PLAQUE PSORIASIS AND ITS TREATMENTS Learn how vitamin D medications play an important role in managing plaque psoriasis WHAT CAUSES PLAQUE PSORIASIS? 2 Understanding Plaque Psoriasis Plaque psoriasis is the most common form of psoriasis. It typically causes raised, red lesions covered with silvery white scales. Of the approximately 7.5 million people in the US with psoriasis, 80% have plaque psoriasis. But remember, plaque psoriasis is not contagious—you cannot catch it from someone else. WHAT’S HAPPENING TO MY SKIN? Psoriasis is a chronic (lifelong) skin disease. It occurs when the immune system “speeds up” the growth cycle of skin cells. A normal skin cell matures and falls off the body in about a month. For people with plaque psoriasis, it can take only 3 or 4 days for new skin cells to develop. Instead of falling off, the cells remain on the skin and form thickened patches (lesions or plaques). While plaque psoriasis is a chronic condition, many patients experience times when their symptoms improve or worsen. WHERE DOES PLAQUE PSORIASIS DEVELOP? Plaque psoriasis can occur on any part of the body, but most commonly on the scalp, knees, elbows, and torso. Sometimes, the lesions can appear in the same place on the left and right sides of the body. No one knows exactly what causes plaque psoriasis, although changes in the immune system that cause psoriasis may be genetic for some people. This means people could get the disease, or inherit it, from their parents. It’s impossible to predict who will develop plaque psoriasis, but having 1 or both parents with plaque psoriasis may increase the likelihood of the child developing the disease. For example, if 1 parent has plaque psoriasis, there is a 10% chance the child will get it. But if both parents have plaque psoriasis, then there is a 50% chance it will be passed on to the child. However, for people with plaque psoriasis, certain situations or environments may trigger the condition to flare up: Stress Weather Injury to skin Diet Certain medications Illness/allergies SORILUX Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 18 years and older. SORILUX Foam has only been studied in plaque psoriasis. It is not known if SORILUX Foam is safe and effective in people under 18 years old. Important Safety Information 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). The medicine in SORILUX Foam has been shown to cause hypercalcemia. If hypercalcemia occurs, stop using SORILUX Foam until calcium levels return to normal SORILUX Foam is flammable. Avoid fire, flame, or smoking during and right after you apply SORILUX Foam to your skin Please see accompanying full Prescribing Information, including Patient Information Leaflet. 3 4 Treating Plaque Psoriasis Plaque psoriasis may be chronic, but there are medications available to help treat some aspects of the disease. Your doctor may decide to use different medicine(s) based on what may work best for you. Tell your doctor about all medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. TOPICAL STEROIDS Topical steroids (available in creams, ointments, gels, foams, or lotions applied to the skin) are most frequently prescribed for patients with plaque psoriasis. Steroids are anti-inflammatory medications used to reduce the swelling and redness of psoriatic lesions. Topical steroids are available in different strengths from “super potent” (Class 1) to “least potent” (Class 7). Stronger steroids are generally more effective than less potent ones for treating plaque psoriasis, but they also have a greater risk of side effects. ADDITIONAL TREATMENTS Topical medications—used on the skin at the lesion site — For example, retinoids, anthralin, salicylic acid, coal tar Phototherapy—also known as light therapy; the skin is exposed to artificial ultraviolet light to slow the growth of affected skin cells SORILUX Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 18 years and older. SORILUX Foam has only been studied in plaque psoriasis. It is not known if SORILUX Foam is safe and effective in people under 18 years old. Important Safety Information Avoid excessive exposure of the treated skin to natural or artificial sunlight (including tanning booths and sun lamps). Wear a hat and clothes that cover the treated areas of your skin if you have to be in sunlight The most common side effects of SORILUX Foam are irritation, redness, and itching of the treated skin areas SORILUX Foam is for use on the skin only. Do not get SORILUX Foam in your eyes, mouth, or vagina Tell your doctor if you are pregnant or planning to become pregnant. It is not known if SORILUX Foam can harm your unborn baby Tell your doctor if you 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 breastfeeding a baby. This will help to prevent the baby from accidentally getting SORILUX Foam into his/her mouth Tell your doctor if you are getting light therapy for your psoriasis Tell your doctor if you have any other medical conditions Systemics/biologics—used for moderate to severe psoriasis; taken orally or by injection or intravenous infusion; work throughout the body Please see accompanying full Prescribing Information, including Patient Information Leaflet. 5 6 The Role of Topical Vitamin D There are other prescription topical medications available to help treat plaque psoriasis—namely, vitamin D3 treatments. HOW SORILUX FOAM WORKS The vitamin D in SORILUX Foam is a manmade compound that binds to the receptor similar to natural vitamin D. The precise way that SORILUX Foam helps treat plaque psoriasis is unknown. GETTING THE MOST OUT OF A VITAMIN D3 TREATMENT Doctors have a variety of treatment regimens for plaque psoriasis. Vitamin D3 may be your doctor’s choice for treatment, or it could be a part of your overall plaque psoriasis treatment plan. Talk to your doctor about available plaque psoriasis treatments and ask if a vitamin D3 treatment, such as SORILUX Foam, is right for you. SORILUX Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 18 years and older. SORILUX Foam has only been studied in plaque psoriasis. It is not known if SORILUX Foam is safe and effective in people under 18 years old. Important Safety Information 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). The medicine in SORILUX Foam has been shown to cause hypercalcemia. If hypercalcemia occurs, stop using SORILUX Foam until calcium levels return to normal SORILUX Foam is flammable. Avoid fire, flame, or smoking during and right after you apply SORILUX Foam to your skin Avoid excessive exposure of the treated skin to natural or artificial sunlight (including tanning booths and sun lamps). Wear a hat and clothes that cover the treated areas of your skin if you have to be in sunlight The most common side effects of SORILUX Foam are irritation, redness, and itching of the treated skin areas Tell your doctor if you are pregnant or planning to become pregnant. It is not known if SORILUX Foam can harm your unborn baby Tell your doctor if you 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 breastfeeding a baby. This will help to prevent the baby from accidentally getting SORILUX Foam into his/her mouth SORILUX Foam is Please see accompanying full Prescribing Information, including Patient Information Leaflet. 7 8 SORILUX Foam My Life. My Treatment. My D. Plaque psoriasis is a chronic (lifelong) and unpredictable skin condition. Talk to your doctor to see if SORILUX Foam may work for you. 9 WHAT SHOULD I TELL MY DOCTOR BEFORE USING SORILUX FOAM? Before using SORILUX Foam, tell your doctor if you: Are getting light therapy for your psoriasis WHAT IS SORILUX FOAM? Have any other medical conditions SORILUX Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 18 years and older. SORILUX Foam has only been studied in plaque psoriasis. It is not known if SORILUX Foam is safe and effective in people under 18 years old. 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 SORILUX Foam is the only vitamin D3 treatment available as a topical foam formulation. Important Safety Information 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). The medicine in SORILUX Foam has been shown to cause hypercalcemia. If hypercalcemia occurs, stop using SORILUX Foam until calcium levels return to normal SORILUX Foam is flammable. Avoid fire, flame, or smoking during and right after you apply SORILUX Foam to your skin Avoid excessive exposure of the treated skin to natural or artificial sunlight (including tanning booths and sun lamps). Wear a hat and clothes that cover the treated areas of your skin if you have to be in sunlight SORILUX Foam is for use on the skin only. Do not get SORILUX Foam in your eyes, mouth, or vagina 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 breastfeeding a baby. This will help to prevent the baby from accidentally getting SORILUX Foam into his or her mouth WHAT ARE THE POSSIBLE SIDE EFFECTS OF SORILUX FOAM? 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 (1-888-STIEFEL) or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Please see accompanying full Prescribing Information, including Patient Information Leaflet. 4 10 How Should I Use SORILUX Foam? 11 Dispense SORILUX Foam into hand. Be sure to use SORILUX Foam exactly as your doctor tells you. SORILUX Foam is usually applied 2 times a day (once in the morning and once at night) to the affected skin 5 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 Cover affected area with thin layer of SORILUX Foam. Rub foam gently into affected skin. Avoid excessive exposure of the treated skin to natural or artificial sunlight (including tanning booths and sun lamps). 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 1 6 Break tiny plastic piece on SORILUX Foam can nozzle. 2 Shake SORILUX Foam can. 3 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 Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 18 years and older. SORILUX Foam has only been studied in plaque psoriasis. It is not known if SORILUX Foam is safe and effective in people under 18 years old. Please see accompanying full Prescribing Information, including Patient Information Leaflet. Turn the SORILUX Foam can upside down and press the nozzle. Important Safety Information 12 More About SORILUX Foam SORILUX Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 18 years and older. SORILUX Foam has only been studied in plaque psoriasis. It is not known if SORILUX Foam is safe and effective in people under 18 years old. HOW SHOULD I STORE SORILUX FOAM? Store SORILUX Foam at room temperature, between 68°F to 77°F (20°C to 25°C) SORILUX Foam is flammable. Keep the can away from all sources of fire and heat Do not dispense 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. ADDITIONAL INFORMATION Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use SORILUX Foam for any condition for which it was not prescribed. Do not give SORILUX Foam to other people, even if they have the same condition that you have. It may harm them. Read the Patient Information leaflet that comes with SORILUX Foam before you start using it and each time you get a refill. There may be new information. If you would like more information, talk with your doctor or pharmacist or visit www.soriluxfoam.com. SORILUX Foam is 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). The medicine in SORILUX Foam has been shown to cause hypercalcemia. If hypercalcemia occurs, stop using SORILUX Foam until calcium levels return to normal SORILUX Foam is flammable. Avoid fire, flame, or smoking during and right after you apply SORILUX Foam to your skin Avoid excessive exposure of the treated skin to natural or artificial sunlight (including tanning booths and sun lamps). Wear a hat and clothes that cover the treated areas of your skin if you have to be in sunlight The most common side effects of SORILUX Foam are irritation, redness, and itching of the treated skin areas SORILUX Foam is for use on the skin only. Do not get SORILUX Foam in your eyes, mouth, or vagina Tell your doctor if you are pregnant or planning to become pregnant. It is not known if SORILUX Foam can harm your unborn baby Tell your doctor if you 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 breastfeeding a baby. This will help to prevent the baby from accidentally getting SORILUX Foam into his/her mouth Tell your doctor if you are getting light therapy for your psoriasis Tell your doctor if you have any other medical conditions Please see accompanying full Prescribing Information, including Patient Information Leaflet. 13 NOTES Scan QR code to go to www.soriluxfoam.com www.soriluxfoam.com SORILUX is a trademark of Stiefel Laboratories, Inc. ©2012 Stiefel Laboratories, Inc. All rights reserved. Printed in USA. SLX005R0 May 2012
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