Enstilar

Do not use on broken or infected skin. Also avoid using the medicine in open wounds. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Do not use more than one topical steroid medicine without your doctor's advice.

Avoid having your hair colored within 12 hours before or after you apply betamethasone and calcipotriene to your scalp.

Avoid exposure to sunlight or tanning beds. This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• any other steroid medicines; or
• other medicines to treat psoriasis.

This list is not complete. Other drugs may interact with betamethasone and calcipotriene, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Enstilar is a topical (skin only) prescription medication used to treat plaque psoriasis in patients 18 years of age and older.

It is a single product containing 2 medications: calcipotriene and betamethasone. Calcipotriene belongs to a group of drugs called synthetic vitamin D3 derivatives, but the exact way calcipotriene works to treat plaque psoriasis is unknown. Betamethasone belongs to a group of drugs called topical corticosteroids which work by decreasing inflammation.

This medication comes as a spray foam. It is usually applied to the affected skin once daily.

Common side effects of Enstilar foam are irritation, redness, and itching of the skin treated.

Enstilar is a prescription medication used to treat plaque psoriasis in patients 18 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Leo Pharmaceuticals

Serious side effects have been reported with Enstilar. See the “Enstilar Precautions” section.

The most common side effects of Enstilar are application site:

• irritation
• itching
• inflammation
• changes in skin color
• rash
• worsening of your psoriasis

This is not a complete list of Enstilar side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Enstilar, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Enstilar crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Enstilar.

Use Enstilar exactly as prescribed.

• Apply Enstilar to the affected areas of your skin 1 time a day for up to 4 weeks. You should stop treatment when your plaque psoriasis is under control unless your doctor gives you other instructions.
• Do not use more than 60 grams of Enstilar every 4 days.
• Do not use Enstilar longer than prescribed. Using too much Enstilar, or using it too often, or for too long, can increase your risk of having serious side effects.
• Shake the Enstilar can before you use it.
• Avoid using Enstilar on your face, groin, or under your arms, or if you have thinning of your skin (atrophy) at the treatment site.
• If you accidentally get Enstilar on the face, in the mouth or in the eyes, wash the area with water right away.
• Wash your hands after using Enstilar unless you are using the medicine to treat your hands.
• Do not bandage or tightly cover the treated skin area, unless instructed by your doctor.
• Enstilar is flammable. Avoid heat, flame, or smoking during and right after applying.

How to apply Enstilar Foam:  Follow your doctor’s instructions on how much Enstilar Foam to use and where to use it. 

Wash your hands before applying Enstilar Foam.

Step 1: Remove the cap from the can. Shake the can before use. 

Step 2: Hold the can at least 1.5 inches from the affected area. 

Step 3: The foam can be sprayed holding the can in any position except horizontally. To spray, push down on the nozzle. 

Step 4: Gently rub in Enstilar Foam into your affected skin areas. Repeat the steps above to apply Enstilar Foam to other affected areas as instructed by your doctor.

Step 5: After applying Enstilar Foam, put the cap back on the can.

Step 6: Wash your hands after using Enstilar Foam unless you are using the medicine to treat your hands. 

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 ultraviolet 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 receiving 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, 360, 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.

[Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions For Use)]

Inform patients of the following:

• Instruct patients to shake before use.
• Instruct patients not to use more than 60 g every 4 days.
• Discontinue therapy when control is achieved unless directed otherwise by the physician.
• Avoid use of Enstilar® Foam on the face, underarms, groin or eyes. If this medicine gets on face or in mouth or eyes, wash area right away.
• Wash hands after application.
• Do not occlude the treatment area with a bandage or other covering unless directed by the physician. Instruct the patients not to use other products containing calcipotriene or a corticosteroid with Enstilar® Foam without first talking to the physician.
• Instruct patients who use Enstilar® Foam to 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 Enstilar® Foam.
• Enstilar® Foam is flammable; avoid heat, flame, or smoking when applying this medication.
• The foam can be sprayed holding the can in any orientation except horizontally.

Manufactured by:

LEO Laboratories Ltd.
285 Cashel Road
Dublin 12, Ireland

or

Colep Laupheim GmbH & Co. KG

Fockestraße 12

88471 Laupheim

Germany (DE)

Distributed by:

LEO Pharma Inc.

Seven Giralda Farms,

Madison, NJ 07940

Read the Patient Information and Instructions for Use before you use Enstilar® Foam.

Important information: For skin use only (topical use). Do not get Enstilar® Foam in your mouth, eyes or vagina. If you accidentally get Enstilar® Foam on the face, in the mouth or in the eyes, wash the area with water right away. Do not swallow Enstilar® Foam.

How to apply Enstilar® Foam:

Follow your doctor’s instructions on how much Enstilar® Foam to use and where to use it.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:

LEO Laboratories Ltd.
285 Cashel Road
Dublin 12, Ireland

or

Colep Laupheim GmbH & Co. KG

Fockestraße 12

88471 Laupheim

Germany (DE)

Distributed by:

LEO Pharma Inc.

Seven Giralda Farms,

Madison, NJ 07940

Issued: 11/2016