Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Dovobet is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Due to the content of calcipotriol, Dovobet is contraindicated in patients with known disorders of calcium metabolism (see section 4.4).
Due to the content of corticosteroid, Dovobet is contraindicated in the following conditions: 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 (see section 4.4).
Dovobet gel contains a potent group III steroid and concurrent treatment with other steroids must be avoided. Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic 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 (see section 4.8).
In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Dovobet gel (scalp application) and high doses of Dovobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment (see section 5.1).
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.
Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose (15 g) is exceeded. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed.
Treatment of more than 30% of the body surface should be avoided (see section 4.2).
Dovobet 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 medicinal 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.
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped (see section 4.3).
When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.
With long-term use there is an increased risk of local and systemic corticosteroid adverse reactions. The treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid (see section 4.8).
There is no experience with the use of Dovobet in guttate psoriasis.
Dovobet ointment for body psoriasis lesions has been used in combination with Dovobet gel for scalp psoriasis lesions, but there is limited experience of combination of Dovobet with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.
During Dovobet treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).
Dovobet gel contains butylhydroxytoluene (E321) as an excipient, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
No interaction studies have been performed with Dovobet.
There are no adequate data from the use of Dovobet in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), 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, Dovobet should only be used when the potential benefit justifies the potential risk.
Betamethasone passes into breast milk, but risk of an adverse effect on 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 Dovobet to women who breast-feed. The patient should be instructed not to use Dovobet on the breast when breast-feeding.
Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility (see section 5.3).
Dovobet has no or negligible influence on the ability to drive and use machines.
The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies including post-authorisation safety studies and spontaneous reporting.
The most frequently reported adverse reaction during treatment is pruritus.
Adverse reactions are listed by MedDRA SOC and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
| Infections and infestations | |
| Uncommon ≥1/1,000 to <1/100 | Skin infection*, Folliculitis |
| Immune system disorders | |
| Rare ≥1/10,000 to <1/1,000 | Hypersensitivity |
| Eye disorders | |
| Uncommon ≥1/1,000 to <1/100 | Eye irritation |
| Not known | Vision, blurred** |
| Skin and subcutaneous tissue disorders | |
| Common ≥1/100 to < 1/10 | Pruritus |
| Uncommon ≥1/1,000 to <1/100 | Exacerbation of psoriasis, Dermatitis, Erythema, Rash***, Acne, Skin burning sensation, Skin irritation, Dry skin |
| Rare ≥1/10,000 to <1/1,000 | Skin striae, Skin exfoliation |
| Not known | Hair colour changes**** |
| General disorders and administration site conditions | |
| Uncommon ≥1/1,000 to <1/100 | Application site pain***** |
| Rare ≥1/10,000 to <1/1,000 | Rebound effect |
* Skin infections including bacterial, fungal and viral skin infections have been reported.
** See section 4.4.
*** Various types of rash reactions such as rash erythematous and rash pustular have been reported.
**** Transient discolouration of the hair at scalp application site, to a yellowish colour in white or grey hair, has been reported.
***** Application site burning is included in application site pain.
The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively:
Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, 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 section 4.4).
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, impact on the metabolic 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 on large areas and during long-term treatment (see section 4.4).
No clinically relevant differences between the safety profiles in adult and adolescent populations have been observed.
A total of 216 adolescent subjects were treated in three open label clinical trials.
See section 5.1 for further details regarding the trials.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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