lity to drive and use machines
Trastuzumab may have a minor influence on the ability to drive or use machines (see section 4.8). Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
4.8 Undesirable effects
Summary of the safety profile
Amongst the most serious and/or common adverse reactions reported in trastuzumab usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Tabulated list of adverse reactions
In this section, the following categories of frequency have been used: 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, adverse reactions are presented in order of decreasing seriousness.
Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous trastuzumab alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting.
All the terms included are based on the highest percentage seen in pivotal clinical trials
Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8,386) and in post-marketing
System organ class
Adverse reaction
Frequency
Infections and infestations
Infection
Very common
Nasopharyngitis
Very common
Neutropenic sepsis
Common
Cystitis
Common
Herpes zoster
Common
Influenza
Common
Sinusitis
Common
Skin infection
Common
Rhinitis
Common
Upper respiratory tract infection
Common
Urinary tract infection
Common
Erysipelas
Common
Cellulitis
Common
Pharyngitis
Common
Sepsis
Uncommon
Neoplasms benign, malignant and unspecified (incl. Cysts and polyps)
Malignant neoplasm progression
Not known
Neoplasm progression
Not known
Blood and lymphatic system disorders
Febrile neutropenia
Very common
Anaemia
Very common
Neutropenia
Very common
White blood cell count decreased/leukopenia
Very common
Thrombocytopenia
Very common
Hypoprothrombinaemia
Not known
Immune thrombocytopenia
Not known
Immune system disorders
Hypersensitivity
Common
+Anaphylactic reaction
Not known
+Anaphylactic shock
Not known
Metabolism and nutrition disorders
Weight decreased/Weight loss
Very common
Anorexia
Very common
Hyperkalaemia
Not known
Psychiatric disorders
Insomnia
Very common
Anxiety
Common
Depression
Common
Thinking abnormal
Common
Nervous system disorders
1Tremor
Very common
Dizziness
Very common
Headache
Very common
Paraesthesia
Very common
Dysgeusia
Very common
Peripheral neuropathy
Common
Hypertonia
Common
Somnolence
Common
Ataxia
Common
Paresis
Rare
Brain oedema
Not known
Eye disorders
Conjunctivitis
Very common
Lacrimation increased
Very common
Dry eye
Common
Papilloedema
Not known
Retinal haemorrhage
Not known
Ear and labyrinth disorders
Deafness
Uncommon
Cardiac disorders
1Blood pressure decreased
Very common
1Blood pressure increased
Very common
1Heart beat irregular |
