ustekinumab-aekn

FDA Drug Profile — SELARSDI, Ustekinumab-aekn, Selarsdi

Drug Details

Generic Name
ustekinumab-aekn
Brand Names
SELARSDI, Ustekinumab-aekn, Selarsdi
Application Number
BLA761343
Sponsor
A-S Medication Solutions
NDC Codes
8
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
USTEKINUMAB, USTEKINUMAB-AEKN

Indications and Usage

1 INDICATIONS AND USAGE SELARSDI is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) moderately to severely active Crohn’s disease (CD). ( 1.3 ) moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) 1.1 Plaque Psoriasis (PsO) SELARSDI™ is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Psoriatic Arthritis (PsA) SELARSDI is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn’s Disease (CD) SELARSDI is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease. 1.4 Ulcerative Colitis SELARSDI is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.