OTEZLA�
apremilast
Manufacturer: Amgen Inc.
FDA-Approved Indications (4)
OTEZLA is indicated for the treatment of adult patients with oral ulcers associated with Beh�et�s Disease.
indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis
Population: adults and pediatric ≥6 years weighing ≥20 kg
indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
Population: adults
indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease
Population: adults
Indications & Usage
1 INDICATIONS AND USAGE OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis ( 1.1 ) Plaque psoriasis who are candidates for phototherapy or systemic therapy ( 1.2 ) Oral ulcers associated with Behçet's Disease ( 1.3 ) Pediatric patients 6 years of age and older with: Active psoriatic arthritis ( 1.1 ) Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy ( 1.2 ) In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg. 1.1 Psoriatic Arthritis OTEZLA is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis. OTEZLA XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis. 1.2 Plaque Psoriasis OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. OTEZLA is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. OTEZLA XR is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.3 Oral Ulcers Associated with Behçet's Disease OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.
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