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 USTEKINUMAB-TTWE 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-TTWE 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-TTWE 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-TTWE is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis USTEKINUMAB-TTWE is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.