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Protopic® Safety Information

Indications and clinical use:
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.

Maintenance: 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®.

Most serious warning and precautions:
Risk of skin malignancy and lymphoma: Long-term safety of topical calcineurin inhibitors has not been established. Although causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Protopic® ointment 0.1% and 0.03%. Therefore:

● Continuous long-term use of Protopic® ointment should be avoided and application limited to areas of involvement with atopic dermatitis
● Protopic® ointment is not indicated in children less than 2 years of age. Only 0.03% Protopic® ointment is indicated for use in children 2-15 years of age

Other relevant warnings and precautions:
● Risk of skin burning (burning sensation, stinging, soreness) or pruritus
● Risk of infections
● Avoid use on pre-malignant and malignant skin conditions
● Do not use in immunocompromised adults and children
● Discontinue use in patients who do not improve within 6 weeks of twice-daily treatment
● Risk of lymphadenopathy
● Risk of acute renal failure
● Risk of varicella zoster virus infection (chickenpox or shingles), herpes simplex virus infection or eczema herpeticum
● Minimize or avoid natural or artificial sunlight exposure
● Risk of increased systemic absorption in patients with a skin barrier defect
● Use in pregnant and nursing women

For more information:
Please consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for more important information relating to adverse reactions, drug interactions, and dosing/administration information which have not been discussed in this piece. The Product Monograph is also available by calling LEO Pharma Medical Information at 1-800-263-4218.

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