Prescribing information

 

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to nonsteroidal anti-inflammatory drugs; active enthesitis-related arthritis (ERA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active juvenile psoriatic arthritis (JPsA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1,2

Full indication for Cosentyx can be found here


Convenience of a monthly injection with Cosentyx after initial loading doses*1,2

The ‘hand rule’ of Cosentyx dosing

Cosentyx is administered by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.1,2 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. 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.1,2 

Depending on the patient dosing regimen, the dosing schedule may look something like this:

Infographic detailing the hand rule of Cosentyx dosing.

Click the button to download a quick guide on Cosentyx Dosing

Dosing regimen intended for healthcare professionals in Great Britain only. Please refer to the NI SmPC for product availability and dosing in Northern Ireland.2 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.1,2

Convenience of flexible dosing tailored to your patients’ needs*1,2

Graphic detailing the three potential treatment regimens that psoriatic arthritis patients are initially assigned: First-line biologic naïve who receive 150 mg; First-line biologic with moderate to severe plaque psoriasis who receive 300 mg; and anti-TNF inadequate responders who receive 300 mg.

 

Psoriatic arthritis (PsA) alone or in combination with MTX

Graphic detailing the dosage and up-titration for patients depending on their disease indication. PsA biologic naïve patients receive 150 mg monthly, can be up-titrated to 300 mg monthly. PsA switch patients with an inadequate response to TNF⍺ receive 300 mg monthly. PsA with concomitant moderate to severe PsO receive 300 mg monthly but can be up titrated to 300 mg Q2W if they weigh 90 kg or over.

Depending on a patient’s diagnosis and clinical response, up-titration may be prescribed at any point during the treatment journey with Cosentyx.1,2 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. 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.1,2

Click on the magnifying glass icon to show/hide additional information for full posology in PsA

Icon depicting a magnifying glass
For patients with concomitant moderate to severe plaque psoriasis, the recommended dose is 300 mg of Cosentyx 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.1,2
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.1,2
Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.1,2
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.1,2
Special populations
Elderly patients (aged 65 years and over): No dose adjustment is required.1,2
Renal impairment/hepatic impairment: Cosentyx has not been studied in these patient populations. No dose recommendations can be made.1,2
Paediatric population: The safety and efficacy of Cosentyx in children with plaque psoriasis and in the 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.1,2

 


Flexible dosing based on your patients’ needs with Cosentyx*1,2

AxSpA patients are initially assigned:

Graphic showing the recommended doses patients are initially assigned for ankylosing spondylitis; AS recommended dose of 150mg; nr-AxSpA recommended dose of 150mg. 

 

Axial spondyloarthritis (AxSpA)

Graphic detailing the dosage up-titration for patients depending on disease indication. Ankylosing spondylitis patients receive 150mg monthly, can be up-titrated to 300mg monthly. Non-radiographic-axSpA patients receive 150mg monthly with no recommended up-titration.

Depending on a patient’s diagnosis and clinical response, up-titration may be prescribed at any point during the treatment journey with Cosentyx.1,2

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. 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.1,2

Click on the magnifying glass icon to show/hide additional information for full posology in axSpA

Icon depicting a magnifying glass
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.1,2
Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg1,2
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.1,2
Special populations
Elderly patients (aged 65 years and over): No dose adjustment is required.1,2
Renal impairment/hepatic impairment: Cosentyx has not been studied in these patient populations. No dose recommendations can be made.1,2
Paediatric population: The safety and efficacy of Cosentyx in children with plaque psoriasis and in the 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.1,2

 


Dosing in JIA patients*

Juvenile idiopathic arthritis (JIA) alone or in combination with MTX

Graphic showing the dosing in JIA. For ERA dosing is 75mg monthly for patients <50 kg. For patients ≥50 kg dosing is 150 mg monthly. For JPsA, dosing is 75mg monthly for patients <50 kg. For patients ≥50 kg dosing is 150 mg monthly.

The 150 mg and 300 mg solution for injection in pre-filled syringe and in pre-filled pen 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.1 Dosing regimen intended for healthcare professionals in Great Britain only. Please refer to the NI SmPC for dosing in Northern Ireland.2

Click on the magnifying glass icon to show/hide additional information for full posology in JIA

Icon depicting a magnifying glass
The recommended dose is based on body weight (as per the table below) and administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing.1,2
Dosing for > 90 kg and PsO: Visual for body weight greater than or equal to 90 kg. 300 mg every 2 weeks or 300 mg every 4 weeks.  b) Visual for body weight less than 90 kg. 300 mg every 4 weeks
The 150 mg and 300 mg solution for injection in pre-filled syringe and in pre-filled pen 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.1,2
Special populations
Renal impairment/hepatic impairment: Cosentyx has not been studied in these patient populations. No dose recommendations can be made.1,2
Paediatric population: The safety and efficacy of Cosentyx in children with JIA below the age of 6 years have not been established.1,2

 


Flexibility to dose every 2 weeks for patients with PsA and concomitant PsO*1,2

For adult patients with PsA and concomitant moderate to severe PsO, the recommended dose is 300 mg of Cosentyx by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.1,2

Based on weight and clinical response, a maintenance dose of 300 mg every 2 weeks may provide additional benefit for adult patients with a body weight ≥90 kg. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.1,2

Body weight ≥90 kg

Visual for body weight greater than or equal to 90 kg. 300 mg every 2 weeks or 300 mg every 4 weeks.

 

Body weight <90 kg

Visual for body weight less than 90 kg. 300 mg every 4 weeks

 

Click on the magnifying glass icon to show/hide additional information for full posology in PsA with PsO

Icon depicting a magnifying glass
For patients with concomitant moderate to severe plaque psoriasis, the recommended dose is 300 mg of Cosentyx 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.1,2
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.1,2
Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg1,2
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.1,2
Special populations
Elderly patients (aged 65 years and over): No dose adjustment is required.1,2
Renal impairment/hepatic impairment: Cosentyx has not been studied in these patient populations. No dose recommendations can be made.1,2
Paediatric population: The safety and efficacy of Cosentyx in children with plaque psoriasis and in the 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.1,2

 


Flexible dosing with the UnoReady pen® and SensoReady® pen.1,2

 

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. Please refer to the Cosentyx SmPC for full product information and administration, including dosing in special populations, before prescribing.1,2 Cosentyx has not been studied in patients with renal impairment or hepatic impairment. No dose recommendations can be made.

Therapeutic Indications1,2

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs; active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active enthesitis-related arthritis (ERA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active juvenile psoriatic arthritis (JPsA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1,2

*Individual dosing may vary – please consult the SmPC for further information.1,2
Pre-filled syringe for paediatric patients.1 
Bodyweight at time of dosing.1,2

AS, ankylosing spondylitis; axSpA, axial spondyloarthritis; CRP, C-reactive protein; DMARD, disease modifying anti-rheumatic drug; ERA, enthesitis-related arthritis; HS, hidradenitis suppurativa; JIA, juvenile idiopathic arthritis; JPsA, juvenile psoriatic arthritis; MRI, magnetic resonance imaging; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; NSAID, non-steroidal anti-inflammatory drug; PsA, psoriatic arthritis; PsO, plaque psoriasis; Q2W, every 2 weeks; SmPC, Summary of Product Characteristics; TNFα, tumour necrosis factor alpha.

References:

  1. Cosentyx® (secukinumab) GB Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/3669/smpc [Accessed December 2023].
  2. Cosentyx® (secukinumab) NI Summary of Product Characteristics. Available at: https://www.emcmedicines.com/en-gb/northernireland/medicine?id=ecdc7f05-... [Accessed December 2023].
Rate this content: 
Average: 4 (1 vote)
UK | December 2023 | 298716

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]