Regulatory Affairs

COSENTYX® (secukinumab)

150 mg/1 mL Solution for injection in a pre-filled syringe or pre-filled pen

National Succinct Statement (NSS)

Version 4.0

Effective date: 09-Dec-2024

Safety Label Change (SLC) Tracking number: 2024-PSB/GLC-1458-s

Document status: Final

Property of Novartis
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis

COSENTYX®

Important note:

Before prescribing, consult full prescribing information: EU: https://www.ema.europa.eu/en. 

Disclaimer: This link will contain the most updated product information approved by the reference country.

Presentation: Secukinumab. solution for subcutaneous injection in pre-filled syringe or pre-filled pen containing 150 mg of secukinumab.

Indications:

Adult plaque psoriasis

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Paediatric plaque psoriasis

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

Hidradenitis suppurativa (HS)

Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.

Psoriatic arthritis

Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease‑modifying anti‑rheumatic drug (DMARD) therapy has been inadequate.

Axial spondyloarthritis (axSpA)

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.

Non-radiographic axial spondyloarthritis (nr-axSpA)

Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non‑steroidal anti‑inflammatory drugs (NSAIDs).

Juvenile idiopathic arthritis (JIA)

Enthesitis-related arthritis (ERA)

Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Juvenile psoriatic arthritis (JPsA)

Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Dosage and 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 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 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 one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.

Table 1      Recommended dose for paediatric plaque psoriasis

*Some patients may derive additional benefit from the higher dose.

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.

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, please refer to adult plaque psoriasis recommendation.

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 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

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.

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.

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. The syringe or 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.

Contraindications: ♦Cosentyx is contraindicated in patients who have/had severe hypersensitivity reactions reaction to the active substance or to any of the excipients.♦ Clinically important, active infection, e.g. active tuberculosis

Warnings and precautions: 

♦Infections: Caution in patients with chronic or history of recurrent infection. If a patient develops a serious infection, the patient should be closely monitored and Cosentyx should not be administered until the infection resolves. 

♦Pre-treatment evaluation of tuberculosis: Evaluate patients for tuberculosis infection prior to initiating treatment with Cosentyx. Cosentyx should not be given to patients with active tuberculosis. Initiation of treatment for latent tuberculosis should be considered prior to administering Cosentyx. Anti-tuberculosis therapy should be considered prior to initiation of Cosentyx in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active tuberculosis during and after treatment.

♦Hepatitis B reactivation: Consider testing patients for HBV infection before initiating treatment with Cosentyx in accordance with clinical guidelines for immunosuppressants. Cosentyx should not be given to patients with active hepatitis B. Monitor patients with evidence of positive HBV serology for clinical and laboratory signs of HBV reactivation during Cosentyx treatment. Consider discontinuation of the treatment if reactivation of HBV occurs while on Cosentyx and treat patients according to clinical guidelines.

♦Inflammatory bowel disease: Patients with inflammatory bowel disease (e.g., Crohn’s disease and ulcerative colitis) treated with Cosentyx should be followed closely.

Cases of new onset IBD have been reported with post-marketing use.

♦Hypersensitivity reactions: Rare cases of anaphylactic reactions and angioedema have been observed during clinical trials and in the post-marketing setting in patients receiving Cosentyx. Administration of Cosentyx should be discontinued immediately and appropriate therapy initiated if an anaphylactic or other serious allergic reaction occurs.

♦Eczematous eruptions: Cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma (exfoliative dermatitis), were reported with post-marketing use. Some cases resulted in hospitalization. For some patients Cosentyx treatment may need to be discontinued.

♦Latex-sensitive individuals: The removable caps of the 1 mL Cosentyx pre-filled syringe/pen, and 0.5 mL pre-filled syringe contain a derivative of natural rubber latex.

♦Vaccinations: Cosentyx should not be given concurrently with live vaccines. Prior to initiating therapy with Cosentyx, it is recommended that pediatric patients receive all age-appropriate immunizations as per current immunization guidelines.

♦ Concomitant immunosuppressive therapy: In psoriasis studies, the safety and efficacy of secukinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. Secukinumab was administered concomitantly with methotrexate (MTX), sulfasalazine and/or corticosteroids in arthritis studies (including in patients with psoriatic arthritis and ankylosing spondylitis). Caution should be exercised when considering concomitant use of other immunosuppressants and secukinumab.

Pregnancy, lactation, females and males of reproductive potential

Pregnancy: There are no adequate data from the use of secukinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy.

Lactation: It is not known whether secukinumab is excreted in human milk. Immunoglobulins are excreted in human milk and it is not known if secukinumab is absorbed systemically after ingestion. Because of the potential for adverse reactions in nursing infants from secukinumab, a decision on whether to discontinue breast‑feeding during treatment and up to 20 weeks after treatment or to discontinue therapy with Cosentyx must be made taking into account the benefit of breast‑feeding to the child and the benefit of therapy to the woman.

Fertility: The effect of secukinumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

Adverse drug reactions: 

Very common (≥10%): 

Upper respiratory tract infections (nasopharyngitis, upper respiratory tract infection, rhinitis, pharyngitis, sinusitis, tonsillitis).

Common (≥1 to <10%): 

Oral herpes, diarrhoea, Nausea,  dermatitis (including eczema), rhinorrhoea, headache, fatigue

Uncommon (≥0.1 to <1%): 

Oral candidiasis, Otitis externa, lower respiratory tract infections, neutropenia, tinea pedis, conjunctivitis, inflammatory bowel disease (including Crohn’s disease and ulcerative colitis), dyshidrotic eczema, urticaria.

Rare (≥1/10 000 to <1/1 000): Anaphylactic reactions, Angioedema, Exfoliative dermatitis, Hypersensitivity vasculitis

Frequency not known: 

Mucosal and cutaneous candidiasis, pyoderma gangrenosum.

Interactions: 

Live vaccines should not be given concurrently with Cosentyx.

In a study in adult subjects with plaque psoriasis, no interaction was observed between secukinumab and midazolam (CYP 3A4 substrate).

No interaction was seen when secukinumab was administered concomitantly with methotrexate (MTX) and/or corticosteroids in arthritis studies (including in patients with psoriatic arthritis and axial spondyloarthritis).

Packs and prices: Country-specific.

Legal classification: Country-specific.

Leaflet revision date: February 2025.

NSS version number: 4.0

Leaflet presentation: R02.