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Sorilux

Last reviewed on RxList: 11/30/2016
Drug Description

SORILUX™
(calcipotriene) Foam, 0.005%

For topical use

DESCRIPTION

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:

SORILUX™
  (calcipotriene)  Structural Formula Illustration

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.

Indications & Dosage

INDICATIONS

SORILUX (calcipotriene foam) Foam is indicated for the topical treatment of plaque psoriasis in patients aged 18 years and older.

DOSAGE AND ADMINISTRATION

For topical use only. SORILUX (calcipotriene foam) Foam is not for oral, ophthalmic, or intravaginal use.

Apply a thin layer of SORILUX (calcipotriene foam) Foam twice daily to the affected areas and rub in gently and completely.

HOW SUPPLIED

Dosage Forms And Strengths

0.005%, white foam

How Supplied

SORILUX (calcipotriene) Foam, 0.005%, is supplied as follows:

60 g aluminum can NDC 0145-2130-06

Storage and Handling

  • Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
  • FLAMMABLE. AVOID FIRE. FLAME. OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).
  • Avoid contact with eyes.
  • Keep out of reach of children.

Manufactured for: Stiefel Laboratories, Inc. Research Triangle Park, NC 27709. Manufactured by: DPT Laboratories, Ltd. 307 E. Josephine Street San Antonio, TX 78215. Revised: 2010

Side Effects & Drug Interactions

SIDE EFFECTS

Clinical Trials Experience

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

SORILUX (calcipotriene foam) Foam was studied in three-vehicle controlled trials. Seven hundred and thirty one subjects with plaque psoriasis, including 473 exposed to SORILUX (calcipotriene foam) Foam were treated twice daily for 8 weeks.

Adverse events reported in greater than 1% of subjects and in a higher rate in subjects treated with SORILUX (calcipotriene foam) Foam compared to vehicle were limited to erythema.

DRUG INTERACTIONS

No drug interaction studies were conducted with SORILUX (calcipotriene foam) Foam.

Warnings & Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

FlammabiUty

The propellant in SORILUX (calcipotriene foam) is flammable. Instruct the patient to avoid fire, flame, and/or smoking during and immediately following application.

Effects on Calcium Metabolism

Transient, rapidly reversible elevation of serum calcium has occurred with use of calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.

Ultraviolet Light Exposure

Instruct the patient to avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps. Physicians may wish to limit or avoid use of phototherapy in patients who use SORILUX (calcipotriene foam) Foam. [See Nonclinical Toxicology]

Unevaluated Uses

SORILUX (calcipotriene foam) Foam has not been evaluated in patients with erythrodermic, exfoliative, or pustular psoriasis.

Patient Counseling Information

[See FDA-Approved Patient Labeling]

The patient should be instructed as follows:

  • Do not place SORILUX (calcipotriene foam) Foam in the refrigerator or freezer.
  • Avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sun lamps.
  • If SORILUX (calcipotriene foam) Foam gets in or near their eyes, to rinse thoroughly with water.
  • Talk to their doctor if their skin does not improve after treatment with SORILUX (calcipotriene foam) Foam for 8 weeks.
  • Wash their hands after applying SORILUX (calcipotriene foam) Foam unless their hands are the affected site
  • Avoid fire, flame, or smoking during and immediately following application since SORILUX (calcipotriene foam) Foam is flammable.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Calcipotriene topically administered to mice for up to 24 months at dose levels of 3, 10, or 30 mcg/kg/day (corresponding to 9, 30, or 90 mcg/m2/day) showed no significant changes in tumor incidence when compared to controls. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. [See WARNINGS AND PRECAUTIONS]

The genotoxic potential of calcipotriene was evaluated in an Ames assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, and a mouse micronucleus assay. All assay results were negative.

Studies in rats at doses up to 54 mcg/kg/day (318 mcg /m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Use In Specific Populations

Pregnancy

Teratogenic Effects, Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Therefore, SORILUX (calcipotriene foam) Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 mcg/kg/day (132 mcg/m2/day). Rabbits administered 36 mcg/kg/day (396 mcg/m2/day) resulted in fetuses with a significant increase in the incidences of incomplete ossification of pubic bones and forelimb phalanges. In a rat study, doses of 54 mcg/kg/day (318 mcg/m2/day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The maternal and fetal no-effect exposures in the rat (43.2 mcg/m2/day) and rabbit (17.6 mcg/m2/day) studies are approximately equal to the expected human systemic exposure level (18.5 mcg/m2/day) from dermal application.

Nursing Mothers

It is not known whether calcipotriene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SORILUX (calcipotriene foam) Foam is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of SORILUX (calcipotriene foam) Foam in pediatric patients less than 18 years of age have not been established.

Geriatric Use

Clinical studies of SORILUX (calcipotriene foam) Foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Overdosage & Contraindications

OVERDOSE

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with use of topical calcipotriene. [See WARNINGS AND PRECAUTIONS]

CONTRAINDICATIONS

SORILUX (calcipotriene foam) Foam should not be used by patients with known hypercalcemia.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Mechanism of Action

Calcipotriene is a synthetic vitamin D3 analog that has a similar receptor binding affinity as natural vitamin D3. However, the exact mechanism of action contributing to the clinical efficacy in the treatment of psoriasis is unknown.

Pharmacodynamics

The pharmacodynamics of SORILUX (calcipotriene foam) Foam are unknown.

Pharmacokinetics

The systemic absorption of calcipotriene in psoriatic subjects was evaluated at steady state following application of SORILUX Foam or calcipotriene ointment. In the SORILUX Foam treatment group, 15 out of 16 subjects showed calcipotriene plasma concentrations below the limit of quantitation (10 pg/mL), while in the calcipotriene ointment treated group, 5 out of 16 subjects had measurable calcipotriene plasma concentrations at various time points. All measurable plasma calcipotriene concentrations were below 25 pg/mL.

The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin D. Absorbed calcipotriene is known to be converted to inactive metabolites within 24 hours of application and the metabolism occurs via a similar pathway to the natural hormone.

Clinical Studies

In two multi-center, randomized, double-blind, vehicle-controlled clinical studies a total of 659 subjects with psoriasis were randomized 2:1 to SORILUX (calcipotriene foam) Foam or vehicle; subjects applied the assigned medication 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.

Table 1: Investigator Static Global Assessment (ISGA) Scale

Disease Severity Grade Definition
clear 0 No evidence of scaling, erythema, or plaque thickness
almost clear 1 Occasional fine scale, faint erythema, and barely perceptible plaque thickness
mild 2 Fine scale with light coloration and mild plaque elevation
moderate 3 Coarse scale with moderate red coloration and moderate plaque thickness
severe 4 Thick tenacious scale with deep coloration and severe plaque thickness

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 study.

Table 2: Number and Percent of Subjects Achieving Success at Week 8 in Each Study

  Study 1 Study 2
  SORILUX Foam
N=223
Vehicle Foam
N=113
SORILUX Foam
N=214
Vehicle Foam
N=109
Number (%) of Subjects with Treatment Success 31(14%) 8 (7%) 58 (27%) 17 (16%)

In one study, subjects graded as "mild" at baseline showed a greater response to vehicle than SORILUX (calcipotriene foam) Foam.

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

Table 3: Number and Percent of Subjects Achieving Success by Baseline ISGA Score and by Study

  Study 1 Study 2
ISGA scores at baseline SORILUX Foam
(N=223)
Vehicle Foam
(N=113)
SORILUX Foam
(N=214)
Vehicle Foam
(N=109)
mild 2/73 (2.7%) 3/34 (8.8%) 8/56 (14.3%) 4/31 (12.9%)
moderate 29/150 (19.3%) 5/79 (6.3%) 50/158 (31.6%) 13/78 (16.7%)

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

Medication Guide

PATIENT INFORMATION

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.

Break tiny plastic piece on SORILUX Foam can nozzle - Illustration

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

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

Shake SORILUX Foam can - Illustration

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.

Turn SORILUX Foam can upside down and press nozzle - Illustration

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.

Dispense SORILUX Foam into hand - Illustration

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.

Cover affected area with thin layer of SORILUX Foam -  Illustration

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.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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