Summary of safety profile The overall safety profile of Teysuno in combination with cisplatin is based primarily on clinical study data from 593 patients with advanced gastric cancer treated with this regimen. In addition, there is post-marketing experience in over 866,000 Asian (mainly Japanese) patients.
Among 593 patients treated with Teysuno in combination with cisplatin, the most common severe adverse reactions (Grade 3 or higher with frequency of at least 10%) were neutropaenia, anaemia, and fatigue. Tabulated list of adverse reactions The following headings are used to rank the adverse reactions by frequency: 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), and not known (cannot be estimated from the available data).
The frequencies of very common, common, and uncommon adverse reactions are from 593 patients treated with Teysuno in combination with cisplatin in clinical trials. The frequencies of medically relevant rare and very rare adverse reactions are estimated from post-marketing surveillance of 866,000 patients in Asia (mostly Japanese) treated with Teysuno-based therapy.
Each term is presented in its most common category only and within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 9:
Adverse reactions reported by decreasing seriousness in each frequency grouping System Organ Classa Very common Common Uncommon Rare / Very rare 17 Infections and infestations Neutropenic sepsis, septic shock, sepsis, infection, pneumonia, bacteremia, respiratory tract infection, upper respiratory tract infection, pyelonephritis acute, urinary tract infection, pharyngitis, nasopharyngitis, rhinitis, tooth infection, candidiasis, oral herpes, paronychia, furuncle Hepatitis B reactivation Neoplasms benign, malignant and unspecified (Incl.
cysts and polyps) Tumour haemorrhage, cancer pain Blood and lymphatic system disorders Neutropenia, leukopenia, anaemia, thrombo- cytopenia Febrile neutropenia, lymphopenia Pancytopenia, prothrombin time prolonged, international normalised ratio increased, hypoprothrombinaemia, prothrombin time shortened, granulocytosis, leukocytosis, eosinophilia, lymphocytosis, monocyte count decreased, monocyte count increased, thrombocythaemia Disseminated intravascular coagulation Immune system disorders Hypersensitivity Endocrine disorders Adrenal haemorrhage Metabolism and nutrition disorders Anorexia Dehydration, hypokalaemia, hyponatraemia, hypocalcaemia, hypomagnesaemia, hypoalbuminaemia, hyperkalaemia Hyperglycaemia, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, hypophosphatameia, hypermagnesaemia, gout, hypoproteinaemia, hyperglobulinaemia, hyperlipidaemia, oral intake reduced Hyperammonaemia Psychiatric disorders Insomnia Confusional state, restlessness, personality disorder, hallucination, depression, anxiety, libido decreased, sexual inhibition Nervous system disorders Peripheral neuropathy Dizziness, headache, dysgeusia Cerebrovascular accident, cerebellar infarction, cerebrovascular disorder, convulsion, ischaemic stroke, syncope, hemiparesis, aphasia, ataxia, metabolic encephalopathy, loss of consciousness, acoustic neuritis, memory impairment, balance disorder, somnolence, tremor, ageusia, parosmia, burning sensation, formication Leukoenceph- alopathy, anosmia Eye disorders Vision disorder, lacrimal disorder, conjunctivitis, corneal disorder b Eye allergy, eyelid ptosis, erythema of eyelid Ear and labyrinth disorders Hearing impairment, deafness Vertigo, ear congestion, ear discomfort Cardiac disorders Cardiac failure, acute myocardial infarction, pericardial effusion, atrial fibrillation, angina pectoris, cardiac fibrillation, tachycardia, palpitations Vascular disorders Hypotension, deep vein thrombosis, hypertension Iliac artery thrombosis, hypovolaemic shock, arterial limb thrombosis, thrombosis, flushing, pelvic venous thrombosis, thrombophlebitis, phlebitis, phlebitis superficial, orthostatic hypotension, haematoma, hyperaemia, hot flush Respiratory, thoracic and mediastinal disorders Dyspnoea, epistaxis, hiccups, cough Pulmonary embolism, respiratory tract haemorrhage, exertional dyspnoea, pharyngolaryngeal pain, rhinorrhoea, pharyngeal erythema, rhinitis allergic, dysphonia, productive cough, nasal congestion Interstitial lung disease 18 Gastrointestinal disorders Diarrhoea, vomiting, nausea, constipation Gastrointestinal haemorrhage, stomatitis, gastrointestinal inflammation, flatulence, abdominal pain, dysphagia, abdominal discomfort, dyspepsia, dry mouth Gastrointestinal perforation, oesophagitis, gastrointestinal infection, ileus, gastrointestinal obstruction, ascites, lip oedema, oesophageal spasm, gastric ulcer, gastroesophageal reflux disease, reflux gastritis, retroperitoneal fibrosis, gastrointestinal disorder, anal haemorrhage, haemorrhoids, salivary hypersecretion, retching, salivary gland disorder, cheilitis, aerophagia, eructation, glossodynia, oral pain, teeth brittle Acute pancreatitis, terminal ileitis Hepatobiliary disorders Hyperbilirubinemia, alanine aminotransferase increased, aspartate aminotransferase increased Liver function test abnormal, gamma glutamyltransferase increased Acute hepatic failure Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome, rash, skin hyperpigmentation, dry skin, pruritus, alopecia, Exfoliative rash, skin exfoliation, necrolytic migratory erythema, blood blister, dermatitis allergic, skin reaction, dermatitis acneiform, erythema, increased tendency to bruise, purpura, hyperhidrosis, night sweats, nail atrophy, pigmentation disorder, skin discoloration, hypertrichosis Toxic epidermal necrolysis, Stevens- Johnson syndrome, photosensitivity reaction, nail disorder 19 Musculoskeletal and connective tissue disorders Musculoskeletal pain Muscle spasms, arthralgia, pain in extremity, back pain, neck pain, bone pain, […]