Registered Kenya · PPB

DOCEXAN 80MG INJECTION

DOCETAXIL 80MG INJECTION

H2022/CTD10270/22254 DOCETAXIL USP 80MG INJECTION GENERIC/BIOSIMILARS

What it does

Docetaxel is a medication used to treat certain types of cancer.

Commonly used for: breast cancer, lung cancer, prostate cancer, gastric cancer

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2022/CTD10270/22254
Registration date
-
Expiry date
2028 June 26
Status
Registered
Active ingredient
DOCETAXIL 80MG INJECTION
Strength
-
Pack size
1 X 1S VIAL
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Generics Africa
Applicant / LTR
BEACON MEDICARE LIMITED
Country of origin
FOREIGN
Manufacturer location
Generics Africa Limited, RAFIKI BUSINESS PARK, OFF THIKA SUPER HIGHWAY, RING ROAD, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:31:08 · updated 2026-09-18 02:23:33

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Docetaxel is a medication used to treat certain types of cancer.

What it treats

  • breast cancer
  • lung cancer
  • prostate cancer
  • gastric cancer

How it works

Docetaxel works by stopping cancer cells from growing and dividing, which helps to slow down or stop the spread of the cancer.

Who it's for

This medicine is for adults with specific types of cancer as determined by their doctor.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: docetaxil

Docetaxel is a chemotherapeutic agent belonging to the taxane family. It is primarily used in the treatment of various malignancies, including breast cancer, non-small cell lung cancer, prostate cancer, and gastric cancer. Docetaxel works by inhibiting microtubule depolymerization, thus preventing cell division and leading to apoptosis in rapidly dividing cells.

Indications

  • Breast cancer
  • Non-small cell lung cancer
  • Prostate cancer
  • Gastric cancer
  • Head and neck cancer

Dosage

Children: There is limited information on the use of docetaxel in children. Refer to the BNF for Children for guidance on potential paediatric dosing.

Adults: Dosage varies based on the specific cancer type and treatment protocol. Refer to clinical guidelines or the BNF for specific dosing regimens.

Mechanism of action

Docetaxel binds to the beta-tubulin subunit of microtubules, promoting microtubule polymerization and stabilizing the microtubule structure. This action disrupts the normal mitotic spindle formation, thereby inhibiting mitosis and resulting in cell cycle arrest in the G2/M phase. The drug ultimately leads to apoptosis in cancer cells.

Pharmacodynamics

Docetaxel exhibits dose-dependent cytotoxicity against various cancer cell lines. The drug's antitumor activity is attributed to its ability to inhibit the normal dynamics of microtubules, which are essential for cell division. This interference with the mitotic process leads to a reduction in tumor cell proliferation.

Pharmacokinetics

Docetaxel is administered intravenously and has a bioavailability of nearly 100%. It is extensively metabolized in the liver by cytochrome P450 enzymes, primarily CYP3A4, and has a half-life of approximately 36 hours. The drug is excreted mainly in the feces, with a small percentage eliminated in the urine. The volume of distribution is high, indicating significant tissue binding.

Contra-indications

  • Hypersensitivity to docetaxel or any of its excipients
  • Severe liver impairment
  • Neutrophil count less than 1500 cells/mm³ (before starting treatment)
  • Pregnancy

Adverse effects

  • Myelosuppression
  • Nausea and vomiting
  • Alopecia
  • Peripheral edema
  • Fatigue
  • Diarrhea
  • Stomatitis
  • Hypersensitivity reactions
  • Fluid retention

Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase docetaxel concentrations
  • CYP3A4 inducers (e.g., rifampicin, St. John's Wort) may decrease docetaxel concentrations
  • Concomitant use with other myelosuppressive agents may increase the risk of severe bone marrow suppression

Precautions

  • Monitor blood counts regularly during treatment
  • Use caution in patients with liver disease or impaired liver function
  • Ensure proper hydration to minimize fluid retention
  • Administer antihistamines and corticosteroids to mitigate hypersensitivity reactions

Pregnancy

Docetaxel is contraindicated in pregnancy due to potential harm to the fetus. Effective contraception is advised during treatment.

Breast-feeding

It is not known whether docetaxel is excreted in human milk. Due to potential serious adverse effects in nursing infants, breastfeeding is not recommended during treatment.

Storage

Store in a refrigerator (2-8 degrees Celsius). Protect from light. Do not freeze.

Formulations

  • Injection: 20 mg/1 mL, 80 mg/4 mL
  • Concentrate for solution for infusion

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.