At the end of the follow-up period (actual median follow-up time of 8 years), lymphedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).In study TAX316, asthenia that started during the treatment period and persisted into the follow- up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%).

The overall safety profile of docetaxel in pediatric patients receiving monotherapy or TCF was consistent with the known safety profile in adults.Docetaxel has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluorouracil (TCF).Docetaxel monotherapy was evaluated in a dose-finding phase 1 trial in 61 pediatric patients (median age 12.5 years, range 1 to 22 years) with a variety of refractory solid tumors. Hypersensitivity reactions may occur within a few minutes following initiation of a Docetaxel Injection infusion. C Phen ® (as a combination product containing Chlorpheniramine, Phenylephrine)see Phenylephrine; C Phen DM ® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)see Phenylephrine; C Phen DM ® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)see Dextromethorphan; C-500 ® Chewable Tabletsee Ascorbic Acid The use of gloves is recommended If Docetaxel Injection initial diluted solution, or final dilution for infusion should come into contact with the skin, immediately and thoroughly wash with soap and water. [see Adverse Reactions (6.1), Clinical Studies (14)][see Dosage and Administration (2.7), Adverse Reactions (6)]Second primary malignancies, notably acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), Non-Hodgkin’s Lymphoma (NHL), and renal cancer, have been reported in patients treated with docetaxel-containing regimens. Diarrhea, abdominal cramping, fever, and It may increase the amount of Taking cyclosporine with certain drugs used to treat cancer may increase the amounts of those medications in your body. All patients should be premedicated with oral corticosteroids (see below for prostate cancer) such as dexamethasone 16 mg per day (e.g., 8 mg twice daily) for 3 days starting 1 day prior to Docetaxel Injection administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions For metastatic castration-resistant 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 Injection infusion Docetaxel Injection in combination with doxorubicin and cyclophosphamide should be administered when the neutrophil count is ≥1,500 cells/mmFor patients who are dosed initially at Docetaxel Injection 75 mg/mCombination therapy with Docetaxel Injection for metastatic castration-resistant prostate cancer Docetaxel Injection should be administered when the neutrophil count is ≥1,500 cells/mmPatients treated with Docetaxel Injection in combination with cisplatin and fluorouracil must receive antiemetics and appropriate hydration according to current institutional guidelines. Docetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. Some may be better suited for you than others. 45963-790-56 Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Docetaxel Injection and for 1 week after the last dose.Verify pregnancy status in females of reproductive potential prior to initiating Docetaxel Injection.Docetaxel Injection can cause fetal harm when administered to a pregnant woman Based on genetic toxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of Docetaxel Injection.Based on findings in animal studies, Docetaxel Injection may impair fertility in males of reproductive potential The alcohol content of Docetaxel Injection should be taken into account when given to pediatric patients The efficacy of docetaxel in pediatric patients as monotherapy or in combination has not been established. Six percent of patients treated with TAC discontinued treatment due to adverse reactions, compared to 1.1% treated with FAC; fever in the absence of infection and allergy being the most common reasons for withdrawal among TAC-treated patients. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).In study TAX316, amenorrhea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%). Notify health care professional immediately if theseoccur. Two patients died in each arm within 30 days of their last study treatment; 1 death per arm was attributed to study drugs.

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