Ebetaxel (Paclitaxel Ebewe)

Ebetaxel (Paclitaxel Ebewe) Special Precautions



EBEWE Pharma




Mega Lifesciences
Full Prescribing Info
Special Precautions
Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Since significant hypersensitivity reactions may occur, appropriate supportive equipment should be available.
Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during medicinal product administration.
Patients must be pretreated with corticosteroids, antihistamines and H2 antagonists before treatment with paclitaxel (see Dosage & Administration).
Paclitaxel should be given before cisplatin when used in combination (see Interactions).
Significant hypersensitivity reactions characterised by dyspnoea and hypotension requiring treatment, angioedema and generalised urticaria have occurred in <1% of patients receiving paclitaxel after adequate premedication. These reactions are probably histamine-mediated. In the case of severe hypersensitivity reactions, paclitaxel infusion should be discontinued immediately, symptomatic therapy should be initiated and the patient should not be re-challenged with the medicinal product.
Bone marrow suppression (primarily neutropenia) is the dose-limiting toxicity. Frequent monitoring of blood counts should be instituted. Patients should not be re-treated with paclitaxel until neutrophil counts recover to ≥1,500 cells/mm3, (≥1,000/mm3 for KS patients), and platelet counts recover to ≥100,000 platelets/mm3 (≥75,000/mm3 for KS patients). In the KS clinical study, the majority of patients were receiving granulocyte colony stimulating factor (G-CSF).
Patients with hepatic impairment may be at increased risk of toxicity, particularly Grade 3-4 myelosuppression. There is no evidence that the 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 moderate to severe hepatic impairment. Patients should be monitored closely for the development of profound myelosuppression (see Dosage & Administration). Inadequate data are available to recommend dose alterations in patients with mild to moderate hepatic impairments (see Pharmacology: Pharmacokinetics under Actions).
No data are available for patients with severe baseline cholestasis. Patients with severe hepatic impairment must not be treated with paclitaxel.
Severe cardiac conduction abnormalities have been reported rarely with single agent paclitaxel. If patients develop significant conduction abnormalities during paclitaxel administration, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with paclitaxel. Hypotension, hypertension, and bradycardia have been observed during paclitaxel administration. Patients are usually asymptomatic and generally do not require treatment. Frequent vital sign monitoring, particularly during the first hour of paclitaxel infusion, is recommended. Severe cardiovascular events were observed more frequently in patients with NSCLC than breast or ovarian carcinoma. A single case of heart failure related to paclitaxel was seen in the AIDS-KS clinical study.
When paclitaxel is used in combination with doxorubicin or trastuzumab for initial treatment of metastatic breast cancer, attention should be placed on the monitoring of cardiac function. When patients are candidates for treatment with paclitaxel in these combinations, they should undergo baseline cardiac assessment including history, physical examination, ECG, echocardiogram, 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 more details see Summary of Product Characteristics of trastuzumab or doxorubicin.
Although the occurrence of peripheral neuropathy is frequent, the development of severe symptoms is rare. In severe cases, a dose reduction of 20% (25% for KS patients) for all subsequent courses of paclitaxel is recommended. In NSCLC patients and in ovarian cancer patients treated in the first-line setting, the administration of paclitaxel as a three hour infusion in combination with cisplatin, resulted in a greater incidence of severe neurotoxicity than both single agent paclitaxel and cyclophosphamide followed by cisplatin.
Special care should be taken to avoid intra-arterial application of paclitaxel, since in animal studies testing for local tolerance severe tissue reactions were observed after intra-arterial application.
Paclitaxel in combination with radiation of the lung, irrespective of their chronological order, may contribute to the development of interstitial pneumonitis.
Pseudomembranous colitis has been rarely reported including cases in patients who have not been concomitantly treated with antibiotics. This reaction should be considered in the differential diagnosis of cases of severe or persistent diarrhoea occurring during or shortly after treatment with paclitaxel.
In KS patients, severe mucositis is rare. If severe reactions occur, the paclitaxel dose should be reduced by 25%.
[If applicable]: Since [Paclitaxel - parenteral dosage form] contains ethanol (49 Vol-%), consideration should be given to possible CNS and other effects.
[For injectable products containing FM27 in rubber material, e.g. in removable needle shields or tip caps:] Latex-sensitive individuals: The [name of the affected part of the product, e.g. removable needle shield] of Ebetaxel contains a derivative of natural rubber latex. Although no natural rubber latex is detected in the [name of the affected part of the product], the safe use of Ebetaxel in latex-sensitive individuals has not been studied.
Effects on ability to drive and use machines: Paclitaxel has not been demonstrated to interfere with the ability to drive and use machines.
[If applicable]: However, it should be noted that [Paclitaxel - parenteral dosage form] contains alcohol (see Precautions and Description).
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