Gobivaz · 4.1 Therapeutic indications · 3

HOS-101025 · has-adverse-reaction-information · PDF-Seite 99

Summary of the safety profile In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse reaction (AR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients. The most serious ARs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia (see section 4.4). 99 Tabulated list of adverse reactions ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 1. Within the designated system organ classes, the ARs are listed under headings of frequency and 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. Table 1 Tabulated list of ARs Infections and infestations Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis) Common: Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess Uncommon: Sepsis including septic shock, pyelonephritis Rare: Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis

Auszug; vollständigen Abschnitt im Original lesen.

HOS-101013 · has-adverse-reaction-information · PDF-Seite 42

Summary of the safety profile In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse reaction (AR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients. The most serious ARs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia (see section 4.4). Tabulated list of adverse reactions ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 1. Within the designated system organ classes, the ARs are listed under headings of frequency and 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. Table 1 Tabulated list of ARs Infections and infestations Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis) Common: Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess Uncommon: Sepsis including septic shock, pyelonephritis Rare: Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis Neoplasms, benign, malignant and unspecified

Auszug; vollständigen Abschnitt im Original lesen.

HOS-101019 · has-adverse-reaction-information · PDF-Seite 71

Summary of the safety profile In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse reaction (AR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients. The most serious ARs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia (see section 4.4). Tabulated list of adverse reactions ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 2. Within the designated system organ classes, the ARs are listed under headings of frequency and 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. Table 2 Tabulated list of ARs Infections and infestations Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis) Common: Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess Uncommon: Sepsis including septic shock, pyelonephritis Rare: Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis Neoplasms, benign, malignant and unspecified

Auszug; vollständigen Abschnitt im Original lesen.

HOS-101007 · has-adverse-reaction-information · PDF-Seite 11

Summary of the safety profile In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse reaction (AR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients. The most serious ARs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia (see section 4.4). Tabulated list of adverse reactions ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 2. Within the designated system organ classes, the ARs are listed under headings of frequency and 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. 11  Table 2 Tabulated list of ARs Infections and infestations Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis) Common: Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess Uncommon: Sepsis including septic shock, pyelonephritis Rare: Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis Neo

Auszug; vollständigen Abschnitt im Original lesen.

HOS-101009 · has-contraindication-information · PDF-Seite 36

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section 4.4). Moderate or severe heart failure (NYHA class III/IV) (see section 4.4).

HOS-101015 · has-contraindication-information · PDF-Seite 65

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section 4.4). Moderate or severe heart failure (NYHA class III/IV) (see section 4.4).

HOS-101021 · has-contraindication-information · PDF-Seite 93

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section 4.4). Moderate or severe heart failure (NYHA class III/IV) (see section 4.4). 93

HOS-101003 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section 4.4). Moderate or severe heart failure (NYHA class III/IV) (see section 4.4).

HOS-101014 · has-indication-information · PDF-Seite 62

Rheumatoid arthritis (RA) GOBIVAZ, in combination with methotrexate (MTX), is indicated for: • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate. • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the GOBIVAZ 50 mg SmPC. Psoriatic arthritis (PsA) GOBIVAZ, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Golimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. 62 Axial spondyloarthritis Ankylosing spondylitis (AS) GOBIVAZ is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-Axial SpA) GOBIVAZ is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) GOBIVAZ is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis (pUC) GOBIVAZ is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP)

Auszug; vollständigen Abschnitt im Original lesen.

HOS-101008 · has-indication-information · PDF-Seite 33

Rheumatoid arthritis (RA) GOBIVAZ, in combination with methotrexate (MTX), is indicated for: • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate. • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis (pJIA) GOBIVAZ in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX. Psoriatic arthritis (PsA) GOBIVAZ, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Golimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. 33 Axial spondyloarthritis Ankylosing spondylitis (AS) GOBIVAZ is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-Axial SpA) GOBIVAZ is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) GOBIVAZ is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

HOS-101020 · has-indication-information · PDF-Seite 91

Rheumatoid arthritis (RA) GOBIVAZ, in combination with methotrexate (MTX), is indicated for: • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate. • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the GOBIVAZ 50 mg SmPC. Psoriatic arthritis (PsA) GOBIVAZ, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Golimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. 91 Axial spondyloarthritis Ankylosing spondylitis (AS) GOBIVAZ is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-Axial SpA) GOBIVAZ is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) GOBIVAZ is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

HOS-101002 · has-indication-information · PDF-Seite 2

Rheumatoid arthritis (RA) GOBIVAZ, in combination with methotrexate (MTX), is indicated for: • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate. • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis (pJIA) GOBIVAZ in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX. Psoriatic arthritis (PsA) GOBIVAZ, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Golimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. 2 Axial spondyloarthritis Ankylosing spondylitis (AS) GOBIVAZ is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-Axial SpA) GOBIVAZ is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) GOBIVAZ is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis (pUC) GOBIVAZ is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age a

Auszug; vollständigen Abschnitt im Original lesen.

HOS-101023 · has-interaction-information · PDF-Seite 98

No interaction studies have been performed. Concurrent use with other biological therapeutics The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4). Live vaccines/therapeutic infectious agents Live vaccines should not be given concurrently with golimumab (see sections 4.4 and 4.6). Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4). Methotrexate Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX (see section 5.2). 98

HOS-101011 · has-interaction-information · PDF-Seite 40

No interaction studies have been performed. Concurrent use with other biological therapeutics The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4). 40 Live vaccines/therapeutic infectious agents Live vaccines should not be given concurrently with golimumab (see sections 4.4 and 4.6). Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4). Methotrexate Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX (see section 5.2).

HOS-101017 · has-interaction-information · PDF-Seite 70

No interaction studies have been performed. Concurrent use with other biological therapeutics The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4). Live vaccines/therapeutic infectious agents Live vaccines should not be given concurrently with golimumab (see sections 4.4 and 4.6). Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4). Methotrexate Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX (see section 5.2).

HOS-101005 · has-interaction-information · PDF-Seite 10

No interaction studies have been performed. Concurrent use with other biological therapeutics The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4). Live vaccines/therapeutic infectious agents Live vaccines should not be given concurrently with golimumab (see sections 4.4 and 4.6). Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4). Methotrexate Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX (see section 5.2).

HOS-101012 · has-pregnancy-information · PDF-Seite 41

Women of childbearing potential Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment. Pregnancy There is a moderate amount (approximately 400) of prospectively collected pregnancies exposed to golimumab resulting in live birth with known outcomes, including 220 pregnancies exposed during the first trimester. In a population-based study from Northern Europe including 131 pregnancies (and 134 infants), there were 6/134 (4.5%) events of major congenital anomalies following in utero exposure to golimumab vs 599/10,823 (5.5%) events for non-biologic systemic therapy compared to 4.6% in the general population of the study. Confounder-adjusted odds ratios were OR 0.79 (95% CI 0.35-1.81) for golimumab vs. non-biologic systemic therapy and OR 0.95 (95% CI 0.42-2.16) for golimumab vs. the general population, respectively. Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). The available clinical experience is limited. Golimumab should only be used during pregnancy if clearly needed. Golimumab crosses the placenta. Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last golimumab injection during pregnancy (see sections 4.4 and 4.5). Breast-feeding It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion. Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment. Fertility No animal fertility studies have been conducted with golimumab. A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility (see section 5.3).

HOS-101006 · has-pregnancy-information · PDF-Seite 10

Women of childbearing potential Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment. Pregnancy There is a moderate amount (approximately 400) of prospectively collected pregnancies exposed to golimumab resulting in live birth with known outcomes, including 220 pregnancies exposed during the first trimester. In a population-based study from Northern Europe including 131 pregnancies (and 134 infants), there were 6/134 (4.5%) events of major congenital anomalies following in utero exposure to golimumab vs 599/10,823 (5.5%) events for non-biologic systemic therapy compared to 4.6% in the general population of the study. Confounder-adjusted odds ratios were OR 0.79 (95% CI 0.35-1.81) for golimumab vs. non-biologic systemic therapy and OR 0.95 (95% CI 0.42-2.16) for golimumab vs. the general population, respectively. 10 Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). The available clinical experience is limited. Golimumab should only be used during pregnancy if clearly needed. Golimumab crosses the placenta. Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last golimumab injection during pregnancy (see sections 4.4 and 4.5). Breast-feeding It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion. Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment. Fertility No animal fertility studies have been conducted with golimumab. A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNF-α, showed no relevant effects on fertility (see section 5.3).

HOS-101018 · has-pregnancy-information · PDF-Seite 70

Women of childbearing potential Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment. Pregnancy There is a moderate amount (approximately 400) of prospectively collected pregnancies exposed to golimumab resulting in live birth with known outcomes, including 220 pregnancies exposed during the first trimester. In a population-based study from Northern Europe including 131 pregnancies (and 134 infants), there were 6/134 (4.5%) events of major congenital anomalies following in utero exposure to golimumab vs 599/10,823 (5.5%) events for non-biologic systemic therapy compared to 4.6% in the general population of the study. Confounder-adjusted odds ratios were OR 0.79 (95% CI 0.35-1.81) for golimumab vs. non-biologic systemic therapy and OR 0.95 (95% CI 0.42-2.16) for golimumab vs. the general population, respectively. Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). The available clinical experience is limited. Golimumab should only be used during pregnancy if clearly needed. Golimumab crosses the placenta. Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last golimumab injection during pregnancy (see sections 4.4 and 4.5). 70 Breast-feeding It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion. Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment. Fertility No animal fertility studies have been conducted with golimumab. A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNF-α, showed no relevant effects on fertility (see section 5.3).

HOS-101024 · has-pregnancy-information · PDF-Seite 99

Women of childbearing potential Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment. Pregnancy There is a moderate amount (approximately 400) of prospectively collected pregnancies exposed to golimumab resulting in live birth with known outcomes, including 220 pregnancies exposed during the first trimester. In a population-based study from Northern Europe including 131 pregnancies (and 134 infants), there were 6/134 (4.5%) events of major congenital anomalies following in utero exposure to golimumab vs 599/10,823 (5.5%) events for non-biologic systemic therapy compared to 4.6% in the general population of the study. Confounder-adjusted odds ratios were OR 0.79 (95% CI 0.35-1.81) for golimumab vs. non-biologic systemic therapy and OR 0.95 (95% CI 0.42-2.16) for golimumab vs. the general population, respectively. Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). The available clinical experience is limited. Golimumab should only be used during pregnancy if clearly needed. Golimumab crosses the placenta. Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last golimumab injection during pregnancy (see sections 4.4 and 4.5). Breast-feeding It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion. Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment. Fertility No animal fertility studies have been conducted with golimumab. A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility (see section 5.3).

HOS-101016 · has-warning-information · PDF-Seite 65

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 Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab. Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period. Further treatment with golimumab must not be given if a patient develops a serious infection or sepsis (see section 4.3). Golimumab should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection. Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate. Patients taking TNF-blockers are more susceptible to serious infections. Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving golimumab. Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. Patients who develop a new infection while undergoing treatment with golimumab should be monitored closely and undergo a complete diagnostic evaluation. Administration of golimumab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of golimumab treatment should be carefully considered before initiation of golimumab therapy. In at-risk patients treated with golimumab, an invasive fungal infection should be suspected if they develop a serious systemic illness. Diagnosis and administration of empiric antifungal therapy in these patients 65 should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections, if feasible. Tuberculosis There have been reports of tuberculosis in patients receiving golimumab. It should be noted that i

Auszug; vollständigen Abschnitt im Original lesen.

HOS-101022 · has-warning-information · PDF-Seite 94

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 Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab. Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period. Further treatment with golimumab must not be given if a patient develops a serious infection or sepsis (see section 4.3). Golimumab should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection. Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate. Patients taking TNF-blockers are more susceptible to serious infections. Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving golimumab. Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. Patients who develop a new infection while undergoing treatment with golimumab should be monitored closely and undergo a complete diagnostic evaluation. Administration of golimumab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of golimumab treatment should be carefully considered before initiation of golimumab therapy. In at-risk patients treated with golimumab, an invasive fungal infection should be suspected if they develop a serious systemic illness. Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections, if feasible. Tuberculosis There have been reports of tuberculosis in patients receiving golimumab. It should be noted that in the majority of these reports, tuberculosis was extrapu

Auszug; vollständigen Abschnitt im Original lesen.

HOS-101004 · 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 Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab. Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period. Further treatment with golimumab must not be given if a patient develops a serious infection or sepsis (see section 4.3). Golimumab should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection. Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate. Patients taking TNF-blockers are more susceptible to serious infections. Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving golimumab. 5 Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. Patients who develop a new infection while undergoing treatment with golimumab should be monitored closely and undergo a complete diagnostic evaluation. Administration of golimumab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of golimumab treatment should be carefully considered before initiation of golimumab therapy. In at-risk patients treated with golimumab, an invasive fungal infection should be suspected if they develop a serious systemic illness. Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections, if feasible. Tuberculosis There have been reports of tuberculosis in patients receiving golimumab. It should be noted that in

Auszug; vollständigen Abschnitt im Original lesen.

HOS-101010 · has-warning-information · PDF-Seite 36

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 Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab. Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period. Further treatment with golimumab must not be given if a patient develops a serious infection or sepsis (see section 4.3). Golimumab should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection. Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate. Patients taking TNF-blockers are more susceptible to serious infections. Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving golimumab. Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. Patients who develop a new infection while undergoing treatment with golimumab should be monitored closely and undergo a complete diagnostic evaluation. Administration of golimumab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of golimumab treatment should be carefully considered before initiation of golimumab therapy. In at-risk patients treated with golimumab, an invasive fungal infection should be suspected if they develop a serious systemic illness. Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections, if feasible. Tuberculosis There have been reports of tuberculosis in patients receiving golimumab. It should be noted that in the majority of these reports, tuberculosis was extrapu

Auszug; vollständigen Abschnitt im Original lesen.