Anzatax Adverse Reactions





Zuellig Pharma


Full Prescribing Info
Adverse Reactions
The following is based on the experience of 812 patients treated in Phase II and III clinical trials. The frequency and severity of adverse effects are generally similar between patients receiving paclitaxel for the treatment of ovarian, breast or lung cancer.
None of the observed effects were clearly influenced by age. Unless stated otherwise, percent figures, where given, are based on observed incidence when using the recommended dosing regime. If other regimes are used, the incidence of reaction may be higher. Safety of the paclitaxel/platinum combination has been investigated in a large randomised trial in ovarian cancer and in two Phase III trials in NSCLC. Unless otherwise mentioned, the combination of paclitaxel with platinum agents did not result in any clinically relevant changes to the safety profile of single agent paclitaxel.
Adverse effects reported were those occurring during or following the first course of therapy, and have, where possible, been grouped by frequency according to the following criteria. Very common: ≥1/10; Common: ≥1/100 and <1/10; Uncommon: ≥1/1000 and <1/100; Rare: ≥1/10000 and <1/1000; Very rare: <1/10000.
Cardiovascular: Very common: Hypotension.
Common: Bradycardia; ECG abnormalities (non-specific repolarisation and sinus tachycardia).
Uncommon: ECG abnormalities (premature beats). Rare: Myocardial infarction; congestive heart failure (typically in patients who have received other chemotherapy, notably anthracyclines).
Six severe cardiovascular events possibly related to paclitaxel administration occurred including asymptomatic ventricular tachycardia, tachycardia with bigeminy, atrioventricular block (2 patients), and syncopal episodes (2 patients - in one associated with severe hypotension and coronary stenosis resulting in death). Severe hypotensive reactions have been associated with serious hypersensitivity reactions and have required intervention.
Haematological: Very common: Anaemia; neutropenia (Overall, 52% of the patients experienced severe Grade IV neutropenia and 56% had Grade III/IV severe neutropenia on their first course. Neutrophil nadirs occurred at a median of 11 days after paclitaxel administration).
Common: Febrile neutropenia (associated with an infectious episode, including UTI and URTI).
Rare: Five septic episodes, which were associated with severe neutropenia attributable to paclitaxel administration had a fatal outcome.
Patients who have received prior radiation or cisplatin therapy exhibit more frequent myelosuppression, which is generally of greater severity (see Precautions and Interactions).
Reports of thrombocytopenia after paclitaxel therapy are less frequent and less severe than neutropenia, with platelet nadir (<50 x 109 cells/L) observed 8 or 9 days after paclitaxel administration in 5% of patients. Haemorrhage has been reported in patients receiving paclitaxel but this does not appear to be related to thrombocytopenia. Patients (3%) may require platelet transfusions.
Hepatobiliary: Very common: Elevated alkaline phosphatase; elevated AST; elevated ALT.
Common: Elevated bilirubin.
Rare: Hepatic necrosis; hepatic encephalopathy (leading to death).
Hypersensitivity: Very common: Flushing; rash.
Common: Dyspnoea; hypotension; chest pains; tachycardia.
Infections: Febrile neutropenia occurred in 5% of all courses and 30% of all courses were associated with an infectious episode. The most common infections involve the upper respiratory tract, urinary tract and blood (sepsis). In Phase II clinical trials, five septic episodes resulted in death.
Gastrointestinal: Very common: Nausea; vomiting; diarrhoea; mucositis (These manifestations were usually mild to moderate at the recommended dose.)
Rare: Bowel perforation (There have been several cases of bowel perforation associated with patients receiving paclitaxel.
Patients receiving paclitaxel who complain of abdominal pain with other signs and symptoms, should have bowel perforation excluded).
Neutropenic enterocolitis has been reported.
Musculoskeletal: Very common: Arthralgia; myalgia (The symptoms were usually transient occurring two to three days after paclitaxel administration and resolving within a few days.)
Neurological: Very common: Peripheral neuropathy (Peripheral neuropathy occurs and is dose dependent with 60% of patients experiencing Grade I toxicity, 10% Grade II and 2% Grade III at the recommended doses. Neuropathy was present in 87% of patients at higher doses. Severity of symptoms also increased with dose; 4% of patients experienced severe symptoms at the recommended dose versus 10% at higher doses. Neurologic symptoms may occur following the first course and symptoms may worsen with increasing exposure to paclitaxel. Peripheral neuropathy was the cause of paclitaxel discontinuation in 2% of patients. Sensory symptoms have usually improved or resolved within several months of paclitaxel discontinuation.)
Rare: Optic nerve and/or visual disturbances (scintillating scotomata) particularly in patients who have received higher doses than recommended; these effects generally have been reversible; motor neuropathy with resultant minor distal weakness and autonomic neuropathy resulting in paralytic ileus and orthostatic hypotension.
There is a report of a grand mal seizure in a patient receiving paclitaxel and the seizure recurred after treatment with paclitaxel was recommenced. There is also a second report of a grand mal seizure in a patient with significant hepatic impairment during infusion with paclitaxel.
Skin and appendages: Very common: Alopecia.
Rare: Nail and skin changes (mild and transient); radiation-recall dermatitis; recall dermatitis.
Local: Phlebitis following intravenous administration has been reported. Extravasation leading to oedema, pain, erythema and induration has been reported. On occasions, extravasation can lead to cellulitis. Skin discolouration may also occur.
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