Enstilar, Cutaneous foam

/ Dexcel

Enstilar foam should be applied to the affected area once daily. The recommended treatment period is 4 weeks. The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand.
Concomitant use with other topical products containing calcipotriol in addition to Enstilar:  the total dose of all calcipotriol containing products should not exceed 15 g per day.
The total body surface area treated should not exceed 30%.
Special populations
Renal and hepatic impairment
The safety and efficacy of Enstilar foam in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Paediatric population
The safety and efficacy of Enstilar foam in children below 18 years have not been established. Enstilar is not indicated for children below 18 years of age.

Topical treatment of psoriasis vulgaris in adults.

Hypersensitivity to the active substances or to any of the excipients.
Enstilar is contraindicated in erythrodermic and pustular psoriasis.
Due to the content of calcipotriol, Enstilar is contraindicated in patients with known disorders of calcium metabolism.
Due to the content of corticosteroid, Enstilar is contraindicated in the following conditions if present in the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.

Effects on endocrine system:
Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impaired glycaemic control of diabetes mellitus may occur also during topical corticosteroid treatment due to systemic absorption.
Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin, or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids.
Visual disturbance:
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for a referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Effects on calcium metabolism:
Due to the content of calcipotriol in Enstilar, hypercalcaemia may occur. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the maximum daily dose of Enstilar (15 g) is not exceeded.
Local adverse reactions:
Enstilar contains a potent group III-steroid and concurrent treatment with other steroids on the same treatment area must be avoided. Skin of the face and genitals are very sensitive to corticosteroids. The medicinal product should not be used in these areas.
The patient must be instructed in correct use of the product to avoid application and accidental transfer to the face, mouth, and eyes. Hands must be washed after each application to avoid accidental transfer to these areas as well as unintended drug absorption on the hands.
Concomitant skin infections:
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be discontinued.
Discontinuation of treatment:
When treating psoriasis with topical corticosteroids, there may be a risk of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.
Long-term use:
Long-term use of corticosteroids may increase the risk of local and systemic adverse reactions. Treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid.
Unevaluated use:
There is no experience with the use of Enstilar in guttate psoriasis.
Adverse reactions to excipients:
Enstilar contains butylhydroxytoluene (E321) as an excipient, which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Caution:
Extremely flammable aerosol. Pressurised container: May burst if heated. Protect from sunlight. Do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on an open flame or other ignition source. Keep away from sparks, open flames and other ignition sources. No smoking.

Side Effects:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (<1/10,000)
Not known: Cannot be estimated from available data

Infections and infestations:
Uncommon: Folliculitis
Immune system disorders:
Uncommon: Hypersensitivity
Metabolism and nutrition disorders:
Uncommon: Hypercalcaemia*
Eye disorders:
Not known: Vision, blurred**
Skin and subcutaneous tissue disorders:
Uncommon: Skin hypopigmentation
Not known: Hair colour changes***
General disorders and administration site conditions:
Uncommon: Rebound effect, application site pruritus, application site irritation, application site pain****

* Mild hypercalcaemia has been observed.
** See Special Precautions
***Transient discolouration of the hair at scalp application site, to a yellowish colour in white or grey hair, has been reported for calcipotriol and betamethasone combination products.
****Application site burning is included in application site pain.

Paediatric population
No clinically relevant differences between the safety profiles in adult and adolescent populations have been observed. A total of 106 adolescent subjects were treated in one open-label clinical trial.
The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively:
Calcipotriol:
Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, psoriasis aggravated, photosensitivity and hypersensitivity reactions, including very rare cases of angioedema and facial oedema.
Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria (see special precautions).
Betamethasone (as dipropionate):
Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, and colloid milia.
When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis.
Systemic reactions due to topical use of corticosteroids are rare in adults; however, they can be severe. Adrenocortical suppression, cataract, infections, impaired glycaemic control of diabetes mellitus, and increase of intra-ocular pressure can occur, especially after long-term treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied onto large skin areas, and during long-term treatment (see special precautions).

No interaction studies have been performed with Enstilar.

Pregnancy:
There are no adequate data from the use of Enstilar in pregnant women. When administered orally in animals, studies of calcipotriol have not shown teratogenic effects, though reproductive toxicity has been shown. Studies in animals with glucocorticoids have shown reproductive toxicity, but a number of epidemiological studies (less than 300 pregnancy outcomes) have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Enstilar should only be used when the potential benefit justifies the potential risk.
Breastfeeding:
Betamethasone passes into breast milk, but risk of an adverse reaction in the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing Enstilar to women who breastfeed. The patient should be instructed not to use Enstilar on the breast when breastfeeding.
Fertility:
Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility.

Usage above the recommended dose may cause elevated serum calcium which subsides when treatment is discontinued. The symptoms of hypercalcaemia include polyuria, constipation, muscle weakness, confusion, and coma.
Excessive prolonged use of topical corticosteroids may result in adrenocortical suppression which is usually reversible. Symptomatic treatment may be indicated.

In case of chronic toxicity, the corticosteroid treatment must be discontinued gradually.
See prescribing information for full details.

Method of administration
For cutaneous use.
The can should be shaken for a few seconds before use. Enstilar should be applied by spraying holding the can at least 3 cm from the skin. The foam can be sprayed holding the can in any orientation except horizontally.
Enstilar should be sprayed directly onto each affected skin area and rubbed in gently.
If used on the scalp, Enstilar should be sprayed into the palm of the hand and then applied to affected scalp areas with the fingertips. Hair washing instructions are provided in the package leaflet.
The hands should be washed after using Enstilar (unless Enstilar is used to treat the hands) to avoid accidentally spreading to other parts of the body. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. It is recommended not to take a shower or bath immediately after application of Enstilar. Let the foam remain on the scalp and/or skin during the night or during the day.