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Taxane chemotherapy Pregnancy: SPC section 4.6: Paclitaxel has been shown to be embryotoxic and foetotoxic in rabbits, and to decrease fertility in rats. There is no information on the use of paclitaxel in pregnant women. As with other cytotoxic drugs, paclitaxel may cause foetal harm, and is therefore contraindicated during pregnancy. Women should be advised to avoid becoming pregnant during therapy with paclitaxel, and to inform the treating physician immediately should this occur. It is not known whether paclitaxel is excreted in human milk. Paclitaxel is contraindicated during lactation. Breastfeeding should be discontinued for the duration of paclitaxel therapy.

Paclitaxel (Specialist drug)

Brand names: Taxol, Abraxane (nab-paclitaxel)

Paclitaxel is a specialist intravenous taxane cytotoxic agent used in the treatment of ovarian, breast, lung and other solid tumours.

Adult dose

Dose: Conventional paclitaxel (Paclitaxel 6 mg/ml concentrate for solution for infusion) ONLY - not nab-paclitaxel (Abraxane). Doses are per m2 body surface area, given as an intravenous infusion after premedication. Ovarian carcinoma, first-line (with cisplatin): paclitaxel 175 mg/m2 IV over 3 hours, followed by cisplatin 75 mg/m2, every three weeks; or paclitaxel 135 mg/m2 as a 24-hour infusion, followed by cisplatin 75 mg/m2, with a three week interval between courses. Ovarian carcinoma, second-line: 175 mg/m2 over three hours, with a three week interval between courses. Breast carcinoma, adjuvant (node-positive, following AC therapy): 175 mg/m2 over three hours every three weeks for four courses. Breast carcinoma, first-line: with doxorubicin (50 mg/m2), paclitaxel 220 mg/m2 IV over three hours with a three-week interval between courses, given 24 hours after doxorubicin; with trastuzumab, 175 mg/m2 IV over 3 hours with a 3-week interval between courses. Breast carcinoma, second-line: 175 mg/m2 over three hours, with a three-week interval between courses. Advanced non-small cell lung carcinoma: 175 mg/m2 over three hours, followed by cisplatin 80 mg/m2, with a three week interval between courses. AIDS-related Kaposi's sarcoma: 100 mg/m2 as a three-hour IV infusion every two weeks.
Route: Intravenous infusion through an in-line filter with a microporous membrane 0.22 micrometre; avoid intra-arterial application. Specialist use only: under the supervision of a physician experienced in cancer chemotherapy.
Frequency: Every three weeks (ovarian, breast and non-small cell lung carcinoma regimens); every two weeks (AIDS-related Kaposi's sarcoma).
SCOPE: the SPC pinned for this card is conventional paclitaxel 6 mg/ml concentrate (PL145100035, EBEWE Pharma). The page also names Abraxane (nab-paclitaxel, albumin-bound); no Abraxane regimen is given here, and none of these figures may be applied to it or to any other paclitaxel formulation - other products differ and are not covered. Indications in section 4.1: ovarian carcinoma, breast carcinoma, advanced non-small cell lung carcinoma and AIDS-related Kaposi's sarcoma (limited efficacy data for KS). No maximum dose is printed in section 4.2; none is stated. PREMEDICATION (all patients, section 4.2): corticosteroids, antihistamines and H2 antagonists prior to the infusion - dexamethasone 20 mg oral or IV (oral: approximately 12 and 6 hours before; IV: 30 to 60 min before; 8-20 mg for KS patients); diphenhydramine 50 mg IV, or an equivalent antihistamine such as chlorpheniramine, 30 to 60 min before; cimetidine or ranitidine, printed in the table as '300 mg IV 50 mg IV' 30 to 60 min before (the PDF extraction does not make clear which strength belongs to which drug - check the SPC table before use). SEQUENCING: in combination, give paclitaxel before cisplatin (section 4.4/4.5); with doxorubicin, give paclitaxel 24 hours after doxorubicin. RE-TREATMENT AND DOSE REDUCTION: do not readminister until the neutrophil count is 1,500/mm3 (1,000/mm3 for KS patients) and the platelet count is 100,000/mm3 (75,000/mm3 for KS patients); patients with severe neutropenia (neutrophil count < 500/mm3 for 7 days) or severe peripheral neuropathy should receive a dose reduction of 20% for subsequent courses (25% for KS patients); in KS, if severe mucositis occurs the dose should be reduced by 25% (section 4.4). Subsequent doses are given according to individual patient tolerance. PAEDIATRIC: not recommended below 18 years (lack of data on safety and efficacy). Some sections of the product information we used were incomplete — check the full SPC.

Dose adjustments

Renal

SPC section 4.2 gives no renal dose adjustment (none is printed). Section 4.5: patients treated with paclitaxel and cisplatin may have an increased risk of renal failure compared with cisplatin alone in gynaecological cancers.

Hepatic

SPC section 4.2: inadequate data are available to recommend dosage alterations in patients with mild to moderate hepatic impairment; patients with severe hepatic impairment should not be treated with paclitaxel. Section 4.4: patients with hepatic impairment may be at increased risk of toxicity, particularly grade III-IV myelosuppression; no evidence that toxicity is increased with a three-hour infusion in mildly abnormal liver function, but with a longer infusion increased myelosuppression may be seen in moderate to severe impairment; no data in severe baseline cholestasis.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Severe hypersensitivity to paclitaxel or to any ingredient, especially macrogol glycerol ricinolate (section 4.3)
  • Pregnancy and lactation (section 4.3)
  • Baseline neutrophils < 1,500/mm3 (< 1,000/mm3 for KS patients) (section 4.3)
  • In Kaposi's sarcoma: concurrent, serious, uncontrolled infections (section 4.3)
  • Severe hepatic impairment - should not be treated with paclitaxel (sections 4.2, 4.4)

Side effects

  • Bone marrow suppression (primarily neutropenia) is the dose-limiting toxicity: severe neutropenia (< 500 cells/mm3) in 28% of patients; thrombocytopenia in 11%; anaemia in 64% (severe in 6%) (sections 4.4, 4.8)
  • Neurotoxicity, mainly peripheral neuropathy: more frequent and severe with a 175 mg/m2 3-hour infusion (85% neurotoxicity, 15% severe) than a 135 mg/m2 24-hour infusion (25% peripheral neuropathy, 3% severe) when combined with cisplatin; can persist beyond 6 months after discontinuation (section 4.8)
  • Arthralgia or myalgia in 60% of patients, severe in 13% (section 4.8)
  • Hypersensitivity: significant reaction with possible fatal outcome in < 1% of patients; minor reactions (mainly flushing and rash) in 34% of patients (section 4.8); macrogol glycerol ricinolate may cause severe allergic reactions (section 4.4)
  • Injection site reactions (localised oedema, pain, erythema, induration); extravasation can result in cellulitis, skin sloughing or peeling and discoloration (section 4.8)
  • Cardiovascular: hypotension, hypertension and bradycardia during administration; severe cardiac conduction abnormalities reported rarely; a single case of heart failure related to paclitaxel in the Kaposi's sarcoma clinical study (section 4.4)
  • Pseudomembranous colitis reported rarely; interstitial pneumonitis with lung radiation; contains ethanol (396 mg/ml) - possible CNS effects (section 4.4)
  • Note: the retrieved section 4.8 was truncated at the source-fetch limit (it breaks off at disseminated intravascular coagulation), so this list is not complete

Interactions

  • Cisplatin: give paclitaxel before cisplatin; after cisplatin there is more profound myelosuppression and about a 20% decrease in paclitaxel clearance (section 4.5)
  • Doxorubicin: elimination of doxorubicin and its active metabolites can be reduced when given closer in time - give paclitaxel 24 hours after doxorubicin (section 4.5)
  • CYP2C8 or CYP3A4 inhibitors (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir): use caution - paclitaxel toxicity may be increased (section 4.5)
  • CYP2C8 or CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine): concomitant use not recommended - efficacy may be compromised (section 4.5)
  • Protease inhibitors: paclitaxel clearance was significantly lower with nelfinavir and ritonavir (not with indinavir) in KS patients; use with caution (section 4.5)

Monitoring

  • Frequent monitoring of blood counts; do not retreat until neutrophils and platelets reach the thresholds in section 4.2 (section 4.4)
  • Appropriate supportive equipment available for hypersensitivity reactions; patients must be pretreated with corticosteroids, antihistamines and H2 antagonists (section 4.4)
  • Frequent vital sign monitoring, particularly during the first hour of the infusion (section 4.4)
  • Continuous cardiac monitoring in subsequent therapy if significant conduction abnormalities develop (section 4.4)
  • With doxorubicin or trastuzumab for metastatic breast cancer: baseline cardiac assessment (history, physical examination, ECG, echocardiogram and/or MUGA scan) and cardiac function monitored during treatment, e.g. every three months, and more often (e.g. every 1-2 cycles) if function deteriorates (section 4.4)
  • Hepatic impairment: monitor closely for development of profound myelosuppression (section 4.4)
  • Severe or persistent diarrhoea during or shortly after treatment: consider pseudomembranous colitis (section 4.4)

Clinical monograph

How it works

It binds to tubulin and stabilises microtubules, preventing their depolymerisation and thereby arresting mitosis and inducing cell death.

Prescribing in practice

  • Severe hypersensitivity reactions can occur, so premedication with a corticosteroid and antihistamines is required and infusion must take place where resuscitation facilities are available.
  • Dose-limiting myelosuppression, especially neutropenia, and peripheral neuropathy are common.
  • It is metabolised by CYP2C8 and CYP3A4, so caution is needed with interacting drugs, and the solvent-based formulation contains an excipient that contributes to hypersensitivity risk.

Monitoring

Monitor full blood count before each course and assess for neuropathy and infusion reactions during treatment.

Counselling the patient

  • You will be given premedication to reduce the risk of a reaction; report any flushing, breathlessness or rash during the infusion.
  • Report fever or signs of infection urgently and any numbness or tingling in the hands and feet.

Evidence & guidelines

Use across solid tumours is supported by NICE guidance and landmark taxane trials.

Reference: SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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