Sign Out
Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
For some patients, a dosage of 150 mg may be acceptable.
Pediatric patients: The recommended dose is based on body weight (Table 15) and administered by subcutaneous injection with initial dosing 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. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. (See Table 15.)
Click on icon to see table/diagram/imageThe 75 mg solution for injection supporting the pediatric patients with body weight <50 kg is not registered in this country.
The 150 mg and 300 mg solution for injection in pre-filled pen is not indicated for administration to pediatric patients with a weight <50 kg. The 150 mg powder for solution for injection presentation is appropriate for administration to this population.
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 one subcutaneous injection of 300 mg or 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 one subcutaneous injection of 300 mg or 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 (Table 16) and administered by subcutaneous injection 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. (See Table 16.)
Click on icon to see table/diagram/imageThe 75 mg solution for injection supporting the pediatric patients with body weight <50 kg is not registered in this country.
The 150 mg and 300 mg solution for injection in pre-filled syringe and in pre-filled pen are not indicated for administration to pediatric patients with a weight <50 kg.
Special populations: Renal impairment/hepatic impairment: Secukinumab has not been studied specifically in these patient populations.
Pediatric patients: Safety and effectiveness in pediatric patients with the JIA categories of ERA and JPsA below the age of 6 years have not been established.
Safety and effectiveness in pediatric patients with plaque psoriasis below the age of 6 years have not 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: Pre-filled pen: Fraizeron is administered by subcutaneous injection. If possible, areas of the skin that show psoriasis should be avoided as injection sites.
After proper training in subcutaneous injection technique, patients may self-inject Fraizeron or be injected by a caregiver if a physician determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients and/or caregivers should be instructed to inject the full amount of Fraizeron according to the instructions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet.
Full instructions for use are provided in Patient Counselling Information.
