ENSTILAR® (calcipotriene and betamethasone dipropionate)

ENSTILAR® (calcipotriene and betamethasone dipropionate) foam

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ENSTILAR® (calcipotriene and betamethasone dipropionate)

Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only.

Calcipotriene Hydrate: Calcipotriene hydrate is a synthetic vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol,24-cyclo-propyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empiricalformula C27H40O3·H2O), a molecular weight of 430.6

Betamethasone Dipropionate: Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11β,16β), with the empirical formula C28H37FO7, a molecular weight of 504.6

Enstilar® Foam: Each gram of Enstilar Foam contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of white petrolatum, polyoxypropylene stearyl ether, mineral oil, all-rac-alpha-tocopherol, and butylhydroxytoluene. Enstilar Foam is a white to off-white opalescent liquid in a pressurized aluminum spray can with a continuous valve and actuator. The propellants used in Enstilar Foam are dimethyl ether and butane. At administration,the product is a white to off-white foam after evaporation of the propellants.Enstilar Foam has the appearance of a non-expanding foam that gradually collapses after spraying.

Indications and usage

Enstilar Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis in patients 12 years and older.

Mechanism of Action

Enstilar Foam combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in the treatment of plaque psoriasis are unknown.

Dosage and administration

  • Shake before use. Apply Enstilar Foam to affected area(s) once daily for up to 4 weeks. Discontinue therapy when control is achieved. Do not use more than 60 grams every 4 days.
  • Do not use with occlusive dressings unless directed by a healthcare provider.
  • Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
  • Not for oral, ophthalmic, or intravaginal use.

Warnings and precautions

Flammability: The propellants in Enstilar Foam are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application

Hypercalcemia and Hypercalciuria: Hypercalcemia and hypercalciuria have been observed with use of Enstilar Foam. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized.

Effects on Endocrine System: Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroids, use over a large surface area or on areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop.

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Ophthalmic Adverse Reactions: Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.

Adverse reactions

Adverse reactions reported in < 1% of subjects included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis.

Use in specific populations

Pregnancy: Available data with Enstilar Foam are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of Enstilar Foam is likely to be low.

Observational studies suggest an increased risk of havinglow birth weight infants with the maternal use of potent or super potent topical corticosteroids. Advise pregnant women that Enstilar® Foam may increase the potential risk of having a low birth weight infant and to use Enstilar Foam on the smallest area of skin and for the shortest duration possible.

Lactation: There is no information regarding the presence oftopically administered calcipotriene and betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production.Concentrations of calcipotriene in plasma are low after topical administration, and therefore, concentrations in human milk are likely to be low. It is not known whether topical administration of large amounts of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Enstilar® Foam and any potential adverse effects on the breastfed child from Enstilar Foam or from the underlying maternal condition.

To minimize potential exposure to the breastfed infant via breast milk, use Enstilar Foamon the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Enstilar Foam directly to the nipple and areola to avoid direct infant exposure

Storage

  • Store Enstilar Foam at 20°C – 25°C (68°F – 77°F); excursions permitted between 15°C – 30°C (59° F – 86°F). [See USP controlled room temperature].
  • Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Do not freeze.
  • Unused product should be discarded six months after the can has been opened.
  • Keep out of the reach of children.
  • Enstilar Foam is flammable; avoid heat, flame or smoking when using this product.
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