Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.
From the official U.S. FDA label for docetaxel (docetaxel trihydrate), the active ingredient registered with NAFDAC.
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 …
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 …
4. CONTRAINDICATIONS Docetaxel Injection is contraindicated in patients with: • neutrophil counts of
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. …
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 …
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Taxotere 20 mg Concentrate for Solution for Infusion contains Docetaxel (Docetaxel Trihydrate) (20 mg/mL), as concentrate for solution for infusion, according to its NAFDAC registration record.
Yes. Taxotere 20 mg Concentrate for Solution for Infusion is listed on the NAFDAC register under registration number B4-4447, and its registration is active as of 28 October 2026.
No WHO falsified or substandard medical product alert currently matches Taxotere 20 mg Concentrate for Solution for Infusion in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number B4-4447, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
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 ther (Summarised from the official U.S. FDA label for docetaxel (docetaxel trihydrate). Always follow your doctor or pharmacist.)
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