Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.3 · PDF-Seite 12

HOS-130844 · Präparat HOS-096973

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Breast-feeding (see section 4.6).

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Wechselwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.5 · PDF-Seite 15

HOS-130845 · Präparat HOS-096973

No formal drug interaction studies have been performed. Results from an in vitro test in human hepatocytes suggest that blinatumomab did not affect CYP450 enzyme activities.

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Wechselwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.5 · PDF-Seite 15

HOS-130846 · Präparat HOS-096973

Initiation of BLINCYTO treatment causes transient release of cytokines during the first days of treatment that may suppress CYP450 enzymes. Patients who are receiving medicinal products that are CYP450 and transporter substrates with a narrow therapeutic index should be monitored for adverse effects (e.g. warfarin) or drug concentrations (e.g. cyclosporine) during this time. The dose of the concomitant medicinal product should be adjusted as needed.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): cyclosporine (HOS-084512) warfarin (HOS-085950)

Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 16

HOS-130847 · Präparat HOS-096973

Summary of the safety profile

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 16

HOS-130848 · Präparat HOS-096973

The adverse reactions described in this section were identified in clinical studies of patients with B-cell precursor ALL (N = 1 045).

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 16

HOS-130849 · Präparat HOS-096973

The most serious adverse reactions that may occur during blinatumomab treatment include: infections (22.6%), neurologic events (12.2%), neutropenia/febrile neutropenia (9.1%), cytokine release syndrome (2.7%), and tumour lysis syndrome (0.8%).

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 16

HOS-130850 · Präparat HOS-096973

The most common adverse reactions were: pyrexia (70.8%), infections – pathogen unspecified (41.4%), infusion-related reactions (33.4%), headache (32.7%), nausea (23.9%), anaemia (23.3%), thrombocytopenia (21.6%), oedema (21.4%), neutropenia (20.8%), febrile neutropenia (20.4%), diarrhoea (19.7%), vomiting (19.0%), rash (18.0%), hepatic enzyme increased (17.2%), cough (15.0%), bacterial infectious disorders (14.1%), tremor (14.1%), cytokine release syndrome (13.8%),

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 16–17

HOS-130851 · Präparat HOS-096973

16 leukopenia (13.8%), constipation (13.5%), decreased immunoglobulins (13.4%), viral infectious disorders (13.3%), hypotension (13.0%), back pain (12.5%), chills (11.7%), abdominal pain (10.6%), tachycardia (10.6%), insomnia (10.4%), pain in extremity (10.1%), and fungal infectious disorders (9.6%).

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 17

HOS-130852 · Präparat HOS-096973

Tabulated list of adverse reactions

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 17

HOS-130853 · Präparat HOS-096973

Adverse reactions are presented below by system organ class and frequency category. Frequency categories were determined from the crude incidence rate reported for each adverse reaction in clinical studies of patients with B-cell precursor ALL (N = 1 045). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 17

HOS-130854 · Präparat HOS-096973

MedDRA system Very common Common Uncommon organ class (≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1 000 to < 1/100) Infections and Bacterial infectionsa, b Sepsis infestations Viral infectionsa, b Pneumonia Infections - pathogen Fungal infectionsa, b unspecifieda, b Blood and lymphatic Febrile neutropenia Leukocytosis5 Lymphadenopathy system disorders Anaemia1 Lymphopenia6 Haemophagocytic Neutropenia2 lymphohistiocytosis Thrombocytopenia3 (HLH) Leukopenia4 Immune system Cytokine release Hypersensitivity Cytokine storm disorders syndromea Metabolism and Tumour lysis syndrome nutrition disorders Psychiatric disordersa Insomnia18 Confusional state18 Disorientation18 Nervous system Headache18 Encephalopathy18 Speech disorder18 disordersa Tremor18 Aphasia18 Paraesthesia18 Seizure18 Cognitive disorder18 Memory impairment Dizziness18 Somnolence18 Hypoaesthesia18 Cranial nerve disorderb Ataxia18 Immune effector cell- associated neurotoxicity syndrome (ICANS) Cardiac disorders Tachycardia7 Vascular disorders Hypotension8 Flushing Capillary leak Hypertension9 syndrome Respiratory, thoracic Cough Dyspnoea Dyspnoea exertional and mediastinal Productive cough Acute respiratory disorders Respiratory failure failure Wheezing Gastrointestinal Nausea Pancreatitisa disorders Diarrhoea Vomiting Constipation Abdominal pain Hepatobiliary Hyperbilirubinaemiaa, 10 disorders

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 17–18

HOS-130855 · Präparat HOS-096973

17  MedDRA system Very common Common Uncommon organ class (≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1 000 to < 1/100) Skin and subcutaneous Rash11 tissue disorders Musculoskeletal and Back pain Bone pain connective tissue Pain in extremity disorders General disorders and Pyrexia12 Chest pain14 administration site Chills Pain conditions Oedema13 Investigations Hepatic enzyme Weight increased increaseda, 15 Blood alkaline Decreased phosphatase increased immunoglobulins16 Injury, poisoning and Infusion-related procedural reactions17 complications a Additional information is provided in “Description of selected adverse reactions”. b MedDRA high level group terms (MedDRA version 23.0).

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18

HOS-130856 · Präparat HOS-096973

Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse reaction in the table above. The terms contributing to the relevant adverse reaction are indicated below: 1 Anaemia includes anaemia and haemoglobin decreased. 2 Neutropenia includes neutropenia and neutrophil count decreased. 3 Thrombocytopenia includes platelet count decreased and thrombocytopenia. 4 Leukopenia includes leukopenia and white blood cell count decreased. 5 Leukocytosis includes leukocytosis and white blood cell count increased. 6 Lymphopenia includes lymphocyte count decreased and lymphopenia. 7 Tachycardia includes sinus tachycardia, supraventricular tachycardia, tachycardia, atrial tachycardia and ventricular tachycardia. 8 Hypotension includes blood pressure decreased and hypotension. 9 Hypertension includes blood pressure increased and hypertension. 10 Hyperbilirubinaemia includes blood bilirubin increased and hyperbilirubinaemia. 11 Rash includes erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash pruritic, catheter site rash, rash pustular, genital rash, rash papular and rash vesicular. 12 Pyrexia includes body temperature increased and pyrexia. 13 Oedema includes bone marrow oedema, periorbital oedema, eyelid oedema, eye oedema, lip oedema, face oedema, localised oedema, generalised oedema, oedema, oedema peripheral, infusion site oedema, oedematous kidney, scrotal oedema, oedema genital, pulmonary oedema, laryngeal oedema, angioedema, circumoral oedema and lymphoedema. 14 Chest pain includes chest discomfort, chest pain, musculoskeletal chest pain and non-cardiac chest pain. 15 Hepatic enzyme increased includes alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hepatic enzyme increased, liver function test increased and transaminases increased. 16 Decreased immunoglobulins includes blood immunoglobulin G decreased, blood immunoglobulin A decreased, blood immunoglobulin M decreased, globulins decreased, hypogammaglobulinaemia, hypoglobulinaemia and immunoglobulins decreased. 17 Infusion-related reactions is a composite term that includes the term infusion-related reaction and the following events occurring with the first 48 hours of infusion and event lasted ≤ 2 days: pyrexia, cytokine release syndrome, hypotension, myalgia, acute kidney injury, hypertension, rash, tachypnoea, swelling face, face oedema and rash erythematous. 18 Events may represent ICANS.

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18

HOS-130857 · Präparat HOS-096973

Description of selected adverse reactions

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18

HOS-130858 · Präparat HOS-096973

Neurologic events including ICANS

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18

HOS-130859 · Präparat HOS-096973

In the randomised phase III clinical study (N = 267) and the single-arm phase II clinical study (N = 189) in patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL treated with BLINCYTO, 66.0% of patients experienced one or more neurologic adverse

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18–19

HOS-130860 · Präparat HOS-096973

18 reactions (including psychiatric disorders), primarily involving the CNS. Serious and grade ≥ 3 neurologic adverse reactions were observed in 11.6% and 12.1% of patients respectively, of which the most common serious adverse reactions were encephalopathy, tremor, aphasia, and confusional state. The majority of neurologic events (80.5%) were clinically reversible and resolved following interruption of BLINCYTO. The median time to the first event was within the first 2 weeks of treatment. One case of fatal encephalopathy has been reported in an earlier phase II clinical single-arm study.

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19

HOS-130861 · Präparat HOS-096973

Neurologic events were reported for 62.2% of adult patients with Philadelphia chromosome-positive relapsed or refractory B-cell precursor ALL (N = 45). Serious and grade ≥ 3 neurologic events were reported at 13.3% each in adult patients with Philadelphia chromosome-positive relapsed or refractory B-cell precursor ALL.

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19

HOS-130862 · Präparat HOS-096973

Neurologic events were reported for 71.5% of adult patients with MRD positive B-cell precursor ALL (N = 137), 22.6% of patients experienced serious events. Grade ≥ 3 and grade ≥ 4 events, respectively, were reported for 16.1% and 2.2% of adult patients with MRD positive B-cell precursor ALL.

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Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19

HOS-130863 · Präparat HOS-096973

Neurologic events were reported in 61.2% of adult patients in CD19-positive B-cell precursor ALL in the consolidation phase where BLINCYTO was administered alternating with chemotherapy (N = 147). Grade ≥ 3 and grade ≥ 4 events, respectively, were reported for 28.6% and 2.0% of adult patients with CD19-positive B-cell precursor ALL in the consolidation phase.

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