Taxol Adverse Reactions

Unless stated otherwise, the frequencies and severity of adverse reactions on Taxol treatment are generally comparable in individuals with ovarian cancer, breast cancer or non-small cell lung cancer.
The safety profile of Taxol was investigated in clinical studies in >3000 patients. Significant adverse reactions are myelotoxicity, neurotoxicity and hypersensitivity reactions.
Adverse effects are increased with combination therapy with doxorubicin (especially myocardial infarction) and trastuzumab (cardiomyopathy, infections [46% vs 27%]). The combination of Taxol with trastuzumab in individuals who underwent previous anthracycline treatment led to an increased and to more pronounced cardiac disorders compared to patients on Taxol monotherapy (NYHA class I/II 10% vs. 0%; NYHA class III/IV 2% vs. 1%) but was rarely associated with fatalities. With the exception of these rare cases, all individuals responded to an adequate treatment.
The frequency of the listed adverse reactions is defined as follows: "very common" (≥1/10); "common" (<1/10, ≥1/100); "uncommon" (<1/100, ≥1/1,000); "rare" (<1/1,000, ≥1/10,000); "very rare" (<1/10,000); "not known" (cannot be estimated based on the available data).
Infections and infestations: Very common: infection (24%; mainly urinary tract infections, upper respiratory tract infections).
Uncommon: septic shock, pneumonia, peritonitis.
Rare: pneumonia, sepsis.
Benign, malignant and non-specific neoplasias (including cysts and polyps): Very rare: acute myeloid leukaemia, myelodysplastic syndrome.
Blood and lymphatic system disorders: Very common: neutropenia (28-81%), anaemia (78%; Hb <8 g/dl 16%), thrombocytopenia (11%), haemorrhage (14%).
Rare: febrile neutropenia.
Immune system disorders: Very common: milder hypersensitivity reactions (approx. 34%, primarily reddening and skin rash).
Uncommon: severe hypersensitivity reactions requiring treatment (incl. hypotension, angioneurotic oedema, dyspnea, generalized urticaria, oedema, back pain, chills, pneumonitis).
Rare: anaphylactic reactions sometimes with fatal outcome.
For hypersensitivity reactions, see also Hypersensitivity Reactions under Precautions.
Metabolism and nutrition disorders: Very rare: anorexia.
Not known: tumor lysis syndrome.
Psychiatric disorders: Very rare: confusion.
Nervous system disorders: Very common: primarily peripheral neuropathy, especially paraesthesia (66%; on the 3-hour treatment regimen with Taxol/cisplatin 79%, grade III 11%, on the 24-hour regimen with Taxol/cisplatin 24%, grade III 3%).
Rare: motor neuropathy (with mild distal weakness).
Very rare: autonomic neuropathy with resulting paralytic ileus and orthostatic hypotension, grand mal seizures, other convulsions, encephalopathy, dizziness, headaches, ataxia.
Incidence and severity of neurologic manifestations are generally dose-dependent. In 1% of patients, peripheral neuropathy resulted in treatment discontinuation. Paraesthesia generally improved or disappeared within few months of discontinuing Taxol.
Eye disorders: Very rare: reversible optic nerve damage and/or visual disorders (scintillating scotomata), particularly in patients who have received higher doses than recommended.
Not known: macular oedema.
Ear and labyrinth disorders: Very rare: hearing loss and tinnitus, vertigo.
Cardiac disorders: Very common: ECG changes (approx. 17%).
Common: bradycardia (usually mild and did not require treatment).
Uncommon: cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, AV block, syncope, myocardial infarction.
Vascular disorders: Very common: hypotension (approx. 22%).
Uncommon: hypertension, thrombosis, thrombophlebitis.
Respiratory, thoracic and mediastinal disorders: Rare: dyspnoea, pleural effusion, respiratory insufficiency, interstitial pneumonia, pulmonary fibrosis, pulmonary embolism.
Very rare: cough, radiation pneumonia with concomitant radiotherapy.
Gastrointestinal disorders: Very common: nausea/vomiting (43%), diarrhoea (28%), mucositis (18%, observed more frequently on the 24-hour infusion than on the 3-hour infusion); these gastrointestinal adverse reactions are mild to moderate in nature.
Rare: bowel obstruction, bowel perforation, ischaemic colitis, pancreatitis.
Very rare: mesenteric thrombosis, pseudomembranous colitis, oesophagitis, constipation, ascites, neutropenic enterocolitis.
Hepatobiliary disorders: Common: severely elevated (>5x ULN) AST (SGOT) and alkaline phosphatase.
Uncommon: severely elevated bilirubin.
Very rare: liver necrosis (with fatal outcome), hepatic encephalopathy (with fatal outcome).
Skin and subcutaneous tissue disorders: Very common: alopecia (in virtually all cases).
Common: transient and mild changes to nails and skin.
Rare: pruritus, skin rash, phlebitis, erythema, cellulitis, skin flaking, necrosis and fibrosis, recurrence of radiation-induced skin reactions ("radiation recall").
Very rare: Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, exfoliative dermatitis, urticaria, onycholysis.
Not known: scleroderma, cutaneous lupus erythematosus.
Musculoskeletal, connective tissue and bone disorders: Very common: arthralgia, myalgia (60%; severe in 13%).
More severe arthralgia/myalgia was observed in patients who received Taxol as adjuvant therapy for breast cancer than in patients on AC therapy alone.
Not known: systemic lupus erythematosus.
Renal and urinary disorders: Rare: elevated creatinine.
General disorders and administration site conditions: Common: local reactions at the application site in form of localised oedema, pain, erythema, and induration.
Uncommon: cellulitis, skin induration and/or flaking associated with extravasation, skin discoloration.
Rare: asthenia, malaise, fever, dehydration, oedema, recurrence of skin reactions at a site of previous extravasation when Taxol is injected at a different site ("recall").
Local reactions occurred more frequently on the 24-hour infusion than on the 3-hour infusion. They either occurred during the infusion or with a delay of 7-10 days.