Taxol Special Precautions

Monitoring of Vital Functions: Frequent monitoring of vital functions, especially during the first hours of Taxol infusion, is recommended in all patients. See also Cardiovascular Toxicity as follows.
Observation of the Infusion Site: As extravasation cannot be ruled out, keeping the infusion site under surveillance is recommended. See also Adverse Reactions.
Ethanol: As Taxol contains 0.4 g/ml ethanol, physicians should look out for any CNS and other effects.
Myelosuppression: Regular blood tests are required during Taxol treatment, as myelosuppression (primarily neutropenia) is the dose-limiting factor.
Myelosuppression is more pronounced with the 24-hour infusion compared to the 3-hour infusion. See also Adverse Reactions.
Nervous System: Although peripheral neuropathy is relatively common, severe symptoms occur rarely.
In patients with non-small cell lung cancer and in patients with ovarian cancer (who receive Taxol as first-line treatment), use of combination therapy of Taxol (infusion over 3 hours) and cisplatin resulted in a higher incidence rate of severe neurotoxicity than monotherapy with Taxol.
In patients who received Taxol as adjuvant therapy for breast cancer after anthracycline treatment, severe neurotoxicity was detected more often than in patients on AC therapy alone.
See also Adverse Reactions.
Hypersensitivity Reactions: Severe hypersensitivity reactions such as anaphylaxis have been observed during treatment with Taxol (histamine release). Therefore, premedication with corticosteroid, H₁ and H₂ antagonists must take place (see also Dosage & Administration). In rare cases, reactions were fatal despite appropriate premedication. If severe hypersensitivity reactions occur, the Taxol infusion must be discontinued immediately and symptomatic therapy initiated. Reuse of Taxol should not be be considered in this case.
Cardiovascular Toxicity: Severe cardiac conduction disorders occur rarely. In the case of a significant conduction disorder during Taxol infusion, appropriate therapy should be carried out. Further treatment with Taxol in this case should only be performed under close cardiac monitoring.
Hypotension, hypertension and bradycardia have been observed in patients with healthy hearts on Taxol treatment.
Patients were usually asymptomatic and no treatment was generally necessary.
Severe cardiac events occurred more frequently in individuals with non-small cell lung cancer than in patients with ovarian or breast cancer.
With combination treatment of Taxol with trastuzumab, cardiac function must be monitored by measurement of left ventricular ejection fraction (LVEF).
Non-Small Cell Lung Cancer: With regards to non-small cell lung cancer, there is no experience of treating individuals with brain metastases, individuals >75 years of age or individuals with non-compensated cardiovascular diseases with Taxol. Such patients should only be treated with particular caution.
Hepatic impairment: In the case of mild hepatic impairment, toxicity (especially grade III-IV myelosuppression) from Taxol may be increased. In mild to moderate hepatic impairment, the dose should be adjusted (see Dosage & Administration).
Use of Taxol is not recommended in the case of severe hepatic impairment.
Pseudomembranous colitis: In rare cases, pseudomembranous colitis has been reported during Taxol treatment, including in patients who have not received concurrent antibiotic treatment. This should be considered in the differential diagnosis of severe or persistent cases of diarrhoea occurring during or shortly after treatment with Taxol.
Vaccinations: Concomitant use of Taxol with a live vaccine can greatly accelerate replication of vaccine strains and/or potentiate the adverse reaction to the vaccine strain, as the normal defence mechanisms are potentially suppressed by Taxol. In a patient treated with Taxol, vaccination with a live vaccine can lead to a serious infection. The patient's antibody reaction to the vaccine may be reduced. Use of live vaccines should be avoided and the advice of a specialist should be sought.
Effect on the ability to drive and operate machines: Paclitaxel does not appear to reduce reactions. Impairment of the ability to drive or operate machines due to ethanol and administered premedication should be taken into account.