Ebetaxel Special Precautions





Firma Vai Hong
Full Prescribing Info
Special Precautions
Paclitaxel should only be administered by specially trained physicians with experience in the use of tumour therapy. Adequate emergency equipment must be kept ready as severe hypersensitivity reactions may occur.
Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.
Patients must undergo prior treatment with corticosteroids, antihistaminic agents and H2 antagonists (see Dosage & Administration).
In combination therapy with cisplatin, paclitaxel must be given initially (see Interactions).
Severe anaphylactic reactions characterised by dyspnoea and hypotension requiring treatment, angioedema and generalised urticaria may occur in less than 1% of patients receiving paclitaxel despite pre-medication treatment. These reactions may be a result of histamine release. In case of severe hypersensitivity reactions, paclitaxel infusion must be discontinued immediately and a symptomatic therapy be initiated. Repeated treatment courses with paclitaxel are contraindicated in these patients.
Myelosuppression (primarily neutropenia) is a dose-limiting reaction. Frequent monitoring of haematological parameters is indicated. Treatment should only be continued after blood counts have adequately recovered and demonstrate neutrophils of at least 1,500/mm³ and platelets of at least 100,000/mm³.
Severe impulse conduction disorders in the heart have been rarely reported after administration of paclitaxel as a single agent. If severe disorders of impulse conduction during paclitaxel therapy occur, adequate treatment should be initiated and careful regular monitoring of the cardiac function must be performed throughout subsequent paclitaxel therapy courses.
Hypotension, hypertension and bradycardia have been observed during paclitaxel therapy; patients were generally asymptomatic and did not require treatment.
Frequent monitoring of vital parameters, especially in the first hour of paclitaxel infusion, is recommended. Severe cardiovascular side effects were more frequently observed in patients with non-small-cell lung cancer than in patients with breast or ovarian cancer.
If paclitaxel is concurrently used with doxorubicin or trastuzumab for initial treatment of metastatic breast cancer, careful monitoring of the cardiac function must be performed.
Patients for whom this combination therapy is recommended should undergo initial examination of the heart including a case history, clinical examination, ECG, echocardiography and/or MUGA scan. Cardiac function should be further monitored during treatment (e.g. every three months). Monitoring may help to identify patients who develop cardiac dysfunction and treating physicians should carefully assess the cumulative dose (mg/m2) of anthracycline administered when making decisions regarding frequency of ventricular function assessment. When testing indicates deterioration in cardiac function, even asymptomatic, treating physicians should carefully assess the clinical benefits of further therapy against the potential for producing cardiac damage, including potentially irreversible damage. If further treatment is administered, monitoring of cardiac function should be more frequent (e.g. every 1-2 cycles). For further information see SPC for Trastuzumab or Doxorubicin.
Peripheral neuropathy commonly occurs during treatment with paclitaxel, but severe symptoms rarely develop. In case of severe peripheral neuropathies a dose reduction by 20% in subsequent treatment courses is recommended.
In patients with non-small-cell lung cancer or ovarian cancer receiving first-line therapy, administration of paclitaxel as a three-hour infusion in combination with cisplatin, neurotoxicity was more common than in patients who were either treated with paclitaxel alone or cyclophosphamide followed by cisplatin.
Patients with hepatic impairment may be at increased risk of toxicity, particularly Grade 3-4 myelosuppression. There is no evidence that toxicity of paclitaxel is increased when given as a 3-hour infusion to patients with mildly abnormal liver function. When paclitaxel is given as a longer infusion, increased myelosuppression may be seen in patients with mild to moderate hepatic impairments. Patients should be monitored closely for the development of profound myelosuppression. Inadequate data are available to recommend dosage alterations in patients with mild to moderate hepatic impairments. No data are available for patients with severe baseline cholestasis. Patients with severe hepatic impairment must not be treated with paclitaxel.
Since paclitaxel contains ethanol (401.66 mg/ml), attention must be paid to a potential impact on the central nervous system or other effects.
Intraarterial application of paclitaxel must be strictly avoided as in animal studies this mode of application has caused severe tissue reactions.
Pseudomembranous colitis has been rarely reported; in some of the cases patients did not receive concomitant therapy with antibiotics. This should be kept in mind in the differential diagnosis of severe or persistent diarrhoea which occurs during or shortly after paclitaxel therapy.
If the use of paclitaxel is combined with radiation therapy on the lungs, irrespective of the order of treatment, it may contribute to the development of interstitial pneumonitis.
Effects on the ability to drive and use machines: Paclitaxel has not been shown to impair the ability to drive and use machines. However, it should be taken into consideration that paclitaxel contains ethanol (see Excipients/Inactive Ingredients under Description and Precautions.).
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