ENSTILAR

What it is

ENSTILAR is a foam aerosol formulation containing calcipotriol 50 microgram/g and betamethasone dipropionate 500 microgram/g.

Approved indications

— Chronic stable plaque type psoriasis vulgaris.

Dosing overview

The provided sources do not contain dosing information specific to ENSTILAR.

Key safety warnings

ENSTILAR should not be used in or near the eyes. Corticosteroids are absorbed through the skin, and systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used; suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children. Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children. Chronic corticosteroid therapy may interfere with the growth and development of children, and paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and to exogenous corticosteroid effects; HPA axis suppression, Cushing's syndrome linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue, and if this occurs, treatment should be discontinued. Visual disturbance may be reported with systemic and topical corticosteroid use, and if a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy.

Contraindications

Hypersensitivity to betamethasone dipropionate, other corticosteroids or any components in the formulation is a contraindication. ENSTILAR is contraindicated in most viral infections of the skin, such as vaccinia, varicella, Herpes simplex, and also tuberculosis and acne rosacea.

PBS listing

ENSTILAR received a restricted benefit listing in November 2016 for chronic stable plaque type psoriasis vulgaris, subject to a cap on PBS expenditure. The provided sources do not contain information on specific PBS item numbers or ex-manufacturer pricing.

Regulatory history

ENSTILAR (ARTG 263292) was first listed on the Australian Register of Therapeutic Goods on 11 October 2016. The product received PBAC recommendation in November 2016 for chronic stable plaque type psoriasis vulgaris as a restricted benefit listing with a cap on PBS expenditure. In July 2023, a PBAC submission for an increase in maximum quantity was not recommended.