Docetaxel 10 mg/mL Concentrate for Solution for Infusion

1. INDICATIONS AND USAGE Docetaxel Injection is a microtubule inhibitor indicated for: • Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) • Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) • Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer ( 1.3 ) • Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untrea …

• DOSAGE AND ADMINISTRATION For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration ]
• Administer in a facility equipped to manage possible complications (e.g., anaphylaxis)
• Administer in a facility equipped to manage possible complications (e.g., anaphylaxis)
• Administer intravenously (IV) over 1 hour every 3 weeks
• PVC equipment is not recommended. • BC locally advanced or metastatic: 60 mg/m 2 to 100 mg/m 2 single agent • BC adjuvant: 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 cycles • NSCLC: after platinum therapy failure: 75 mg/m 2 single agent • NSCLC: chemotherapy-naive: 75 mg/m 2 followed by cisplatin 75 mg/m 2 • CRPC: 75 mg/m 2 with 5 mg prednisone twice a day continuously • GC: 75 mg/m 2 followed by cisplatin 75 mg/m 2 (both on day 1 only) followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion • SCCHN: 75 mg/m 2 followed by cisplatin 75 mg/m 2 IV (day 1), followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion; for 4 cycles • SCCHN: 75 mg/m 2 followed by cisplatin 100 mg/m 2 IV (day 1), followed by fluorouracil 1000 mg/m 2 per day as a 24-hr IV (days 1-4); for 3 cycles For all patients: • Pre-medicate with oral corticosteroids • Adjust dose as needed Breast Cancer • For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended …

3. DOSAGE FORMS AND STRENGTHS • 20 mg/2 mL multiple-dose vial • 80 mg/8 mL multiple-dose vial • 160 mg/16 mL multiple-dose vial • Multiple-dose vial 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL ( 3 )

• The alcohol content of Docetaxel Injection should be taken into account when given to pediatric patients [ see Warnings and Precautions ]
• The efficacy of docetaxel
• In pediatric patients as monotherapy or in combination has not been established
• 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). …

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly patients. Non-Small Cell Lung Cancer In a study conducted in chemotherapy-naive patients with NSCLC (TAX326), 148 patients (36%) in the docetaxel+cisplatin group were 65 years of age or greater. …

• PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Bone Marrow Suppression Advise patients that periodic assessment of their blood count will be performed to detect neutropenia, thrombocytopenia, and/ or anemia [see Contraindications , Warnings and Precautions ]
• Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever. …

4. CONTRAINDICATIONS Docetaxel Injection is contraindicated in patients with: • neutrophil counts of

7. DRUG INTERACTIONS Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4. In vivo studies showed that the exposure of docetaxel increased 2.2-fold when it was co-administered with ketoconazole, a potent inhibitor of CYP3A4. Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of Docetaxel Injection and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. …

5. WARNINGS AND PRECAUTIONS • Second primary malignancies: In patients treated with docetaxel-containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer. ( 5.7 ) • Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe cutaneous adverse reactions have been reported. Severe skin toxicity may require dose adjustment or permanent treatment discontinuation. ( 5.8 ) • Neurologic reactions: Reactions including paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent. …

6. ADVERSE REACTIONS The most serious adverse reactions from docetaxel are: • Toxic Deaths [see Boxed Warning, Warnings and Precautions ( 5.1 )] • Hepatic Impairment [see Boxed Warning, Warnings and Precautions ( 5.2 )] • Hematologic Effects [see Boxed Warning, Warnings and Precautions ( 5.3 )] • Enterocolitis and Neutropenic Colitis [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Boxed Warning, Warnings and Precautions ( 5.5 )] • Fluid Retention [see Boxed Warning, Warnings and Precautions ( 5.6 )] • Second Primary Malignancies [see Warnings and Precautions ( 5.7 )] • Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] • Neurologic Reactions [ see Warnings an …

8.1 Pregnancy Risk Summary Based on findings in animal reproduction studies and its mechanism of action, Docetaxel Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fet …

10. OVERDOSAGE There is no known antidote for Docetaxel Injection 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/m 2 and the other received 200 mg/m 2 as 1-hour infusions. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.