In controlled clinical trials, the most frequent adverse experiences reported for Dovonex® (calcipotriene) Cream, 0.005% were cases of skin irritation, which occurred in approximately 10-15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions associated with the use of Dovonex® Cream have been identified post-approval: contact dermatitis including allergic contact dermatitis, erythema, skin exfoliation, skin burning sensation, application site pain, application site pigmentation disorder, urticaria, photosensitivity, rash 1, dry skin, hypercalcaemia and hypersensitivity.
- rash erythematous, rash maculo-papular, rash morbilliform, rash popular, and rash pustular
Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored. [See PRECAUTIONS]
Apply a thin layer of Dovonex® Cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Dovonex® Cream have been demonstrated in patients treated for eight weeks.
Dovonex® (calcipotriene) Cream, 0.005% is available in:
60 gram aluminum tubes NDC 50222-260-06
120 gram aluminum tubes NDC 50222-260-12
Store at controlled room temperature 15°C — 25°C (59°F — 77°F). Do not freeze.
LEO Laboratories Ltd.
Dublin 12, Ireland
LEO Pharma Inc.
Seven Giralda Farms
Madison, NJ 07940, USA
To report SUSPECTED ADVERSE REACTIONS, contact
LEO Pharma Inc at 1-877-494-4536 or FDA at 1-800-FDA-1088
Net Wt. 60 g
Dovonex® (calcipotriene) Cream, 0.005%
Net Wt. 120 g
| DOVONEX |
|Labeler — LEO Pharma Inc. (832692615)|
|Registrant — LEO Pharma A/S (306218108)|
|LEO Laboratories Ltd.||306218108||MANUFACTURE (50222-260)|
Revised: 01/2020 LEO Pharma Inc.
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