Sorilux

Sorilux

Generic Name: calcipotriene

Company: Stiefel Laboratories, Inc.

Treatment for: Plaque Psoriasis

FDA Approves Sorilux

The U.S. Food and Drug Administration (FDA) has approved Sorilux (calcipotriene) Foam, 0.005%, for the topical treatment of plaque psoriasis in patients aged 18 years and older.

Sorilux Patient Information

Important: For skin use only. Do not get Sorilux Foam in your eyes, mouth, or vagina.

Read the Patient Information that comes with Sorilux Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is Sorilux Foam?

Sorilux Foam is a prescription medicine used on the skin (topical) to treat psoriasis in people 18 years and older.

It is not known if Sorilux Foam is safe and effective in people under 18 years old.

Who should not use Sorilux Foam?

Do not use Sorilux Foam if you have been told by your doctor that you have a high level of calcium in your blood (hypercalcemia).

What should I tell my doctor before using Sorilux Foam?

Before you use Sorilux Foam, tell your doctor if you:

are getting light therapy for your psoriasis

have any other medical conditions

are pregnant or planning to become pregnant. It is not known if Sorilux Foam can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

are breastfeeding. It is not known if Sorilux Foam passes into breast milk. Do not apply Sorilux Foam to the chest area if you are breast feeding a baby. This will help to prevent the baby from accidentally getting Sorilux Foam into their mouth.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

How should I use Sorilux Foam?

Apply Sorilux Foam exactly as prescribed. Sorilux Foam is usually applied to the affected skin areas two times each day.

Sorilux Foam is for use on the skin only. Do not get Sorilux Foam in your eyes, mouth or vagina.

Sorilux Foam is flammable. Avoid fire, flame, or smoking during and right after you apply Sorilux Foam to your skin.

Avoid excessive sunlight. Wear a hat and clothes that cover the treated areas of your skin if you have to be in sunlight.

Instructions for applying Sorilux Foam

Before applying Sorilux Foam for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.

Shake the Sorilux Foam can before use.

Turn the Sorilux Foam can upside down and press the nozzle.

Dispense a small amount of Sorilux Foam into the palm of your hand.

Use enough Sorilux Foam to cover the affected area with a thin layer. Gently rub the foam into the affected area until it disappears into the skin.

Avoid getting Sorilux Foam in or near the eyes, mouth, or vagina. Wash hands after applying Sorilux Foam (excluding affected areas of the hands).

Sorilux side effects

The most common side effects of Sorilux Foam are irritation, redness, and itching of the treated skin areas.

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

These are not all the possible side effects of Sorilux Foam. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to Stiefel Laboratories, Inc. at 1-888-784-3335 (STIEFEL) or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See also: Sorilux side effects (in more detail)

How should I store Sorilux Foam?

Store Sorilux Foam at room temperature, between 68°F to 77°F (20C° to 25°C).

Sorilux Foam is flammable. Keep the can away from all sources of fire and heat.

Do not spray Sorilux Foam near fire or direct heat. Never throw the can into a fire, even if the can is empty.

Do not puncture the Sorilux Foam can.

Keep Sorilux Foam and all medicines out of the reach of children.

General Information about Sorilux Foam

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Sorilux Foam for a condition for which it was not prescribed. Do not give Sorilux Foam to other people even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Sorilux Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Sorilux Foam that is written for health professionals.

What are the ingredients of Sorilux Foam?

Active ingredient: calcipotriene

Inactive Ingredients: cetyl alcohol, dibasic sodium phosphate, edetate disodium, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, stearyl alcohol, dl-a-tocopherol, and white petrolatum. The foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane/isobutane) propellant.