Posology : מינונים

4.2       Posology and method of administration

Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated.

Posology

Adult Plaque psoriasis
The recommended dose is 300 mg of secukinumab 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.

Paediatric plaque psoriasis (adolescents and children from the age of 6 years) The recommended dose is based on body weight (Table 1) 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 injection of 150 mg.
Table 1       Recommended dose for paediatric plaque psoriasis

Body weight at time of dosing               Recommended dose
<25 kg                                      75 mg
25 to <50 kg                                75 mg
≥50 kg                                      150 mg (*may be increased to 300 mg) *Some patients may derive additional benefit from the higher dose.

Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs.

Psoriatic arthritis
For patients with concomitant moderate to severe plaque psoriasis, please refer to adult plaque psoriasis recommendation.

For patientswho are anti-TNFα 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.

COS POW API May23 V9                                                  Based on EU reference 04/2023 For other patients, 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.

Axial spondyloarthritis (axSpA)

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
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)
Administer Cosentyx with or without a loading dosage by subcutaneous injection (see section 5.1). The recommended dosage:
• With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dosage is 150 mg every 4 weeks.

Juvenile idiopathic arthritis (JIA)

Enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) The recommended dose is based on body weight (Table 2) 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.

Table 2          Recommended dose for juvenile idiopathic arthritis

Body weight at time of dosing                        Recommended dose <50 kg                                               75 mg
≥50 kg                                               150 mg

Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs.

For all of the above indications, available data suggest that a clinical response is usually achieved within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response by 16 weeks of treatment. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.

Special populations

Elderly patients (aged 65 years and over)
No dose adjustment is required (see section 5.2).
Renal impairment / hepatic impairment
Cosentyx has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population

The safety and efficacy of Cosentyx in children with plaque psoriasis and in the juvenile idiopathic arthritis (JIA) categories of ERA and JPsA below the age of 6 years have not been established.

COS POW API May23 V9                                                  Based on EU reference 04/2023 The safety and efficacy of Cosentyx in children below the age of 18 years in other indications have not yet been established. No data are available.

Method of administration
Cosentyx is to be administered by subcutaneous injection. If possible, areas of the skin that show psoriasis should be avoided as injection sites. The powder for solution for injection must be reconstituted before use.

The reconstitution, dose preparation and administration of the powder for solution for injection is to be done by a healthcare professional. For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the Instructions for Use in the package leaflet.