Loading…
PACLITAXEL is a brand name for Paclitaxel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ovarian carcinoma: in the first-line chemotherapy of ovarian cancer, paclitaxel infusion is indicated for the treatment of patients with advanced carcinoma of the ovary or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin. In the second-line chemotherapy of ovarian cancer,…
Verbatim from this product's MHRA label. Tap a section to expand.
g. g. 6). Ovarian carcinoma First-line chemotherapy of ovarian carcinoma: although other dosage regimens are under investigation, a combination regimen of paclitaxel infusion and cisplatin is recommended. 1). Second-line chemotherapy of ovarian carcinoma: the recommended dose of paclitaxel infusion is 175 mg/m² administered over a period of three hours, with a three week interval between courses.
Breast carcinoma Adjuvant chemotherapy in breast carcinoma: the recommended dose of paclitaxel infusion is 175 mg/m² administered over a period of three hours every three weeks for four courses, following AC therapy. First-line chemotherapy of breast carcinoma: when used in combination with doxorubicin (50 mg/m²), paclitaxel infusion should be administered 24 hours after doxorubicin.
1). 1). Paclitaxel infusion may be started the day following the first dose of trastuzumab or immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated (for detailed trastuzumab posology see the Summary of Product Characteristics of trastuzumab).
Second-line chemotherapy of breast carcinoma: the recommended dose of paclitaxel infusion is 175 mg/m² administered over a period of three hours, with a three-week interval between courses. Advanced non-small cell lung carcinoma Treatment of advanced NSCLC: the recommended dose of paclitaxel infusion is 175 mg/m² administered over a period of three hours, followed by cisplatin 80 mg/m², with a three week interval between courses.
AIDS-related Kaposi's sarcoma Treatment of AIDS-related KS: the recommended dose of paclitaxel infusion is 100 mg/m² administered as a three-hour intravenous infusion every two weeks. Subsequent doses of paclitaxel infusion should be administered according to individual patient tolerance.
Paclitaxel infusion should not be readministered until the neutrophil count is 1,500/mm³ ( 1,000/mm³ for KS patients) and the platelet count is 100,000/mm³ ( 75,000/mm³ for KS patients). 4). 2). Patients with severe hepatic impairment should not be treated with paclitaxel.
Paediatric use:
Paclitaxel is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
The frequency and severity of undesirable effects, unless otherwise mentioned, are generally similar between patients receiving paclitaxel for the treatment of ovarian carcinoma, breast carcinoma, or NSCLC. None of the observed toxicities were clearly influenced by age.
The most frequent significant undesirable effect was bone marrow suppression. Severe neutropenia (< 500 cells/mm³) occurred in 28% of patients, but was not associated with febrile episodes. Only 1% of patients experienced severe neutropenia for 7 days.
Thrombocytopenia was reported in 11% of patients. Three percent of patients had a platelet count nadir < 50,000/mm³ at least once while on study. Anaemia was observed in 64% of patients, but was severe (Hb < 5 mmol/l) in only 6% of patients.
Incidence and severity of anaemia is related to baseline haemoglobin status. Neurotoxicity, mainly peripheral neuropathy, appeared to be more frequent and severe with a 175 mg/m2 3-hour infusion (85% neurotoxicity, 15% severe) than with a 135 mg/m2 24-hour infusion (25% peripheral neuropathy, 3% severe) when paclitaxel was combined with cisplatin.
In NSCLC patients and in ovarian cancer patients treated with paclitaxel over three hours followed by cisplatin, there is an apparent increase in the incidence of severe neurotoxicity. 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 several months of paclitaxel discontinuation. Pre-existing neuropathies resulting from prior therapies are not a contraindication for paclitaxel therapy.
Furthermore, it has been demonstrated that peripheral neuropathies can persist beyond 6 months of paclitaxel discontinuation. Arthralgia or myalgia affected 60% of patients and was severe in 13% of patients. A significant hypersensitivity reaction with possible fatal outcome (defined as hypotension requiring therapy, angioedema, respiratory distress requiring bronchodilator therapy, or generalised urticaria) occurred in two (< 1%) of patients.
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.
2). 5). 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 should be discontinued immediately, symptomatic therapy should be initiated and the patient should not be rechallenged with the drug. Bone marrow suppression (primarily neutropenia) is the dose-limiting toxicity.
Frequent monitoring of blood counts should be instituted. Patients should not be retreated until neutrophils recover to 1,500/mm³ ( 1,000/mm³ for KS patients) and platelets recover to 100,000/mm³ ( 75,000/mm³ for KS patients). In the KS clinical study, the majority of patients were receiving granulocyte colony stimulating factor (G-CSF).
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 in those with 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.
4). 6) and should not be used in patients with baseline neutrophils < 1,500/mm³ (< 1,000/mm³ for KS patients). In KS, paclitaxel is also contraindicated in patients with concurrent, serious, uncontrolled infections.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Paclitaxel in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Thirty-four percent of patients (17% of all courses) experienced minor hypersensitivity reactions. These minor reactions, mainly flushing and rash, did not require therapeutic intervention nor did they prevent continuation of paclitaxel therapy.
Injection site reactions during intravenous administration may lead to localised oedema, pain, erythema, and induration; on occasion, extravasation can result in cellulitis. Skin sloughing and/or peeling has been reported, sometimes related to extravasation.
Skin discoloration may also occur. e. “recall”, has been reported rarely. A specific treatment for extravasation reactions is unknown at this time. Below lists undesirable effects regardless of severity associated with the administration of single agent paclitaxel administered as a three hour infusion in the metastatic setting and adverse reactions from post-marketing experience which may be attributed to paclitaxel regardless of the treatment regimen.
The frequency of undesirable effects listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, < 1/100); rare (≥1/10,000, < 1/1,000); very rare (< 1/10,000), and not known (cannot be estimated from the available data).
, hypotension, angioneurotic oedema, respiratory distress, generalised urticaria, chills, back pain, chest pain, tachycardia, abdominal pain, pain in extremities, diaphoresis and hypertension) Rare: anaphylactic reactions Very rare: anaphylactic shock Metabolism and nutrition disorders: Very rare: anorexia Psychiatric disorders: Very rare: confusional state Nervous system disorders: Very common: neurotoxicity (mainly: peripheral neuropathy*) Rare: motor neuropathy (with resultant minor distal weakness) Very rare: autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension), grand mal seizures, convulsions, encephalopathy, dizziness, headache, ataxia * Can persist beyond 6 months of paclitaxel discontinuation Eye disorders: Very rare: optic nerve and/or visual disturbances (scintillating scotomata), particularly in patients who have received higher doses than recommended Ear and labyrinth disorders: Very rare: ototoxicity, hearing loss, tinnitus, vertigo Cardiac disorders: Common: bradycardia Uncommon: cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, AV block and syncope, myocardial infarction Very rare: atrial fibrillation, supraventricular tachycardia Vascular disorders: Very common: hypotension Uncommon: hypertension, thrombosis, thrombophlebitis Very rare: shock Respiratory, thoracic and mediastinal disorders: Rare: dyspnoea, pleural effusion, interstitial pneumonia, lung fibrosis, pulmonary embolism, respiratory failure Very rare: cough Gastrointestinal disorders: Very common: nausea, vomiting, diarrhoea, mucosal inflammation Rare: bowel obstruction, bowel perforation, ischaemic colitis, pancreatitis Very rare: mesenteric thrombosis, pseudomembranous colitis, oesophagitis, constipation, ascites, neutropenic colitis Hepato-biliary disorders: Very rare: hepatic necrosis, hepatic […]
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. 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.
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.
Patients with hepatic impairment may be at increased risk of toxicity, particularly grade III-IV myelosuppression. There is no evidence that the toxicity of paclitaxel is increased when given as a three-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. 2). 2). No data are available for patients with severe baseline cholestasis. Patients with severe hepatic impairment should not be treated with paclitaxel.
Since paclitaxel 6mg/ml infusion contains ethanol (396 mg/ml), consideration should be given to possible CNS and other effects. 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.
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.
Paclitaxel in combination with radiation of the lung, irrespective of their chronological order, may contribute to the development of interstitial pneumonitis. In KS patients, severe mucositis is rare. If severe reactions occur, the paclitaxel dose should be reduced by 25%.
6). Hormonal contraception is contraindicated in hormone receptor positive tumors. This product contains macrogolglycerol ricinoleate which may cause severe allergic reactions.