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ONIVYDE 5 mg/ml concentrate for solution for infusion(七)
hould observe caution when driving or using machines.
4.8 Undesirable effects
Summary of the safety profile
The following adverse reactions, considered to be possibly or probably related to the administration of ONIVYDE, were reported in 264 patients with metastatic adenocarcinoma of the pancreas, 147 of whom received ONIVYDE monotherapy (120 mg/m2) and 117 received ONIVYDE (80 mg/m2) in combination with 5-FU/LV.
The most common adverse reactions (incidence ≥ 20%) of ONIVYDE+5FU/LV were: diarrhoea, nausea, vomiting, decreased appetite, neutropenia, fatigue, asthenia, anaemia, stomatitis and pyrexia. The most common serious adverse reactions (≥ 2%) of ONIVYDE therapy were diarrhoea, vomiting, febrile neutropenia, nausea, pyrexia, sepsis, dehydration, septic shock, pneumonia, acute renal failure, and thrombocytopenia.
The rates of adverse reactions leading to permanent treatment discontinuation were 11% for the ONIVYDE+5-FU/LV arm and 12% for the monotherapy arm.
The most frequently reported adverse reactions leading to discontinuation were infection and diarrhoea for ONIVYDE+5-FU/LV arm, and vomiting and diarrhoea for the monotherapy arm.
Tabulated list of adverse reactions
The adverse reactions that may occur during treatment with ONIVYDE are summarised below and are presented by system organ class and frequency category (Table 3). Within each system organ class and frequency category, adverse reactions are presented in order of decreasing seriousness. Frequencies categories used for adverse reactions are: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100) and rare (≥ 1/10,000 to < 1/1,000)**.
Table 3: Adverse reactions reported with ONIVYDE therapy in the NAPOLI-1 clinical study
MedDRA* system organ class
Adverse reaction frequency**
Infections and infestations
Common: Septic shock, Sepsis, Pneumonia, Febrile neutropenia, Gastroenteritis, Oral candidiasis
Uncommon: Biliary sepsis
Blood and lymphatic system disorders
Very common: Neutropenia, Leukopenia, Anaemia, Thrombocytopenia
Common: Lymphopenia
Immune system disorders
Uncommon: Hypersensitivity
Metabolism and nutrition disorders
Very common: Hypokalaemia, Hypomagnesaemia, Dehydration, Decreased appetite
Common: Hypoglycaemia, Hyponatraemia, Hypophosphataemia
Psychiatric disorders
Common: Insomnia
Nervous system disorders
Very common: Dizziness
Common: Cholinergic syndrome, Dysgeusia
Cardiac disorders
Common: Hypotension
Vascular disorders
Common: Pulmonary embolism, Embolism, Deep vein thrombosis
Uncommon: Thrombosis
Respiratory, thoracic and mediastinal disorders
Common: Dyspnoea, Dysphonia
Uncommon: Hypoxia
Gastrointestinal disorders
Very common: Diarrhoea, Vomiting, Nausea, Abdominal pain, Stomatitis
Common: Colitis, Haemorrhoids
Uncommon: Oesophagitis, Proctitis
Hepatobiliary disorders
Common: Hypoalbuminaemia
Skin and subcutaneous tissue disorders
Very common: Alopecia
Uncommon: Rash maculo-papular, Nail discolouration
Renal and urinary disorders
Common: Acute renal failure
General disorders and administration site conditions
Very common: Pyrexia, Peripheral oedema, Mucosal inflammation, Fatigue, Asthenia
Common: Infusion related reaction, Oedema
Investigations
Very common: Weight decrease
Common: Increased bilirubin, Increased alan |
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