Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.3 · PDF-Seite 9

HOS-223645 · Präparat HOS-217212

Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1. Acute diffuse infiltrative pulmonary and pericardial disease.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): boron (HOS-112765)

Gegenanzeigen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.3 · PDF-Seite 9

HOS-223647 · Präparat HOS-217212

When Bortezomib SUN is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.

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Wechselwirkungen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.5 · PDF-Seite 13

HOS-223648 · Präparat HOS-217212

In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4. Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.

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Wechselwirkungen · Bortezomib Sun

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HOS-223649 · Präparat HOS-217212

A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients. Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ketoconazole (HOS-084513) ritonavir (HOS-084521)

Wechselwirkungen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.5 · PDF-Seite 13

HOS-223650 · Präparat HOS-217212

In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 17 patients.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): omeprazole (HOS-085912)

Wechselwirkungen · Bortezomib Sun

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HOS-223651 · Präparat HOS-217212

A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC reduction of 45% based on data from 6 patients. Therefore, the concomitant use of bortezomib with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital and St. John’s Wort) is not recommended, as efficacy may be reduced.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): phenobarbital (HOS-085617) carbamazepine (HOS-085618) phenytoin (HOS-084531)

Wechselwirkungen · Bortezomib Sun

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HOS-223652 · Präparat HOS-217212

In the same drug-drug interaction study assessing the effect of dexamethasone, a weaker CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 7 patients.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dexamethasone (HOS-084535)

Wechselwirkungen · Bortezomib Sun

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HOS-223653 · Präparat HOS-217212

A drug-drug interaction study assessing the effect of melphalan-prednisone on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 17% based on data from 21 patients. This is not considered clinically relevant.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): prednisone (HOS-084526)

Wechselwirkungen · Bortezomib Sun

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HOS-223655 · Präparat HOS-217212

During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving bortezomib treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): glucose (HOS-088412)

Nebenwirkungen · Bortezomib Sun

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HOS-223656 · Präparat HOS-217212

Summary of the safety profile Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy. The most commonly reported adverse reactions during treatment with bortezomib are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.

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Nebenwirkungen · Bortezomib Sun

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HOS-223657 · Präparat HOS-217212

Tabulated summary of adverse reactions 14 Multiple myeloma Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib. These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7. Overall, bortezomib was administered for the treatment of multiple myeloma in 3,974 patients.

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Nebenwirkungen · Bortezomib Sun

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HOS-223658 · Präparat HOS-217212

Adverse reactions are listed below by system organ class and frequency grouping. 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); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 7 has been generated using Version 14.1 of the MedDRA. Post-marketing adverse reactions not seen in clinical trials are also included.

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Nebenwirkungen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 15–19

HOS-223659 · Präparat HOS-217212

Table 7: Adverse reactions in patients with multiple myeloma treated with bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication# System Organ Incidence Adverse reaction Class Infections and Common Herpes zoster (inc disseminated & ophthalmic), infestations Pneumonia*, Herpes simplex*, Fungal infection* Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic#, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection* Rare Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome Neoplasms benign, Rare Neoplasm malignant, Leukaemia plasmacytic, Renal cell malignant and carcinoma, Mass, Mycosis fungoides, Neoplasm benign* unspecified (incl cysts and polyps) Blood and lymphatic Very Thrombocytopenia*, Neutropenia*, Anaemia* system disorders Common Common Leukopenia*, Lymphopenia* Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia# Rare Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura)#, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration Immune system Uncommon Angioedema#, Hypersensitivity* disorders Rare Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction Endocrine disorders Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion Rare Hypothyroidism Metabolism and nutrition Very Decreased appetite disorders Common Common Dehydration, Hypokalaemia*, Hyponatraemia*, Blood 15 System Organ Incidence Adverse reaction Class glucose abnormal*, Hypocalcaemia*, Enzyme abnormality* Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention Rare Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia *, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance Psychiatric disorders Common Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness Rare Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased Nervous system disorders Very Neuropathies*, Peripheral sensory neuropathy, Common Dysaesthesia*, Neuralgia* Common Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache* Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome#, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia Rare Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia, Guillain-Barré syndrome#, Demyelinating polyneuropathy# Eye disorders Common Eye swelling*, Vision abnormal*, Conjunctivitis* Uncommon Eye haemorrhage*, Eyelid infection*, Chalazion#, Blepharitis#, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge Rare Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy#, Different degrees of visual impairment (up to blindness)* Ear and labyrinth Common Vertigo* disorders Uncommon Dysacusis (inc tinnitus)*,Hearing impaired (up to and inc 16 System Organ Incidence Adverse reaction Class deafness), Ear discomfort* Rare Ear haemorrhage, Vestibular neuronitis, Ear disorder NOS Cardiac disorders Uncommon Cardiac tamponade#, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia Rare Atrial flutter, Myocardial infarction*, Atrioventricular block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest Vascular disorders Common Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident#, Deep vein thrombosis*, Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)* Rare Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency Respiratory, thoracic and Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract mediastinal disorders infection*, Cough* Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing Rare Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upper-airway cough syndrome Gastrointestinal disorders Very Nausea and vomiting symptoms*, Diarrhoea*, Common Constipation Common Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic#, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue 17 System Organ Incidence Adverse reaction Class coated, Gastrointestinal motility disorder*, Salivary gland disorder* Rare Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces Hepatobiliary disorders Common Hepatic enzyme abnormality* Uncommon Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis Rare Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis Skin and subcutaneous Common Rash*, Pruritus*, Erythema, Dry skin tissue disorders Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis#, Stevens-Johnson syndrome#, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer#, Acne*, Blister*, Pigmentation disorder* Rare Skin reaction, Jessner's lymphocytic infiltration, Palmar- plantar erythrodysaesthesia syndrome, Haemorrhage subcutaneous, Livedo reticularis, Skin induration, Papule, Photosensitivity reaction, Seborrhoea, Cold sweat, Skin disorder NOS, Erythrosis, Skin ulcer, Nail disorder Musculoskeletal and Very Musculoskeletal pain* connective tissue Common disorders Common Muscle spasms*, Pain in extremity, Muscular weakness Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness, Myopathies*,Sensation of heaviness Rare Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst Renal and urinary Common Renal impairment* disorders Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakiuria Rare Bladder irritation Reproductive system and Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction breast disorders Rare Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration Congenital, familial and Rare Aplasia, Gastrointestinal malformation, Ichthyosis genetic disorders General disorders and Very Pyrexia*, Fatigue, Asthenia administration site Common 18 System Organ Incidence Adverse reaction Class conditions Common Oedema (inc peripheral), Chills, Pain*, Malaise* Uncommon General physical health deterioration*, Face oedema*, Injection site reaction*, Mucosal disorder*, Chest pain, Gait disturbance, Feeling cold, Extravasation*, Catheter related complication*, Change in thirst*, Chest discomfort, Feeling of body temperature change*, Injection site pain* Rare Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia(inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body Investigations Common Weight decreased Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*, C-reactive protein increased Rare Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal* Injury, poisoning and Uncommon Fall, Contusion procedural complications Rare Transfusion reaction, Fractures*, Rigors*, Face injury, Joint injury*, Burns, Laceration, Procedural pain, Radiation injuries* Surgical and medical Rare Macrophage activation procedures NOS=not otherwise specified * Grouping of more than one MedDRA preferred term. # Post-marketing adverse reaction regardless of indication

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Nebenwirkungen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 19

HOS-223660 · Präparat HOS-217212

Mantle cell lymphoma (MCL) The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below. Additional adverse drug reactions identified associated with the use of the combination therapy (BzmbR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%). The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to bortezomib alone. Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anaemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders. Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BzmbR-CAP arm and with at least a possible or probable causal relationship to the components of the BzmbR-CAP arm, are listed in Table 8 below. Also included are adverse drug reactions identified in the BzmbR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.

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Nebenwirkungen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 19–20

HOS-223661 · Präparat HOS-217212

Adverse reactions are listed below by system organ class and frequency grouping. Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); 19 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, undesirable effects are presented in order of decreasing seriousness. Table 8 has been generated using Version 16 of the MedDRA.

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Nebenwirkungen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 20–21

HOS-223662 · Präparat HOS-217212

Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with BzmbR-CAP in a clinical trial System Organ Incidence Adverse reaction Class Infections and Very Pneumonia* infestations common Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex* Uncommon Hepatitis B, Infection*, Bronchopneumonia Blood and lymphatic Very Thrombocytopenia*, Febrile neutropenia, Neutropenia*, system disorders common Leukopenia*, Anaemia*, Lymphopenia* Uncommon Pancytopenia* Immune system Common Hypersensitivity* disorders Uncommon Anaphylactic reaction Metabolism and nutrition Very Decreased appetite disorders Common Common Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*, Diabetes mellitus*, Fluid retention Uncommon Tumour lysis syndrome Psychiatric disorders Common Sleep disorders and disturbances* Nervous system disorders Very Peripheral sensory neuropathy, Dysaesthesia*, Common Neuralgia* Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance Eye disorders Common Vision abnormal* Ear and labyrinth Common Dysacusis (inc tinnitus)* disorders Uncommon Vertigo*, Hearing impaired (up to and inc deafness) Cardiac disorders Common Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock) Vascular disorders Common Hypertension*, Hypotension*, Orthostatic hypotension Respiratory, thoracic and Common Dyspnoea*, Cough*, Hiccups mediastinal disorders Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute) Gastrointestinal disorders Very Nausea and vomiting symptoms*, Diarrhoea*, Common Stomatitis*, Constipation Common Gastrointestinal haemorrhage (inc mucosal)*, Abdominal distension, Dyspepsia, Oropharyngeal pain*, Gastritis*, Oral ulceration*, Abdominal discomfort, Dysphagia, Gastrointestinal inflammation*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder* Uncommon Colitis (inc clostridium difficile)* 20 System Organ Incidence Adverse reaction Class Hepatobiliary disorders Common Hepatotoxicity (inc liver disorder) Uncommon Hepatic failure Skin and subcutaneous Very Hair disorder* tissue disorders Common Common Pruritus*, Dermatitis*, Rash* Musculoskeletal and Common Muscle spasms*, Musculoskeletal pain*, Pain in connective tissue extremity disorders Renal and urinary Common Urinary tract infection* disorders General disorders and Very Pyrexia*, Fatigue, Asthenia administration site Common conditions Common Oedema (inc peripheral), Chills, Injection site reaction*, Malaise* Investigations Common Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased * Grouping of more than one MedDRA preferred term.

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Nebenwirkungen · Bortezomib Sun

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HOS-223663 · Präparat HOS-217212

Description of selected adverse reactions Herpes zoster virus reactivation Multiple myeloma Antiviral prophylaxis was administered to 26% of the patients in the Bzmb+M+P arm. The incidence of herpes zoster among patients in the Bzmb+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.

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Nebenwirkungen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 21

HOS-223664 · Präparat HOS-217212

Mantle cell lymphoma Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzmbR-CAP arm. The incidence of herpes zoster among patients in the BzmbR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).

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Nebenwirkungen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 21

HOS-223665 · Präparat HOS-217212

Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP). The overall incidence of hepatitis B infections was similar in patients treated with BzmbR-CAP or with R-CHOP (0.8% vs 1.2% respectively).

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Nebenwirkungen · Bortezomib Sun

Bortezomib SUN 3.5 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 21

HOS-223666 · Präparat HOS-217212

Peripheral neuropathy in combination regimens Multiple myeloma In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:

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