Kyntheum

Kyntheum is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. Posology The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.

Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.

2). Renal and hepatic impairment Kyntheum has not been studied in these patient populations. No dose recommendations can be made. Paediatric population The safety and efficacy of Kyntheum in children and adolescents below the age of 18 years have not yet been established.

No data are available. 3 Method of administration Kyntheum is administered by subcutaneous injection. Each pre-filled syringe is for single use only. Kyntheum should not be injected into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

The pre-filled syringe must not be shaken. After proper training in subcutaneous injection technique, patients may self-inject Kyntheum when deemed appropriate by a physician. Patients should be instructed to inject the full amount of Kyntheum according to the instructions provided in the package leaflet.

Detailed instructions for use are included at the end of the package leaflet.

1%). Tabulated list of adverse reactions Adverse reactions from clinical trials and post-marketing experience (Table 1) are listed by MedDRA system organ class (SOC). Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first.

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).

Within each frequency grouping adverse reactions are presented in order of decreasing seriousness. 4). 4% of patients treated with placebo. The majority of infections consisted of nasopharyngitis, upper respiratory tract infection, pharyngitis, urinary tract infections, bronchitis, influenza and sinusitis, which did not necessitate treatment discontinuation.

1% of patients treated with placebo. 0%, respectively. 1 for patients treated with ustekinumab. 2 for patients treated with ustekinumab. 4). 5% of patients treated with placebo. Most of the brodalumab-associated neutropenias were mild, transient and reversible.

5% of patients receiving brodalumab compared to none of the patients who received ustekinumab or placebo. 2% of patients who received ustekinumab. No serious infections were associated with neutropenia. 3% of the patients had anti-brodalumab antibodies at baseline).

Of these patients, none had neutralising antibodies. No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with anti-brodalumab antibody development. 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 national reporting system listed in Appendix V.

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. Inflammatory bowel disease (including Crohn's disease and ulcerative colitis) Cases of new or exacerbations of inflammatory bowel disease have been reported with IL-17 inhibitors.

8). If a patient develops signs and symptoms of inflammatory bowel disease, or experiences an exacerbation of pre-existing inflammatory bowel disease, treatment should be discontinued and appropriate medical management should be initiated.

Suicidal ideation and behaviour Suicidal ideation and behaviour, including completed suicide, have been reported in patients treated with brodalumab. The majority of patients with suicidal behaviour had a history of depression and/or suicidal ideation or behaviour.

A causal association between treatment with brodalumab and increased risk of suicidal ideation and behaviour has not been established. The risk and benefit of treatment with brodalumab should be carefully weighed for patients with a history of depression and/or suicidal ideation or behaviour, or for patients who develop such symptoms.

Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal ideation, anxiety, or other mood changes, and they should contact their healthcare provider if such events occur.

If a patient suffers from new or worsening symptoms of depression and/or suicidal ideation or behaviour is identified, it is recommended to discontinue treatment. Hypersensitivity reactions Rare cases of anaphylactic reactions have been reported in the post-marketing setting.

In the event of an anaphylactic reaction, or any other serious allergic reaction, administration of brodalumab should be discontinued and appropriate therapy initiated. 4 Infections Brodalumab may increase the risk of infections. 8).

1. Active Crohn’s disease. g. 4).