Fraizeron Dosage/Direction for Use

Plaque psoriasis: Adult patients: The recommended dose is 300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. Based on clinical response, a maintenance dose of 300 mg every 2 weeks may provide additional benefit for patients with a body weight of 90 kg or higher. Each 300 mg dose is given as two subcutaneous injections of 150 mg.
Pediatric patients: The recommended dose is based on body weight (Table 14) and administered by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. Each 75 mg dose is given as one subcutaneous injection of 75 mg. Each 150 mg dose is given as one subcutaneous injection of 150 mg. Each 300 mg dose is given as two subcutaneous injections of 150 mg. (See Table 14.)


Click on icon to see table/diagram/image


Psoriatic arthritis: The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. Based on clinical response, the dose can be increased to 300 mg.
For patients with concomitant moderate to severe plaque psoriasis, the dosage and administration for adult plaque psoriasis is recommended.
For patients who are anti-TNF-alpha inadequate responders (IR), the recommended dose is 300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. Each 300 mg dose is given as two subcutaneous injections of 150 mg.
Axial spondyloarthritis (axSpA): Ankylosing spondylitis (AS): The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. Based on clinical response, the dose can be increased to 300 mg.
Each 300 mg dose is given as two subcutaneous injections of 150 mg.
Non-radiographic axial spondyloarthritis (nr-axSpA): The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing.
Juvenile Idiopathic Arthritis (JIA): Enthesitis-Related Arthritis (ERA) and Juvenile Psoriatic Arthritis (JPsA): The recommended dose is based on body weight. For patients weighing < 50 kg the dose is 75 mg. For patients weighing ≥ 50 kg the dose is 150 mg. Fraizeron is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing (every 4 weeks). Each 75 mg dose is given as one subcutaneous injection of 75 mg. Each 150 mg dose is given as one subcutaneous injection of 150 mg.
Special populations: Renal impairment / hepatic impairment: Fraizeron has not been studied specifically in these patient populations.
Pediatric patients: Safety and effectiveness in pediatric patients with plaque psoriasis and in the JIA categories of ERA and JPsA below the age of 6 years have not yet been established.
Safety and effectiveness in pediatric patients below the age of 18 years in other indications have not yet been established.
Geriatric patients (65 years or above): No dose adjustment is required.
Method of administration: Powder for solution for injection: Fraizeron is administered by subcutaneous injection. Fraizeron powder for solution must be reconstituted before use. Full instructions for use are provided in Cautions for Usage.