Sorilux

The most common side effects of Sorilux are:

• irritation
• redness
• itching of the treated skin areas.

Sorilux can cause high levels of calcium in your blood (hypercalcemia). Symptoms of hypercalcemia include:

• Nausea and vomiting
• Loss of appetite
• Excessive thirst
• Frequent urination
• Constipation
• Abdominal pain
• Muscle weakness
• Muscle and joint aches
• Confusion
• Lethargy and fatigue

This is a potentially serious side effect. If you develop symptoms of hypercalcemia, call your doctor right away.

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. Ask your doctor or pharmacist for more information.

You should not use calcipotriene topical if you are allergic to it, or if you have:

• high levels of calcium in your blood (hypercalcemia); or

• high levels of vitamin D in your body (usually caused by taking too much vitamin D supplements).

To make sure calcipotriene topical is safe for you, tell your doctor if you are receiving phototherapy (light treatments) for your psoriasis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether calcipotriene topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Calcipotriene topical is not approved for use by anyone younger than 18 years old.

• 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 Sorilux while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Sorilux or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sorilux (calcipotriene foam). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Sorilux Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older.

0.005%, white foam

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Sorilux Foam was studied in four vehicle-controlled trials. A total of 1094 subjects with plaque psoriasis, including 654 exposed to Sorilux Foam, were treated twice daily for 8 weeks.

Adverse reactions reported in ≥1% of subjects treated with Sorilux Foam and at a higher incidence than subjects treated with vehicle were application site erythema (2%) and application site pain (3%). The incidence of these adverse reactions was similar between the body and scalp.

In two multi-center, randomized, double-blind, vehicle-controlled clinical trials a total of 659 subjects with psoriasis were randomized 2:1 to Sorilux Foam or vehicle; subjects applied the assigned treatment twice daily for 8 weeks. Baseline disease severity was graded using a 5-point Investigator Static Global Assessment scale (ISGA), on which subjects scored either "mild" or "moderate" as shown in Table 1.

Efficacy evaluation was carried out at Week 8 with treatment success being defined as a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score. Approximately 30% of enrolled subjects were graded as "mild" on the ISGA scale. The study population ranged in age from 12 to 89 years with 10 subjects less than 18 years of age at baseline. The subjects were 54% male and 88% Caucasian. Table 2 presents the efficacy results for each trial.

In one trial, subjects graded as "mild" at baseline showed a greater response to vehicle than Sorilux Foam.

Table 3 presents the success rates by disease severity at baseline for each trial.

In another multi-center, randomized, double-blind, vehicle-controlled clinical trial, a total of 363 subjects with moderate plaque psoriasis of the scalp and body were randomized 1:1 to Sorilux Foam or vehicle. Subjects applied the assigned treatment to the affected areas twice daily for 8 weeks. Baseline disease severity of the scalp was graded using a 6-point ISGA; a score of "moderate" corresponded to grade 3.

The primary efficacy evaluation for scalp involvement was carried out at Week 8 with treatment success being defined as a score of "clear" (grade 0) or "almost clear" (grade 1). The study population ranged in age from 12 to 97 years with 11 subjects less than 18 years of age at baseline. The subjects were 60% male and 87% Caucasian. Table 4 presents the efficacy results for the trial.

The contribution to efficacy of individual components of the vehicle has not been established.

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

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

What is Sorilux Foam?

Sorilux Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis of the scalp and body 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 breastfeeding 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 natural or artificial sunlight including tanning booths and sunlamps. 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. 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. See Figure A.

Figure A

2. Shake the can of Sorilux Foam before use. See Figure B.

Figure B

3. Turn the can of Sorilux Foam upside down and press the nozzle. See Figure C.

Figure C

4. Dispense a small amount of Sorilux Foam into the palm of your hand. See Figure D.

Figure D

5. Use enough Sorilux Foam to cover the affected area with a thin layer. Apply Sorilux Foam to your scalp when your hair is dry. Part your hair and apply directly on the affected area. Gently rub the foam into the affected area until it disappears into the skin. See Figures E, F and G.

Figure E

Figure F

Figure G

6. Avoid getting Sorilux Foam on your face or in or near the eyes, mouth, or vagina. If Sorilux Foam gets on your face or in or near your eyes, rinse with water. Wash hands after applying Sorilux Foam unless your hands are a treated area.

What are the possible side effects of Sorilux Foam?

The most common side effects of Sorilux Foam are redness and pain 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 FDA at 1-800- FDA-1088.

You may also report side effects to Mayne Pharma at 1-844-825-8500.

How should I s tore 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 can of Sorilux Foam.

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

This Patient Information has been approved by the U.S. Food and Drug Administration.

Sorilux is a registered trademark of Mayne Pharma LLC.

Distributed by:
Mayne Pharma
Greenville, NC 27834

November 2016

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

Tell your doctor about all other medicines you use, especially:

• vitamin or mineral supplements that contain calcium or vitamin D.

This list is not complete and other drugs may interact with Sorilux. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.