STEQEYMA

STEQEYMA is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which STEQEYMA is indicated Posology Plaque psoriasis The recommended posology of STEQEYMA is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.

Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment. Patients with body weight > 100 kg For patients with a body weight > 100 kg the initial dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter.

In these patients, 45 mg was also shown to be efficacious. 1, Table 4). Psoriatic arthritis (PsA) The recommended posology of STEQEYMA is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.

Alternatively, 90 mg may be used in patients with a body weight >100 kg. Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment. 4). Renal and hepatic impairment Ustekinumab has not been studied in these patient populations.

No dose recommendations can be made. Paediatric population The safety and efficacy of ustekinumab in children with psoriasis less than 6 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established.

The pre-filled pen has not been studied in the paediatric population and is not recommended for use in paediatric patients. 2 of the pre-filled syringe SmPC for posology and method of administration in paediatric patients 6 years and older with psoriasis Crohn’s Disease and Ulcerative Colitis In the treatment regimen, the first dose of STEQEYMA is administered intravenously.

2 of the STEQEYMA 130 mg Concentrate for solution for infusion SmPC. The first subcutaneous administration of 90 mg STEQEYMA should take place at week 8 after the intravenous dose. After this, dosing every 12 weeks is recommended. 1).

2). 1). Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose or 16 weeks after switching to the 8-weekly maintenance dose. Immunomodulators and/or corticosteroids may be continued during treatment with STEQEYMA.

In patients who have responded to treatment with STEQEYMA, corticosteroids may be reduced or discontinued in accordance with standard of care. In Crohn’s disease or Ulcerative Colitis, if therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.

4). Renal and hepatic impairment Ustekinumab has not been studied in these patient populations. No dose recommendations can be made. Paediatric population The safety and efficacy of ustekinumab for the treatment of Crohn’s disease in paediatric patients weighing less than 40 kg or ulcerative colitis in children less than 18 years have not yet been established.

No data are available. The pre-filled pen has not been studied in the paediatric population and is not recommended for use in paediatric patients. 2 of the Concentrate for solution for infusion and pre-filled syringe SmPC for posology and method of administration in paediatric patients weighing at least 40 kg with Crohn’s disease.

Method of administration STEQEYMA 45 mg pre-filled pens are for subcutaneous injection only. If possible, areas of the skin that show psoriasis should be avoided as injection sites. After proper training in subcutaneous injection technique, patients or their caregivers may inject STEQEYMA if a physician determines that it is appropriate.

However, the physician should ensure appropriate follow-up of patients. Patients or their caregivers should be instructed to inject the prescribed amount of STEQEYMA according to the directions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet.

6.

Summary of the safety profile The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis and headache.

Most were considered to be mild and did not necessitate discontinuation of study treatment. 4). The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Tabulated list of adverse reactions The safety data described below reflect exposure in adults to ustekinumab in 14 phase 2 and phase 3 studies in 6 710 patients (4 135 with psoriasis and/or psoriatic arthritis, 1 749 with Crohn’s disease and 826 patients with ulcerative colitis).

This includes exposure to ustekinumab in the controlled and non-controlled periods of the clinical studies in patients with psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis for at least 6 months (4 577 patients) or at least 1 year (3 648 patients).

2 194 patients with psoriasis, Crohn’s disease or ulcerative colitis were exposed for at least 4 years while 1,148 patients with psoriasis or Crohn’s disease were exposed for at least 5 years. Table 1 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.

The adverse reactions are classified by System Organ Class and frequency, using 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), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4, Systemic and respiratory hypersensitivity reactions. Description of selected adverse reactions Infections In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.

34 in placebo-treated patients. 4). 3 years for ulcerative colitis studies. 02 per patient-year of follow-up in ustekinumab-treated patients (289 serious infections in 15 227 patient-years of follow-up) and serious infections reported included pneumonia, anal abscess, cellulitis, diverticulitis, gastroenteritis and viral infections.

In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did not develop tuberculosis. 23 for placebo-treated patients (1 patient in 434 patient-years of follow-up). 46 for placebo-treated patients (2 patients in 433 patient-years of follow-up).

In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis clinical […]

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 Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections.

8). Opportunistic infections including reactivation of tuberculosis, other opportunistic bacterial infections (including atypical mycobacterial infection, listeria meningitis, pneumonia legionella, and nocardiosis), opportunistic fungal infections, opportunistic viral infections (including encephalitis caused by herpes simplex 2), and parasitic infections (including ocular toxoplasmosis) have been reported in patients treated with ustekinumab.

3). Prior to initiating treatment with STEQEYMA, patients should be evaluated for tuberculosis infection. 3). Treatment of latent tuberculosis infection should be initiated prior to administering STEQEYMA. Anti-tuberculosis therapy should also be considered prior to initiation of STEQEYMA in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.

Patients receiving STEQEYMA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment. 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 STEQEYMA should not be administered until the infection resolves. Malignancies Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy.

8). The risk of malignancy may be higher in psoriasis patients who have been treated with other biologics during the course of their disease. No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving ustekinumab.

Thus, caution should be exercised when considering the use of STEQEYMA in these patients. 8). Systemic and respiratory hypersensitivity reactions Systemic Serious hypersensitivity reactions have been reported in the post-marketing setting, in some cases several days after treatment.

Anaphylaxis and angioedema have occurred. 8). Respiratory Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported during post-approval use of ustekinumab. Clinical presentations included cough, dyspnoea, and interstitial infiltrates following one to three doses.

Serious outcomes have included respiratory failure and prolonged hospitalisation. Improvement has been reported after discontinuation of ustekinumab and also, in some cases, administration of corticosteroids. 8). Cardiovascular events Cardiovascular events including myocardial infarction and cerebrovascular accident have been observed in patients with psoriasis exposed to ustekinumab in a post- marketing observational study.

Risk factors for cardiovascular disease should be regularly assessed during treatment with STEQEYMA. Vaccinations It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STEQEYMA.

Specific studies have not been conducted in patients who had recently received live viral or live bacterial vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving ustekinumab.

Before live viral or live bacterial vaccination, treatment with STEQEYMA should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination. Prescribers should consult the Summary of Product Characteristics for the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.

6). If there is a clear clinical benefit for the individual infant, administration of a live vaccine might be considered at an earlier timepoint, if infant ustekinumab serum levels are undetectable. Patients receiving STEQEYMA may receive concurrent inactivated or non-live vaccinations.

1). Concomitant immunosuppressive therapy In psoriasis studies, the safety and efficacy of ustekinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX […]

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