Sorafenib
Pronunciation: pronunciation varies by local usage.
- Generic name
- sorafenib
- Brand names
- NEXAVAR
- Drug class
- Multikinase inhibitor (oral anticancer/targeted therapy)
- Form
- Tablet, 200 mg
- Route
- Oral
- Legal status
- Prescription-only anticancer medicine
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What sorafenib is and how it works
Sorafenib is an oral multikinase inhibitor anticancer medicine used to treat certain types of liver, kidney, and thyroid cancers. (1)
It is approved for unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and radioactive iodine-refractory differentiated thyroid carcinoma. Treatment is prescribed by an oncologist and continued until no longer benefiting or toxicity unacceptable. Dosing is twice daily on an empty stomach, with dose modifications managed by the clinician.
Mechanism of action: how sorafenib works
Sorafenib is a multikinase inhibitor that targets multiple intracellular and cell surface kinases. (1)
What sorafenib is used for
Unresectable hepatocellular carcinoma (HCC)
Sorafenib is FDA-approved for the treatment of unresectable hepatocellular carcinoma. (1)
Advanced renal cell carcinoma (RCC)
Sorafenib is FDA-approved for the treatment of advanced renal cell carcinoma. (1)
Differentiated thyroid carcinoma (DTC)
Sorafenib is FDA-approved for the treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment. (1)
Before taking sorafenib
Do not take / not appropriate for
- Do not take sorafenib if you have a known severe hypersensitivity to sorafenib or any of its components. (all indications) (1)
- Do not use sorafenib in combination with carboplatin and paclitaxel in patients with squamous cell lung cancer, due to increased risk of mortality and toxicity. (concomitant use in squamous cell lung cancer) (1)
Tell your clinician about
- Any history of heart problems.
- Uncontrolled high blood pressure or bleeding disorders.
- Any planned surgery.
- Liver problems or abnormal liver function tests.
- Current use of warfarin or other blood thinners, as well as other prescription and over-the-counter medicines, especially strong CYP3A4 inducers (e.g., St. John's Wort, rifampin, carbamazepine) or QT-prolonging drugs.
- Pregnancy, plans for pregnancy, or breastfeeding – sorafenib can cause fetal harm; effective contraception is required.
- If you have a thyroid condition, particularly differentiated thyroid cancer, as TSH monitoring may be needed.
How to take sorafenib
- The recommended dose is 400 mg (two 200 mg tablets) taken by mouth twice daily, without food (at least 1 hour before or 2 hours after a meal).
- Treatment is continued under oncologist supervision until the patient is no longer clinically benefiting from therapy or unacceptable toxicity occurs.
- Dose reductions or interruptions may be necessary to manage certain side effects; these changes are determined only by the prescribing clinician.
- Any decision to continue, interrupt, or change the dose of sorafenib is made by your oncology team, not by you on your own.
- Regular monitoring of blood pressure and liver function is required.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss a dose, do not take an extra dose to make up for it. Contact your prescriber or oncology team for instructions on when to take the next dose.
Overdose
If you think you have taken too much sorafenib, seek emergency medical attention or contact a Poison Control Center immediately. Specific overdose-management steps were not established in this research pass; let emergency clinicians determine appropriate care. (1)
Side effects
Common side effects occurring in 20% or more of patients include diarrhea, fatigue, infection, hair loss, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, abdominal pain, hypertension, and hemorrhage. Serious side effects can occur and require immediate medical attention.
Hand-foot skin reaction
What to notice: Redness, swelling, peeling, or blisters on the palms of the hands or soles of the feet.
What to do: Tell your oncology team if bothersome or severe. (1)
Diarrhea
What to notice: Frequent loose or watery stools.
What to do: Stay adequately hydrated and consult your prescriber if diarrhea is severe, persistent, or accompanied by weakness. (1)
Hypertension
What to notice: High blood pressure, often without noticeable symptoms; may cause headache.
What to do: Blood pressure should be monitored as directed; if elevated, your clinician will manage it. (1)
Cardiovascular events
What to notice: Possible signs of a heart problem, such as chest pain or shortness of breath.
What to do: Contact your clinician immediately, or seek emergency care if severe. (1)
Severe bleeding
What to notice: Signs of unusual or severe bleeding.
What to do: Seek emergency medical care. (1)
Gastrointestinal perforation
What to notice: Severe abdominal pain or other signs of a possible bowel problem.
What to do: Seek emergency medical care. (1)
Severe skin reactions
What to notice: Widespread rash, blistering, or peeling skin.
What to do: Seek emergency medical care. (1)
Liver injury
What to notice: Possible signs of a liver problem, such as yellowing of the skin or eyes, or unusual tiredness.
What to do: Contact your oncology team promptly. (1)
Serious warnings
Cardiovascular events — emergency
Symptoms: Chest pain, pressure, or tightness, or shortness of breath.
Action: Call emergency services immediately. Do not delay. (1)
Severe hemorrhage — emergency
Symptoms: Signs of severe or internal bleeding.
Action: Call emergency services immediately. (1)
Severe skin reactions — emergency
Symptoms: Widespread rash, blistering, or peeling skin.
Action: Seek emergency medical attention and inform the oncology team. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Strong CYP3A4 inducers | Drugs such as St. John's Wort, rifampin, carbamazepine, phenytoin, phenobarbital, dexamethasone, and rifabutin may decrease sorafenib plasma levels, reducing its effectiveness. | Tell your oncology team about all medicines and supplements you take, so they can determine whether the combination should be avoided. (1) |
| Neomycin and other oral antibiotics that alter gut flora | Neomycin has been shown to significantly reduce sorafenib exposure. Similar effects could occur with other antibiotics that affect the gut. | Tell your prescriber before taking any oral antibiotic, so they can decide whether it is appropriate alongside sorafenib. (1) |
| Warfarin | Increased risk of bleeding; sorafenib can affect warfarin levels. | Regular monitoring of INR/prothrombin time is required; dose adjustments of warfarin may be needed only by the clinician. (1) |
| Other QT-prolonging drugs | Combining sorafenib with other QT-prolonging drugs may increase risk related to QT-interval effects. | Tell your oncology team or prescriber about any other QT-prolonging medicine, so they can assess and determine whether the combination should be avoided. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Sorafenib can cause fetal harm based on its mechanism of action and animal data. Effective contraception is required during treatment and for 6 months after the final dose for females of reproductive potential, and for 3 months after the final dose for males with pregnant partners. (1)
Lactation
Breastfeeding is not recommended during treatment and for 2 weeks after the last dose. (1)
Renal impairment
No dose adjustment is needed for mild-to-severe renal impairment. Sorafenib has not been studied in patients on dialysis. (1)
Hepatic impairment
No dose adjustment is needed for mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Safety and efficacy have not been established in severe (Child-Pugh C) hepatic impairment. (1)
Pediatrics
The reviewed approved indications and dosing are for adults. No pediatric dosing or safety data were found in this research pass; pediatric use is unresolved. (1)
Monitoring
Before starting
- The clinical team will confirm diagnosis and assess baseline liver function, blood pressure, and concomitant medications; cardiac status and bleeding risk assessment are matters for clinician review before starting.
- Pregnancy screening in females of reproductive potential is a matter for clinician review before starting.
- Review all concurrent medicines for potential interactions (e.g., warfarin, CYP3A4 inducers, QT-prolonging agents).
During treatment
- Monitor blood pressure weekly during the first 6 weeks of treatment and periodically thereafter.
- Monitor liver function tests regularly; dose modifications may be needed for hepatotoxicity.
- For patients on warfarin, monitor INR/prothrombin time closely; increased bleeding risk.
- In patients with differentiated thyroid carcinoma, monitor TSH levels as sorafenib may impair thyroid suppression.
- Tell the oncology team about any planned elective surgery well in advance; the treating clinician will determine perioperative sorafenib management because of impaired wound-healing risk.
- Watch for signs of cardiovascular events, hemorrhage, severe skin reactions, and GI perforation.
Storage
Storage conditions were not detailed in the reviewed product information. Refer to the product packaging and pharmacy instructions.
Professional information
Clinician-facing context only. Use the current local product label and guidelines.
United States
Indication: All approved indications
Dose summary: 400 mg (two 200 mg tablets) orally twice daily, without food. Dose modifications for toxicity (cardiovascular events, hemorrhage, hypertension, dermatologic reactions, GI perforation, QT prolongation, liver injury) are described in the full prescribing information.
Renal context: No dose adjustment required for mild-to-severe renal impairment; not studied in dialysis. (1)
Hepatic guidance
No dose adjustment required for mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment; use in severe (Child-Pugh C) impairment has not been studied.
Overdose note
Medication errors require product identification, dose reconstruction, and supportive monitoring; contact a poison center and/or oncologist if overdose occurs. (1)
Frequently asked questions
Should I take sorafenib with food?
No. Take sorafenib on an empty stomach—at least 1 hour before or 2 hours after a meal. (1)
What if I miss a dose?
Do not take an extra dose. Contact your oncology team for guidance on when to take your next dose. (1)
Can I take sorafenib if I am pregnant or could become pregnant?
Sorafenib can harm an unborn baby, so effective contraception is required during treatment and for a period after the final dose (6 months for females of reproductive potential, 3 months for males with pregnant partners). Discuss pregnancy plans and any pregnancy risk with your oncologist before starting or continuing treatment. (1)
What is the mechanism of action of sorafenib?
Sorafenib is a multikinase inhibitor that targets multiple intracellular and cell surface kinases. (1)
What is the generic name of Sorafenib?
The generic name is sorafenib. It is sold under brand names including NEXAVAR. (1)
What class of drug is sorafenib?
Sorafenib is classed as: Multikinase inhibitor (oral anticancer/targeted therapy). (1)
References
- NEXAVAR (sorafenib) tablets, for oral use — full prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-05 · source 1
- SORAFENIB TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
- Sorafenib — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- sorafenib — FDA approval record (Drugs@FDA ANDA209050)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- sorafenib — RxNorm normalized drug concept (RXCUI 495881)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient sorafenib names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Nexavar200 mg · bayer healthcare pharmaceuticals inc.
Canada
- NEXAVAR