Foam Attributes


Foam attributes of Sorilux Foam

The difference is in the delivery

Calcipotriene delivered in an elegant, aqueous-based foam that is easy to apply and convenient for patients to use.1,2

Can of Sorilux calcipotriene foam, 0.005 percent , 60 grams, for topical use only, Mayne Pharma

SORILUX Foam contains VersaFoam®–AEF

  • Spreadable formulation that can be applied to hair–bearing and non—hair–bearing areas2
  • Absorbs quickly without greasiness or residue2,3
  • Aqueous–based emulsion, free of ethanol
  • Penetrates the skin barrier to deliver the molecule into the epidermis and dermis3
  • Free of preservatives and fragrances

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

Product characteristics of SORILUX Foam

ACTIVE INGREDIENT:

Calcipotriene 50 mcg/g (synthetic vitamin D3 analog)

DOSING:

A thin layer of emollient foam should be applied twice daily to the affected areas and rubbed into the skin gently and completely. Avoid contact with the face and eyes

HOW SUPPLIED:

60 g and 120 g aluminum cans

SORILUX Foam does not contain:

  • Steroids
  • Ethanol
  • Preservatives
  • Fragrances

References: 1. SORILUX Foam [package insert]. Greenville, NC: Mayne Pharma; 2016. 2. Weiss S, Wyres M, Brundage T. A novel foam vehicle is consistently preferred by patients for dermatologic conditions. J Am Acad Dermatol. 2011;64(2):AB50. 3. Data on file. Greenville, NC; Mayne Pharma LLC.

Indication

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

For more information, please see full Prescribing Information and Patient Information Leaflet

Important Safety Information

  • SORILUX Foam should not be used by patients with known hypercalcemia
  • The propellant in SORILUX Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application
  • 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
  • Physicians may wish to limit or avoid use of phototherapy in patients who use SORILUX Foam
  • Safety and effectiveness of SORILUX Foam in pediatric patients less than 18 years of age have not been established
  • Instruct the patient to avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps
  • SORILUX Foam is not for oral, ophthalmic, or intravaginal use
  • 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

Medical Information & Adverse Drug Events Reporting

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.