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Paxene is a brand name for Paclitaxel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Paxene is indicated for the treatment of patients with: – advanced AIDS-related Kaposi’s sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy; – metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy; – advanced carcinoma of the…
Verbatim from this product's EMA label. Tap a section to expand.
6). All patients must be pre-medicated with corticosteroids, antihistamines and H2 antagonists prior to Paxene. The following is a recommended pre-medication regimen: dexamethasone (8 - 20 mg) given orally (12 and 6 hours) or intravenously (30 - 60 mins) prior to Paxene, chlorpheniramine 10 mg intravenously or an equivalent antihistamine 30 to 60 minutes before Paxene and cimetidine (300 mg) or ranitidine (50 mg) intravenously 30 to 60 minutes before Paxene.
Appropriate supportive medicinal products should be readily available in case of severe hypersensitivity reactions. For use of cisplatin in treatment of advanced ovarian carcinoma and non-small cell lung carcinoma, please consult the cisplatin Summary of Product Characteristics for information.
2Medicinal product no longer authorised AIDS-related Kaposi’s sarcoma The recommended dose of Paxene is 100 mg/m2 administered as a 3-hour intravenous infusion every two weeks. Metastatic breast and ovarian cancer (second-line treatment) The recommended dose of Paxene is 175 mg/m2 administered as a 3-hour intravenous infusion every three weeks.
Advanced ovarian carcinoma (first-line treatment) Although other dose regimens/combinations are under investigation, a combination regimen of Paxene and cisplatin is recommended.
According to the duration of infusion, two dose regimes of Paxene are recommended:
Paxene 175 mg/m2 administered as a 3-hour intravenous infusion, followed by cisplatin 75 mg/m2 every three weeks or Paxene 135 mg/m2 as a 24-hour infusion, followed by cisplatin 75 mg/m2 every three weeks. Advanced non-small cell lung carcinoma The recommended dose of Paxene is 175 mg/m2 administered as a 3-hour intravenous infusion, followed by cisplatin at a dose of 80 mg/m2 every three weeks.
Dose adjustments during treatment Metastatic breast carcinoma, ovarian cancer and non-small cell lung carcinoma: Courses of Paxene should not be repeated until the neutrophil count is at least 1,500 cells/mm3 and the platelet count is at least 100,000 cells/mm3.
Patients who experience severe neutropenia (neutrophils < 500 cells/mm3 for a week or longer) or severe peripheral neuropathy during Paxene therapy should have their dose reduced by 20 % (NSCLC and first-line treatment of ovarian cancer) or 25 % (MBC and MOC) for subsequent courses of Paxene.
Monotherapy The following adverse reactions relate to 166 MBC and 120 MOC patients treated with 175 mg/m2 Paxene administered as a 3-hour infusion as second-line chemotherapy in two clinical studies and were considered possibly or probably related to Paxene.
As the AIDS-KS population is very specific, safety data from a clinical study of 107 AIDS-KS patients are presented separately at the end of this section. 6Medicinal product no longer authorised Bone marrow suppression was the major dose-limiting toxicity of Paxene.
Severe neutropenia (< 500 cells/mm3) occurred in 26 % of patients treated with Paxene during the entire treatment period. 19 % of patients had severe neutropenia for > 7 days. Thrombocytopenia was observed in 6 % of patients. Two percent of patients had a platelet count nadir < 50,000 cells/mm3.
Anaemia (Hb< 11 g/dl) was observed in approximately 9 % of treated patients but was severe in less than 1 % (Hb< 8 g/dl). Neuropathy occurred in 18 % of patients treated with Paxene. Paraesthesia was observed in 48 % of patients. Severe neuropathy and severe paraesthesia occurred in 3 % and 5 % of patients, respectively.
Peripheral neuropathy can occur following the first course and can worsen with increasing exposure to paclitaxel. Peripheral neuropathy was the cause of paclitaxel discontinuation in a few cases. Sensory symptoms have usually improved or resolved within months of paclitaxel discontinuation.
Pre-existing neuropathies resulting from prior therapies are not a contraindication for paclitaxel therapy. The other most commonly reported nervous system disorder is somnolence, which affected 14 % of patients. Arthralgia was reported in 32 % of all patients (5 % severe) and myalgia in 47 % (6 % severe).
Injection site reactions including reactions secondary to extravasation were usually mild and consisted of erythema, tenderness, skin discolouration, or swelling at the injection site but can result in cellulitis. e. “recall” has been reported rarely.
2). 5). Hypersensitivity reactions Minor symptoms such as flushing or skin reactions do not require interruption of therapy. However, severe reactions, such as hypotension requiring treatment, dyspnoea requiring bronchodilators, angio-oedema or generalised urticaria require immediate discontinuation of paclitaxel and aggressive symptomatic therapy.
Patients experiencing severe reactions should not be rechallenged with the product. Patients should be observed closely during the initial cycles of treatment. Appropriate supportive therapies should be readily available in case of a severe hypersensitivity reaction.
Haematology Paclitaxel causes bone marrow suppression (particularly neutropenia). Therefore, frequent complete blood counts should be performed on all patients during treatment. Patients with baseline neutrophil counts < 1,500 cells/mm3 (< 1,000 cells/mm3 for AIDS-KS) should not receive paclitaxel.
Patients should not be re-treated with subsequent cycles of paclitaxel until neutrophil counts recover to ≥ 1,500 cells/mm3 (≥ 1,000 cells/mm3 for AIDS-KS patients) and platelets recover to a level of ≥ 100,000 cells/mm3 (≥ 75,000 cells/mm3 for AIDS-KS patients).
2). Mucositis Moderate to severe mucositis is uncommon with the recommended dose and schedule of Paxene. 2). Neuropathy Neuropathy, primarily peripheral sensory neuropathy, occurs very commonly and is usually of mild to moderate intensity.
Severe peripheral neuropathy occurred in 3 % of patients treated with the recommended dose and schedule of Paxene. In the treatment of NSCLC and the first-line treatment of ovarian cancer, the administration of paclitaxel as a 3 hour infusion in combination with cisplatin 4Medicinal product no longer authorised resulted in a greater incidence of severe neurotoxicity than both single-agent paclitaxel and cyclophosphamide followed by cisplatin.
Hypersensitivity to paclitaxel or to any of the excipients. Severe hepatic impairment. Baseline neutrophil count < 1,500 cells/mm3 (< 1,000 cells/mm3 for AIDS-KS). Concurrent, serious, uncontrolled infections. Pregnancy and lactation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients who experience mucositis (Grade 2 or worse) during Paxene therapy should have their dose reduced by 25 % for subsequent courses of Paxene. AIDS-related Kaposi’s sarcoma Courses of Paxene should not be repeated until the neutrophil count is at least 1,000 cells/mm3 and the platelet count is at least 75,000 cells/mm3.
Patients who experience severe neutropenia (neutrophils < 500 cells/mm3 for a week or longer), severe peripheral neuropathy or mucositis (Grade 3 or worse) during Paxene therapy should have their dose reduced by 25 % to 75 mg/m2 for subsequent courses of Paxene.
2). Patients with severe hepatic dysfunction should not be treated with paclitaxel. 2).
Paediatric use:
Safety and efficacy in children and adolescents (under 18 years) has not been established. Therefore, paclitaxel is not recommended for paediatric use. Paxene should be administered via an infusion control device (pump) using non-PVC tubing and connectors.
6). 3Medicinal product no longer authorised
There is no known specific treatment for extravasation reactions. The table below lists undesirable effects associated with the administration of single agent paclitaxel as a 3 hour infusion in the metastatic setting (286 patients treated in Paxene clinical studies and 812 patients treated in other paclitaxel clinical studies), and those reported in the postmarketing surveillance of paclitaxel*.
Where event incidence differed between Paxene and other paclitaxel clinical studies, the most frequent incidence is presented. The frequency of undesirable effects listed below is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. , hypotension, angioneurotic oedema, respiratory distress, generalised urticaria) Rare*: anaphylactic reactions Very rare*: anaphylactic shock (including fatal hypersensitivity) Metabolism and nutrition disorders Very common: anorexia Uncommon: dehydration, weight loss and gain Psychiatric disorders Very rare*: confusional state Nervous system disorders Very common: neuropathy (mainly peripheral), paraesthesia, somnolence Common: severe neuropathy (mainly peripheral), dizziness, nervousness, insomnia, depression, abnormal thinking, hypokinesia, abnormal gait, hypaesthesia, taste perversion, headache Rare*: motor neuropathy (with resultant minor distal weakness) Very rare*: acute encephalopathy, autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension), seizures Eye disorders Uncommon: dry eyes, amblyopia, visual field defect Very rare*: optic nerve and/or visual disturbances (scintillating scotoma), particularly in patients who have received higher doses than recommended Ear and labyrinth disorders Common: tinnitus Very rare*: sensorineural hearing loss, vertigo Cardiac disorders Common: tachycardia, palpitation, bradycardia, syncope Uncommon: congestive heart failure, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, AV block and syncope, myocardial infarction Very rare*: atrial fibrillation Vascular disorders Very common: hypotension Common: vasodilatation (flushing) Uncommon: thrombophlebitis, hypertension, thrombosis Very rare*: shock Respiratory, thoracic and mediastinal disorders Common: dyspnoea, epistaxis 8Medicinal product no longer authorised Rare: pleural effusion, lung fibrosis Very rare*: cough, pulmonary hypertension Gastrointestinal disorders Very common: nausea, vomiting, diarrhoea, mucosal inflammation, constipation, stomatitis, abdominal pain Common: dry mouth, mouth ulceration, melaena, dyspepsia Very rare*: bowel obstruction, bowel perforation, pseudomembranous colitis, ischemic colitis, mesenteric thrombosis, necrotising enterocolitis, oesophagitis, ascites, acute pancreatitis Hepatobiliary disorders Very rare*: hepatic necrosis, hepatic encephalopathy Skin and subcutaneous tissue disorders Very common: alopecia Common: transient skin change, dry skin, exfoliative […]
If severe peripheral neuropathy occurs the benefit of continued treatment should be weighed against the risks. 2). Cardiac conduction abnormalities and arrhythmias In patients treated with paclitaxel severe conduction abnormalities are rare.
Mild electrocardiogram changes have been observed during administration of paclitaxel. Cardiac monitoring is not recommended except in patients with serious conduction abnormalities or arrhythmias. In the rare event of serious conduction abnormalities or arrhythmias, appropriate therapy and continuous cardiac monitoring is recommended during subsequent cycles of therapy.
Hypotension, hypertension and bradycardia have been observed during administration of paclitaxel but patients are usually asymptomatic and do not require therapy. Additionally, in Paxene MBC and MOC studies tachycardia, palpitation and syncope were observed.
Therefore, frequent monitoring of vital signs during the first hours of Paxene infusion is recommended. In the MBC and MOC studies a total of two patients experienced Grade 4 congestive heart failure. A single case of heart failure related to Paxene was seen in the AIDS-KS clinical study.
Severe cardiovascular events were observed more frequently in patients with NSCLC than breast or ovarian carcinoma. Hepatic impairment 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 given as a longer infusion, increased myelosuppression may be seen in patients with moderate to severe hepatic impairment.
2). 2). No data are available for patients with severe baseline cholestasis. Patients with severe hepatic impairment should not be treated with paclitaxel. Gastrointestinal 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. 7). Paclitaxel, particularly in combination with radiation of the lung and/or gemcitabine, irrespective of their chronological order, may contribute to the development of interstitial pneumonitis.
Like other genotoxic cytostatics, paclitaxel can have genotoxic effects. Male patients treated with Paxene are advised not to father a child during and up to six months after treatment. Paxene contains polyoxyl castor oil, which can cause an allergic reaction.
5Medicinal product no longer authorised Since Paxene contains ethanol, consideration should be given to possible central nervous system and other effects. The amount of alcohol in this medicinal product may alter the effects of other medicines.