Tyrosine Kinase Inhibitor (HCC) Pregnancy: §4.6: there are no data on the use of sorafenib in pregnant women; animal studies have shown reproductive toxicity including malformations and sorafenib crosses the placenta in rats, so harmful foetal effects are anticipated. Sorafenib should not be used during pregnancy unless clearly necessary, after careful consideration of the needs of the mother and the risk to the foetus. Women of childbearing potential must use effective contraception during treatment. Women must not breast-feed during sorafenib treatment. Animal studies indicate sorafenib can impair male and female fertility.

Sorafenib

Brand names: Nexavar

Sorafenib is an oral multikinase inhibitor used in hepatocellular carcinoma and certain other cancers, prescribed under specialist oncology supervision.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 400 mg (two 200 mg tablets)

Route: Oral

Frequency: Twice daily

Max: 800 mg total daily dose — §4.2 states 400 mg twice daily is equivalent to a total daily dose of 800 mg (this is the recommended dose; no separate maximum is stated)

UK SPC (Sorafenib 200 mg film-coated tablets, Sorafenib Zentiva) §4.2: the recommended dose in adults is 400 mg sorafenib (two tablets of 200 mg) twice daily, equivalent to a total daily dose of 800 mg. Treatment should be supervised by a physician experienced in the use of anticancer therapies and should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. DOSE REDUCTIONS: management of suspected adverse reactions may require temporary interruption or dose reduction. In hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC), reduce to two tablets of 200 mg (400 mg) once daily. In differentiated thyroid carcinoma (DTC), reduce to 600 mg daily in divided doses (two 200 mg tablets and one 200 mg tablet twelve hours apart); if further reduction is needed, 400 mg daily in divided doses (two 200 mg tablets twelve hours apart), and if necessary further to one 200 mg tablet once daily. After improvement of non-haematological adverse reactions the dose may be increased. ADMINISTRATION: for oral use; take without food or with a low or moderate fat meal — if a high-fat meal is intended, take at least 1 hour before or 2 hours after the meal; swallow tablets with a glass of water. PAEDIATRIC: safety and efficacy in children and adolescents aged under 18 years have not yet been established; no data are available — no paediatric dose exists. Elderly: no dose adjustment required in patients above 65 years. Hepatic impairment: no dose adjustment required in Child-Pugh A or B; no data in Child-Pugh C. NOTE: the eMC §4.5 interactions section was not captured in the source bundle — the interactions listed below are from US labelling §7 and must be verified against the UK SPC §4.5.

Dose adjustments

Renal

§4.2: no dose adjustment is required in patients with mild, moderate or severe renal impairment. No data are available in patients requiring dialysis. Monitoring of fluid balance and electrolytes is advised in patients at risk of renal dysfunction.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients (eMC §4.3)
US labelling §4 (not in the UK SPC §4.3 text fetched): sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

Side effects

Diarrhoea (very common)
Fatigue (very common)
Hand foot skin reaction / palmar-plantar erythrodysaesthesia and rash (very common)
Alopecia and infection (very common)
Hypertension, including hypertensive crisis
Haemorrhage (including gastrointestinal, respiratory tract and cerebral haemorrhage)
Most important serious reactions per §4.8: myocardial infarction/ischaemia, gastrointestinal perforation, drug-induced hepatitis, haemorrhage and hypertension/hypertensive crisis

Interactions

Strong CYP3A4 inducers (e.g. rifampicin) — avoid concomitant use where possible; they decrease the mean AUC of sorafenib and may decrease antitumour activity (US §7.1)
Neomycin — avoid concomitant use; decreases the mean AUC of sorafenib (US §7.1)
Warfarin — may increase the risk of bleeding or raise the INR; monitor INR and for clinical bleeding episodes (US §7.2)
Drugs that prolong the QT/QTc interval — avoid coadministration, as sorafenib prolongs the QT/QTc interval (US §7.3; eMC §4.4 also notes QT interval prolongation)
Anti-diabetic medicines — blood glucose should be checked regularly in diabetic patients as dosage may need adjustment, since symptomatic hypoglycaemia has been reported (eMC §4.4)

Clinical monograph

How it works

It inhibits multiple tyrosine and serine/threonine kinases, including VEGFR, PDGFR, and RAF kinases, suppressing tumour-cell proliferation and angiogenesis.

Prescribing in practice

Hand-foot skin reaction, hypertension, and bleeding are characteristic adverse effects, and severe or persistent toxicity requires dose interruption or specialist adjustment.
It can cause QT-interval prolongation and gastrointestinal perforation, so use with caution in patients with relevant risk factors.
It is a CYP-interacting drug, so review concomitant medicines and avoid potent enzyme inducers where possible.

Monitoring

Monitor blood pressure regularly, especially early in treatment, and review skin, liver function, and signs of bleeding at oncology follow-up.

Counselling the patient

Report skin changes on the palms and soles, unusual bleeding, or severe abdominal pain.
Attend for blood pressure checks and do not stop or change the dose without specialist advice.

Evidence & guidelines

Sorafenib is an established systemic therapy for advanced hepatocellular carcinoma with preserved liver function.

Reference: Llovet et al. NEJM 2008 (SHARP trial); EASL-EORTC Clinical Practice Guidelines HCC 2022; MHRA SPC Nexavar; 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways