ustekinumab-hmny

FDA Drug Profile — Starjemza

Drug Details

Generic Name
ustekinumab-hmny
Brand Names
Starjemza
Application Number
BLA761419
Sponsor
Hikma Pharmaceuticals USA Inc.
NDC Codes
4
Dosage Forms
INJECTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
USTEKINUMAB

Indications and Usage

1 INDICATIONS AND USAGE STARJEMZA 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) STARJEMZA 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) STARJEMZA 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) STARJEMZA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease. 1.4 Ulcerative Colitis STARJEMZA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.