Newtaxel-A

Newtaxel-A

docetaxel

Manufacturer:

Korea United Pharma

Distributor:

Qualimed
Full Prescribing Info
Contents
Docetaxel (as trihydrate).
Description
For 0.5 mL vial: Each vial contains Docetaxel trihydrate equivalent to Docetaxel 20 mg.
Each diluent vial contains Dehydrated ethanol 229.3 mg, Water for Injection q.s. 1.8 mL.
For 2 mL vial: Each vial contains Docetaxel trihydrate equivalent to Docetaxel 80 mg.
Each diluent vial contains Dehydrated ethanol 891.8 mg, Water for Injection q.s. 7 mL.
Action
Pharmacology: Pharmacodynamics: Mechanism of action: Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin. The binding of docetaxel to microtubules does not alter the number of protofilaments.
Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
Pharmacodynamic effects: Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays. Docetaxel achieves high intracellular concentrations with a long cell residence time. In addition, docetaxel was found to be active on some but not all cell lines over expressing the p glycoprotein which is encoded by the multidrug resistance gene. In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
Pharmacokinetics: Following intravenous administration, docetaxel is rapidly distributed to body tissues. It is extensively metabolized via hepatic cytochromes of the CYP3A4 group, and excreted chiefly in the faeces as metabolites. Only about 6% of a dose is excreted in urine within 7 days. The terminal elimination half-life is about 11 hours. Docetaxel is more than 95% bound to plasma proteins in the blood.
Indications/Uses
Breast Cancer: Docetaxel in combination with doxorubicin is indicated for first line therapy of patients with locally advanced or metastatic breast cancer.
Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
Non-Small Cell Lung Cancer: Docetaxel as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
Prostate Cancer: Docetaxel in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.
Ovarian Cancer: Docetaxel in combination with carboplatin is indicated for the first line therapy of patient with advanced ovarian carcinoma of epithelial.
Head and Neck Cancer: Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
Gastric Adenocarcinoma: Docetaxel in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
Esophageal Cancer: Docetaxel is indicated for the treatments of patients with advanced or relapsing esophageal squamous cell carcinoma.
Dosage/Direction for Use
Premedication Regimen: All patients should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day (e.g., 8 mg BID) for 3 days starting 1 day prior to Docetaxel administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. For hormone-refractory metastatic prostate cancer, given the concurrent use of prednisone, the recommended premedication regimen is oral dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before the Docetaxel infusion.
Breast Cancer: For the prior treatment for breast cancer, the recommended dose of Docetaxel in combination with doxorubicin 50 mg/m2 is 75 mg/m2.
The recommended dose of Docetaxel is 60-100 mg/m2 administered intravenously over 1 hour every 3 weeks for failure of prior chemotherapy.
In the adjuvant treatment of operable node-positive breast cancer, the recommended Docetaxel dose is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities.
Non-Small Cell Lung Cancer: The recommended dose is 75-100 mg/m2 administered intravenously over 1 hour every 3 weeks, 75 mg/m2 administered intravenously followed by platinum-based chemotherapy.
Prostate Cancer: For hormone-refractory metastatic prostate cancer, the recommended dose of Docetaxel is 75 mg/m2 every 3 weeks as a 1 hour intravenous infusion. Prednisone 5 mg orally twice daily is administered continuously.
Ovarian Cancer: For the prior treatment of patients with advanced ovarian carcinoma of epithelial, the recommended dose of Docetaxel in combination with carboplatin is 75 mg/m2 1 hour every 3 weeks intravenous infusion, followed by carboplatin AUC 6.0 mg/mL·min administered intravenously as a 30-minute to 1 hour infusion.
*Amount of Carboplatin is calculated by Calvert Formula: Total dose (mg)=tAUC x (GFR+25) used with Cockcroft and Gault and Jelliffe formulas for Glomerular Filtration Rate (GFR).*
Head and Neck Cancer: Patients must receive premedication with antiemetics, and appropriate hydration (prior to and after cisplatin administration). Prophylaxis for neutropenic infections should be administered. All patients treated on the Docetaxel containing arms of the TAX323 and TAX324 studies received prophylactic antibiotics.
Induction chemotherapy followed by radiotherapy (TAX323): For the induction treatment of locally advanced inoperable SCCHN, the recommended dose of Docetaxel is 75 mg/m2 as a 1 hour intravenous infusion followed by cisplatin 75 mg/m2 intravenously over 1 hour, on day one, followed by fluorouracil as a continuous infusion at 750 mg/m2 per day for five days. This regimen is administered every 3 weeks for 4 cycles. Following chemotherapy, patients should receive radiotherapy.
Induction chemotherapy followed by chemoradiotherapy (TAX 324): For the induction treatment of patients with locally advanced (unresectable, low surgical cure, or organ preservation) SCCHN, the recommended dose of Docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3 hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4. This regimen is administered every 3 weeks for 3 cycles. Following chemotherapy, patients should receive chemoradiotherapy.
Gastric Adenocarcinoma: The recommended dose of Docetaxel is 75 mg/m2 as a 1 hour intravenous infusion, followed by cisplatin 75 mg/m2, as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m2 per day given as a 24-hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.
Esophageal Cancer: The recommended dose of Docetaxel for adults is 70 mg/m2 every 3-4 weeks as a 1 hour intravenous infusion once daily.
Dosage Preparation and Administration: Initial Diluted Solution: If the vials are stored under refrigeration, allow the appropriate number of vials of Docetaxel Injection Concentrate and diluent (13% ethanol in water) vials to stand at room temperature for approximately 5 minutes.
Aseptically withdraw the entire contents of the appropriate diluent vial (approximately 1.8 mL for Docetaxel 20 mg and approximately 7.1 mL for Docetaxel 80 mg) into a syringe by partially inverting the vial, and transfer it to the appropriate vial of Docetaxel Injection Concentrate.
Mix the initial diluted solution by repeated inversions for at least 45 seconds to assure full mixture of the concentrate and diluent. Do not shake.
The initial diluted Docetaxel solution (10 mg docetaxel/mL) should be clear; however, there may be some foam on top of the solution due to the polysorbate 80. Allow the solution to stand for a few minutes to allow any foam to dissipate. It is not required that all foam dissipate prior to continuing the preparation process.
The initial diluted solution may be used immediately or stored either in the refrigerator or at room temperature for a maximum of 8 hours.
Final Dilution for Infusion: Aseptically withdraw the required amount of initial diluted Docetaxel solution (10 mg docetaxel/mL) with a calibrated syringe and inject into a 250 mL infusion bag or bottle of either 0.9% Sodium Chloride solution or 5% Dextrose solution to produce a final concentration of 0.3 to 0.74 mg/mL. If a dose greater than 200 mg of Docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/mL Docetaxel is not exceeded.
Thoroughly mix the infusion by manual rotation.
As with all parenteral products, Docetaxel should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and container permit. If the Docetaxel initial diluted solution or final dilution for intravenous infusion is not clear or appears to have precipitation, these should be discarded.
The final Docetaxel dilution for infusion should be administered intravenously as a 1-hour infusion under ambient room temperature and lighting conditions.
Dosage Adjustments During Treatment: Breast Cancer: Patients who are dosed initially at 100 mg/m2 and who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than 1 week, or severe or cumulative cutaneous reactions during Docetaxel therapy should have the dosage adjusted from 100 mg/m2 to 75 mg/m2. If the patient continues to experience these reactions, the dosage should either be decreased from 75 mg/m2 to 55 mg/m2 or the treatment should be discontinued. Conversely, patients who are dosed initially at 60 mg/m2 and who do not experience febrile neutropenia, neutrophils <500 cells/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during Docetaxel therapy may tolerate higher doses. Patients who develop ≥grade 3 peripheral neuropathy should have Docetaxel treatment discontinued entirely.
Docetaxel in combination with doxorubicin and cyclophosphamide should be administered when the neutrophil count is ≥1,500 cells/mm3. Patients who experience febrile neutropenia should receive G-CSF in all subsequent cycles. Patients who continue to experience this reaction should remain on G-CSF and have their Docetaxel dose reduced to 60 mg/m2. Patients who experience Grade 3 or 4 stomatitis should have their Docetaxel dose decreased to 60 mg/m2. Patients who experience severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during Docetaxel therapy should have their dosage of Docetaxel reduced from 75 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/m2, treatment should be discontinued.
Non-Small Cell Lung Cancer: Patients who are dosed initially at 75 mg/m2 and who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or other grade 3/4 non-hematological toxicities during Docetaxel treatment should have treatment withheld until resolution of the toxicity and then resumed at 55 mg/m2. Patients who develop ≥grade 3 peripheral neuropathy should have Docetaxel treatment discontinued entirely.
For patients who are dosed initially at Docetaxel 75 mg/m2 in combination with cisplatin, and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm3, in patients who experience febrile neutropenia, and in patients with serious non-hematologic toxicities, the Docetaxel dosage in subsequent cycles should be reduced to 65 mg/m2. In patients who require a further dose reduction, a dose of 50 mg/m2 is recommended. For cisplatin dosage adjustments, see manufacturers' prescribing information.
Prostate Cancer: Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm3. Patients who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during Docetaxel therapy should have the dosage of Docetaxel reduced from 75 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/m2, the treatment should be discontinued.
Ovarian Cancer: For patients who are dosed initially at Docetaxel 75 mg/m2 in combination with cisplatin or carboplatin, and whose nadir of platelet count during the previous course of therapy is <25,000/mm3 (cisplatin), 75,000/mm3 (carboplatin), in patients who experience febrile neutropenia, and in patients with serious non-hematologic toxicities, the Docetaxel dosage in subsequent cycles should be reduced to 65 mg/m2. For cisplatin dosage adjustments, see manufacturers' prescribing information.
Gastric or Head and Neck Cancer: Patients treated with Docetaxel in combination with cisplatin and 5-fluorouracil must receive antiemetics and appropriate hydration according to current institutional guidelines. In both studies, G-CSF was recommended during the second and/or subsequent cycles in case of febrile neutropenia, or documented infection with neutropenia, or neutropenia lasting more than 7 days. If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite GCSF use, the Docetaxel dose should be reduced from 75 to 60 mg/m2. If subsequent episodes of complicated neutropenia occur the Docetaxel dose should be reduced from 60 to 45 mg/m2. In case of Grade 4 thrombocytopenia the Docetaxel dose should be reduced from 75 to 60 mg/m2. Patients should not be retreated with subsequent cycles of Docetaxel until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3. Discontinue treatment if these toxicities persist.
Recommended dose modifications for toxicities in patients treated with Docetaxel in combination with cisplatin and 5-fluorouracil are shown as follows: (see table.)

Click on icon to see table/diagram/image

Hepatic Impairment: Docetaxel should not be given to patients with bilirubin >upper limit of normal (ULN), or to patients with AST and/or ALT >3.5 x ULN, and ALP >6 x ULN.
Overdosage
There is no known antidote for Docetaxel overdosage. In case of overdosage, the patient should be kept in a specialized unit where vital functions can be closely monitored. Anticipated complications of overdosage include: bone marrow suppression, peripheral neurotoxicity, and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.
In two reports of overdose, one patient received 150 mg/m2 and the other received 200 mg/m2 as 1-hour infusions. Both patients experienced severe neutropenia, mild asthenia, cutaneous reactions, and mild paresthesia, and recovered without incident.
Contraindications
Patients with a history of severe hypersensitivity reactions to Docetaxel or to other drugs formulated with polysorbate 80.
Patients with neutrophil counts of <1,500 cells/mm3; Patients who are pregnant and breast feeding; Patients with systemic infection; Patients with severe hepatic and renal dysfunction; Patients with severe myelosuppression; Patients with interstitial pneumonia; Patients with edema.
Warnings
The incidence of treatment-related mortality associated with Docetaxel therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive Docetaxel as a single agent at a dose of 100 mg/m2.
Docetaxel should generally not be given to patients with bilirubin higher than upper limit of normal (ULN), or to patients with SGOT and/or SGPT more than 1.5 × ULN concomitant with alkaline phosphatase more than 2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase more than 1.5 × ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death. Bilirubin, SGOT or SGPT, and alkaline phosphatase values should be obtained prior to each cycle of Docetaxel therapy and reviewed by the treating physician.
Docetaxel therapy should not be given to patients with neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood cell counts should be performed on all patients receiving Docetaxel.
Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received the recommended 3-day dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the Docetaxel infusion and administration of appropriate therapy. The drug must not be given to patients who have a history of severe hypersensitivity reactions to Docetaxel or to other drugs formulated with polysorbate 80.
Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites).
Special Precautions
Toxic Death: Breast Cancer: Docetaxel administered at 100 mg/m2 was associated with deaths considered possibly or probably related to treatment in 2.0% (19/965) of metastatic breast cancer patients, both previously treated and untreated, with normal baseline liver function and in 11.5% (7/61) of patients with various tumor types who had abnormal baseline liver function (ALT and AST >1.5 times ULN together with ALP >2.5 times ULN). Among patients dosed at 60 mg/m2, mortality related to treatment occurred in 0.6% (3/481) of patients with normal liver function, and in 3 of 7 patients with abnormal liver function. Approximately half of these deaths occurred during the first cycle. Sepsis accounted for the majority of the deaths.
Non-Small Cell Lung Cancer: Docetaxel administered at a dose of 100 mg/m2 in patients with locally advanced or metastatic non-small cell lung cancer who had a history of prior platinum based chemotherapy was associated with increased treatment-related mortality (14% and 5% in two randomized, controlled studies). There were 2.8% treatment-related deaths among the 176 patients treated at the 75 mg/m2 dose in the randomized trials. Among patients who experienced treatment-related mortality at the 75 mg/m2 dose level, 3 of 5 patients had a PS of 2 at study entry.
Used in Pregnancy & Lactation: Docetaxel can cause fetal harm when administered to pregnant women. Studies in both rats and rabbits at doses ≥0.3 and 0.03 mg/kg/day, respectively (about 1/50 and 1/300 the daily maximum recommended human dose on a mg/m2 basis), administered during the period of organogenesis, have shown that Docetaxel is embryotoxic and fetotoxic (characterized by intrauterine mortality, increased resorption, reduced fetal weight, and fetal ossification delay). The doses indicated above also caused maternal toxicity. There are no adequate and well-controlled studies in pregnant women using Docetaxel. If Docetaxel is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Docetaxel.
It is not known whether Docetaxel is excreted in human milk. Because many drugs are excreted inhuman milk, and because of the potential for serious adverse reactions in nursing infants from Docetaxel, a decision should be made whether to discontinue nursing or to discontinue the drug,taking into account the importance of the drug to the mother.
Use in Children: The safety and effectiveness of Docetaxel in pediatric patients have not been established.
Use in Elderly: In a study conducted in chemotherapy-naïve patients with NSCLC (TAX326), 148 patients (36%) in the Docetaxel + cisplatin group were 65 years of age or greater. Patients treated with Docetaxel + cisplatin who were 65 years of age or greater were more likely to experience diarrhea (55%), infections (42%), peripheral edema (39%) and stomatitis (28%) compared to patients less than the age of 65 administered the same treatment (43%, 31%, 31% and 21%, respectively).
When Docetaxel was combined with carboplatin for the treatment of chemotherapy-naïve, advanced non-small cell lung carcinoma, patients 65 years of age or greater experienced higher frequency of infection compared to similar patients treated with Docetaxel + cisplatin, and a higher frequency of diarrhea, infection and peripheral edema than elderly patients treated with vinorelbine + cisplatin.
Of the 333 patients treated with Docetaxel every three weeks plus prednisone in the prostate cancer study (TAX327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years. In patients treated with Docetaxel every three weeks, the following TEAEs occurred at rates ≥10% higher in patients 65 years of age or greater compared to younger patients: anemia (71% vs. 56%), infection (37% vs. 24%), nail changes (34% vs. 23%), anorexia (21% vs. 10%), weight loss (15% vs. 4%) respectively.
Among the 221 patients treated with Docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 54 were 65 years of age or older and 2 patients were older than 75 years. In this study, the number of patients who were 65 years of age or older was insufficient to determine whether they respond differently from younger patients. However, the incidence of serious adverse reactions was higher in the elderly patients compared to younger patients. The incidence of the following adverse reactions (all grades, regardless of relationship): lethargy, stomatitis, diarrhea, dizziness, edema, febrile neutropenia/neutropenic infection occurred at rates >10% higher in patients who were 65 years of age or older compared to younger patients. Elderly patients treated with TCF should be closely monitored.
Among the 174 and 251 patients who received the induction treatment with NEWTAXEL-A in combination with cisplatin and 5-fluorouracil (TPF) for SCCHN in the TAX323 and TAX324 studies, 18 (10%) and 32 (13%) of the patients were 65 years of age or older, respectively.
Use In Pregnancy & Lactation
Docetaxel can cause fetal harm when administered to pregnant women. Studies in both rats and rabbits at doses ≥0.3 and 0.03 mg/kg/day, respectively (about 1/50 and 1/300 the daily maximum recommended human dose on a mg/m2 basis), administered during the period of organogenesis, have shown that Docetaxel is embryotoxic and fetotoxic (characterized by intrauterine mortality, increased resorption, reduced fetal weight, and fetal ossification delay). The doses indicated above also caused maternal toxicity.
There are no adequate and well-controlled studies in pregnant women using Docetaxel. If Docetaxel is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Docetaxel.
It is not known whether Docetaxel is excreted in human milk. Because many drugs are excreted inhuman milk, and because of the potential for serious adverse reactions in nursing infants from Docetaxel, a decision should be made whether to discontinue nursing or to discontinue the drug,taking into account the importance of the drug to the mother.
Adverse Reactions
Hematologic: Reversible marrow suppression was the major dose-limiting toxicity of Docetaxel. The median time to nadir was 7 days, while the median duration of severe neutropenia (<500 cells/mm3) was 7 days. Frequent monitoring of blood counts is essential, and patients should not be given Docetaxel until neutrophil counts recover to a level >1,500/mm3. Febrile neutropenia (<500 cells/mm3), thrombocytopenia (<100,000 cells/mm3), anemia, leucopenia, oligochromemia has been reported. Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported. Very rare cases of acute myeloid leukemia and myelodysplastic syndrome have been reported in association with Docetaxel when used in combination with other chemotherapy agents and/or radiotherapy. Treatment-related acute myeloid leukemia has occurred in 3 of 744 patients (0.4%) who received Docetaxel, doxorubicin and cyclophosphamide and in 1 of 736 patients (0.1%) who received fluorouracil, doxorubicin and cyclophosphamide.
Hypersensitivity Reactions: Hypersensitivity reactions may occur within a few minutes following initiation of a Docetaxel infusion. Minor events, including flushing, rash with or without pruritus, chest tightness, back pain, dyspnea, drug fever, or chills, have been reported. Hypersensitivity reactions require immediate discontinuation of the Docetaxel infusion and administration of appropriate therapy. Docetaxel must not be given to patients who have a history of severe hypersensitivity reactions. Rare cases of anaphylactic shock have been reported. Very rarely these cases resulted in a fatal outcome in patients who received premedication.
Cutaneous: Eruptions generally occurred within 1 week after Docetaxel infusion. Reversible cutaneous reactions characterized by a rash including localized eruptions, mainly on the feet and/or hands, but also on the arms, face, or thorax, usually associated with pruritus, have been observed. Very rare cases of cutaneous lupus erythematosus and rare cases of bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis occurs. In some cases multiple factors may have contributed to the development of these effects.
Nerve System: Severe neurosensory symptoms (paresthesia, dysesthesia, pain) were observed in 4.1% of metastatic breast cancer patients, and resulted in treatment discontinuation in 2%. When these symptoms occur, dosage must be adjusted. If symptoms persist, treatment should be discontinued. Confusion and rare cases of seizures or transient loss of consciousness have been observed, sometimes appearing during the infusion of the drug.
Cardiovascular: Hypotension, sinus tachycardia, atrial flutter, dysrhythmia, unstable angina, pulmonary edema, and hypertension occurred rarely. In combination therapy with Docetaxel, doxorubicin and cyclophosphamide, cardiovascular events were reported; congestive heart failure (2.3% at 70 months median follow-up), one patient died due to heart failure.
Others: Alopecia, arthralgia, myalgia, asthenia, fatigue have been reported. Excessive tearing, which can be related to conjunctivitis or blockage of the tear ducts, may occur. Infusion site reactions were generally mild and consisted of hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation, or swelling of the vein. Diffuse pain, chest pain, radiation recall phenomenon have been reported rarely. When these symptoms occur, dosage must be adjusted or treatment should be discontinued.
Storage
Store at temperatures between 2-8°C under refrigeration. Do not freeze.
ATC Classification
L01CD02 - docetaxel ; Belongs to the class of plant alkaloids and other natural products, taxanes. Used in the treatment of cancer.
Presentation/Packing
Soln for inj 20 mg/0.5 mL [yellow to yellowish brown colored, transparent viscous solution in a vial + 1.8 mL (clear, colorless diluent)] x 1's. 80 mg/2 mL [+ 7 mL (clear, colorless diluent)] x 1's.
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