Calcitrene (Calcipotriene)

Generic Name

Calcipotriene

Brand Names

Calcitrene, Calyxra, Cipotrex, Pellix, Sorilux, Trionex

FDA approval date: October 01, 1996

Classification: Vitamin D Analog

Form: Ointment, Cream, Aerosol, Kit, Solution

What is Calcitrene (Calcipotriene)?

Calcitrene ® ointment.

Approved To Treat

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Brand Information

Calcitrene (Calcipotriene)

1DESCRIPTION

Calcitrene

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 C

Calcipotriene is a white or off-white crystalline substance. Calcitrene

2CLINICAL PHARMACOLOGY

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 D

Clinical studies with radiolabelled 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.

Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins. The active form of the vitamin, 1,25-dihyroxy vitamin D

There is evidence that maternal 1,25-dihydroxy vitamin D

3CLINICAL STUDIES

Adequate and well-controlled trials of patients treated with Calcitrene

Subtracting percentages of patients using placebo (vehicle only) from percentages of patients using calcipotriene who had at least marked improvements after 8 weeks yields 39.9% for once daily and 49.6% for twice daily. This adjustment for placebo effect indicated that what might appear to be differences between once and twice daily use may reflect differences in the studies independent from the frequency of dosing. Although there was a numerical difference in comparison across studies, twice daily dosing has not been shown to be superior in efficacy to once daily dosing.

Over 400 patients have been treated in open label clinical studies of calcipotriene for periods of up to one year. In half of these studies, patients who previously had not responded well to calcipotriene were excluded. The adverse events in these extended studies included skin irritation in approximately 25% of patients and worsening of psoriasis in approximately 10% of patients. In one of these open label studies, half of the patients no longer required calcipotriene by 16 weeks of treatment, because of satisfactory therapeutic results.

4INDICATIONS AND USAGE

Calcitrene

5CONTRAINDICATIONS

Calcitrene

6ADVERSE REACTIONS

In controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing.

7OVERDOSAGE

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of Calcitrene

8DOSAGE AND ADMINISTRATION

Apply a thin layer of Calcitrene

9HOW SUPPLIED

Calcitrene

60 gram aluminum tube

9.1STORAGE

Store at controlled room temperature 15°C-25°C (59°F-77°F). Do not freeze.

10PRINCIPAL DISPLAY PANEL - 120 g Tube Carton

NDC 51672-5278-4

120 g

Calcitrene^®
Calcipotriene Ointment

Rx only

TaroPharma^®

FOR TOPICAL DERMATOLIGIC USE ONLY.

Keep this and all medications out of the reach of children.

TaroPharma^®

Principal Display Panel - 120 g Tube Carton