Taltz

HOS-097371 · has-adverse-reaction-information · PDF-Seite 41

Summary of the safety profile The most frequently reported adverse reactions were injection site reactions (15.5 %) and upper respiratory tract infections (16.4 %) (most frequently nasopharyngitis). Tabulated list of adverse reactions Adverse reactions from clinical studies and post-marketing reports (Table 1) 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). A total of 8 956 patients have been treated with Taltz in blinded and open-label clinical studies in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and other autoimmune conditions. Of these, 6 385 patients were exposed to Taltz for at least one year, cumulatively representing 19 833 adult patient years of exposure and 196 children cumulatively representing 343 patient years of exposure. Table 1. List of adverse reactions in clinical studies and post-marketing reports System organ class Frequency Adverse reaction Infections and infestations Very common Upper respiratory tract infection Common Tinea infection, Herpes simplex (mucocutaneous) Uncommon Influenza, Rhinitis, Oral candidiasis, Conjunctivitis, Cellulitis Rare Oesophageal candidiasis Blood and lymphatic system Uncommon Neutropenia, disorders

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097365 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile The most frequently reported adverse reactions were injection site reactions (15.5 %) and upper respiratory tract infections (16.4 %) (most frequently nasopharyngitis). Tabulated list of adverse reactions Adverse reactions from clinical studies and post-marketing reports (Table 1) 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). A total of 8 956 patients have been treated with Taltz in blinded and open-label clinical studies in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and other autoimmune conditions. Of these, 6 385 patients were exposed to Taltz for at least one year, cumulatively representing 19 833 adult patient years of exposure and 196 children cumulatively representing 343 patient years of exposure. 7 Table 1. List of adverse reactions in clinical studies and post-marketing reports System organ class Frequency Adverse reaction Infections and infestations Very common Upper respiratory tract infection Common Tinea infection, Herpes simplex (mucocutaneous) Uncommon Influenza, Rhinitis, Oral candidiasis, Conjunctivitis, Cellulitis Rare Oesophageal candidiasis Blood and lymphatic system Uncommon Neutrop

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097361 · has-contraindication-information · PDF-Seite 5

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

HOS-097367 · has-contraindication-information · PDF-Seite 39

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

HOS-097366 · has-indication-information · PDF-Seite 36

Plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy. Psoriatic arthritis Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (radiographic axial spondyloarthritis) Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis Taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein 36 (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Juvenile idiopathic arthritis (JIA) Juvenile psoriatic arthritis (JPsA) Taltz, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy. Enthesitis-related arthritis (ERA) Taltz, alone or in combination with methotrexate, is indicated for the treatment of active ERA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.

HOS-097360 · has-indication-information · PDF-Seite 2

Plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy. 2 Psoriatic arthritis Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (radiographic axial spondyloarthritis) Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis Taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Juvenile idiopathic arthritis (JIA) Juvenile psoriatic arthritis (JPsA) Taltz, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy. Enthesitis-related arthritis (ERA) Taltz, alone or in combination with methotrexate, is indicated for the treatment of active ERA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.

HOS-097369 · has-interaction-information · PDF-Seite 40

In plaque psoriasis studies, the safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated. In population pharmacokinetic analyses, clearance of ixekizumab was not affected by concomitant administration of oral corticosteroids, NSAIDs, sulfasalazine, or methotrexate. Cytochrome P450 substrates Results from an interaction study in patients with moderate-to-severe psoriasis determined that 12 weeks of administration of ixekizumab with substances metabolised by CYP3A4 (i.e., midazolam), CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these substances.

HOS-097363 · has-interaction-information · PDF-Seite 6

In plaque psoriasis studies, the safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated. In population pharmacokinetic analyses, clearance of ixekizumab was not affected by concomitant administration of oral corticosteroids, NSAIDs, sulfasalazine, or methotrexate. Cytochrome P450 substrates Results from an interaction study in patients with moderate-to-severe psoriasis determined that 12 weeks of administration of ixekizumab with substances metabolised by CYP3A4 (i.e., midazolam), CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these substances.

HOS-097364 · has-pregnancy-information · PDF-Seite 6

Women of childbearing potential Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment. 6 Pregnancy There is a limited amount of data from the use of ixekizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or post-natal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Taltz during pregnancy. Breast-feeding It is not known whether ixekizumab is excreted in human milk or absorbed systemically after ingestion. However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys. A decision should be made whether to discontinue breast-feeding or to discontinue Taltz taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility The effect of ixekizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).

HOS-097370 · has-pregnancy-information · PDF-Seite 40

Women of childbearing potential Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment. Pregnancy There is a limited amount of data from the use of ixekizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or post-natal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Taltz during pregnancy. Breast-feeding It is not known whether ixekizumab is excreted in human milk or absorbed systemically after ingestion. However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys. A decision should be made whether to discontinue breast-feeding or to discontinue Taltz taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility The effect of ixekizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).

HOS-097362 · has-warning-information · PDF-Seite 5

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 Treatment with Taltz is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections (see section 4.8). Taltz should be used with caution in patients with clinically important 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 an infection develops, patients should be carefully monitored and Taltz discontinued if the patient is not responding to standard therapy or if the infection becomes serious. Taltz should not be resumed until the infection resolves. Taltz must not be given to patients with active tuberculosis (TB). Anti-TB therapy prior to initiation of Taltz in patients with latent TB should be considered. 5 Hypersensitivity Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported. If a serious hypersensitivity reaction occurs, administration of Taltz should be discontinued immediately and appropriate therapy initiated. Inflammatory bowel disease (including Crohn's disease and ulcerative colitis) Cases of new or exacerbations of inflammatory bowel disease have been reported with ixekizumab (see section 4.8). Ixekizumab 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, ixekizumab should be discontinued and appropriate medical management should be initiated. Immunisations Taltz should not be used with live vaccines. No data are available on the response to live vaccines; there are insufficient data on response to inactive vaccines (see section 5.1). Excipients with known effect Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 40 mg dose and per 80 mg dose, that is to say essentially “sodium-free”. Polysorbate This medicinal product contains 0.15 mg of polysorbate 80 in each 40 mg pre-filled syringe which is equivalent to

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097368 · has-warning-information · PDF-Seite 39

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 Treatment with Taltz is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections (see section 4.8). Taltz should be used with caution in patients with clinically important 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 an infection develops, patients should be carefully monitored and Taltz discontinued if the patient is not responding to standard therapy or if the infection becomes serious. Taltz should not be resumed until the infection resolves. Taltz must not be given to patients with active tuberculosis (TB). Anti-TB therapy prior to initiation of Taltz in patients with latent TB should be considered. Hypersensitivity Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported. If a serious hypersensitivity reaction occurs, administration of Taltz should be discontinued immediately and appropriate therapy initiated. Inflammatory bowel disease (including Crohn's disease and ulcerative colitis) Cases of new or exacerbations of inflammatory bowel disease have been reported with ixekizumab (see section 4.8). Ixekizumab 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, ixekizumab should be discontinued and appropriate medical management should be initiated. Immunisations Taltz should not be used with live vaccines. No data are available on the response to live vaccines; there are insufficient data on response to inactive vaccines (see section 5.1). 39 Excipients with known effect Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say essentially “sodium-free”. Polysorbate This medicinal product contains 0.30 mg of polysorbate 80 in each 80 mg pre-filled pen which is equivalent to 0.30 mg/mL. Polysorbate

Auszug; vollständigen Abschnitt im Original lesen.