ustekinumab-aauz

FDA Drug Profile — USTEKINUMAB-AAUZ, Otulfi

Drug Details

Generic Name
ustekinumab-aauz
Brand Names
USTEKINUMAB-AAUZ, Otulfi
Application Number
BLA761379
Sponsor
Fresenius Kabi USA, LLC
NDC Codes
7
Dosage Forms
INJECTION, SOLUTION, SOLUTION, INJECTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
USTEKINUMAB

Indications and Usage

1 INDICATIONS AND USAGE Ustekinumab-aauz 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 (PsO) , who are candidates for phototherapy or systemic therapy. ( 1.1 ) • active psoriatic arthritis (PsA) . ( 1.2 ) 1.1 Plaque Psoriasis (PsO) Ustekinumab-aauz 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) Ustekinumab-aauz 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) Ustekinumab-aauz is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis Ustekinumab-aauz is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.