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Cosentyx

Cosentyx Dosage/Direction for Use

secukinumab

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Full Prescribing Info
Dosage/Direction for Use
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 one subcutaneous injection of 300 mg or 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 16) 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 one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. (See Table 16.)

Click on icon to see table/diagram/image

The solution for injection in pre-filled pen 150 mg/ml and 300mg/2ml are not indicated for administration to paediatric patients with a weight <50 kg. Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs.
Hidradenitis suppurativa (HS): 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, the maintenance dose can be increased to 300 mg every 2 weeks. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
Psoriatic arthritis: For patients with concomitant moderate to severe plaque psoriasis, refer to adult plaque psoriasis recommendation as previously mentioned.
For patients who 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 one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
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 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 17) 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 17.)

Click on icon to see table/diagram/image

The solution for injection in pre-filled pen 150 mg/ml and 300mg/2ml are not indicated for administration to paediatric patients with a weight <50 kg. Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs.
For all of the previously mentioned 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 Pharmacology: Pharmacokinetics under Actions).
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.
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.
Vial: 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 Special precautions for disposal and other handling under Cautions and the Instructions for Use in the package leaflet.
Pre-filled pen: The pen must not be shaken.
After proper training in subcutaneous injection technique, patients may self-inject Cosentyx or be injected by a caregiver if a physician determines that this is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients or caregivers should be instructed to inject the full amount of Cosentyx according to the instructions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet.
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