Nplate

HOS-095078 · has-adverse-reaction-information · PDF-Seite 30

Summary of the safety profile Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, the overall subject incidence of all adverse reactions for romiplostim-treated subjects was 91.5% (248/271). The mean duration of exposure to romiplostim in this study population was 50 weeks. The most serious adverse reactions that may occur during Nplate treatment include: reoccurrence of thrombocytopenia and bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, medication errors and progression of existing MDS to AML. The most common adverse reactions observed include hypersensitivity reactions (including cases of rash, urticaria and angioedema) and headache. Tabulated list of adverse reactions Frequencies 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 30 known (cannot be estimated from the available data). Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence. MedDRA system Very common Common Uncommon organ class Infections and Upper respiratory Gastroenteritis Influenza infestations tract infection Pharyngitis*** Localised infection Rhinitis*** Conjunctivitis*** Nasopharyngitis Ear infection*** Sinusitis***/**** Bronchitis**** Neoplasms benign, Multiple myeloma malignant and Myelofibrosis unspecified (including cysts and polyps) Blood and lymphatic Bone marrow Aplastic anaemia system disorders disorder* Bone marrow failure Thrombocytopenia* Leucocytosis Anaemia Splenomegaly Thrombocythaemia Platelet count increased

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HOS-095072 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, the overall subject incidence of all adverse reactions for romiplostim-treated subjects was 91.5% (248/271). The mean duration of exposure to romiplostim in this study population was 50 weeks. The most serious adverse reactions that may occur during Nplate treatment include: reoccurrence of thrombocytopenia and bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, medication errors and progression of existing MDS to AML. The most common adverse reactions observed include hypersensitivity reactions (including cases of rash, urticaria and angioedema) and headache. Tabulated list of adverse reactions Frequencies 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 the available data). Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence. MedDRA system Very common Common Uncommon organ class Infections and Upper respiratory tract Gastroenteritis Influenza infestations infection Pharyngitis*** Localised infection Rhinitis*** Conjunctivitis*** Nasopharyngitis Ear infection*** Sinusitis***/**** Bronchitis**** Neoplasms benign, Multiple myeloma malignant and Myelofibrosis unspecified (including cysts and polyps) 8 MedDRA system Very common Common Uncommon organ class Blood and lymphatic Bone marrow Aplastic anaemia system disorders disorder* Bone marrow failure Thrombocytopenia* Leucocytosis Anaemia

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HOS-095068 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to E. coli derived proteins.

HOS-095074 · has-contraindication-information · PDF-Seite 27

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to E. coli derived proteins. 27

HOS-095067 · has-indication-information · PDF-Seite 2

Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Paediatrics: Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). 2

HOS-095073 · has-indication-information · PDF-Seite 25

Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).

HOS-095070 · has-interaction-information · PDF-Seite 7

No interaction studies have been performed. The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown. Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. Platelet counts should be monitored when combining romiplostim with other medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range (see section 4.2). Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1). Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range (see section 4.2).

HOS-095076 · has-interaction-information · PDF-Seite 29

No interaction studies have been performed. The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown. Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. Platelet counts should be monitored when combining romiplostim with other 29 medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range (see section 4.2). Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1). Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range (see section 4.2).

HOS-095077 · has-pregnancy-information · PDF-Seite 30

Pregnancy There are no or limited amount of data from the use of romiplostim in pregnant women. Studies in animals have shown that romiplostim crossed the placenta and increased foetal platelet counts. Post implantation loss and a slight increase in peri-natal pup mortality also occurred in animal studies (see section 5.3). Romiplostim is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding It is unknown whether romiplostim/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from romiplostim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility There is no data available on fertility.

HOS-095071 · has-pregnancy-information · PDF-Seite 7

Pregnancy There are no or limited amount of data from the use of romiplostim in pregnant women. Studies in animals have shown that romiplostim crossed the placenta and increased foetal platelet counts. Post implantation loss and a slight increase in peri-natal pup mortality also occurred in animal studies (see section 5.3). Romiplostim is not recommended during pregnancy and in women of childbearing potential not using contraception. 7 Breast-feeding It is unknown whether romiplostim/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from romiplostim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility There is no data available on fertility.

HOS-095069 · 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. Reoccurrence of thrombocytopenia and bleeding after cessation of treatment Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim. There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents. Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with romiplostim. It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines. Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support. Increased bone marrow reticulin Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines. 5 Increased reticulin may be suggested by morphological changes in the peripheral blood cells and can be detected through bone marrow biopsy. Therefore, examinations for cellular morphological abnormalities using peripheral blood smear and complete blood count (CBC) prior to and during treatment with romiplostim are recommended. See section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials. If a loss of efficacy and abnormal peripheral blood smear is observed in patients, administration of romiplostim should be discontinued, a physical examination should be performed, and a bone marrow biopsy with appropriate staining for reticulin should be considered. If available, comparison to a prior bone marrow biopsy should be made. If efficacy is maintained and abnormal peripheral blood smear is observed in patients, the physician should follow appropriate clinical judgment, including consideration of a bone marrow biopsy, and the risk-benefit of romiplostim and alternative ITP treatment options should be re-assessed. Thrombotic/thromboembolic complications Thrombotic/thromboembolic events including deep vein thrombosis, pulmonary embolism, and myocardial infarction have been observed with the use of romiplostim in the ITP populat

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HOS-095075 · has-warning-information · PDF-Seite 28

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. Reoccurrence of thrombocytopenia and bleeding after cessation of treatment Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim. There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents. Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with romiplostim. It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines. Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support. Increased bone marrow reticulin Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines. Increased reticulin may be suggested by morphological changes in the peripheral blood cells and can be detected through bone marrow biopsy. Therefore, examinations for cellular morphological abnormalities using peripheral blood smear and complete blood count (CBC) prior to and during treatment with romiplostim are recommended. See section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials. If a loss of efficacy and abnormal peripheral blood smear is observed in patients, administration of romiplostim should be discontinued, a physical examination should be performed, and a bone marrow biopsy with appropriate staining for reticulin should be considered. If available, comparison to a prior bone marrow biopsy should be made. If efficacy is maintained and abnormal peripheral blood smear is observed in patients, the physician should follow appropriate clinical judgment, including consideration of a bone marrow biopsy, and the risk-benefit of romiplostim and alternative ITP treatment options should be re-assessed. Thrombotic/thromboembolic complications Thrombotic/thromboembolic events including deep vein thrombosis, pulmonary embolism, and myocardial infarction have been observed with the use of romiplostim in the ITP population. These events have occurred regardless of platelet co

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