Docetaxel

🔴 Red Flag (Important) Information

(Main things clinicians must consider)

• Severe neutropenia and infection risk → FBC must be checked before every cycle.

• Premedication with corticosteroids (e.g. dexamethasone) is mandatory → reduces hypersensitivity reactions and fluid retention.

• Potentially fatal hypersensitivity reactions → more likely during first or second infusion.

• Severe gastrointestinal toxicity (enterocolitis, perforation) → abdominal pain + diarrhoea + fever is an emergency.

• Interstitial lung disease and respiratory failure → stop immediately if new or worsening dyspnoea/cough.

• Hepatotoxicity risk → contraindicated in severe liver impairment.

• Contains ethanol → caution in liver disease, epilepsy, alcohol dependence.

🔹 1. Basic Information

Generic name: Docetaxel
Brand name: Docetaxel Teva
Drug class: Taxane (antimitotic chemotherapy agent)
Formulation: Concentrate for solution for IV infusion
Strengths: 20 mg vial, 80 mg vial

Mechanism of Action:
Promotes microtubule stabilisation and prevents depolymerisation → inhibits mitosis → leads to cancer cell death.

🔹 2. Indications (FULL – As per Approved SAHPRA PI)

Docetaxel is indicated for the treatment of the following malignancies:

• Breast cancer

• Ovarian cancer

• Non-small cell lung cancer (NSCLC)

• Prostate cancer

• Head and neck cancer

(No further line-of-therapy or combination restrictions are specified in the approved PI.)

🔹 3. Dosing & Administration

• Dose is calculated based on body surface area (mg/m²)

• Administered as intravenous infusion

• Typical schedule: Once every 3 weeks

• Infusion duration: Approximately 1 hour

• Administered in a hospital or oncology unit under specialist supervision

Premedication:

• Oral corticosteroid (e.g. dexamethasone)

• Start 1 day before infusion and continue for 1–2 days after

🔹 4. Dose Modifications

Dose and schedule may be adjusted based on:

• Neutropenia or febrile neutropenia

• Severe diarrhoea or mucositis

• Hepatic dysfunction

• Peripheral neuropathy

• Other Grade ≥3 toxicities

Discontinue permanently for:

• Severe hypersensitivity reactions

• Life-threatening gastrointestinal toxicity

• Severe lung toxicity

🔹 5. Co-medications / Interactions

Commonly used with:

• Corticosteroid premedication

• Growth factors (e.g. G-CSF) if high neutropenia risk

Avoid or use with caution:

• Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole)

• HIV protease inhibitors

• Concomitant alcohol-containing medicines

🔹 6. Contraindications

• Hypersensitivity to docetaxel or excipients

• Baseline neutropenia

• Severe hepatic impairment

• Pregnancy and breastfeeding

• Children and adolescents (<18 years)

🔹 7. Monitoring Requirements

Before each cycle:

• Full blood count (mandatory)

• Liver function tests

• Clinical assessment for infection or bleeding

During treatment:

• Monitor for diarrhoea, abdominal pain, fever

• Monitor respiratory symptoms

• Assess for neuropathy and fluid retention

🔹 8. Side Effects (Clinically Relevant)

Very Common / Common

• Neutropenia, anaemia, thrombocytopenia

• Diarrhoea, nausea, vomiting

• Alopecia

• Fatigue, flu-like symptoms

• Peripheral oedema and fluid retention

• Mucositis

Serious

• Febrile neutropenia

• Severe hypersensitivity reactions

• Gastrointestinal perforation or enterocolitis

• Interstitial lung disease

• Hepatotoxicity

• Thromboembolic events

🔹 9. Use in Special Populations

• Hepatic impairment: Contraindicated if severe

• Renal impairment: No specific adjustment stated

• Elderly: Increased toxicity risk → monitor closely

• Fertility: May impair male fertility

🔹 10. Duration of Use / When to Stop

Continue until:

• Completion of planned chemotherapy course, or

• Disease progression, or

• Unacceptable toxicity

Permanently discontinue for:

• Life-threatening toxicity

• Recurrent severe adverse events despite dose reduction

https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2024/08/Docetaxel-Teva_PIL_June24.pdf