"The US Food and Drug Administration (FDA) has approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar, Leo Pharma Inc) for topical treatment of plaque psoriasis in adults 18 years of age and older, according to a "...
Hypercalcemia And Hypercalciuria
Hypercalcemia and hypercalciuria have been observed with use of Taclonex® Topical Suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following Taclonex® Topical Suspension treatment of more than 8 weeks has not been evaluated.
Hypothalamic-Pituitary-Adrenal Axis Suppression
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In a trial of 32 subjects treated with both Taclonex® Topical Suspension on the scalp and Taclonex® Ointment on the body, adrenal suppression was identified in 5 of 32 subjects (16%) after 4 weeks of treatment and in 2 of 11 subjects (18%) who continued treatment for 8 weeks. In another trial of 43 subjects treated with Taclonex® Topical Suspension on body (including the scalp in 36 out of 43 subjects) adrenal suppression was identified in 3 out of 43 subjects (7%) after 4 weeks of treatment and in none of the 36 subjects who continued treatment for 8 weeks. [See CLINICAL PHARMACOLOGY]
Evaluation of HPA Axis Suppression
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.
If HPA axis suppression is documented, attempt to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [See Use in Specific Populations]
Cushing's Syndrome, Hyperglycemia, And Diabetes Mellitus
Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [See Use in Specific Populations]
Local Adverse Reactions With Topical Corticosteroids
Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. Do not use on face, axillae, or groin. Do not use if atrophy is present at the treatment site.
Allergic Contact Dermatitis With Topical Corticosteroids
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.
Allergic Contact Dermatitis With Topical Calcipotriene
Allergic contact dermatitis has been observed with use of topical calcipotriene. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.
Concomitant Skin Infections
Treat concomitant skin infections with an appropriate antimicrobial agent. If the infection persists, discontinue Taclonex® Topical Suspension until the infection has been adequately treated.
Avoid eye exposures. Taclonex® Topical Suspension may cause eye irritation.
Risks Of Ultraviolet Light Exposures
Patients who apply Taclonex® Topical Suspension to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. Physicians may wish to limit or avoid use of phototherapy in patients who use Taclonex® Topical Suspension.
Patient Counseling Information
See FDA-approved patient labeling (PATIENT INFORMATION and INSTRUCTIONS FOR USE)
Inform patients of the following:
- This medication is to be used as directed by the physician.
- Do not use this medication for any disorder other than for which is has been prescribed
- This medication is for external use only.
- Avoid contact with the face or eyes. If this medicine gets on face or in eyes, wash area right away.
- Do not apply Taclonex® Topical Suspension to the scalp in the 12 hours before or after any chemical treatments to the hair. Since hair treatments may involve strong chemicals, talk with physician first.
- Wash hands after application.
- If applied to the scalp, do not wash hair or take a bath or shower right after application.
- Do not bandage or otherwise occlude the treated skin area unless directed by the physician.
- Instruct patients to report any signs of adverse reactions to their physician.
- Instruct patients not to use other products containing calcipotriene or a corticosteroid with Taclonex® Topical Suspension without first talking to the physician.
- Instruct patients who use Taclonex® Topical Suspension to avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).
Carcinogenesis, Mutagenesis, Impairment Of Fertility
When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10, and 30 mcg/kg/day (corresponding to 9, 30, and 90 mcg/m²/day), no significant changes in tumor incidence were observed when compared to control.
In a study in which albino hairless mice were exposed to both ultra-violet radiation (UVR) and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors.
A 104-week oral carcinogenicity study was conducted with calcipotriene in male and female rats at doses of 1, 5 and 15 mcg/kg/day (corresponding to dosages of approximately 6, 30, and 90 mcg/m²/day). Beginning week 71, the dosage for high-dose animals of both genders was reduced to 10 mcg/kg/day (corresponding to a dosage of approximately 60 mcg/m²/day). A treatment-related increase in benign C-cell adenomas was observed in the thyroid of females that received 15 mcg/kg/day. A treatment-related increase in benign pheochromocytomas was observed in the adrenal glands of males that received 15 mcg/kg/day. No other statistically significant differences in tumor incidence were observed when compared to control. The relevance of these findings to patients is unknown.
When betamethasone dipropionate was applied topically to CD-1 mice for up to 24 months at dosages approximating 1.3, 4.2, and 8.5 mcg/kg/day in females, and 1.3, 4.2, and 12.9 mcg/kg/day in males (corresponding to dosages of up to approximately 26 mcg/m²/day and 39 mcg/m²/day, in females and males, respectively), no significant changes in tumor incidence were observed when compared to control.
When betamethasone dipropionate was administered via oral gavage to male and female Sprague Dawley rats for up to 24 months at dosages of 20, 60, and 200 mcg/kg/day (corresponding to dosages of approximately 120, 260, and 1200 mcg/m²/day), no significant changes in tumor incidence were observed when compared to control.
Calcipotriene did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test, or the mouse micronucleus test. Betamethasone dipropionate did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test.
Studies in rats with oral doses of up to 54 mcg/kg/day (324 mcg/m²/day) of calcipotriene indicated no impairment of fertility or general reproductive performance. Studies in male rats at oral doses of up to 200 mcg/kg/day (1200 mcg/m²/day), and in female rats at oral doses of up to 1000 mcg/kg/day (6000 mcg/m²/day), of betamethasone dipropionate indicated no impairment of fertility.
Use In Specific Populations
Pregnancy Category C
Animal reproduction studies have not been conducted with Taclonex® Topical Suspension. Taclonex® Topical Suspension contains calcipotriene that has been shown to be fetotoxic and betamethasone dipropionate that has been shown to be teratogenic in animals when given systemically. There are no adequate and well-controlled studies in pregnant women. Taclonex® Topical Suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.
Teratogenicity studies with calcipotriene were performed by the oral route in rats and rabbits. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 mcg/kg/day (144 mcg/m²/day); a dosage of 36 mcg/kg/day (432 mcg/m²/day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 mcg/kg/day (324 mcg/m²/day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles were most likely due to the effect of calcipotriene upon calcium metabolism. The estimated maternal and fetal no-adverse effect levels (NOAEL) in the rat (108 mcg/m²/day) and rabbit (48 mcg/m²/day) derived from oral studies are lower than the maximum topical dose of calcipotriene in man (460 mcg/m²/day).
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in mice and rabbits when given by the subcutaneous route at dosages of 156 mcg/kg/day (468 mcg/m²/day) and 2.5 mcg/kg/day (30 mcg/m²/day), respectively. Those dose levels are lower than the maximum topical dose in man (about 5,950 mcg/m²/day). The abnormalities observed included umbilical hernia, exencephaly and cleft palate. Pregnant women were excluded from the clinical studies conducted with Taclonex® Topical Suspension.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman.
The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing.
Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients have not been studied. Because of a higher ratio of skin surface area to body mass, children under the age of 12 years are at particular risk of systemic adverse effects when they are treated with topical corticosteroids. [See WARNINGS AND PRECAUTIONS]
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Of the total number of subjects in the controlled clinical studies of Taclonex® Topical Suspension in psoriasis vulgaris on non-scalp areas, 124 were 65 years or older, while 36 were 75 years or older. Of the total number of subjects in the controlled clinical studies of Taclonex® Topical Suspension in scalp psoriasis, 334 were 65 years or older, while 84 were 75 years or older.
No overall differences in safety or effectiveness of Taclonex® Topical Suspension were observed between subjects in these age ranges versus younger subjects. All other reported clinical experience has not identified any differences in response between elderly and younger patients.
- Safety and efficacy in patients with known or suspected disorders of calcium metabolism have not been evaluated
- Safety and efficacy in patients with known erythrodermic, exfoliative, or pustular psoriasis have not been evaluated
- Safety and efficacy in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated
Last reviewed on RxList: 8/11/2014
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