Saphnelo

HOS-099003 · has-adverse-reaction-information · PDF-Seite 20

Summary of the safety profile The most commonly reported adverse reactions during anifrolumab treatment were upper respiratory tract infection (32%), bronchitis (9.8%), infusion-related reaction (9.4%) and herpes zoster (5.4%). The most common serious adverse reactions were herpes zoster (0.3%) and bronchitis (0.3%). Tabulated list of adverse reactions Adverse reactions reported from controlled clinical trials and post-marketing data are classified by MedDRA System Organ Class (SOC), see Table 1. Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: 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 available data). Table 1 Adverse reactions MedDRA SOC MedDRA Preferred Term Frequency Infections and infestations Upper respiratory tract infection* Very common Bronchitis* Common Herpes zoster Common Respiratory tract infection* Common Immune system disorders Hypersensitivity Common Anaphylactic reaction Uncommon§ Musculoskeletal and Arthralgia Not known connective tissue disorders Injury, poisoning and Infusion-related reaction‡ Common procedural complications * Grouped terms: Upper respiratory tract infection (including Upper respiratory tract infection, Nasopharyngitis, Pharyngitis); Bronchitis (including Bronchitis, Bronchitis viral, Tracheobronchitis); Respiratory tract infection (including Respiratory tract infection, Respiratory tract infection viral, Respiratory tract infection bacterial). § See ‘Description of selected adverse reactions’ below and section 4.4. ‡ Applies to intravenous infusion route of administration only. 20 Long-term safety: Patients who completed Trials 1 and 2, the Phase III intravenous trials through Week 52 were eligible to continue on treatment in a randomised, double-blind, placebo-controlled lo

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HOS-098997 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most commonly reported adverse reactions during anifrolumab treatment were upper respiratory tract infection (32%), bronchitis (9.8%), infusion-related reaction (9.4%) and herpes zoster (5.4%). The most common serious adverse reactions were herpes zoster (0.3%) and bronchitis (0.3%). Tabulated list of adverse reactions Adverse reactions reported from controlled clinical trials and post-marketing data are classified by MedDRA System Organ Class (SOC), see Table 1. Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: 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 available data). Table 1 Adverse reactions MedDRA SOC MedDRA Preferred Term Frequency Infections and infestations Upper respiratory tract infection* Very common Bronchitis* Common Herpes zoster Common Respiratory tract infection* Common Immune system disorders Hypersensitivity Common Anaphylactic reaction Uncommon§ Musculoskeletal and Arthralgia Not known connective tissue disorders 6  MedDRA SOC MedDRA Preferred Term Frequency Injury, poisoning and Infusion-related reaction‡ Common procedural complications * Grouped terms: Upper respiratory tract infection (including Upper respiratory tract infection, Nasopharyngitis, Pharyngitis); Bronchitis (including Bronchitis, Bronchitis viral, Tracheobronchitis); Respiratory tract infection (including Respiratory tract infection, Respiratory tract infection viral, Respiratory tract infection bacterial). § See ‘Description of selected adverse reactions’ below and section 4.4. ‡ Applies to intravenous infusion route of administration only. Long-term safety Patients who completed Trials 1 and 2 (Phase III intravenous trials) through Week 52 were eligible to continue on treatment in a randomised, double-

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HOS-098993 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098999 · has-contraindication-information · PDF-Seite 17

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098998 · has-indication-information · PDF-Seite 16

Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.

HOS-098992 · has-indication-information · PDF-Seite 2

Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.

HOS-098995 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. Anifrolumab is not expected to undergo metabolism by hepatic enzymes or renal elimination. The formation of some CYP450 enzymes is suppressed by increased levels of certain cytokines during chronic inflammation. Anifrolumab modestly suppresses the levels of some cytokines; the impact on CYP450 activity is unknown. In patients who are being treated with other medicines that are CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin), therapeutic monitoring is recommended. Immune response Non-live vaccines Immune response to non-live seasonal influenza vaccine was assessed in a small number of adult patients with moderate to severe SLE in an exploratory study. Humoral antibody responses induced by seasonal influenza virus vaccination were numerically comparable between patients receiving anifrolumab in addition to standard of care and those receiving standard of care alone. Live vaccines The concurrent use of anifrolumab with live and live attenuated vaccines has not been studied (see section 4.4).

HOS-099001 · has-interaction-information · PDF-Seite 19

No interaction studies have been performed. Anifrolumab is not expected to undergo metabolism by hepatic enzymes or renal elimination. The formation of some CYP450 enzymes is suppressed by increased levels of certain cytokines during chronic inflammation. Anifrolumab modestly suppresses the levels of some cytokines; the impact on CYP450 activity is unknown. In patients who are being treated with other medicines that are CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin), therapeutic monitoring is recommended. Immune response Non-live vaccines Immune response to non-live seasonal influenza vaccine was assessed in a small number of adult patients with moderate to severe SLE in an exploratory study. Humoral antibody responses induced by seasonal influenza virus vaccination were numerically comparable between patients receiving anifrolumab in addition to standard of care and those receiving standard of care alone. Live vaccines The concurrent use of anifrolumab with live and live attenuated vaccines has not been studied (see section 4.4).

HOS-098996 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are limited data (less than 300 pregnancy outcomes) from the use of Saphnelo in pregnant women. Animal studies are inconclusive with respect to reproductive toxicity (see section 5.3). Saphnelo is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the possible benefit justifies the potential risk. 5 Breast-feeding It is not known whether anifrolumab is excreted in human milk. Anifrolumab was detected in the milk of female cynomolgus monkeys (see section 5.3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue from Saphnelo therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There are no fertility data in humans. Animal studies show no adverse effects of anifrolumab on indirect measures of fertility (see section 5.3).

HOS-099002 · has-pregnancy-information · PDF-Seite 19

Pregnancy There are limited data (less than 300 pregnancy outcomes) from the use of Saphnelo in pregnant women. Animal studies are inconclusive with respect to reproductive toxicity (see section 5.3). Saphnelo is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the possible benefit justifies the potential risk. Breast-feeding It is not known whether anifrolumab is excreted in human milk. Anifrolumab was detected in the milk of female cynomolgus monkeys (see section 5.3). A risk to the suckling child cannot be excluded. 19 A decision must be made whether to discontinue breast-feeding or to discontinue from Saphnelo therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There are no fertility data in humans. Animal studies show no adverse effects of anifrolumab on indirect measures of fertility (see section 5.3).

HOS-098994 · 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. Patient groups excluded from clinical studies Anifrolumab has not been studied in combination with other biologic therapies, including B-cell-targeted therapies. Therefore, treatment with anifrolumab is not recommended in combination with biologic therapies. 3 Anifrolumab has not been studied in patients with severe active central nervous system lupus or severe active lupus nephritis (see section 5.1). Hypersensitivity Serious hypersensitivity reactions including anaphylaxis have been reported following administration of anifrolumab (see section 4.8). In the intravenous and subcutaneous clinical trials of 52-week treatment duration, serious hypersensitivity reactions (including angioedema) were reported for 0.5% of patients receiving anifrolumab. In patients with a history of infusion-related reactions and/or hypersensitivity, premedication (e.g., an antihistamine) may be administered before the infusion of anifrolumab (see section 4.2). If a serious infusion-related or hypersensitivity reaction (e.g., anaphylaxis) occurs, administration of anifrolumab should be interrupted immediately, and appropriate therapy initiated. Infections Anifrolumab increases the risk of respiratory infections and herpes zoster; disseminated herpes zoster events have been observed (see section 4.8). SLE patients also taking immunosuppressants may be at higher risk of herpes zoster infections. In controlled-clinical trials serious and sometimes fatal infections (including pneumonia) occurred, including in patients receiving anifrolumab. Due to the mechanism of action, anifrolumab should be used with caution in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection. Treatment with anifrolumab should not be initiated in patients with any clinically significant active infection until the infection resolves or is adequately treated. Patients should be instructed to seek medical advice if signs or symptoms of clinically significant infection occur. If a patient develops an infection, or is not responding to standard therapy, they should be closely monitored and careful consideration given to interrupting anifrolumab therapy until the infection resolves. Studies in patients with a history of primary i

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HOS-099000 · has-warning-information · PDF-Seite 17

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. Patient groups excluded from clinical studies Anifrolumab has not been studied in combination with other biologic therapies, including B-cell-targeted therapies. Therefore, treatment with anifrolumab is not recommended in combination with biologic therapies. Anifrolumab has not been studied in patients with severe active central nervous system lupus or severe active lupus nephritis (see section 5.1). 17 Hypersensitivity Serious hypersensitivity reactions including anaphylaxis have been reported following administration of anifrolumab (see section 4.8). In the intravenous and subcutaneous clinical trials of 52-week treatment duration, serious hypersensitivity reactions (including angioedema) were reported for 0.5% of patients receiving anifrolumab. If a serious hypersensitivity reaction (e.g., anaphylaxis) occurs, administration of anifrolumab should be interrupted immediately, and appropriate therapy initiated. Infections Anifrolumab increases the risk of respiratory infections and herpes zoster; disseminated herpes zoster events have been observed (see section 4.8). SLE patients also taking immunosuppressants may be at higher risk of herpes zoster infections. In controlled-clinical trials serious and sometimes fatal infections (including pneumonia) occurred, including in patients receiving anifrolumab. Due to the mechanism of action, anifrolumab should be used with caution in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection. Treatment with anifrolumab should not be initiated in patients with any clinically significant active infection until the infection resolves or is adequately treated. Patients should be instructed to seek medical advice if signs or symptoms of clinically significant infection occur. If a patient develops an infection, or is not responding to standard therapy, they should be closely monitored and careful consideration given to interrupting anifrolumab therapy until the infection resolves. Studies in patients with a history of primary immunodeficiency have not been conducted. The placebo-controlled clinical trials excluded patients with a history of active TB or latent TB in whom an adequate course of treatment could not be confirmed. Anti-tubercul

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