Calcipotriene Foam

SORILUX contains the compound calcipotriene, a synthetic vitamin D3 analog, for topical dermatological use.

Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-lα,3β,24-triol. The structural formula is represented below:

Molecular Formula: C27H40O3     Molecular Weight: 412.6

Calcipotriene is a white or off-white crystalline substance. SORILUX Foam contains calcipotriene 50 mcg/g in an aqueous-based emulsion foam vehicle consisting of cetyl alcohol, dibasic sodium phosphate, edetate disodium, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, stearyl alcohol, dl-α-tocopherol, and white petrolatum. SORILUX (calcipotriene foam) Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane/isobutane) propellant.

Included as part of the PRECAUTIONS section.

SORILUX
(SOR-i-lux)
(calcipotriene) Foam

Important: For skin use only. Do not get SORILUX (calcipotriene foam) Foam in your eyes, mouth, or vagina.

Read the Patient Information that comes with SORILUX (calcipotriene foam) 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 (calcipotriene foam) Foam?

SORILUX (calcipotriene foam) 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 (calcipotriene foam) Foam is safe and effective in people under 18 years old.

Who should not use SORILUX (calcipotriene foam) Foam?

Do not use SORILUX (calcipotriene foam) 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 (calcipotriene foam) Foam?

Before you use SORILUX (calcipotriene foam) 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 (calcipotriene foam) 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 (calcipotriene foam) Foam passes into breast milk. Do not apply SORILUX (calcipotriene foam) Foam to the chest area if you are breast feeding a baby. This will help to prevent the baby from accidentally getting SORILUX (calcipotriene foam) 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 (calcipotriene foam) Foam?

• Apply SORILUX (calcipotriene foam) Foam exactly as prescribed. SORILUX (calcipotriene foam) Foam is usually applied to the affected skin areas two times each day.
• SORILUX (calcipotriene foam) Foam is for use on the skin only. Do not get SORILUX (calcipotriene foam) Foam in your eyes, mouth or vagina.
• SORILUX (calcipotriene foam) Foam is flammable. Avoid fire, flame, or smoking during and right after you apply SORILUX (calcipotriene foam) 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 (calcipotriene foam) Foam

1. Before applying SORILUX (calcipotriene foam) 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. See Figure A.

Figure A: Break tiny plastic piece on SORILUX (calcipotriene foam) Foam can nozzle.

2. Shake the SORILUX (calcipotriene foam) Foam can before use. See Figure B.

Figure B: Shake SORILUX (calcipotriene foam) Foam can.

3. Turn the SORILUX (calcipotriene foam) Foam can upside down and press the nozzle. See Figure C.

Figure C: Turn SORILUX (calcipotriene foam) Foam can upside down and press nozzle.

4. Dispense a small amount of SORILUX (calcipotriene foam) Foam into the palm of your hand. See Figure D.

Figure D: Dispense SORILUX (calcipotriene foam) Foam into hand.

5. Use enough SORILUX (calcipotriene foam) Foam to cover the affected area with a thin layer. Gently rub the foam into the affected area until it disappears into the skin. See Figure E.

Figure E: Cover affected area with thin layer of SORILUX (calcipotriene foam) Foam. Rub foam gently into affected skin.

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

What are the possible side effects of SORILUX (calcipotriene foam) Foam?

The most common side effects of SORILUX (calcipotriene foam) 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 (calcipotriene foam) 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.

How should I store SORILUX (calcipotriene foam) Foam?

• Store SORILUX (calcipotriene foam) Foam at room temperature, between 68°F to 77°F (20C° to 25°C).
• SORILUX (calcipotriene foam) Foam is flammable. Keep the can away from all sources of fire and heat.
• Do not spray SORILUX (calcipotriene foam) Foam near fire or direct heat. Never throw the can into a fire, even if the can is empty.
• Do not puncture the SORILUX (calcipotriene foam) Foam can.

Keep SORILUX (calcipotriene foam) Foam and all medicines out of the reach of children.

General Information about SORILUX (calcipotriene foam) Foam

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use SORILUX (calcipotriene foam) Foam for a condition for which it was not prescribed. Do not give SORILUX (calcipotriene foam) 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 (calcipotriene foam) Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about SORILUX (calcipotriene foam) 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-α-tocopherol, and white petrolatum. The foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane/isobutane) propellant.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• It may take several weeks to see the full effects.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• This medicine may catch on fire. Do not use near an open flame or while smoking.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using calcipotriene foam while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Store at room temperature. Do not refrigerate or freeze.
• Store in a dry place. Do not store in a bathroom.
• Protect from heat or open flame. Do not puncture or burn even if it seems empty.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.