Spevigo · 4.3 Contraindications · 2

HOS-100217 · has-adverse-reaction-information · PDF-Seite 20

Summary of the safety profile The most frequently reported adverse reactions are infections (33.3%) with serious infections in 3 patients (3.2%) (see Description of selected adverse reactions). Tabulated list of adverse reactions Table 1 provides a list of the adverse reactions reported in clinical trials as well as in the post- marketing setting. The adverse reactions are listed by MedDRA System Organ Class (SOC) and frequency category 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 (frequency cannot be estimated from the available data). 20 Table 1: Adverse reactions System organ class Adverse reactions Frequencies Infections and infestations Infectiona) Very common b) Immune system disorders Hypersensitivity Not known Skin and subcutaneous tissue Pruritus Common disorders General disorders and Injection site reactions Very commonc) administration site conditions Fatigue Common a) The most commonly reported infections were Urinary tract infection (Common) and Upper respiratory tract infection (Very common) b) Derived from open-label extension trials and post-marketing experience c) Not reported in Effisayil 1 Description of selected adverse reactions Infections During the 1-week placebo-controlled period in Effisayil 1, infections were reported in 17.1% of patients treated with spesolimab compared with 5.6% of patients treated with placebo. In Effisayil 1, serious infection (urinary tract infection) was reported in 1 patient (2.9%) in the spesolimab group and no patient in the placebo group. During the placebo-controlled period of up to 48 weeks in Effisayil 2, infections were reported in 33.3% of patients treated with Spevigo and 33.3% of patients treated with placebo. In Effisayil 2, serious infections were reported in 3 patients (3.2%) in the Spevigo group and no patient in the placebo group. Infections observed in clinical trials with spesolimab were generally mild to moderate with no distinct pattern regarding pathogen or type of infection. Hypersensitivity Hypersensitivity comprises immedia

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100211 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most frequently reported adverse reactions are infections (17.1%) with urinary tract infection reported as serious in 1 patient (2.9%) (see Description of selected adverse reactions). Tabulated list of adverse reactions Table 1 provides a list of the adverse reactions reported in clinical trials as well as in the post- marketing setting. The adverse reactions are listed by MedDRA System Organ Class (SOC) and frequency category 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 (frequency cannot be estimated from the available data). Table 1: Adverse reactions System organ class Adverse reactions Frequencies a) Infections and infestations Infection Very common Immune system disorders Hypersensitivityb) Not known Skin and subcutaneous tissue Pruritus Common disorders General disorders and Injection site reactions Very commonc) administration site conditions Fatigue Common a) The most commonly reported infections were Urinary tract infection (Common) and Upper respiratory tract infection (Very common) b) Derived from open-label extension trials and post-marketing experience c) Not reported in Effisayil 1 Description of selected adverse reactions Infections During the 1-week placebo-controlled period in Effisayil 1, infections were reported in 17.1% of patients treated with spesolimab compared with 5.6% of patients treated with placebo. In Effisayil 1, serious infection (urinary tract infection) was reported in 1 patient (2.9%) in the spesolimab group and no patient in the placebo group. During the placebo-controlled period of up to 48 weeks in Effisayil 2, infections were reported in 33.3% of patients treated with Spevigo and 33.3% of patients treated with 6 placebo. In Effisayil 2, serious infections were reported in 3 patients (3.2%) in the Spevigo group and no patient in the placebo group. Infections observed in clinical trials with spesolimab were generally mild to moderate with no distinct pattern regarding pathogen or type of infection. Hypersensitivity Hypersensitivity com

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100213 · has-contraindication-information · PDF-Seite 18

Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). Clinically important active infections (e.g. active tuberculosis, see section 4.4).

HOS-100207 · has-contraindication-information · PDF-Seite 3

Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). Clinically important active infections (e.g. active tuberculosis, see section 4.4).

HOS-100206 · has-indication-information · PDF-Seite 2

Spevigo is indicated for the treatment of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy.

HOS-100212 · has-indication-information · PDF-Seite 16

Spevigo is indicated for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age.

HOS-100209 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. In GPP patients, spesolimab is not expected to cause cytokine-mediated CYP interactions as a perpetrator. Live vaccines should not be given concurrently with spesolimab (see section 4.4). There is limited experience from the concomitant use of spesolimab with immunosuppressants in GPP patients (see section 4.4).

HOS-100215 · has-interaction-information · PDF-Seite 20

No interaction studies have been performed. In GPP patients, spesolimab is not expected to cause cytokine-mediated CYP interactions as a perpetrator. Live vaccines should not be given concurrently with spesolimab (see section 4.4). There is limited experience from the concomitant use of spesolimab with immunosuppressants (see section 4.4).

HOS-100210 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited data from the use of spesolimab in pregnant women. Non-clinical studies using a surrogate, mouse specific anti-IL36R monoclonal antibody do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Human immunoglobulin (IgG) is known to cross the placental barrier. As a precautionary measure, it is preferable to avoid the use of spesolimab during pregnancy. 5 Breast-feeding No data are present on excretion of spesolimab in human milk. In humans, excretion of IgG antibodies in milk occurs during the first few days after birth, which is decreasing to low concentrations soon afterwards. Consequently, transfer of IgG antibodies to the newborns through milk, may happen during the first few days. In this short period, a risk to the breastfed child cannot be excluded. Afterwards, spesolimab can be used during breastfeeding if clinically needed. If treatment was discontinued before the last trimester of pregnancy, breastfeeding can be started immediately after birth. Fertility There are no data available on the effect of spesolimab on human fertility. Studies in mice using a surrogate, mouse specific anti-IL36R monoclonal antibody, do not indicate direct or indirect harmful effects with respect to fertility from antagonism of IL36R (see section 5.3).

HOS-100216 · has-pregnancy-information · PDF-Seite 20

Pregnancy There are no or limited data from the use of spesolimab in pregnant women. Non-clinical studies using a surrogate, mouse specific anti-IL36R monoclonal antibody do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Human immunoglobulin (IgG) is known to cross the placental barrier. As a precautionary measure, it is preferable to avoid the use of spesolimab during pregnancy. Breast-feeding No data are present on excretion of spesolimab in human milk. In humans, excretion of IgG antibodies in milk occurs during the first few days after birth, which is decreasing to low concentrations soon afterwards. Consequently, transfer of IgG antibodies to the newborns through milk, may happen during the first few days. In this short period, a risk to the breastfed child cannot be excluded. Afterwards, spesolimab can be used during breastfeeding if clinically needed. If treatment was discontinued before the last trimester of pregnancy, breastfeeding can be started immediately after birth. Fertility There are no data available on the effect of spesolimab on human fertility. Studies in mice using a surrogate, mouse specific anti-IL36R monoclonal antibody, do not indicate direct or indirect harmful effects with respect to fertility from antagonism of IL36R (see section 5.3).

HOS-100214 · has-warning-information · PDF-Seite 18

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 Spesolimab may increase the risk of infections (see section 4.8). In patients with a chronic infection or a history of recurrent infection, the potential risks and expected clinical benefits of treatment should be considered prior to prescribing spesolimab. Treatment with spesolimab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be instructed to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with spesolimab. If a patient is on treatment with Spevigo subcutaneous injection for GPP flare prevention, and develops a clinically important active infection, treatment with Spevigo should be stopped. Re- initiation can be considered once the infection resolves or is adequately treated. Pre-treatment evaluation for tuberculosis Prior to initiating treatment with spesolimab, patients should be evaluated for tuberculosis (TB) infection. Spesolimab is contraindicated to patients with active TB infection (see section 4.3). Anti-TB therapy should be considered prior to initiating spesolimab treatment in patients with latent TB, a history of TB or possible previous exposure to people with active tuberculosis in whom an adequate course of treatment cannot be confirmed. During and after spesolimab treatment, patients should be monitored for signs and symptoms of active TB. Hypersensitivity reactions Hypersensitivity reactions may occur with monoclonal antibodies such as spesolimab. Hypersensitivity may include immediate reactions such as anaphylaxis and delayed reactions such as 18 drug reaction with eosinophilia and systemic symptoms (DRESS). Immediate hypersensitivity reactions, including anaphylactic reactions have been reported in patients treated with spesolimab (see section 4.8). If a patient develops signs of anaphylaxis or other serious hypersensitivity, spesolimab treatment should be discontinued immediately and appropriate treatment should be initiated (see section 4.3). Use in patients with an immediate, life-threatening GPP flare For the treatment of GPP flares, see Spevigo 450 mg concentrate for solution for infusion Summary of Product Characteristics.

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100208 · has-warning-information · PDF-Seite 3

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. 3 Infections Spesolimab may increase the risk of infections (see section 4.8). In patients with a chronic infection or a history of recurrent infection, the potential risks and expected clinical benefits of treatment should be considered prior to prescribing spesolimab. Treatment with spesolimab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be instructed to seek medical advice if signs or symptoms of clinically important infection occur after treatment with spesolimab. Pre-treatment evaluation for tuberculosis Prior to initiating treatment with spesolimab, patients should be evaluated for tuberculosis (TB) infection. Spesolimab is contraindicated to patients with active TB infection (see section 4.3). Anti-TB therapy should be considered prior to initiating spesolimab treatment in patients with latent TB, a history of TB or possible previous exposure to people with active tuberculosis in whom an adequate course of treatment cannot be confirmed. After spesolimab treatment, patients should be monitored for signs and symptoms of active TB. Hypersensitivity and infusion-related reactions Hypersensitivity and infusion-related reactions may occur with monoclonal antibodies such as spesolimab. Hypersensitivity may include immediate reactions such as anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Immediate hypersensitivity reactions, including anaphylactic reactions have been reported in patients treated with spesolimab (see section 4.8). If a patient develops signs of anaphylaxis or other serious hypersensitivity, spesolimab treatment should be discontinued immediately and appropriate treatment should be initiated (see section 4.3). If a patient develops mild or moderate hypersensitivity during an intravenous infusion or other infusion-related reactions, treatment should be stopped and appropriate medical therapy should be considered (e.g., systemic anti-histamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion (see section 4.2). Use in patients with an

Auszug; vollständigen Abschnitt im Original lesen.