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Docetaxel 10 mg/mL Concentrate for Solution for Infusion

NAFDAC Reg. No. B4-7683 · Drug

Registered with NAFDAC — registration activeAs of 6 November 2026 · synced automatically from official sources.
Product
Docetaxel 10 mg/mL Concentrate for Solution for Infusion
NAFDAC number
B4-7683
Active ingredient
Docetaxel (Docetaxel Trihydrate)
Strength
10 mg/mL
Form
Concentrate for solution for infusion
Pack size
1 x 2 mL; 1 x 8 mL (in vials)
Manufacturer
Not listed
Applicant (holder)
Novartis Nigeria Limited
Approved
25 May 2023
Status
Active View on NAFDAC ↗
Registration valid to
24 May 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Docetaxel 10 mg/mL Concentrate for Solution for Infusion is on the NAFDAC register with an active registration (B4-7683). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Docetaxel 10 mg/mL Concentrate for Solution for Infusion is used for

From the official U.S. FDA label for docetaxel (docetaxel trihydrate), the active ingredient registered with NAFDAC.

Boxed warning: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with docetaxel 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/m 2 [see Warnings and Precautions ( 5.1 )] . …
What it is used for

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 …

Possible side effects

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 …

Do not use if

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

Warnings

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. …

Pregnancy & breastfeeding

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 …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Docetaxel 10 mg/mL Concentrate for Solution for Infusion

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Docetaxel 10 mg/mL Concentrate for Solution for Infusion

What is in Docetaxel 10 mg/mL Concentrate for Solution for Infusion?

Docetaxel 10 mg/mL Concentrate for Solution for Infusion contains Docetaxel (Docetaxel Trihydrate) (10 mg/mL), as concentrate for solution for infusion, according to its NAFDAC registration record.

Is Docetaxel 10 mg/mL Concentrate for Solution for Infusion registered with NAFDAC?

Yes. Docetaxel 10 mg/mL Concentrate for Solution for Infusion is listed on the NAFDAC register under registration number B4-7683, and its registration is active as of 6 November 2026.

Has Docetaxel 10 mg/mL Concentrate for Solution for Infusion been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Docetaxel 10 mg/mL Concentrate for Solution for Infusion in our automatically synced alert list.

How can I check that my pack of Docetaxel 10 mg/mL Concentrate for Solution for Infusion is genuine?

Run a free authenticity scan with the NAFDAC number B4-7683, 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.

What is Docetaxel 10 mg/mL Concentrate for Solution for Infusion used for?

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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