Prescribing information

 

   

Cosentyx® (secukinumab) offers a consistent safety profile across all indications in adult patients1,2

For full safety information, please refer to the Cosentyx Summary of Product Characteristics.

Cosentyx is indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults, adolescents and children from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis in adult patients, alone or in combination with MTX, when the response to previous DMARD therapy has been inadequate; active ankylosing spondylitis in adults who have responded inadequately to conventional therapy; active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated CRP and/or MRI evidence in adults who have responded inadequately to NSAIDs.

Summary of adverse reactions in clinical studies* and post-marketing experience1

The corresponding frequency for each adverse drug reaction is based on the following: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).1

System Organ Class Frequency Adverse reaction
Infections and infestations Very common Upper respiratory tract infections
Common Oral herpes
Tinea pedis
Uncommon Oral candidiasis
Otitis externa
Lower respiratory tract infections
Not known Mucosal and cutaneous candidiasis (including oesophageal candidiasis)
Blood and lymphatic system disorders Uncommon Neutropenia
Immune system disorders Rare Anaphylactic reactions
Nervous system disorders Common Headache
Eye disorders Uncommon Conjunctivitis
Respiratory, thoracic and mediastinal disorders Common Rhinorrhoea
Gastrointestinal disorders Common Diarrhoea
Nausea
Uncommon Inflammatory bowel disease
Skin and subcutaneous tissue disorders Uncommon Urticaria
Dyshidrotic eczema
Rare Exfoliative dermatitis
Hypersensitivity vasculitis
General disorders and administration site conditions Common Fatigue

Table adapted from Cosentyx Summary of Product Characteristics.1

Please refer to the Summary of Product Characteristics for full safety information.

*Placebo-controlled clinical studies (Phase III) in plaque psoriasis, PsA, AS and nr-axSpA patients exposed to 300 mg, 150 mg, 75 mg or placebo up to 12 weeks (psoriasis) or 16 weeks (PsA, AS and nr-axSpA) treatment duration.1

Cases were reported in patients with psoriasis diagnosis.1

Pooled safety analysis across PsO, PsA and AS

Safety data and selected AEs from 21 clinical trials2

  PsO studies

Any Cosentyx (N=5181)
PsA studies

Any Cosentyx (N=1380)
AS studies

Any Cosentyx (N=794)
Total exposure, patient-years 10,416.9 3866.9 1943.1
Min–max exposure (days) 1−1825 8−1827 1−1530
Death, n (%) 9 (0.2) 11 (0.8) 5 (0.6)
Discontinuations due to AEs, n (%) 331 (6.4) 104 (7.5) 58 (7.3)
  EAIR per 100 patient-years (95% CI)
Any AE 204.4 (198.4, 210.5) 147.0 (138.9, 155.5) 140.1 (129.8, 151.0)
Any serious AE 6.9 (6.3, 7.4) 7.9 (7.0, 8.9) 6.3 (5.2, 7.6)
Most common AEs*      
Viral URTI 21.0 (19.9, 22.0) 12.1 (10.9, 13.4) 9.8 (8.4, 11.5)
Headache 6.2 (5.8, 6.8) 3.8 (3.2, 4.5) 5.3 (4.3, 6.5)
Diarrhoea 3.8 (3.4, 4.2) 3.7 (3.1, 4.4) 5.2 (4.2, 6.4)
URTI 5.4 (4.9, 5.9) 9.1 (8.1, 10.2) 5.2 (4.2, 6.4)
Selected AEs      
Serious infections 1.4 (1.2, 1.6) 1.9 (1.5, 2.4) 1.2 (0.8, 1.8)
Candida infections§ 2.2 (1.9, 2.5) 1.5 (1.1, 2.0) 0.7 (0.4, 1.2)
IBD 0.01 (0.00, 0.05) 0.05 (0.01, 0.2) 0.1 (0.0, 0.3)
Crohn’s disease 0.05 (0.02, 0.1) 0.08 (0.02, 0.2) 0.4 (0.2, 0.8)
Ulcerative colitis 0.1 (0.07, 0.2) 0.08 (0.02, 0.2) 0.2 (0.1, 0.5)
MACE|| 0.3 (0.2, 0.5) 0.4 (0.3, 0.7) 0.6 (0.3, 1.1)
Neutropenia 0.3 (0.2, 0.4) 0.2 (0.1, 0.4) 0.5 (0.3, 1.0)
Uveitis 0.02 (0.0, 0.07) 0.1 (0.0, 0.2) 1.4 (0.9, 2.0)
Malignancy** 0.8 (0.6, 1.0) 1.1 (0.8, 1.5) 0.5 (0.2, 0.9)

Table adapted from Deodhar A, et al. 2019.2

Please refer to the Summary of Product Characteristics for full safety information.

Adverse events were reported as exposure adjusted incident rates (EAIRs) per 100 patient-years. Analyses included all patients who received one or more doses of Cosentyx. Approximation was not done if EAIR is less than 0.1.2

Some of the doses and dose regimes used in these studies are not approved for use (including 10 mg/kg intravenous loading and 75 mg subcutaneous dose). Individual patient dosing may vary - please consult the Prescribing Information for full details or refer to the Cosentyx SmPC for full prescribing information.

*AEs in the Cosentyx group that occurred with an incidence rate >5.0 per 100 patient-years during the entire safety period in any of the pooled groups.

Includes cases of common cold (low-level term).2

Values are based on system organ class: infections and infestations.2

§Values are based on the high-level term.2

Values are based on the preferred term.2

||Values are based on Novartis Medical Dictionary for Regulatory Activities query, which comprises (1) any myocardial infarction, (2) any cardiovascular accident, and (3) all other cardiovascular events that are fatal, out of a listing of 2200+ terms.2

**Values are based on standardised MedDRA query.2

Contraindications1

- Hypersensitivity to the active substance or to any of the excipients of Cosentyx (trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, water for injections)

- Clinically important, active infection, e.g. active tuberculosis

Special warnings and precautions1

Infections:

Potential to increase risk of infections; serious infections have been observed. Caution in patients with chronic infection or history of recurrent infection. Advise patients to seek medical advice if signs/symptoms of infection occur. Monitor patients with serious infection closely and do not administer Cosentyx until the infection resolves. Non-serious mucocutaneous candida infections were more frequently reported for Cosentyx in the psoriasis clinical studies. Should not be given to patients with active tuberculosis. Consider anti-tuberculosis therapy before starting Cosentyx in patients with latent tuberculosis.

Inflammatory bowel disease (including Crohn’s disease and ulcerative colitis):

New cases or exacerbations of inflammatory bowel disease have been reported with Cosentyx. Cosentyx, is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, Cosentyx should be discontinued and appropriate medical management should be initiated. 

Hypersensitivity reactions:

Rare cases of anaphylactic reactions have been observed. If serious allergic reactions occur, discontinue immediately and initiate appropriate therapy.

Vaccinations:

Do not give live vaccines concurrently with Cosentyx; inactivated or non-live vaccinations may be given. Paediatric patients should receive all age appropriate immunisations before treatment with Cosentyx.

Latex-sensitive individuals:

The removable needle cap of the 75 mg and 150 mg pre-filled syringe and 150 mg pre-filled pen contains a derivative of natural rubber latex.

 

AE, adverse event; AS, ankylosing spondylitis; CI, confidence interval; CRP, C-reactive protein;  DMARD, disease-modifying anti-rheumatic drug; EAIR, exposure-adjusted incidence rate; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; MedDRA, Medical Dictionary for Regulatory Activities; MRI, magnetic resonance imaging; MTX, methotrexate; N, number of patients in the analysis; n, number of patients with a response; NSAID, non-steroidal anti-inflammatory drug; nr-axSpA, non-radiographic axial spondyloarthritis; PsA, psoriatic arthritis; PsO, plaque psoriasis; SAE, serious adverse event; SmPC, summary of product characteristics; URTI, upper respiratory tract infection.

 

References     

  1. Cosentyx Summary of Product Characteristics.
  2. Deodhar A et al. Arthritis Res Ther 2019;21(1):111.
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UK | April 2023 | 280649

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 uk.patientsafety@novartis.com 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 medinfo.uk@novartis.com