IMPORTANT SAFETY INFORMATION
What is Enstilar Foam?
Enstilar® (calcipotriene and betamethasone dipropionate) Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 12 years of age and older. It is not known if Enstilar Foam is safe and effective in children under 12 years of age.
Enstilar Foam is for use on skin only (topical). Do not get Enstilar Foam near or in your mouth, eyes, or vagina. Avoid using Enstilar Foam on your face, groin, or armpits, or if you have thinning of your skin (atrophy) at the treatment site.
Enstilar Foam is flammable. Avoid fire, flame, and smoking when applying and right after you apply Enstilar Foam.
Enstilar Foam has the appearance of a non-expanding foam that gradually collapses after spraying.
What should I discuss with my healthcare provider before starting Enstilar Foam?
Tell your healthcare provider about all your medical conditions, including if you:
- have a calcium metabolism disorder
- have thinning skin (atrophy) at the treatment site
- are pregnant or plan to become pregnant. It is not known if Enstilar Foam will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Enstilar Foam passes into your breastmilk.
Tell your healthcare provider about all the medicines you take, including any corticosteroid medicines, any other products containing calcipotriene, and any other prescription and over-the-counter medicines, vitamins and herbal supplements. Do not use other products containing calcipotriene or a corticosteroid medicine without talking to your healthcare provider first.
How should I use Enstilar Foam?
Read the Instructions For Use that comes with Enstilar Foam. There you will find information about how to apply and store Enstilar Foam.
Use Enstilar Foam exactly as your healthcare provider says. Do not use more than 60 grams of Enstilar Foam every 4 days.
Do not use Enstilar Foam for longer than prescribed. Using too much Enstilar Foam or using it too often or for too long can increase your risk for having serious side effects.
Do not bandage or cover the treated skin area, unless instructed by your healthcare provider.
Gently rub in Enstilar Foam to your affected areas. Wash your hands after applying Enstilar Foam unless you are using it to treat your hands.
Apply Enstilar Foam 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 healthcare provider gives you other instructions.
What are the possible side effects of Enstilar Foam?
Enstilar Foam may cause serious side effects including:
- Too much calcium in your blood or urine and/or adrenal gland problems
- Cushing's syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol
- High blood sugar and sugar in your urine
- Skin problems, including reactions where Enstilar Foam is applied, and allergic reactions (allergic contact dermatitis). Tell your healthcare provider if you have any skin problems including thinning of your skin, pain/burning, inflammation, itching, irritation, dryness, changes in skin color, redness, infection or raised bumps on your skin.
- Eye problems: Enstilar Foam may increase your chance of getting cataracts and glaucoma. Do not get Enstilar Foam in your eyes because it may cause irritation. If you accidentally get Enstilar Foam on your face, in your mouth or in your eyes, wash the area with water right away. Tell your healthcare provider if you have blurred vision or get any other vision problems during treatment.
The most common side effects include irritation, itching, inflamed hair pores (folliculitis), changes in skin color, rash with raised red bumps or skin welts (hives) and worsening of your psoriasis. These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.
Where do I learn more?
This summary does not include all the information about Enstilar Foam. Read the information that comes with your prescription every time you have a prescription filled. Talk to your healthcare provider or pharmacist about this information. Your healthcare provider is the best person to help you decide if Enstilar Foam is right for you.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You may also report side effects to LEO Pharma Inc. at 1-877-494-4536, option 1, or email to firstname.lastname@example.org.
Please click here for the full Prescribing Information.