Cosentyx

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 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.

3 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.

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 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. 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. Special populations Renal impairment / hepatic impairment Cosentyx has not been studied in these patient populations.

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 [HS] 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. 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.

4). 9 per patient-year of follow-up). 015 per patient-year of follow-up). 8 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.

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.

8). Most of these were mild or moderate upper respiratory tract infections such as nasopharyngitis and did not require treatment discontinuation. 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. 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. 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.

1. g. 4). 4