x 
Adverse reactions listed in the Enstilar®
Summary of Product Characteristics1
  • The estimation of the frequency of adverse reactions over the recommended 4 week treatment course is based on a pooled analysis of data from clinical studies1
  • The most frequently reported adverse reactions during treatment are application site reactions1
Infections and infestations
Uncommon (≥1/1,000 to <1/100)
Follicultis
Immune system disorders
Uncommon (≥1/1,000 to <1/100)
Hypersensitivity
Metabolism and nutrition disorders
Uncommon (≥1/1,000 to <1/100) 
Hypercalcaemia*

Eye disorders
Not known 
Vision, blurred

Skin and subcutaneous tissue disorders
Uncommon (≥1/1,000 to <1/100)
Skin hypopigmentation
Not known
Hair colour changes

General disorders and administration site conditions
Uncommon (≥1/1,000 to <1/100)
Rebound effect
 
Application sire pruritus
 
Application site irritation
FOOTNOTES
+
* Mild hypercalcaemia has been observed.
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.
Transient disclouration 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.

REFERENCES
+
1. Enstilar® Summary of Product Characteristics (last accessed July 2019):
For the UK, accessible at: www.medicines.org.uk
For Ireland, accessible at: www.medicines.ie

MAT-25291 July 2019

Safety & Tolerability

Enstilar® is generally well tolerated1,2

A pooled analysis of three randomised controlled trials in 1,104 patients demonstrated a positive benefit–risk profile for Enstilar®:1

  • Enstilar® was generally well tolerated in adult patients with plaque psoriasis over a 4-week treatment course
  • No clinically relevant changes were observed in albumin-corrected serum calcium and spot urinary calcium: creatinine ratio during Enstilar® treatment for 4 weeks
  • The authors concluded that Enstilar® provides superior efficacy compared with calcipotriol betamethasone ointment and its individual active ingredients, while maintaining a favourable tolerability profile

The risk of hypercalcaemia is low when the maximum daily dose (15g) of calcipotriol is not exceeded2