Enstilar

Enstilar foam is a once-daily, topical, fixed-dose combination foam containing calcipotriene 0.005% (a vitamin D analog) and betamethasone dipropionate 0.064% (a corticosteroid) that may be used to treat plaque psoriasis in adults and children 12 years of age or older.

Enstilar foam is a stable supersaturated solution of calcipotriol/betamethasone dipropionate that has improved clinical efficacy and increased skin penetration compared with standard calcipotriol/betamethasone dipropionate ointments.

Enstilar was approved on October 16, 2015.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

High calcium levels have been reported with the use of topical calcipotriene, an ingredient in Enstilar. Your healthcare provider will monitor you for this and may discontinue Enstilar foam until laboratory values normalize.

Endocrine effects

The use of high-potency steroid products such as betamethasone dipropionate can cause 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 to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify the use of Enstilar foam should HPA axis suppression develop.

Side effects affecting the eyes

May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.

Allergic contact dermatitis

May occur with either calcipotriene or betamethasone dipropionate topical use. May be observed as a failure to heal. Confirm with diagnostic patch testing.

Children

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects. Enstilar foam is not approved for use by anyone younger than 12 years old.

You should not use Enstilar foam if you are allergic to calcipotriene, betamethasone dipropionate, or any other components of the foam.

Tell your doctor if you have ever had:

• too much calcium in your blood or urine
• an adrenal gland disorder
• cataracts or glaucoma
• liver disease
• severe forms of psoriasis (with pus, skin peeling, severe redness)
• have thinning skin at the treatment site
• a skin infection or
• if you are receiving UV light treatments (phototherapy).

Pregnancy

The use of high-potency topical steroid medicine during pregnancy may increase the risk of a low birth weight in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Lactation

It may not be safe to breastfeed while using Enstilar. Ask your doctor about any risks. If you apply betamethasone and calcipotriene to your chest, avoid areas that may come into contact with the baby's mouth.

The most common side effects reported with Enstilar include irritation or itch at the application site, folliculitis (inflammation of the hair follicles), skin hypopigmentation (areas of skin lose their color), high calcium levels, itch, and a flare-up of psoriasis.

Postmarketing studies with topical corticosteroids have reported skin thinning, stretch marks, broken superficial blood vessels (telangiectasia), itching, dryness, dermatitis around the mouth, secondary infection, and miliaria (heat rash).

Side effects affecting the eye including cataracts, glaucoma, and increased intraocular pressure, have been reported during the use of topical corticosteroids, including topical betamethasone products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Enstilar should be applied once daily to the plaques for up to 4 weeks.

• Shake the can before applying the foam.
• Hold the can 1.5 inches (one and a half inches) away from the affected areas and spray the foam onto the plaques by pushing down on the nozzle, in any position except sideways.
• Gently rub in the foam until it is absorbed. After applying, put the cap back on the can and you’re your hands.
• Discontinue treatment once control has been achieved.
• Do not use more than 60 grams every 4 days.
• Do not apply an occlusive dressing over the top of Enstilar foam unless directed by a physician.
• Do not use it on your face, groin, or armpit, or if skin thinning is present at the treatment site.
• Not for oral, ophthalmic, or intravaginal use.

The contents of the Enstilar can are flammable and you should avoid being near sources of fire or flames, or smoking, immediately following application.

After using Enstilar foam

Side effects can occur if your skin absorbs topical steroid medicine. Tell your doctor if you have:

• swelling, weight gain (especially in your face or your upper back and torso);
• thinning skin, stretch marks, acne, increased facial hair;
• irregular menstrual periods, changes in sexual function; or
• memory problems, and feeling irritable.

Also, tell your doctor if you have:

• worsening of your skin condition;
• redness, warmth, swelling, oozing, or severe irritation of any treated skin;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss; or
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

Apply Enstilar foam as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

High doses or long-term use of Enstilar can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Avoid using other skin medications that contain betamethasone or calcipotriene. Do not use Enstilar to treat any skin condition that has not been checked by your doctor.

Avoid getting the foam in your eyes or on your face, underarms, groin area, or areas of thin skin.

Enstilar foam could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Tell your doctor about all your other medicines, especially:

• any other steroid medicine (such as dexamethasone, fludrocortisone, hydrocortisone, prednisone, triamcinolone, and others); or
• any other medicine to treat psoriasis.

This list is not complete. Other drugs may affect Enstilar foam, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed.

Store Enstilar foam between 20°C-25°C (68°F-77°F) and keep away from heat. Do not expose the can to a heat source or store it at temperatures above 49°C (120°F).

• Do not puncture or burn the can. Do not freeze.
• Do not use past the expiry date printed on the side of the can.
• Discard any unused product 6 months after the can has been opened.

Keep out of reach of children.

Leo Pharma makes Enstilar foam.

Active ingredients: Each gram of Enstilar foam contains 52.2 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5mg of betamethasone). It is available in 60-gram aluminum cans.

Inactive ingredients: white petrolatum PPG-11 stearyl ether, mineral oil, all-rac-alpha-tocopherol, and butylhydroxytoluene.

Propellants: dimethyl ether and butane.