Dovonex
(calcipotriene)Dovonex Prescribing Information
Calcipotriene Cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
Apply a thin layer of calcipotriene cream USP, 0.005% to the affected skin twice daily and rub in gently and completely. The safety and efficacy of calcipotriene cream, 0.005% have been demonstrated in patients treated for eight weeks.
Calcipotriene Cream, 0.005% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene Cream, 0.005% should not be used on the face.
Clinical Trials Experience
In controlled clinical trials, the most frequent adverse experiences reported for calcipotriene cream, 0.005% were cases of skin irritation, which occurred in approximately 10 to 15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.
Postmarketing Experience
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 calcipotriene cream, 0.005% have been identified post-approval: contact dermatitis, including allergic contact dermatitis.
Calcipotriene Cream USP, 0.005% contains calcipotriene, a synthetic vitamin D3 derivative, for topical dermatological use.
Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C27H4003, a molecular weight of 412.3, and the following structural formula:
Calcipotriene is a white or off-white crystalline substance. Calcipotriene Cream, 0.005% contains calcipotriene equivalent to 50 mcg/g anhydrous calcipotriene in a cream base of ceteth-20, cetostearyl alcohol, diazolidinyl urea, dibasic sodium phosphate heptahydrate, 2,4-dichlorobenzyl alcohol, edetate disodium, glycerin, mineral oil, phosphoric acid, white petrolatum, sodium hydroxide and purified water.
In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D3 (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D3.
Clinical studies with radiolabelled calcipotriene ointment indicate that approximately 6% (±3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques, or 5% (±2.6%, SD) when applied to normal skin, and much of the absorbed active is converted to inactive metabolites within 24 hours of application. Systemic absorption of the cream has not been studied.
Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins. The active form of the vitamin, 1,25-dihydroxy vitamin D3 (calcitriol), is known to be recycled via the liver and excreted in the bile. Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone.
Adequate and well-controlled trials of patients treated with calcipotriene cream, 0.005% have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued with approximately 50% of patients showing at least marked improvement in the signs and symptoms of psoriasis after 8 weeks of therapy, but only approximately 4% showed complete clearing.
Calcipotriene Cream USP, 0.005% is available in:
60 gram aluminum tubes: NDC 0781-7117-35
120 gram aluminum tubes: NDC 0781-7117-83
Storage and Handling
Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Do not freeze.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Manufactured by Tolmar, Inc.
Fort Collins, CO 80526 for
Sandoz Inc.
Princeton, NJ 08540
44473 Rev. 3 10/21