The Product Monograph for Protopic® has been updated

LEO Pharma Inc. announces updated Health Canada safety information for Protopic®

THORNHILL, ON, Oct. 4, 2021 /CNW/ - LEO Pharma Inc. today announced that Health Canada has approved an update to the Product Monograph of Protopic® (tacrolimus ointment 0.03% and 0.1%), removing the Serious Warnings and Precautions box, also referred to as a boxed warning, regarding a potential association with the use of topical calcineurin inhibitors and malignancy.1 The changes were based on Health Canada's review of newly submitted data.1 Healthcare professionals should refer to the latest Protopic® Product Monograph for more information here.

The removal of the Serious Warnings and Precautions box was based on Health Canada's review of two large, long-term, non-interventional, post-authorization safety studies focussing on the risk of cancer: APPLES™ (A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis) and JOELLE (JOint European Longitudinal Lymphoma and skin cancer Evaluation).1

Protopic®, part of a class of medications called topical calcineurin inhibitors (TCI), is a non-steroid treatment used to treat moderate-to-severe atopic dermatitis in adults and children (2-15 years of age).1 Protopic® can be used for short- and long-term intermittent treatment of atopic dermatitis.1 Atopic dermatitis is the most common type of eczema (a group of diseases that cause inflammation of the skin).2

"Topical calcineurin inhibitors have been used successfully as an effective topical non-steroidal anti-inflammatory for the treatment of atopic dermatitis for more than 20 years in Canada. This update reflects the day-to-day usage of this agent by experienced practitioners and provides patients, pharmacists, and physicians additional reassurance regarding the long-term safety profile of Protopic®." — Dr. Chih-ho Hong, MD, FRCPC, clinical assistant professor, Division of Dermatology, University of British Columbia

"Topical calcineurin inhibitors offer healthcare professionals with efficacious non-steroidal anti-inflammatory treatment options for their patients suffering from atopic dermatitis. This safety update provides healthcare professionals, patients, and their families with additional confidence in the established, long-term safety profile of Protopic®." — Dr. Charles W. Lynde, MD, FRCPC, DABD, FCDA, associate professor, University of Toronto, Department of Medicine

"LEO Pharma Canada is committed to improving the everyday lives of people with skin conditions. Since its approval in 2001, Protopic® has been available to help Canadians suffering from atopic dermatitis. Today, we are proud to announce this update to its safety information and hope that this change brings healthcare professionals added reassurance when prescribing Protopic®." — Gonçalo Goya, general manager, LEO Pharma Canada

The APPLES™ study established the long-term safety of Protopic® in a large cohort of 7,954 children, who initiated treatment with Protopic® for atopic dermatitis before the age of 16 years, over a 10-year period.1,3 The JOELLE study established long-term safety in 32,605 children (< 18 years) and 126,908 adults who initiated treatment with Protopic®, with a median follow-up period of 5.7 years in children and 5.0 years in adults.1,4

Protopic® should not be used in immunocompromised adults and children.1 While a causal relationship has not been established, cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Protopic®.1 The use of Protopic should be avoided on pre-malignant and malignant skin conditions.1 The safety of Protopic® has not been established beyond one year of non-continuous use.1 Protopic® 0.03% is indicated for use in children aged 2–15 years.1 Protopic® is not recommended in patients less than 2 years of age.1 Healthcare professionals should refer to the Protopic® Product Monograph for more information.

For more information, please refer to:

About Atopic Dermatitis

Up to an estimated 17 per cent of Canadians will suffer from atopic dermatitis (AD) at some point in their lives.2 Itchy, inflamed skin, usually behind the knees, the inside of the elbows, and on the face, neck, and hands, are typical of AD.2 AD is a relapsing-remitting chronic disease, meaning that patients experience periods of flare (worsening of the disease) and periods of remission (less disease or periods of clear skin).5,6 Patients suffering with moderate-to-severe AD are more likely to be in a constant state of flare, with some level of baseline AD at all times with additional varying periods of degrees of worsening.5 Given there is no cure for AD, the goals of long-term management are the prevention of flares and the effective management of them when they do occur.7

The quality of life impacts of atopic dermatitis are multifaceted and can be constant for people suffering with moderate-to-severe disease.8 Physical disease symptoms such as itch have significant quality of life implications, including loss of sleep and poor sleep quality.8 AD also affects social, sexual, academic, and occupational functioning and can significantly impact the mental health of the sufferers.8

Protopic® Indications and Clinical Use

Acute Treatment: Protopic®, both 0.03% and 0.1% for adults and only 0.03% for children aged 2 to 15 years is indicated as a second-line therapy for short and long-term intermittent treatment of moderate to severe atopic dermatitis in non-immunocompromised patients, in whom the use of conventional therapies are deemed inadvisable because of potential risks, or who are not adequately responsive to or intolerant of conventional therapies.1

Maintenance Therapy: Protopic® is also indicated for maintenance therapy to prevent flares and prolong flare-free intervals in patients with moderate to severe atopic dermatitis experiencing a high frequency of flares (i.e., occurring 5 or more times per year) who have had an initial response (i.e., lesions cleared, almost cleared or mildly affected) with up to 6 weeks of treatment with twice daily Protopic®.1

About LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. Helping patients for more than 30 years in Canada, LEO Pharma Inc. is a division of LEO Pharma A/S. To learn more about LEO Pharma's commitment to dermatology care in Canada, visit:




LEO Pharma Inc. Canada. Protopic® Product Monograph. August 13, 2021.


Canadian Dermatology Association. Eczema. 2021. Available at: Retrieved August 31, 2021.


Paller AS, et al. No evidence of increased cancer incidence in children using topical
tacrolimus for atopic dermatitis. Journal of the American Academy of Dermatology.


Castellsague J, et al. A cohort study on the risk of lymphoma and skin cancer in users of
topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal
Lymphoma and Skin Cancer Evaluation - JOELLE study). Clin Epidemiol. 2018;10:299-310.


Eczema Society of Canada. Atopic Dermatitis Patient Journey Report. 2020. Available at: Retrieved August 31, 2021.


Eczema Society of Canada. Atopic Dermatitis: A Practical Guide to Management. 2020.
Available at: Retrieved August 31, 2021.


Lynde C, et al. Canadian practical guide for the treatment and management of atopic
dermatitis. J Cutan Med Surg. 2005;8 Suppl 5:1-9.


Eczema Society of Canada. Quality of Life Report – Moderate to Severe Atopic
Dermatitis. 2017. Available at:
Retrieved August 31, 2021.

Protopic® is a registered trademark of LEO Pharma A/S under license and distributed by LEO Pharma Inc. Canada.

SOURCE LEO Pharma Canada

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