Effects on calcium metabolism
Due to the content of calcipotriol, hypercalcaemia may occur if the maximum weekly dose is exceeded. Care should be exercised in patients with other types of psoriasis, since hypercalcaemia has been reported in patients with generalised pustular or erythrodermic exfoliative psoriasis. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the dosage recommendations are followed. The maximum weekly dose in adults is 100 g of cream or ointment (equivalent to 5 mg of calcipotriol) or 60 ml of scalp solution (equivalent to 3 mg of calcipotriol). When cream, ointment or cutaneous solution are applied together, the total dose of calcipotriol should not exceed 5 mg per week.
Local adverse reactions
Dovonex® should not be applied to the face, as it may cause skin irritation
The patient must be instructed in correct use of the product to avoid accidental transfer to the face and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
UV exposure
During Dovonex® * Ointment treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Dovonex® * should be used with UV radiation only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).
Unevaluated use
Due to lack of data, Dovonex® * should be avoided in guttate, erythrodermic, exfoliative and pustular psoriasis.
Due to lack of data, Dovonex® * should be avoided in patients with severe liver and kidney disease.
Adverse reactions to excipients
Dovonex® * ointment contains propylene glycol as an excipient which may cause skin irritation.
Fire hazard
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.