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TOP
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Herceptin150 mg powder for concentrate for solution for infu(十一)
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Common
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Renal and urinary conditions
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Renal disorder
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Common
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Glomerulonephritis membranous
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Not known
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Glomerulonephropathy
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Not known
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Renal failure
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Not known
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Pregnancy, puerperium and perinatal disorders
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Oligohydramnios
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Not known
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Reproductive system and breast disorders
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Breast inflammation/mastitis
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Common
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General disorders and administration site conditions
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Asthenia
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Very common
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Chest pain
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Very common
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Chills
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Very common
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Fatigue
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Very common
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Influenza-like symptoms
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Very common
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Infusion related reaction
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Very common
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Pain
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Very common
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Pyrexia
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Very common
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Peripheral oedema
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Common
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Malaise
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Common
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Mucosal inflammation
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Common
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Oedema
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Common
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Injury, poisoning and procedural complications
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Contusion
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Common
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+ Denotes adverse reactions that have been reported in association with a fatal outcome.
1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions. Specific percentages for these are not available.
* Observed with combination therapy following anthracyclines and combined with taxanes
Note: Specific percentage frequencies have been provided in brackets for terms that have been reported in association with a fatal outcome with the frequency designation 'common' or 'very common'. The specific percentage frequencies relate to total number of these events, both fatal and non-fatal.
The following adverse reactions were reported in pivotal clinical trials with a frequency of 1/10 in either treatment arm (in HERA, BO16348 1% at 1 year) and with no significant difference between the Herceptin-containing arm and the comparator arm: lethargy, hypoaesthesia, pain in extremity, oropharyngeal pain, conjunctivitis, lymphoedema, weight increased, nail toxicity, musculoskeletal pain, pharyngitis, bronchitis, chest discomfort, abdominal pain upper, gastritis, stomatitis, vertigo, hot flush, hypertension, hiccups, palmar-plantar erythrodysaesthesia syndrome, breast pain, onychorrhexis, dyspnoea exertional and dysuria.
Description of selected adverse reaction |
