Power, 2003) showed good tolerability in dogs treated with cyclosporine from 6 months’ to 30 months’ duration. A yearlong safety study was conducted where dogs were administered ATOPICA up to 9x the label dose with no evidence of organ toxicity (liver, kidneys).12 Novartis Animal Health closely monitors any suspected adverse drug events and trends in clinical signs reported. There has been no indication of increased risk of cancer when using ATOPICA.
Q. In advising my clients, what are the most common side effects I should warn them about?
A. Gastrointestinal signs (vomiting/diarrhea) are the most common side effects (3 out of 10 dogs) and usually occur in the first 1 to 2 days of treatment. These potential side effects are generally mild and self-limiting. Clients should be warned of the potential for these side effects prior to treatment initiation. Other side effects (gingival hyperplasia, papillomas) are rare, dose-related and reversible. See label for further details.
Q. What if the dog vomits or has a diarrheic episode when ATOPICA is prescribed?
A. If a patient responds with vomiting, discontinue treatment for a few days, then reintroduce ATOPICA at the same dose with food or decrease the dose by half with food. A variety of antacids, antiemetics and gut protectants have been used to help reduce vomiting. There are anecdotal reports of efficacy but no clear evidence for any of these options. For diarrheic dogs, discontinue treatment for a few days, then reintroduce cyclosporine at a lower dose.
Q. Can I use ATOPICA with allergen-specific immunotherapy (ASIT)?
A. Studies on the concurrent use of ATOPICA with immunotherapy have not been conducted by Novartis Animal Health. However, the two modalities have been used in managing the atopic patient. Immunotherapy may take 4 to 12 months to show any clinical effect. ATOPICA begins targeting the immune cells responsible for clinical signs of atopy generally within 30 days of treatment initiation.
Q. How do I know when to taper the dose of ATOPICA?
A. Every atopic patient is different and must be managed individually. In clinical trials, dogs that showed a 50% improvement in skin lesions and pruritus were started on a tapering dose (i.e., same dose every other day) then reevaluated in 30 days. If continued improvement was seen, then twice-weekly dosing was instituted. In the U.S. field trial, 41% of dogs received EOD dosing after 30 days. By week 16 of the study, 42% of dogs were being managed on twice-weekly dosing.12
Q. Can I use generic cyclosporine instead of ATOPICA?
A. Generics are NOT identical to ATOPICA. “Bioequivalent” products do not have identical pharmacokinetic profiles.
- In humans, “bioequivalent” means that a dose can be found that will yield equivalent blood levels. It does NOT mean the products can be substituted in a 1:1 fashion. (In other words, 100 mg of “generic A” may not achieve similar blood levels as 100 mg of “brand name A.”)
- Differences in the excipients from one product to the next can significantly affect absorption and bioavailability.
- Generics have not been tested in dogs for safety, efficacy or equivalence.
- ATOPICA is the first oral medication specifically developed and FDA-approved to control canine atopic dermatitis.7
- ATOPICA has been tested in controlled clinical trials for safety and efficacy. It comes in 4 doses to ensure accurate dosing for canine patients.
Q. ATOPICA does not seem to be working anymore. What should I do?
A. Perceived lack of efficacy on any dermatology treatment warrants reevaluation of the patient. Dogs that experience a relapse in their atopic symptoms are often suffering from an underlying secondary bacterial and/or fungal infection. These secondary infections should be identified using the 3-Slide Technique™ and treated with the appropriate therapy for the recommended amount of time.