Calcipotriol / Betamethasone (Enstilar)

1. Health Canada Product Monograph — Calcipotriol / Betamethasone

• Calcipotriol / Betamethasone is used for the topical treatment of plaque psoriasis (psoriasis vulgaris) in adults, for up to 4 weeks per treatment course.
• It may also be used in adolescents aged 12 to 17 years for plaque psoriasis, for up to 4 weeks.
• Patients who respond to initial treatment may continue with twice-weekly maintenance therapy on previously affected areas for up to 52 weeks.

• The safety of Calcipotriol / Betamethasone during pregnancy has not been established, and it should be used only if clearly needed, for the shortest time and in the smallest amount necessary.
• Large amounts of topical corticosteroids used over extensive areas of the body during pregnancy have been associated with lower birth weight.

• Calcipotriol / Betamethasone should be used with caution while breastfeeding, and should not be applied to the breast area to avoid direct infant exposure.

• No overall differences in safety or effectiveness have been seen in older adults compared with younger patients, but caution is advised because older skin is more fragile and older adults more often have other health conditions or take other medicines.

• Calcipotriol / Betamethasone has been studied and may be used in adolescents aged 12 to 17 years with plaque psoriasis for up to 4 weeks.
• It is not recommended for children under 12 years of age, as safety and effectiveness have not been evaluated in this age group, and children have a higher risk of corticosteroid-related side effects due to their larger skin surface area relative to body weight.

• Apply Calcipotriol / Betamethasone to the affected skin once daily for up to 4 weeks; treatment should be stopped once the skin clears, and reassessed if there is no improvement after 4 weeks.
• For maintenance, once a response is achieved, the foam may be applied twice weekly (2 to 3 days apart) to previously affected areas for up to 52 weeks; if psoriasis returns, once-daily treatment can be restarted for up to another 4 weeks.
• The maximum daily amount is 15 grams, and the maximum weekly amount across all calcipotriol-containing products is 100 grams; treated skin, including the scalp, should not exceed 30% of the total body surface area.
• No specific dosage adjustment is described for kidney or liver impairment, but the product should be used with caution in patients with severe impairment of either organ, since both active ingredients undergo processing there.
• Shake the can well before each use, and hold it at least 3 cm from the skin when spraying; avoid spraying near the face, and do not inhale the spray.
• When treating the scalp, spray into the palm of the hand first, then apply to the scalp with the fingertips.
• Avoid showering or bathing immediately after applying this product, and wash hands after each application, unless the hands are being treated, to prevent spreading the medicine to unintended areas.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Using more than the recommended amount can raise blood calcium levels (hypercalcemia), which usually returns to normal once treatment is stopped; symptoms of high blood calcium include excessive urination, constipation, muscle weakness, confusion, and, in severe cases, coma.
• Excessive or prolonged use of this corticosteroid-containing product can suppress the body's natural adrenal hormone production, which is usually reversible; if this happens, the corticosteroid should be tapered off gradually rather than stopped abruptly.
• Overdose is unlikely with normal use given the low systemic absorption of a topical application, but the risk rises with use over large areas, for prolonged periods, or under occlusion such as bandages.

• Itching (pruritus) at the application site or elsewhere on the skin may occur.
• Irritation, burning, or stinging where the foam is applied may occur.
• Pain at the application site may occur.
• Dry skin may occur.
• Redness (erythema) of the treated skin may occur.
• A skin rash or dermatitis may occur.
• Inflammation of hair follicles (folliculitis) may occur.
• Acne-like breakouts may occur.
• Lightening or darkening of the skin colour at the treated area may occur.
• Increased hair growth at the application site may occur with prolonged use.
• A temporary worsening of psoriasis at the treated site may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• High blood calcium (hypercalcemia) or high urine calcium (hypercalciuria) can occur, particularly with excessive use.
• Suppression of the body's natural adrenal hormone production can occur with prolonged or extensive use, potentially causing symptoms of adrenal insufficiency.
• Signs of excess corticosteroid in the body (Cushing's syndrome), such as rounded face and weight gain, can occur with extensive or prolonged use.
• Blood sugar control can worsen in people with diabetes, and previously undiagnosed diabetes can be unmasked.
• Thinning of the skin, stretch marks, or visible blood vessels can occur with long-term use, particularly under occlusion or on delicate skin areas.
• Stopping treatment abruptly after prolonged use may trigger a flare of more severe, pustular, or widespread psoriasis.
• Allergic reactions, including hives, swelling of the face (angioedema), and hypersensitivity, can occur rarely.
• With long-term use, increased pressure in the eye or cataracts can occur, particularly if the product contacts the eyes or is used near them.
• Skin infections can worsen if not treated with an appropriate antimicrobial before or during use of this product.
• Permanent stretch marks, visible blood vessels, or small skin-coloured bumps (colloid milia) can occur at the application site with prolonged use.
• Allergic contact dermatitis to an ingredient in the product can develop with repeated use.
• Rare eye changes at the back of the eye (chorioretinopathy) have been reported with long-term maintenance use.

• Use with caution on the face, skin folds such as armpits or groin, or under dressings or bandages, since these increase absorption and the risk of side effects; the product should not be used on the face, armpits, groin, or genitals at all.
• Use with caution in patients with a history of high blood calcium or kidney stones.
• Use with caution in patients with severe liver or kidney impairment.
• Use with caution in patients with guttate (drop-shaped) psoriasis, since there is no experience using this product for that type.
• Use with caution around the eyes, since the product can cause eye irritation and should not contact the eyes.
• Use with caution in children and adolescents, who absorb proportionally more medicine through the skin than adults.
• Use with caution when treating widespread or extensive areas of psoriasis, since this increases the amount of medicine absorbed into the body.
• Use with caution in patients being treated for a skin infection, and treat the infection with an appropriate antimicrobial before or alongside use of this product.

• Contraindicated in patients with known hypersensitivity to calcipotriol, betamethasone, or any other ingredient in the product.
• Contraindicated in patients with disorders of calcium metabolism.
• Contraindicated on skin with viral infections such as herpes or chickenpox, fungal or bacterial skin infections, parasitic skin infections, or skin changes related to tuberculosis.
• Contraindicated on skin with perioral dermatitis, thinned (atrophic) skin, stretch marks, fragile skin blood vessels, ichthyosis, acne, rosacea, ulcers, or open wounds.
• Contraindicated in patients with erythrodermic or pustular (widespread, severe) forms of psoriasis.

• No formal drug interaction studies have been performed with this product, and clinically significant interactions with other medicines are not expected given its low absorption into the bloodstream when used as directed.
• Using this product together with other corticosteroid-containing products on the same area of skin should be avoided, as this increases the risk of skin thinning and other corticosteroid side effects.
• Using more than the recommended weekly amount of any calcipotriol-containing product, including this one, increases the risk of high blood calcium.

• Calcipotriol / Betamethasone is applied to the skin, so food and drink do not affect its use.

• Apply Calcipotriol / Betamethasone once daily, at a consistent time such as in the evening, to build a routine, then switch to twice-weekly application for maintenance once psoriasis has cleared.

• Store Calcipotriol / Betamethasone below 30°C, away from heat sources and open flame, and do not freeze, puncture, or incinerate the can, as its contents are under pressure and flammable; discard 6 months after opening or by the expiry date, whichever comes first.

• Calcipotriol / Betamethasone is for use on affected skin only, and should not be used on the face, skin folds, or broken skin.
• Shake the can before use, and wash your hands after applying, unless treating the hands, to avoid spreading the medicine to other areas.
• Do not use for longer than the recommended treatment period without checking with your doctor or pharmacist, since long-term corticosteroid use has more side effects.
• Tell your doctor if your psoriasis does not improve within 4 weeks, or if it worsens after stopping treatment.