Learn more about a topical calcineurin inhibitor for atopic dermatitis from dermatologist Dr. Cathryn Sibbald
Eczema Society of Canada asked Toronto-based dermatologist Cathryn Sibbald, MD, MSc, FRCPC, DABD, to share her expertise on the topical calcineurin inhibitor Protopic® (tacrolimus) and how this medication is used to manage atopic dermatitis (AD), commonly known as eczema.
What are topical calcineurin inhibitors?
Topical calcineurin inhibitors are medications that help control the inflammation of AD. They are non-steroidal, meaning they do not contain corticosteroids. Protopic® (tacrolimus) ointment is one of the topical calcineurin inhibitors available in Canada.
How does Protopic® work?
AD flares occur due to an inflammatory response in the skin, and the immune system plays a role in this inflammation. Protopic® can help control flares of AD and work by quieting down an overactive immune response in the skin.
Who is Protopic® approved for?
Health Canada has approved Protopic® to treat moderate to severe AD. Protopic® 0.03% is approved for use in children aged 2 to 15 years, and Protopic® 0.1% is a stronger medication approved for use in children and adults 16 years and older.1
How is Protopic® used?
Protopic® is an ointment that is applied directly to the skin. It is typically applied twice daily during the periods of flare until the skin improves, but patients should use their medication exactly as prescribed by their health care provider.
Protopic® can be used to treat or resolve flares, but it can also be prescribed for maintenance therapy, whereby your health care provider may instruct you to use the medication twice a week on areas that are typically affected by flares. It may be helpful to ask your health care provider for a written care plan to ensure you have clear instructions on which medication is applied to which area of the body and when to use one medication or another.
Will this medication sting or burn my skin?
Some users report stinging, burning, or a sensation of warmth for a few minutes when a Protopic® is first applied. For some people, this only occurs for the first few days of use, so if you can, it is best to keep applying the ointment regularly, as if you stop and start, the burning sensation can last longer. Some people find that keeping the ointment cool (e.g., in the fridge) can help minimize the stinging if it happens. Speak with your prescribing health care provider about how to use your topical treatments.
What is maintenance therapy?
AD is a chronic condition, meaning it may clear up for periods of time after treatment, but then it may flare up again. Protopic® has been studied and approved for use as maintenance therapy, meaning it is used between flares. Sometimes, health care providers recommend this treatment method to help prolong periods of time between flares. The medication can be applied once daily, one or two times per week, to areas of the skin that typically flare. If a health care provider, like a dermatologist, recommends this type of treatment plan, ensure you follow their instructions. If you have any concerns about the treatment, consult your prescribing health care provider or pharmacist.
What are the side effects of this medication?
The most common side effects include skin irritation, such as burning and/or stinging, at the site where the medication is applied. For some patients, this is very mild and goes away within a few minutes of applying the medication. For others, this can be very uncomfortable, and the health care provider should be consulted.
Protopic® has been used for more than two decades to treat AD. When it was first approved by Health Canada, it was given a Serious Warnings and Precautions box label due to concern with risks associated with the medication. In 2021, Health Canada reviewed data-related studies of long-term safety and removed the Serious Warnings and Precautions box from the medication.
All medications have risks and benefits, and the details of the risks and benefits should be reviewed with the prescribing health care provider.
What if my atopic dermatitis does not get better?
If you find your AD isn’t responding to treatment, let your doctor know, as your treatment plan may need to be adjusted. A qualified health care professional, such as a dermatologist, can help reassess your or your child’s condition and can potentially adjust the treatment plan. There is no cure for AD, but there are now many treatments that can help patients.
Eczema Society of Canada thanks Cathryn Sibbald, MD, MSc, FRCPC, DABD, for her volunteer contribution to this educational content.
Reference: 1 LEO Pharma Inc. (June 2022). Protopic® (tacrolimus) [Product Monograph], Topical Calcineurin Inhibitor.
Disclaimer: Information provided in this resource does not constitute medical advice and is not intended to be used as a diagnostic tool. The information is up-to-date at time of publication. All medications, interventions, and treatment plans have risks and benefits, and it is important that individuals discuss their or their child’s specific health care needs with a qualified health care professional.
