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Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurative (HS) in adults with an inadequate response to conventional systemic HS therapy.1
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.1
Please refer to the Cosentyx Summary of Product Characteristics for full prescribing details, safety information, administration and dosing including in special populations.1
The recommended dose of Cosentyx in adults with HS is 300 mg delivered at Weeks 0, 1, 2, 3 and 4, followed by a monthly maintenance dose.1
Based on clinical response, the maintenance dose can be up-titrated to 300 mg every two weeks. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.1
Individual dosing may vary – please consult the SmPC for further information.1
Cosentyx pre-filled pens are available in two doses: 150 mg and 300 mg.1,2 Click on the images below to watch the administration videos for the UnoReady® and SensoReady® pens.
Cosentyx is to be administered by subcutaneous injection. If possible, areas of the skin that show psoriasis should be avoided as injection sites. 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.1
The efficacy of Cosentyx in HS has been established through clinical studies. Available evidence suggests that a clinical response is normally achieved within the first 16 weeks of treatment; however, if your patients don’t demonstrate a response to the prescribed Cosentyx dose within this timeframe, consideration should be given to discontinuing the treatment. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.1
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in the Cosentyx SmPC.1
Clinically important, active infection, e.g. active tuberculosis.1
Special warnings and precautions for use
Infections
Cosentyx has the potential to increase the risk of infections. Serious infections have been observed in patients receiving Cosentyx in the post-marketing setting. Caution should be exercised when considering the use of Cosentyx in patients with a chronic infection or a history of recurrent infection. Please see the SmPC for full Information.1
Inflammatory bowel disease (including Crohn’s disease and ulcerative colitis)
Cases of new or exacerbations of inflammatory bowel disease (IBD) have been reported with Cosentyx. Cosentyx is not recommended in patients with IBD. If a patient develops signs or symptoms of IBD or experiences an exacerbation of pre-existing IBD, Cosentyx should be discontinued and appropriate medical management should be initiated.1
Hypersensitivity reactions
If anaphylactic or other serious allergic reaction occurs, administration of Cosentyx should be discontinued immediately and appropriate therapy initiated.1
Vaccinations
Live vaccinations should not be given concurrently with Cosentyx.1
Latex-sensitive individuals – Cosentyx 150 mg solution for injection in pre-filled syringe and 150 mg solution for injection in pre-filled pen only
The removable needle cap of Cosentyx 150 mg in pre-filled syringe and 150 mg pre-filled pen contains a derivative of natural rubber (latex). Use in latex-sensitive individuals has not been studied and there is therefore a potential risk of hypersensitivity reactions, which cannot be completely ruled out.1
Concomitant immunosuppressive therapy
In psoriasis studies, the safety and efficacy of Cosentyx in combination with immunosuppressants, including biologics or phototherapy have not been evaluated. Cosentyx was administered concomitantly with 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 Cosentyx.1
Cosentyx dosing for HS and special populations
No dose adjustment is required for elderly patients (aged 65 years and over).1
Cosentyx should not be given to paediatric patients with HS under the age of 18, as the safety and efficacy of Cosentyx in children have not been established for this indication.1
As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy.1
Due to the potential for adverse reactions in nursing infants from Cosentyx, a decision on whether to discontinue breastfeeding during treatment and up to 20 weeks after treatment or to discontinue therapy with Cosentyx must be made, taking into account the benefit of breastfeeding to the child and the benefit of therapy to the woman.1
Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment.1 The effect of Cosentyx on human fertility has not been evaluated.1
Cosentyx has not been studied in patients with renal/hepatic impairment. No dose recommendations can be made.1
Cosentyx missed dose
If your HS patient misses a dose, they should be advised to take the next dose as soon as they remember. Additionally, prompt them to consult with you about when they should take their subsequent dose.2
Cosentyx overdose
Doses up to 30 mg/kg have been administered intravenously in clinical studies without encountering dose-limiting toxicity. In the event of an overdose, patients should be monitored for any adverse reactions and appropriate symptomatic treatment be instituted.1
This is not an exhaustive list of warnings and precautions. Please refer to the Cosentyx SmPC for full information.1
The most frequently reported adverse reactions are upper respiratory tract infections (17.1%) (most frequently nasopharyngitis, rhinitis).1
Therapeutic indications1
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 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
AS, ankylosing spondylitis; ERA, enthesitis-related arthritis; HS, hidradenitis suppurativa; JPsA, juvenile psoriatic arthritis; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; PsA, psoriatic arthritis; PsO, plaque psoriasis; Q2W, every 2 weeks; Q4W, every 4 weeks; QoL, quality of life; SmPC, summary of product characteristics.
References
Cosentyx® (secukinumab) Summary of Product Characteristics.
Cosentyx® (secukinumab) Patient Information Leaflet.
UK | January 2025 | FA-11252576
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 online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
