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 (see section 5.1). 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 (see section 5.1). 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 (see section 5.1). 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 (see section 5.1).

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. 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 Body weight at time of dosing Recommended dose <25 kg 75 mg 25 to <50 kg 75 mg =50 kg 150 mg (*may be increased to 300 mg) *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-TNFa 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 Body weight at time of dosing Recommended dose <50 kg 75 mg =50 kg 150 mg 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 (see section 5.2). 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.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important, active infection, e.g. active tuberculosis (see section 4.4).

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Secukinumab has the potential to increase the risk of infections. Serious infections have been observed in patients receiving secukinumab in the post-marketing setting. Caution should be exercised when considering the use of secukinumab in patients with a chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and secukinumab should not be administered until the infection resolves. In clinical studies, infections have been observed in patients receiving secukinumab (see section 4.8). Most of these were mild or moderate upper respiratory tract infections such as nasopharyngitis and did not require treatment discontinuation. Related to the mechanism of action of secukinumab, non-serious mucocutaneous candida infections were more frequently reported for secukinumab than placebo in the psoriasis clinical studies (3.55 per 100 patient years for secukinumab 300 mg versus 1.00 per 100 patient years for placebo) (see section 4.8). Tuberculosis Tuberculosis (active and/or latent reactivation) has been reported in patients treated with secukinumab. Patients should be evaluated for tuberculosis infection prior to initiating treatment with secukinumab. Secukinumab should not be given to patients with active tuberculosis (see section 4.3). In patients with latent tuberculosis, anti-tuberculosis therapy should be considered prior to initiation of secukinumab as per clinical guidelines. Patients receiving secukinumab should be monitored for signs and symptoms of active tuberculosis. Inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) Cases of new or exacerbations of inflammatory bowel disease have been reported with secukinumab (see section 4.8). Secukinumab 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, secukinumab should be discontinued and appropriate medical management should be initiated. Hypersensitivity reactions Rare cases of anaphylactic reactions and angioedema have been observed in patients receiving secukinumab. If an anaphylactic reaction, angioedema or other serious allergic reactions occur, administration of secukinumab should be discontinued immediately and appropriate therapy initiated. 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 solution for injection in pre-filled syringe and Cosentyx 150 mg solution for injection in pre-filled pen contains a derivative of natural rubber latex. No natural rubber latex has to date been detected in the removable needle cap. Nevertheless, the use of Cosentyx 150 mg solution for injection in pre-filled syringe and Cosentyx 150 mg solution for injection in pre-filled pen in latex-sensitive individuals has not been studied and there is therefore a potential risk of hypersensitivity reactions which cannot be completely ruled out. Vaccinations Live vaccines should not be given concurrently with secukinumab. Patients receiving secukinumab may receive concurrent inactivated or non-live vaccinations. In a study, after meningococcal and inactivated influenza vaccinations, a similar proportion of healthy volunteers treated with 150 mg of secukinumab and those treated with placebo were able to mount an adequate immune response of at least a 4-fold increase in antibody titres to meningococcal and influenza vaccines. The data suggest that secukinumab does not suppress the humoral immune response to the meningococcal or influenza vaccines. Prior to initiating therapy with Cosentyx, it is recommended that paediatric patients receive all age-appropriate immunisations as per current immunisation 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 (see also section 4.5). Hepatitis B reactivation Hepatitis B virus reactivation can occur in patients treated with secukinumab. In accordance with clinical guidelines for immunosuppresants, testing patients for HBV infection is to be considered before initiating treatment with secukinumab. Patients with evidence of positive HBV serology should be monitored for clinical and laboratory signs of HBV reactivation during secukinumab treatment. If reactivation of HBV occurs while on secukinumab, discontinuation of the treatment should be considered, and patients should be treated according to clinical guidelines.

Live vaccines should not be given concurrently with secukinumab (see also section 4.4). In a study in adult subjects with plaque psoriasis, no

Women of childbearing potential Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment. 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 (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy. Breast-feeding 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.

Cosentyx has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile The most frequently reported adverse reactions are upper respiratory tract infections (17.1%) (most frequently nasopharyngitis, rhinitis). Tabulated list of adverse reactions Adverse reactions from clinical studies and post-marketing reports (Table 3) are listed by MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: 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); and not known (cannot be estimated from the available data). Over 20 000 patients have been treated with secukinumab in blinded and open-label clinical studies in various indications (plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa and other autoimmune conditions), representing 34 908 patient years of exposure. Of these, over 14 000 patients were exposed to secukinumab for at least one year. The safety profile of secukinumab is consistent across all indications. Table 3 List of adverse reactions in clinical studies1) and post-marketing experience System organ class Frequency Adverse reaction Very common Upper respiratory tract infections Common Oral herpes Oral candidiasis Otitis externa Lower respiratory tract infections Uncommon Tinea pedis Infections and infestations Not known Mucosal and cutaneous candidiasis (including oesophageal candidiasis) Blood and lymphatic system disorders Uncommon Neutropenia Anaphylactic reactions Immune system disorders Rare Angioedema Nervous system disorders Common Headache Eye disorders Uncommon Conjunctivitis Respiratory, thoracic and mediastinal disorders Common Rhinorrhoea Diarrhoea Common Nausea Gastrointestinal disorders Uncommon Inflammatory bowel disease Common Eczema Urticaria Uncommon Dyshidrotic eczema Exfoliative dermatitis2) Rare Hypersensitivity vasculitis Skin and subcutaneous tissue disorders Not known Pyoderma gangrenosum General disorders and administration site conditions Common Fatigue 1) Placebo-controlled clinical studies (phase III) in plaque psoriasis, PsA, AS, nr- axSpA and HS patients exposed to 300 mg, 150 mg, 75 mg or placebo up to 12 weeks (psoriasis) or 16 weeks (PsA, AS, nr-axSpA and HS) treatment duration 2) Cases were reported in patients with psoriasis diagnosis Description of selected adverse reactions Infections In the placebo-controlled period of clinical studies in plaque psoriasis (a total of 1 382 patients treated with secukinumab and 694 patients treated with placebo for up to 12 weeks), infections were reported in 28.7% of patients treated with secukinumab compared with 18.9% of patients treated with placebo. The majority of infections consisted of non-serious and mild to moderate upper respiratory tract infections, such as nasopharyngitis, which did not necessitate treatment discontinuation. There was an increase in mucosal or cutaneous candidiasis, consistent with the mechanism of action, but the cases were mild or moderate in severity, non-serious, responsive to standard treatment and did not necessitate treatment discontinuation. Serious infections occurred in 0.14% of patients treated with secukinumab and in 0.3% of patients treated with placebo (see section 4.4). Over the entire treatment period (a total of 3 430 patients treated with secukinumab for up to 52 weeks for the majority of patients), infections were reported in 47.5% of patients treated with secukinumab (0.9 per patient-year of follow-up). Serious infections were reported in 1.2% of patients treated with secukinumab (0.015 per patient-year of follow-up). Infection rates observed in psoriatic arthritis and axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) clinical studies were similar to those observed in the psoriasis studies. Patients with hidradenitis suppurativa are more susceptible to infections. In the placebo-controlled period of clinical studies in hidradenitis suppurativa (a total of 721 patients treated with secukinumab and 363 patients treated with placebo for up to 16 weeks), infections were numerically higher compared to those observed in the psoriasis studies (30.7% of patients treated with secukinumab compared with 31.7% in patients treated with placebo). Most of these were non-serious, mild or moderate in severity and did not require treatment discontinuation or interruption. Neutropenia In psoriasis phase III clinical studies, neutropenia was more frequently observed with secukinumab than with placebo, but most cases were mild, transient and reversible. Neutropenia <1.0-0.5x109/l (CTCAE grade 3) was reported in 18 out of 3 430 (0.5%) patients on secukinumab, with no dose dependence and no temporal relationship to infections in 15 out of 18 cases. There were no reported cases of more severe neutropenia. Non-serious infections with usual response to standard care and not requiring discontinuation of secukinumab were reported in the remaining 3 cases. The frequency of neutropenia in psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and hidradenitis suppurativa was similar to psoriasis. Rare cases of neutropenia <0.5x109/l (CTCAE grade 4) were reported. Immunogenicity In psoriasis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and hidradenitis suppurativa clinical studies, less than 1% of patients treated with secukinumab developed antibodies to secukinumab up to 52 weeks of treatment. About half of the treatment-emergent anti-drug antibodies were neutralising, but this was not associated with loss of efficacy or pharmacokinetic abnormalities. Paediatric population in paediatric patients from the age of 6 years with plaque psoriasis The safety of secukinumab was assessed in two phase III studies in paediatric patients with plaque psoriasis. The first study (paediatric study 1) was a double-blind, placebo- controlled study of 162 patients from 6 to less than 18 years of age with severe plaque psoriasis. The second study (paediatric study 2) is an open-label study of 84 patients from 6 to less than 18 years of age with moderate to severe plaque psoriasis. The safety profile reported in these two studies was consistent with the safety profile reported in adult plaque psoriasis patients. in paediatric patients with JIA The safety of secukinumab was also assessed in a phase III study in 86 juvenile idiopathic arthritis patients with ERA and JPsA from 2 to less than 18 years of age. The safety profile reported in this study was consistent with the safety profile reported in adult patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in clinical studies without dose-limiting toxicity. In the event of , it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC10 Mechanism of action Secukinumab is a fully human IgG1/? monoclonal antibody that selectively binds to and neutralises the proinflammatory cytokine interleukin-17A (IL-17A). Secukinumab works by targeting IL-17A and inhibiting its

Most pharmacokinetics properties observed in patients with plaque psoriasis, psoriatic arthritis and ankylosing spondylitis were similar. Absorption Following a single subcutaneous dose of 300 mg as a liquid formulation in healthy volunteers, secukinumab reached peak serum concentrations of 43.2±10.4 µg/ml between 2 and 14 days post dose. Based on population pharmacokinetic analysis, following a single subcutaneous dose of either 150 mg or 300 mg in plaque psoriasis patients, secukinumab reached peak serum concentrations of 13.7±4.8 µg/ml or 27.3±9.5 µg/ml, respectively, between 5 and 6 days post dose. After initial weekly dosing during the first month, time to reach the maximum concentration was between 31 and 34 days based on population pharmacokinetic analysis. On the basis of simulated data, peak concentrations at steady-state (Cmax,ss) following subcutaneous administration of 150 mg or 300 mg were 27.6 µg/ml and 55.2 µg/ml, respectively. Population pharmacokinetic analysis suggests that steady-state is reached after 20 weeks with monthly dosing regimens. Compared with exposure after a single dose, the population pharmacokinetic analysis showed that patients exhibited a 2-fold increase in peak serum concentrations and area under the curve (AUC) following repeated monthly dosing during maintenance. Population pharmacokinetic analysis showed that secukinumab was absorbed with an average absolute bioavailability of 73% in patients with plaque psoriasis. Across studies, absolute bioavailabilities in the range between 60 and 77% were calculated. The bioavailability of secukinumab in PsA patients was 85% on the basis of the population pharmacokinetic model. Following a single subcutaneous injection of 300 mg solution for injection in pre-filled syringe in plaque psoriasis patients, secukinumab systemic exposure was similar to what was observed previously with two injections of 150 mg. Following subcutaneous administration of 300 mg at weeks 0, 1, 2, 3 and 4 followed by 300 mg every 2 weeks, the mean ± SD steady-state secukinumab trough concentration at week 16 was approximately 55.1±26.7 µg/ml and 58.1±30.1 µg/ml in HS study 1 and HS study 2, respectively. Distribution The mean volume of distribution during the terminal phase (Vz) following single intravenous administration ranged from 7.10 to 8.60 litres in plaque psoriasis patients, suggesting that secukinumab undergoes limited distribution to peripheral compartments. Biotransformation The majority of IgG elimination occurs via intracellular catabolism, following fluid-phase or receptor mediated endocytosis. Elimination Mean systemic clearance (CL) following a single intravenous administration to patients with plaque psoriasis ranged from 0.13 to 0.36 l/day. In a population pharmacokinetic analysis, the mean systemic clearance (CL) was 0.19 l/day in plaque psoriasis patients. The CL was not impacted by gender. Clearance was dose- and time-independent. The mean elimination half-life, as estimated from population pharmacokinetic analysis, was 27 days in plaque psoriasis patients, ranging from 18 to 46 days across psoriasis studies with intravenous administration. In a population pharmacokinetic analysis, the mean systemic CL following subcutaneous administration of 300 mg at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 2 weeks to patients with hidradenitis suppurativa was 0.26 l/day. The mean elimination half-life, as estimated from population pharmacokinetic analysis, was 23 days in hidradenitis suppurativa patients. Linearity/non-linearity The single and multiple dose pharmacokinetics of secukinumab in plaque psoriasis patients were determined in several studies with intravenous doses ranging from 1x 0.3 mg/kg to 3x 10 mg/kg and with subcutaneous doses ranging from 1x 25 mg to multiple doses of 300 mg. Exposure was dose proportional across all dosing regimens. Special populations Elderly patients Based on population pharmacokinetic analysis with a limited number of elderly patients (n=71 for age =65 years and n=7 for age =75 years), clearance in elderly patients and patients less than 65 years of age was similar. Patients with renal or hepatic impairment No pharmacokinetic data are available in patients with renal or hepatic impairment. The renal elimination of intact secukinumab, an IgG monoclonal antibody, is expected to be low and of minor importance. IgGs are mainly eliminated via catabolism and hepatic impairment is not expected to influence clearance of secukinumab. Effect of weight on pharmacokinetics Secukinumab clearance and volume of distribution increase as body weight increases. Paediatric population Plaque psoriasis In a pool of the two paediatric studies, patients with moderate to severe plaque psoriasis (6 to less than 18 years of age) were administered secukinumab at the recommended paediatric dosing regimen. At week 24, patients weighing =25 and <50 kg had a mean ± SD steady-state trough concentration of 19.8 ± 6.96 µg/ml (n=24) after 75 mg of secukinumab and patients weighing =50 kg had mean ±SD trough concentration of 27.3 ± 10.1 µg/ml (n=36) after 150 mg of secukinumab. The mean ± SD steady-state trough concentration in patients weighing <25 kg (n=8) was 32.6 ± 10.8 µg/ml at week 24 after 75 mg dose. Juvenile idiopathic arthritis In a paediatric study, ERA and JPsA patients (2 to less than 18 years of age) were administered secukinumab at the recommended paediatric dosing regimen. At week 24, patients weighing <50 kg, and weighing =50 kg had a mean ± SD steady-state trough concentration of 25.2±5.45 µg/ml (n=10) and 27.9±9.57 µg/ml (n=19), respectively.

Non-clinical data revealed no special hazard for humans (adult or paediatric) based on conventional studies of safety pharmacology, repeated dose and reproductive toxicity, or tissue cross-reactivity. Animal studies have not been conducted to evaluate the carcinogenic potential of secukinumab.

Trehalose dihydrate Histidine Histidine hydrochloride monohydrate Methionine Polysorbate 80 Water for injections

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

2 years

Store in a refrigerator (2°C - 8°C). Do not freeze. Store in the original package in order to protect from light.

Cosentyx 300 mg solution for injection in pre-filled pen Cosentyx 300 mg solution for injection in pre-filled pen is supplied in a single-use pre-filled syringe assembled into a squared-shaped pen with transparent window and label. The pre-filled syringe inside the pen is a 2.25 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½" needle and rigid needle shield of synthetic polyisoprene rubber. Cosentyx 300 mg solution for injection in pre-filled pen is available in unit packs containing 1 pre-filled pen and in multipacks containing 3 (3 packs of 1) pre-filled pens. Not all pack sizes may be marketed.

Cosentyx 300 mg solution for injection in pre-filled pen Cosentyx 300 mg solution for injection is supplied in a single-use pre-filled pen for individual use. The pen should be taken out of the refrigerator 30-45 minutes before injecting to allow it to reach room temperature. Prior to use, a visual inspection of the pre-filled syringe or pre-filled pen is recommended. The liquid should be clear. Its colour may vary from colourless to slightly yellow. You may see a small air bubble, which is normal. Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown. Detailed instructions for use are provided in the package leaflet. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Feb. 16, 2026

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