Dovonex Side Effects

Generic Name: calcipotriene topical

Note: This page contains information about the side effects of calcipotriene topical. Some of the dosage forms included on this document may not apply to the brand name Dovonex.

Not all side effects for Dovonex may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to calcipotriene topical: topical cream, topical foam, topical ointment, topical solution

In addition to its needed effects, some unwanted effects may be caused by calcipotriene topical (the active ingredient contained in Dovonex). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking calcipotriene topical:

More common
  • Skin redness, swelling, or itching
  • skin rash
  • worsening of psoriasis

Some of the side effects that can occur with calcipotriene topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Burning, dryness, irritation, peeling, or redness of the skin
Less common
  • Pain at the application site
Less common or rare
  • Darker color in the treated areas of the skin
  • pus in the hair follicles

For Healthcare Professionals

Applies to calcipotriene topical: topical cream, topical foam, topical ointment, topical solution

Dermatologic

Very common (10% or more): Cream: Skin irritation (up to 15%); Ointment: Burning, itching, skin irritation (up to 15%); Solution: Transient burning, stinging, tingling (about 23%), rash (about 11%)
Common (1% to 10%): Cream: Rash, pruritus, dermatitis, worsening of psoriasis (up to 10%); Ointment: Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis (up to 10%); Solution: Dry skin, irritation, worsening of psoriasis (up to 5%)
Uncommon (0.1% to 1%): Ointment: Skin atrophy, hyperpigmentation, folliculitis (less than 1%)
Rare (less than 0.1%): Facial dermatitis or eczema, allergic contact dermatitis
Frequency not reported: Calcipotriene phototoxicity[Ref]

Clinical trials have shown a higher incidence of severe skin-related adverse reactions in patients older than 65 years of age.

Facial dermatitis or eczema has rarely been reported, occasionally in patients without facial psoriasis.[Ref]

Metabolic

Hypercalcemia was reversible upon drug discontinuation.

Symptomatic hypercalcemia has been reported in a few individuals, particularly those with extensive, unstable disease using more than 100 grams of ointment per week. One patient with symptomatic hypercalcemia had moderate renal impairment. This patient used 200 grams of ointment over the course of a week. At least two patients have experienced hypercalcemia while using less than 100 grams per week. A lower dose of 10 grams per week was tried in one of these patients, however hypercalcemia returned.

There have been several studies of the effect of calcipotriene on serum calcium and urinary calcium. One study observed 34 patients with psoriasis treated with 8.2 to 95.4 grams per week. No difference in calcium or bone metabolism was noted when compared to patients treated with placebo. Another study where 12 of 24 patients received 30 grams per day for 14 days reported no significant alterations in blood or urine calcium concentrations. However, in a higher dose study, 10 patients treated with 100 grams calcipotriene per week experienced an increase in urinary calcium from 4.75 mmol/24 hours to 5.89 mmol/24 hours over four weeks of treatment.[Ref]

Uncommon (0.1% to 1%): Ointment: Hypercalcemia (less than 1%)
Rare (less than 0.1%): Transient increases in serum calcium, symptomatic hypercalcemia[Ref]

Local

Common (1% to 10%): Foam: Application site pain (3%), application site erythema (2%)[Ref]

References

1. Anolik R, Brauer JA, Soter NA "An unusual bullous eruption in a patient with psoriasis: Calcipotriene phototoxicity." J Am Acad Dermatol 62 (2010): 1081-2

2. Cunliffe WJ, Berth-Jones J, Claudy A, Fairiss G, Goldin D, Gratton D, Henderson CA, Holden CA, Maddin WS, Ortonne JP, et al "Comparative study of calcipotriol (MC 903) ointment and betamethasone 17-valerate ointment in patients with psoriasis vulgaris." J Am Acad Dermatol 26 (1992): 736-43

3. Hardman KA, Heath DA, Nelson HM "Hypercalcaemia associated with calcipotriol (Dovonex) treatment." BMJ 306 (1993): 896

4. Dubertret L, Wallach D, Souteyrand P, Perussel M, Kalis B, Meynadier J, Chevrant-Breton J, Beylot C, Bazex JA, Jurgensen HJ "Efficacy and safety of calcipotriol (MC 903) ointment in psoriasis vulgaris. A randomized, double-blind, right/left comparative, vehicle- controlled study." J Am Acad Dermatol 27 (1992): 983-8

5. "Product Information. Dovonex (calcipotriene)." Westwood Squibb Pharmaceutical Corporation, Eatontown, NJ.

6. Mortensen L, Kragballe K, Wegmann E, Schifter S, Risteli J, Charles P "Treatment of psoriasis vulgaris with topical calcipotriol has no short-term effect on calcium or bone metabolism. A randomized, double- blind, placebo-controlled study." Acta Derm Venereol 73 (1993): 300-4

7. Blum R, Schwartzel E, Siskin S, Epinette WW "Evaluating the safety of calcipotriene 30 g per day in patients with psoriasis: A parallel group, vehicle-controlled study." J Clin Pharmacol 38 (1998): 368-72

8. Bourke JF, Berth-Jones J, Iqbal SJ, Hutchinson PE "High-dose topical calcipotriol in the treatment of extensive psoriasis vulgaris." Br J Dermatol 129 (1993): 74-6

9. de Groot AC "Contact allergy to calcipotriol." Contact Dermatitis 30 (1994): 242-3

10. Dwyer C, Chapman RS "Calcipotriol and hypercalcaemia." Lancet 338 (1991): 764-5

11. Murdoch D, Clissold SP "Calcipotriol. A review of its pharmacological properties and therapeutic use in psoriasis vulgaris." Drugs 43 (1992): 415-29

12. Berth-Jones J, Bourke JF, Iqbal SJ, Hutchinson PE "Urine calcium excretion during treatment of psoriasis with topical calcipotriol." Br J Dermatol 129 (1993): 411-4

13. Bruce S, Epinette WW, Funicella T, Ison A, Jones EL, Loss R, Mcphee ME, Whitmore C "Comparative study of calcipotriene (MC 903) ointment and fluocinonide ointment in the treatment of psoriasis." J Am Acad Dermatol 31 (1994): 755-9

14. Berth-Jones J, Chu AC, Dodd WA, Ganpule M, Griffiths WA, Haydey RP, Klaber MR, Murray SJ, Rogers S, Jurgensen HJ "A multicentre, parallel-group comparison of calcipotriol ointment and short-contact dithranol therapy in chronic plaque psoriasis." Br J Dermatol 127 (1992): 266-71

15. Kragballe K, Fogh K, Sogaard H "Long-term efficacy and tolerability of topical calcipotriol in psoriasis. Results of an open study." Acta Derm Venereol 71 (1991): 475-8

16. Highton A, Quell J, Breneman D, Cullen S, Goffe B, Griffiths C, Huerter C, Kingsley D, Piacquadio D, Pincus S, Rogers R, Scher "Calcipotriene ointment 0.005% for psoriasis: a safety and efficacy study." J Am Acad Dermatol 32 (1995): 67-72

17. Bruynzeel DP, Hol CW, Nieboer C "Allergic contact dermatitis to calcipotriol." Br J Dermatol 127 (1992): 66

18. Kragballe K "Treatment of psoriasis by the topical application of the novel cholecalciferol analogue calcipotriol (MC 903)." Arch Dermatol 125 (1989): 1647-52

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