Key points
- Sorafenib is a targeted tablet that blocks several growth signals and the formation of new blood vessels in the tumour [1].
- It is used in liver cancer that cannot be removed by surgery, advanced kidney cancer, and thyroid cancer that no longer responds to radioactive iodine [1].
- In advanced liver cancer, it helped patients live longer [1, 2].
- 400 mg twice a day on an empty stomach (at least 1 hour before or 2 hours after food) [1].
- The most common side effects: diarrhoea, tiredness, hand-foot skin reaction, rash, hair loss, weight and appetite loss, high blood pressure and bleeding [1].
What is this drug and how does it work?
For physicians
Sorafenib, brand name Nexavar, is an oral targeted drug from the group of kinase inhibitors [1]. It blocks several kinases inside the cell (c-CRAF, BRAF and mutant BRAF) and several cell-surface kinases (KIT, FLT-3, RET, RET/PTC, VEGFR-1, VEGFR-2, VEGFR-3 and PDGFR-β); these kinases are thought to be involved in tumour cell signalling, angiogenesis (the formation of new blood vessels) and apoptosis [1].
In animal models, sorafenib inhibited the growth of liver, kidney and thyroid tumours, reduced tumour angiogenesis in liver and kidney models, and increased programmed death of tumour cells [1].
Which cancers is it used for?
According to the FDA label, sorafenib is used in unresectable hepatocellular carcinoma (liver cancer), advanced kidney cancer and differentiated thyroid cancer, and the label requires no specific biomarker test for these uses [1]. Approvals may differ between countries, and not every patient with these cancers is necessarily a candidate for this drug.
For physicians
| Cancer | Conditions of use | Key evidence |
|---|---|---|
| Hepatocellular carcinoma | Unresectable disease [1] | SHARP trial: median overall survival 10.7 vs 7.9 months with placebo (HR 0.69) [1, 2] |
| Advanced kidney cancer (RCC) | Advanced disease [1] | TARGET trial (after one previous systemic treatment): median progression-free survival 167 vs 84 days with placebo (HR 0.44) [1, 3] |
| Differentiated thyroid cancer (DTC) | Locally recurrent or metastatic, progressive disease refractory to radioactive iodine [1] | DECISION trial: median progression-free survival 10.8 vs 5.8 months with placebo (HR 0.59); no significant difference in final overall survival [1, 4] |
Sorafenib with carboplatin and paclitaxel is contraindicated in squamous cell lung cancer, and with gemcitabine and cisplatin it is not recommended in these patients; its safety and efficacy in non-small cell lung cancer have not been established [1].
Place in first-line treatment of liver cancer: sorafenib has been the comparator in several phase 3 trials. In REFLECT, lenvatinib was non-inferior to sorafenib for overall survival (13.6 vs 12.3 months) [5]. In IMbrave150, atezolizumab (Tecentriq) with bevacizumab (Avastin) reduced the risk of death compared with sorafenib (HR 0.58) [6]. In HIMALAYA, the STRIDE regimen (tremelimumab with durvalumab (Imfinzi)) had a median overall survival of 16.43 vs 13.77 months (HR 0.78) [7]. In CheckMate 9DW, nivolumab (Opdivo) with ipilimumab (Yervoy) gave longer overall survival than lenvatinib or sorafenib (23.7 vs 20.6 months; HR 0.79) [8].
How it is taken and dose
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Sorafenib comes as 200 mg oral tablets and is usually taken twice a day; take the tablets without food, that is at least 1 hour before or 2 hours after a meal [1]. Treatment continues as long as the patient benefits and side effects are tolerable [1]. Your doctor may lower the dose or stop treatment temporarily or permanently to control side effects [1].
- Blood pressure is checked every week for the first 6 weeks and regularly after that [1].
- Liver tests are done regularly [1].
- In thyroid cancer, TSH is checked monthly and the dose of the thyroid medicine adjusted [1].
- If you take warfarin, the INR is monitored regularly; in patients at risk, electrolytes and the heart tracing (ECG) are checked [1].
- In women who could become pregnant, a pregnancy test is done before starting [1].
- The medicine is stopped at least 10 days before planned surgery and is not restarted until at least 2 weeks after major surgery and adequate wound healing [1].
- Before starting: blood pressure, liver tests, electrolytes (magnesium, potassium, calcium) and ECG in patients at risk of QT prolongation (heart failure, bradyarrhythmia, QT-prolonging drugs); pregnancy test; TSH in thyroid cancer. Stop at least 10 days before elective surgery [1].
- Dose adjustment (one level = one step of the "dose reduction levels" in the regimen note) [1]:
- Non-haematological toxicity: grade 2, continue at one level lower; grade 3 first occurrence, hold until grade 2 or less and resume one level lower; no improvement within 7 days or second and third occurrence, two levels lower; fourth occurrence, two levels (HCC and RCC) or three levels (DTC) lower; grade 4, stop permanently.
- Hand-foot skin reaction grade 2, first occurrence: in HCC and RCC continue with topical treatment, in DTC reduce to 600 mg; no improvement in 7 days or second and third occurrence: hold until grade 0 to 1 and resume at a lower dose; fourth occurrence: stop permanently. Grade 3: hold until grade 0 to 1 and resume one level lower (in DTC two levels at the second occurrence); third occurrence stop permanently. After at least 28 days at grade 0 to 1 on a reduced dose, the dose can be increased by one level.
- Symptomatic/persistent grade 2 or grade 3 hypertension: hold until symptoms resolve and diastolic pressure is below 90, then one level lower; grade 4: stop permanently.
- Grade 3 congestive heart failure: hold until grade 1 or less and resume one level lower; grade 4: stop permanently. Grade 2 or higher cardiac ischaemia or infarction: stop permanently.
- Also stop permanently for: grade 2 or higher bleeding needing intervention, gastrointestinal perforation, drug-induced liver injury (grade 3 or higher ALT, or AST/ALT above 3 × ULN with bilirubin above 2 × ULN without another cause).
- QTc above 500 ms or an increase of 60 ms or more: hold and correct electrolytes; resume based on clinical judgement.
- If more than 2 dose reductions are needed, stop permanently; if there is no improvement after 30 days off treatment, stop unless the patient is getting clinical benefit.
- Interactions: avoid strong CYP3A4 inducers (such as rifampicin), neomycin and QT-prolonging drugs; with warfarin, monitor INR and bleeding. Contraindicated with carboplatin and paclitaxel in squamous cell lung cancer [1].
- Kidney and liver: mild, moderate or severe renal impairment not on dialysis and mild or moderate hepatic impairment: no adjustment; not studied on dialysis or in Child-Pugh C [1].
- Monitoring: blood pressure weekly for the first 6 weeks and then regularly; regular liver tests; monthly TSH in DTC with levothyroxine adjustment; ECG and electrolytes in high-risk patients; the skin of the hands and feet. After major surgery, do not resume for at least 2 weeks and until adequate wound healing [1].
For physicians
Standard dose (FDA label)
Single-agent sorafenib
Unresectable hepatocellular carcinoma; advanced renal cell carcinoma; progressive differentiated thyroid cancer refractory to radioactive iodine
Unresectable hepatocellular carcinoma; advanced renal cell carcinoma; progressive differentiated thyroid cancer refractory to radioactive iodine
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Sorafenib | 400 mg (2 × 200 mg tablets) | Oral, without food (at least 1 hour before or 2 hours after a meal) | Twice a day, continuously |
Dose reduction levels — HCC and RCC: (1) 400 mg once a day; (2) 200 mg once a day or 400 mg every other day. DTC: (1) 600 mg a day (400 mg and 200 mg about 12 hours apart); (2) 200 mg twice a day; (3) 200 mg once a day [1].
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Side effects
The most common side effects:
- Hand-foot skin reaction (redness, swelling and pain on the palms and soles) and skin rash, mostly in the first 6 weeks; tell your team early so the dose can be adjusted [1].
- Diarrhoea and tiredness [1].
- Hair loss, weight loss and poor appetite, nausea, abdominal pain and itching [1].
- High blood pressure, usually early in treatment; check your blood pressure regularly [1].
For physicians
Hand-foot skin reaction (redness, swelling and pain on the palms and soles) and rash are the most common side effects attributed to sorafenib; they are usually mild to moderate and mostly appear in the first 6 weeks of treatment [1]. The table below shows the frequency of side effects (all grades) in three placebo-controlled trials.
| Side effect | SHARP – liver | TARGET – kidney | DECISION – thyroid |
|---|---|---|---|
| Diarrhoea | 55% | 43% | 68% |
| Fatigue | 46% | 37% | 41% |
| Hand-foot skin reaction | 21% | 30% | 69% |
| Rash or skin peeling | 19% | 40% | 35% |
| Hair loss | 14% | 27% | 67% |
| Weight loss | 30% | 10% | 49% |
| Anorexia or decreased appetite | 29% | 16% | 30% |
| Nausea | 24% | 23% | 21% |
| Abdominal pain | 31% | 11% | 20% |
| High blood pressure | 9% | 17% | 41% |
| Itching | 14% | 19% | 20% |
Some side effects were also seen in the placebo group; for example, fatigue was reported in 45% of the placebo group in SHARP [1].
Serious side effects
These side effects are less common but serious; if you notice any sign of them, tell your team early:
- Heart problems: chest pain, shortness of breath or swollen legs [1].
- Bleeding: vomiting blood, black stools or prolonged bleeding [1].
- Liver damage: yellowing of the skin or eyes, dark urine [1].
- A hole in the bowel (rare): severe abdominal pain with fever [1].
- With warfarin the risk of bleeding goes up; wounds heal more slowly; severe skin reactions; and harm to an unborn baby [1].
For physicians
The FDA label for sorafenib has no boxed warning, but lists these important warnings [1]:
- Cardiovascular events: cardiac ischaemia or infarction in 2.7% (vs 1.3% with placebo) in SHARP, 2.9% (vs 0.4%) in TARGET and 1.9% (vs 0%) in DECISION; heart failure in 1.9% of 2276 patients [1].
- Bleeding: 15.3% vs 8.2% in TARGET and 17.4% vs 9.6% in DECISION; in SHARP the rate of oesophageal variceal bleeding (2.4% vs 4%) was similar to the placebo group [1].
- Hypertension: 9.4% in SHARP, 16.9% in TARGET and 40.6% in DECISION; usually mild to moderate and early in treatment [1].
- Severe skin toxicities: hand-foot skin reaction and rash; rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN), which can be life-threatening [1].
- Gastrointestinal perforation: in fewer than 1% of patients [1].
- Drug-induced liver injury: sorafenib-induced hepatitis can lead to liver failure and death; severe liver injury in 2 of 3357 patients (0.06%) [1].
- QT interval prolongation and risk of ventricular arrhythmia [1].
- Increased bleeding risk with warfarin and impaired wound healing [1].
- Increased mortality in squamous cell lung cancer when combined with carboplatin and paclitaxel [1].
- Impaired TSH suppression in thyroid cancer: TSH above 0.5 mU/L in 41% of patients (vs 16% with placebo) [1].
- Embryo-fetal toxicity [1].
When should I call my doctor?
Contact your treatment team straight away if you have any of these symptoms:
- Any sign of bleeding: vomiting blood or material that looks like coffee grounds, pink or brown urine, red or black tarry stools, coughing up blood, heavier periods than usual or unusual vaginal bleeding, frequent nosebleeds or bruising [1]
- Rash, redness, pain or swelling of the skin, blistering or peeling of the skin or inside the mouth, blisters on the palms or soles [1]
- Fever, nausea, vomiting or severe abdominal pain [1]
- Feeling faint, light-headedness, dizziness or an irregular or fast heartbeat [1]
- Yellowing of the skin or the whites of the eyes, dark tea-coloured urine, pale stools, worsening nausea or vomiting, pain on the right side of the abdomen, bleeding or bruising more easily than usual, or loss of appetite [1]
Chest pain, shortness of breath, palpitations, swelling of the legs, feet and abdomen, feeling light-headed or faint, or heavy sweating may be signs of a serious heart problem and need urgent help [1]; in these cases call your local emergency number.
Interactions, pregnancy and precautions
- Drug interactions: some medicines, such as the antibiotics rifampicin and neomycin, lower the amount of sorafenib; if you take warfarin, more blood clotting tests are needed; and some medicines that affect the heart rhythm should not be taken with it [1]. Ketoconazole did not change sorafenib levels, and omeprazole caused no clinically important change [1]. Give your treatment team a list of all your medicines, supplements and herbal products.
- Food: take the tablets on an empty stomach; a high-fat meal reduces absorption of the medicine [1].
- Missed dose: skip the missed dose, take the next dose at the usual time and do not double the dose [1].
- Overdose: if you take more than prescribed, contact your doctor straight away or go to an emergency department [1].
- Pregnancy and contraception: women who could become pregnant should use effective contraception during treatment and for 6 months after the last dose, and men whose partner could become pregnant or is pregnant should do so during treatment and for 3 months after the last dose [1].
- Breastfeeding: do not breastfeed during treatment and for 2 weeks after the last dose [1].
- Fertility: based on animal studies, sorafenib may reduce male fertility [1].
- Vaccines: the FDA label gives no specific advice about vaccines; talk to your treatment team before any vaccination.
Frequently asked questions
Is sorafenib chemotherapy?
No. Sorafenib is an oral targeted drug from the kinase inhibitor group that blocks tumour cell growth pathways and angiogenesis [1].
Can I take the tablet with food?
What should I do if I miss a dose?
Skip the missed dose and take the next dose at the usual time; do not double the dose [1].
Does sorafenib cause hair loss?
Yes, it can. Hair loss or thinning happens in some patients; depending on the type of cancer, from about 1 in 7 to more than half of patients [1].
What is hand-foot skin reaction and what can be done?
Scientific evidence
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Key studies
5 itemsSorafenib in advanced hepatocellular carcinoma
Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial
Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial
Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma
Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma
Related cancer types
References
8 referencesShow all references, 7 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1NEXAVAR (sorafenib) tablets, for oral use: Prescribing Information
- 2
- 3Sorafenib in Advanced Clear-Cell Renal-Cell Carcinoma
- 4Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial
- 5Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial
- 6Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma
- 7Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma
- 8Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
Printed from the website; the full and up-to-date version: https://drdabiri.com/en/drugs/sorafenib/