Calcipotriene (Dovonex) Adverse Reactions
- abdominal pain
- anorexia
- bronchospasm
- constipation
- contact dermatitis
- depression
- erythema
- exfoliative dermatitis
- fatigue
- folliculitis
- headache
- hot flashes
- hypercalcemia
- hypercalciuria
- hypertension
- nausea/vomiting
- polydipsia
- pruritus
- skin atrophy
- skin hyperpigmentation
- skin irritation
- weakness
- weight loss
- xerosis
Calcipotriene (Dovonex) Adverse Reactions
Reactions occurring in up to 20% of patients during therapy with calcipotriene include skin irritation, burning, and pruritus. Erythema, xerosis, and exfoliative dermatitis occur in 1-10% of patients and may require discontinuation of treatment. In rare instances, allergic contact dermatitis has also been reported. Skin reactions often resolve with continued use. Facial dermatitis occurred in up to 10% of patients in early trials during therapy with calcipotriene. This adverse reaction seemed related to direct application of the product to the face and, as a result, calcipotriene ointment is not recommended for application to the face. Resolution of symptoms occurs within days of treatment withdrawal.
Hypercalcemia and/or hypercalciuria occur almost exclusively when the recommended 100 g/week dosage is approached or exceeded. Although calcium and bone metabolism in humans appear to be unaffected during short-term therapy of stable plaque psoriasis when calcipotriene is used in recommended dosages (<100 grams/week), a significant increase in urine calcium was seen when calcipotriene was administered at the maximum weekly dosage (100 grams/week) for 4 weeks. The urine calcium of subjects receiving less than 77g/week for 1 year was unchanged. The clinical significance of these findings remains undetermined; however, the investigators caution against using calcipotriene in patients with hypercalcemia or those predisposed to renal stone formation. In general, the effectiveness and safety from long-term use are similar to short-term use. Symptoms of severe hypercalcemia include abdominal pain, constipation, depression, fatigue, hypertension, anorexia, weight loss, muscle weakness, nausea/vomiting, and thirst (polydipsia).
According to the manufacturer, non-dermatologic adverse effects were reported in about 2% of patients. These include headache, hot flashes, flu-like symptoms, and increasing bronchospasm. Adverse reactions reported in less than 1% of patients during therapy with calcipotriene included skin atrophy, skin hyperpigmentation, and folliculitis.
A study conducted in albino hairless mice demonstrated that exposure to UV radiation along with application of topical calcipotriene shortened the time to formation of skin tumors. This finding suggests that calcipotriene may increase the effect of UV radiation on skin tumor formation. Patients should be advised to avoid excessive exposure to natural or artificial sunlight while on calcipotriene. It may also be prudent to limit or avoid the use of phototherapy in patients using calcipotriene.
[ Last revised: 5/7/2005 9:40:00 AM ]
References
. Berth-Jones J, Chu A, Dodd W, et al. A multicentre, parallel-group comparison of calcipotriol ointment and short-contact dithranol therapy in chronic plaque psoriasis. Br J Derm 1992;127:266-71.
. Berth-Jones J, Bourke JF, Iqbal SJ, et al. Urine calcium excretion during treatment of psoriasis with topical calcipotriol. Br J Derm 1993;129:411-4.
. Dwyer C, Chapman RS. Calcipotriol and hypercalcemia. Lancet 1991;338:764-5.
. Klaber MR, Hutchinson PE, Holden C et al. Long term treatment of psoriasis with calcipotriol. Br J Derm 1992;127(S40):17-21.
. Dovonex® (calcipotriene) package insert. Princeton, NJ: Bristol-Myers Squibb Company; 2005 Apr.
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