Xamiol®

/ Dexcel

Xamiol gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks for scalp areas and 8 weeks for “non-scalp” areas. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision.
When using calcipotriol containing products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing products should not exceed 30%.
If used on the scalp
All the affected scalp areas may be treated with Xamiol gel. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon).
Special populations:
Renal and hepatic impairment
The safety and efficacy of Xamiol gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Paediatric population
The safety and efficacy of Xamiol gel in children below 18 years have not been established.
Method of administration
Xamiol gel should not be applied directly to the face or eyes. In order to achieve optimal effect, it is recommended not to take a shower or a bath, or to wash the hair in case of scalp application, immediately after application of Xamiol gel. Xamiol gel should remain on the skin during the night or during the day.
When using the bottle
The bottle should be shaken before use and Xamiol gel applied to the affected area. The hands should be washed after use.

Topical treatment of psoriasis vulgaris on the scalp and topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults 18 years of age and older.

Hypersensitivity to the active substances or to any of the excipients.
Xamiol is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Due to the content of calcipotriol, Xamiol gel is contraindicated in patients with known disorders of calcium metabolism.
Due to the content of corticosteroid, Xamiol gel 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, wounds.

Effects on endocrine system:
Xamiol 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.
In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Xamiol gel (scalp application) and high doses of Daivobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment.
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, 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.
Local adverse reactions:
Xamiol gel 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.
Concomitant skin infections:
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped.
Discontinuation of treatment:
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.
Long-term use:
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.
Unevaluated use:
There is no experience with the use of Xamiol gel in guttate psoriasis.
Concurrent treatment and UV exposure:
Daivobet ointment for body psoriasis lesions has been used in combination with Xamiol gel for scalp psoriasis lesions, but there is limited experience of Xamiol with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.
During Xamiol gel 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.
Adverse reactions to excipients:
Xamiol 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.

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 special precautions
***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 gray 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:
Calcipotriol
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.
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, 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.
Paediatric population
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 prescribing information for full details.

No interaction studies have been performed with Xamiol.

Pregnancy
There are no adequate data from the use of Xamiol gel in pregnant women. 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, Xamiol gel should only be used when the potential benefit justifies the potential risk.
Breast-feeding
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 Xamiol gel to women who breast-feed. The patient should be instructed not to use Xamiol on the breast when breast-feeding.
Fertility
Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility.
See prescribing information for full details

Use 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 suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible. In such cases, symptomatic treatment is indicated.
In case of chronic toxicity, the corticosteroid treatment must be discontinued gradually.
It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Daivobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing’s syndrome during treatment and then pustular psoriasis after abruptly stopping treatment.

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life: 2 years. After first opening: 3 months.
Storage: Do not refrigerate. Store in the outer carton in order to protect from light. Store below 25°C.