SORILUX
Generic: CALCIPOTRIENE
Basic Information
Manufacturer
Mayne Pharma
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe
Indications & Usage
1 INDICATIONS AND USAGE SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.
SORILUX ® Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.
( 1 )
SORILUX ® Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS 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 and application site pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
( 6 ) 6.1 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 adult 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 an open-label study, 19 pediatric subjects age 12 to less than 17 years applied SORILUX Foam twice daily for 14 days and once on Day 15.
Adverse reactions included application site pain, application site pruritus and pruritus [see Clinical Pharmacology (12.2 and 12.3) and Pediatric Use (8.4) ] .
In an open-label study, 36 pediatric subjects age 4 to less than 12 years applied SORILUX Foam twice daily for up to 8 weeks.
Adverse reactions included application site pain and contact dermatitis [see Clinical Pharmacology (12.2 and 12.3) and Pediatric Use (8.4) ] .
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of SORILUX Foam.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Subcutaneous: application site vesicles
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
( 6 ) 6.1 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 adult 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 an open-label study, 19 pediatric subjects age 12 to less than 17 years applied SORILUX Foam twice daily for 14 days and once on Day 15.
Adverse reactions included application site pain, application site pruritus and pruritus [see Clinical Pharmacology (12.2 and 12.3) and Pediatric Use (8.4) ] .
In an open-label study, 36 pediatric subjects age 4 to less than 12 years applied SORILUX Foam twice daily for up to 8 weeks.
Adverse reactions included application site pain and contact dermatitis [see Clinical Pharmacology (12.2 and 12.3) and Pediatric Use (8.4) ] .
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of SORILUX Foam.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Subcutaneous: application site vesicles