ustekinumab-ttwe

FDA Drug Profile — PYZCHIVA, USTEKINUMAB-TTWE

Drug Details

Generic Name
ustekinumab-ttwe
Brand Names
PYZCHIVA, USTEKINUMAB-TTWE
Application Number
BLA761373
Sponsor
Cordavis Limited
NDC Codes
12
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
USTEKINUMAB

Indications and Usage

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