Severe hypersensitivity reactions (anaphylaxis):
Potentially life-threatening reactions including hypotension, bronchospasm, angio-oedema, and anaphylactic shock.
Related to polyoxyethylated castor oil excipient.
Premedication with corticosteroids, antihistamines, and histamine-2 receptor antagonists is mandatory.
Permanently discontinue if severe reaction occurs.
Myelosuppression (dose-limiting toxicity):
Neutropenia is common and may be severe or febrile.
Increased risk of infection, sepsis, and septic shock.
Delay treatment until recovery of blood counts.
Peripheral neuropathy:
Dose- and cumulative-dependent sensory and motor neuropathy.
May be irreversible with prolonged exposure.
Reduce dose or discontinue if clinically significant.
Cardiotoxicity:
Bradycardia, hypotension, arrhythmias, myocardial ischaemia, and myocardial infarction reported.
Increased risk with prior anthracycline exposure or cardiac disease.
Severe hepatic toxicity:
Elevated liver enzymes, hepatic necrosis, and hepatic encephalopathy reported.
Use with caution in hepatic impairment.
Pregnancy and breastfeeding:
Contraindicated — teratogenic and embryotoxic.
Effective contraception required during treatment and for at least 6 months after completion.
Generic name: Paclitaxel
Brand name: Paclitaxel Viatris®
Drug class: Antineoplastic agent – taxane
Formulation: Concentrate for dilution for intravenous infusion
Strengths: 30 mg, 100 mg, 300 mg vials (6 mg/mL)
Mechanism of Action:
Paclitaxel promotes microtubule assembly and stabilises microtubules by preventing depolymerisation, resulting in inhibition of mitosis and cell death in rapidly dividing cancer cells.
Oncology indications:
Paclitaxel is indicated for the treatment of the following malignancies:
Ovarian cancer
Breast cancer, including use after surgery or in advanced or metastatic disease
Non-small cell lung cancer, in advanced disease
Paclitaxel may be used:
In combination with other anticancer treatments, or
After failure of prior chemotherapy regimens
Route: Intravenous infusion
Dose and schedule: Determined by treating oncologist based on cancer type, treatment regimen, and patient factors
Premedication: Required prior to each infusion to reduce hypersensitivity reactions
Administration: Given as a slow intravenous infusion via a controlled infusion system
Hepatic impairment:
Use with caution; dose adjustment may be required based on liver function tests.
Paediatrics:
Safety and efficacy not established — not indicated.
Haematologic toxicity: Delay or reduce dose in cases of neutropenia, thrombocytopenia, or febrile neutropenia.
Peripheral neuropathy: Dose reduction or discontinuation for Grade 2–4 neuropathy.
Hepatic dysfunction: Adjust dose according to severity of liver enzyme elevation.
Severe hypersensitivity: Permanently discontinue.
Clinically relevant interactions include:
Cisplatin, doxorubicin
Azole antifungals (e.g. ketoconazole)
Macrolide antibiotics (e.g. erythromycin)
Antiretrovirals (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
Antiepileptics (e.g. carbamazepine, phenytoin)
Rifampicin
Clopidogrel
Concomitant use may alter paclitaxel exposure or toxicity — monitor closely.
Hypersensitivity to paclitaxel or polyoxyethylated castor oil
Severe baseline neutropenia
Pregnancy and breastfeeding
Paediatric patients
Baseline and ongoing:
Complete blood count with differential
Liver function tests
Clinical assessment for neuropathy
Vital signs during infusion (blood pressure, heart rate)
Signs of infection or sepsis
| Frequency | Adverse Effect | Management |
|---|---|---|
| Very common | Neutropenia, alopecia, nausea, vomiting, diarrhoea, mucositis | Supportive care, dose adjustment |
| Common | Peripheral neuropathy, hypotension, bradycardia, myalgia, arthralgia | Symptomatic treatment |
| Serious | Febrile neutropenia, sepsis, anaphylaxis, cardiac events | Stop drug, urgent management |
| Rare/Long-term | Acute myeloid leukaemia, myelodysplastic syndrome | Long-term monitoring |
Elderly: Increased toxicity risk — monitor closely.
Hepatic impairment: Use with caution; increased toxicity risk.
Renal impairment: No specific adjustment stated.
Pregnancy/Lactation: Contraindicated.
Fertility: May cause male infertility — fertility preservation should be discussed prior to treatment.
Continue until:
Completion of planned chemotherapy regimen, or
Disease progression, or
Unacceptable toxicity.
Stop immediately if:
Severe hypersensitivity reaction
Life-threatening infection or sepsis
Severe or progressive neuropathy
Significant cardiac or hepatic toxicity
https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2024/05/pil_paclitaxel_20240427.pdf
| Trade Name | |
|---|---|
| Drug Class | Taxanes |
| Cost | |
| Company | |
|---|---|
| Drug Rep | Admin |
| Indications | Breast Cancer, Lung Cancer, Ovarian Cancer |
| Dosage |