ustekinumab
Drug Details
- Generic Name
- ustekinumab
- Brand Names
- YESINTEK, STELARA, ustekinumab, Stelara
- Application Number
- BLA761406
- Sponsor
- Biocon Biologics Inc.
- NDC Codes
- 10
- Dosage Forms
- INJECTION, SOLUTION, SOLUTION
- Routes
- SUBCUTANEOUS, INTRAVENOUS
- Active Ingredients
- USTEKINUMAB
Indications and Usage
1 INDICATIONS AND USAGE IMULDOSA 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) IMULDOSA 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) IMULDOSA 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) IMULDOSA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease. 1.4 Ulcerative Colitis IMULDOSA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.