Close-up of Enstilar® foam spray can

Enstilar® (calcipotriol / betamethasone dipropionate) logo

At a Glance
Coverage
Product Monograph
Close up of 0.1% and 0.03% Protopic® tubes

Protopic® logo (tacrolimus 0.03%, 0.1% ointment)

At a Glance
Coverage
Product Monograph
Close up of Fucibet® tube

Fucibet® logo (fusidic acid / betamethasone valerate)

At a Glance
Product Monograph

Enstilar® Safety Information

Indication and Clinical Use:
Enstilar® (calcipotriol and betamethasone dipropionate) is indicated for the topical treatment of psoriasis vulgaris in adults for up to 4 weeks.
The use in pediatrics (<18 years of age) is not recommended as safety and efficacy have not been established in this population.

Contraindications:
● Disorders of calcium metabolism
● Viral skin lesions; fungal, bacterial, parasitic skin infections; skin manifestations related to tuberculosis
● Perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds
● Erythrodermic and pustular psoriasis

Relevant warnings and precautions:
● Long-term or concomitant corticosteroid use
● Use with ultraviolet radiation
● Avoid use on broken skin, on mucous membranes, in skin folds, or under occlusive dressing
● Hypercalcemia and hypercalciuria
● Hepatic or renal impairment
● Avoid ophthalmic use
● Avoid use on face, axillae, flexures, groin, or genitals
● Use caution in pregnant patients
● Avoid use on breast if breastfeeding
● Use in children <18 years of age or the elderly ≥65 years of age

For more information:
Please consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for important information relating to adverse reactions, drug interactions, and dosing 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.

Protopic® Safety Information

Protopic® is indicated for:2
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.

Fucibet® Safety Information

Indication and Clinical Use:
Fucibet® (fusidic acid and betamethasone valerate) is indicated for the topical treatment of eczematous dermatoses including atopic eczema, discoid eczema, stasis eczema and seborrhoeic eczema when secondary bacterial infection caused by Staphylococcus aureus is confirmed or suspected.

Fucibet® is suitable in cases where treatment with a potent corticosteroid is appropriate to manage the pruritus and inflammation associated with eczematous dermatoses, and is intended for use during flare-ups for short-term (up to 2 weeks) treatment against bacteria susceptible to fusidic acid.

To reduce the development of drug-resistant bacteria, Fucibet® should only be used to treat infections that are proven or strongly suspected to be caused by bacteria.

Safety and efficacy have been established in patients ≥6 years old. Use with caution in pediatric patients.

Contraindications:
● Systemic fungal infections
● Primary skin infections caused by fungi, virus or bacteria
● Skin eruptions associated with tuberculosis or syphilis
● Perioral dermatitis and rosacea
● Eruptions following vaccinations

Relevant warnings and precautions:
● Avoid long-term continuous use
● Risk of systemic absorption
● Should not be used under occlusive dressing, over extensive areas, or on the face, scalp, axillae or scrotum
● Risk of HPA-axis suppression; Cushing’s syndrome, hyperglycemia, and glycosuria
● Susceptibility to infections
● Use with care near eyes
● Risk of bacterial resistance or microbial overgrowth
● Skin atrophy
● Safety during pregnancy or lactation has not been established

For more information:
Please consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for important information relating to adverse reactions, drug interactions, and dosing 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.

References:

  1. Current Enstilar® spray foam Product Monograph, LEO Pharma Inc.
  2. Current Protopic® Product Monograph, LEO Pharma Inc.
  3. Current Fucibet® Product Monograph, LEO Pharma Inc.