Nexavar (Sorafenib)
Multikinase inhibitor for liver cancer, kidney cancer, and thyroid cancer
Nexavar (sorafenib) is a targeted cancer therapy known as a multikinase inhibitor. It works by blocking specific enzymes (kinases) that cancer cells use to grow and by reducing the blood supply that feeds tumor growth. Nexavar is approved for the treatment of hepatocellular carcinoma (liver cancer), advanced renal cell carcinoma (kidney cancer), and differentiated thyroid carcinoma. It is taken orally as a 200 mg film-coated tablet and requires a prescription.
Quick Facts
Key Takeaways
- Nexavar (sorafenib) is a multikinase inhibitor that treats liver cancer, advanced kidney cancer, and differentiated thyroid cancer by blocking tumor growth and angiogenesis.
- The standard adult dose is 400 mg (two 200 mg tablets) taken twice daily, for a total daily dose of 800 mg. Take it on an empty stomach or with a low-fat meal.
- Common side effects include hand-foot skin reaction, diarrhea, fatigue, rash, high blood pressure, and decreased appetite. Your doctor may adjust the dose if side effects are severe.
- Nexavar interacts with many medications including blood thinners (warfarin), certain antibiotics (neomycin, rifampicin), and other cancer drugs. Always inform your oncologist of all medicines you take.
- It must not be used during pregnancy or breastfeeding. Effective contraception is required for women of childbearing potential during treatment and for at least 2 weeks after the last dose.
What Is Nexavar and What Is It Used For?
Nexavar contains the active substance sorafenib, which belongs to a class of drugs known as multikinase inhibitors. These medications target multiple molecular pathways that are critical for cancer cell survival and proliferation. Sorafenib was one of the first orally available targeted therapies approved for solid tumors, representing a significant advance in oncological treatment when it was first approved by the FDA in 2005 for renal cell carcinoma and in 2007 for hepatocellular carcinoma.
Nexavar works through a dual mechanism of action. First, it directly inhibits the proliferation of cancer cells by blocking the RAF/MEK/ERK signaling pathway, which is a chain of proteins inside the cell that controls growth and division. Second, it reduces the blood supply to tumors by inhibiting the formation of new blood vessels (a process called angiogenesis) through the VEGFR and PDGFR signaling pathways. Without an adequate blood supply, tumors are starved of the oxygen and nutrients they need to grow.
Approved Indications
Nexavar is approved for the treatment of three distinct types of cancer:
- Hepatocellular carcinoma (HCC): The most common type of primary liver cancer. Nexavar was the first systemic therapy to demonstrate a significant survival benefit in patients with advanced HCC. It is typically used in patients who are not candidates for surgical resection or liver transplantation. The landmark SHARP trial (Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol) demonstrated a median overall survival improvement of nearly 3 months compared to placebo.
- Advanced renal cell carcinoma (RCC): Nexavar is used in patients with advanced kidney cancer when standard treatment has not been effective or is considered unsuitable. It was one of the first targeted therapies for metastatic RCC and remains a treatment option, particularly after failure of prior therapies.
- Differentiated thyroid carcinoma (DTC): Nexavar is indicated for locally advanced or metastatic differentiated thyroid cancer that no longer responds to radioactive iodine treatment. The DECISION trial demonstrated significant improvement in progression-free survival compared to placebo in this patient population.
It is important to understand that Nexavar is a targeted therapy, not traditional chemotherapy. While conventional chemotherapy kills all rapidly dividing cells, sorafenib specifically targets molecular pathways that are abnormally active in cancer cells. This more selective approach typically results in a different side effect profile compared to traditional chemotherapy, although side effects can still be significant and require careful management.
What Should You Know Before Taking Nexavar?
Contraindications
You should not take Nexavar if you are allergic to sorafenib or any of the other ingredients in the tablet. Allergic reactions can range from mild skin rashes to severe anaphylactic reactions. If you have had a previous allergic reaction to sorafenib or any multikinase inhibitor, inform your doctor immediately before starting treatment.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Nexavar if any of the following conditions apply to you. These conditions may require special monitoring, dose adjustments, or in some cases, discontinuation of treatment:
Contact your doctor immediately if you experience: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and tiredness. These may be signs of tumor lysis syndrome (TLS), a potentially life-threatening condition that can occur during cancer treatment and lead to kidney failure.
- Skin problems: Nexavar frequently causes rash and skin reactions, particularly on the hands and feet (hand-foot skin reaction). These typically appear within the first 6 weeks of treatment and can range from redness and tingling to painful blisters and peeling. Your doctor may adjust the dose or temporarily stop treatment if skin reactions are severe.
- High blood pressure (hypertension): Nexavar can significantly raise blood pressure. Your doctor will monitor your blood pressure regularly during treatment and may prescribe antihypertensive medications. In some cases, blood pressure elevation can be severe and require treatment interruption.
- Aneurysm or arterial dissection: If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a vessel wall, inform your doctor as Nexavar may increase this risk.
- Diabetes: Blood sugar levels should be monitored regularly in diabetic patients as dose adjustments of diabetes medications may be necessary to minimize the risk of hypoglycemia.
- Bleeding disorders: Nexavar may increase the risk of bleeding. Patients taking warfarin or phenprocoumon (blood-thinning medications) face an even higher risk and require careful monitoring of coagulation parameters.
- Heart problems: Nexavar can cause cardiac ischemia and infarction. If you experience chest pain or signs of heart problems, your doctor may need to interrupt or discontinue treatment. Patients with a history of cardiovascular disease should be monitored particularly closely.
- QT prolongation: Nexavar may affect the electrical activity of the heart, causing a condition known as QT prolongation. This can lead to dangerous heart rhythm abnormalities. ECG monitoring may be necessary during treatment.
- Planned surgery: Nexavar can impair wound healing. Treatment is usually interrupted before any planned surgical procedure and resumed only when adequate wound healing has occurred.
- Impaired liver function: Patients with severe liver impairment may experience more intense side effects. Liver function should be monitored regularly throughout treatment.
- Impaired kidney function: Your doctor will monitor your fluid and electrolyte balance if you have kidney problems.
- Gastrointestinal perforation: Although uncommon, holes in the intestinal wall can occur during treatment. This is a medical emergency requiring immediate attention.
Nexavar may reduce fertility in both men and women. If you are concerned about your future fertility, discuss this with your doctor before starting treatment. Options such as sperm banking or egg freezing may be considered.
Pregnancy and Breastfeeding
Nexavar must not be used during pregnancy as it may cause harm to the developing fetus. Women of childbearing potential must use effective contraception during treatment with Nexavar and for at least 2 weeks after the last dose. If you become pregnant during treatment, inform your doctor immediately so that a decision can be made about whether to continue therapy.
Breastfeeding is not permitted during treatment with Nexavar. The active substance may pass into breast milk and could affect the growth and development of a nursing infant. Women should not breastfeed during treatment and for at least 2 weeks after the last dose.
Children and Adolescents
Nexavar has not been adequately studied in children and adolescents. It is not recommended for use in patients under 18 years of age unless specifically prescribed by a pediatric oncologist in a clinical trial setting.
Driving and Operating Machinery
There is no evidence that Nexavar directly impairs the ability to drive or operate machinery. However, patients experiencing side effects such as fatigue or dizziness should exercise caution when driving or performing tasks that require alertness.
Nexavar tablets contain less than 1 mmol sodium (23 mg) per dose, which means they are essentially sodium-free. This is important for patients on a sodium-restricted diet.
How Does Nexavar Interact with Other Drugs?
Drug interactions with Nexavar can have clinically significant consequences. Some medications can reduce the blood levels of sorafenib, making it less effective, while others may have their own effects amplified when taken alongside Nexavar. Your oncologist must be aware of every medication you take, including over-the-counter drugs and herbal supplements, to ensure safe and effective treatment.
Major Interactions
The following drugs have significant interactions with Nexavar that may require dose adjustments or alternative treatment strategies:
| Drug | Category | Interaction Effect | Clinical Significance |
|---|---|---|---|
| Rifampicin | Antibiotic | Reduces sorafenib blood levels by inducing CYP3A4 metabolism | High – may significantly reduce efficacy |
| Neomycin | Antibiotic | May decrease sorafenib absorption and reduce efficacy | Moderate – monitor response |
| St. John's Wort | Herbal supplement | Strong CYP3A4 inducer; may substantially reduce sorafenib levels | High – avoid concomitant use |
| Warfarin / Phenprocoumon | Anticoagulant | Increased risk of bleeding; altered INR values | High – frequent INR monitoring required |
| Phenytoin / Carbamazepine / Phenobarbital | Antiepileptics | CYP3A4 inducers; reduce sorafenib blood levels | High – consider alternative antiepileptics |
| Doxorubicin / Irinotecan | Cancer drugs | Sorafenib may increase their blood levels and side effects | High – close monitoring required |
| Docetaxel / Paclitaxel | Cancer drugs | Sorafenib may enhance their effects and toxicity | High – dose adjustment may be needed |
| Capecitabine | Cancer drug | Sorafenib may increase capecitabine exposure | Moderate – monitor for toxicity |
Minor Interactions
The following medications have less pronounced but still noteworthy interactions with Nexavar:
- Dexamethasone: A corticosteroid that acts as a mild CYP3A4 inducer. When used for short courses (e.g., as an antiemetic), the clinical impact is usually small. For long-term use, monitoring of sorafenib efficacy is advisable.
- Digoxin: Sorafenib may affect digoxin absorption or metabolism. Digoxin levels should be monitored when starting or stopping Nexavar.
This list is not exhaustive. Always inform your doctor, pharmacist, or oncology nurse about all medications you are currently taking, have recently taken, or may be about to take, including non-prescription drugs, vitamins, and herbal products. Keeping an up-to-date medication list is particularly important for cancer patients taking multiple drugs.
What Is the Correct Dosage of Nexavar?
Adults
Standard Adult Dosage
The recommended dose of Nexavar for adults is two 200 mg tablets taken twice daily (morning and evening), giving a total daily dose of 800 mg. This is the approved dose for all three indications: hepatocellular carcinoma, renal cell carcinoma, and differentiated thyroid carcinoma.
Swallow the tablets whole with a glass of water. Nexavar should be taken either without food or with a low-fat meal. Do not take Nexavar with a high-fat meal, as this can reduce the absorption of sorafenib by approximately 29%, decreasing its effectiveness. If you plan to eat a high-fat meal, take your tablets at least 1 hour before or 2 hours after eating.
It is important to take Nexavar at approximately the same times each day to maintain consistent blood levels of the medication. Treatment typically continues for as long as clinical benefit is observed or until unacceptable toxicity occurs. Your oncologist will assess your response to treatment through regular scans and blood tests.
| Indication | Dose | Frequency | Daily Total |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | 400 mg (2 tablets) | Twice daily | 800 mg |
| Renal Cell Carcinoma (RCC) | 400 mg (2 tablets) | Twice daily | 800 mg |
| Differentiated Thyroid Carcinoma (DTC) | 400 mg (2 tablets) | Twice daily | 800 mg |
Your doctor may reduce the dose or temporarily interrupt treatment if you experience severe side effects. Common dose reductions are to 400 mg once daily (one dose reduction) or, if necessary, to 400 mg every other day. Dose modifications should always be directed by your treating physician.
Children
Nexavar has not yet been studied in children and adolescents. There are no established pediatric dosing guidelines, and it is not recommended for patients under 18 years of age outside of clinical trials.
Elderly Patients
No dose adjustment is required for elderly patients based on age alone. However, elderly patients may be more susceptible to certain side effects, particularly fatigue, diarrhea, and skin reactions. Close monitoring is recommended, and dose adjustments should be guided by tolerability.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you frequently forget doses, consider setting a daily alarm or using a pill organizer.
Overdose
If you or someone else has taken more than the prescribed dose, contact your doctor or poison control center immediately. Overdose increases the risk and severity of side effects, particularly diarrhea and skin reactions. There is no specific antidote for sorafenib overdose; treatment is supportive and directed at managing symptoms.
What Are the Side Effects of Nexavar?
Side effects of Nexavar are largely related to its mechanism of action. Because it inhibits multiple kinases, including those involved in angiogenesis and cell signaling, side effects can affect multiple organ systems. Many side effects are manageable with appropriate supportive care and dose modifications. Your oncologist and oncology nurses are experienced in managing these effects and will work with you to optimize both efficacy and tolerability.
It is important to report any new or worsening symptoms to your healthcare team promptly. Early intervention can often prevent side effects from becoming severe. The frequency categories below are based on clinical trial data and post-marketing surveillance.
Very Common
May affect more than 1 in 10 patients
- Diarrhea
- Nausea and vomiting
- Fatigue and weakness
- Pain (mouth, abdominal, headache, bone, tumor)
- Hair loss (alopecia)
- Hand-foot skin reaction (redness, pain, blistering of palms and soles)
- Itching or rash
- Bleeding (including brain, gastrointestinal, and respiratory)
- High blood pressure (hypertension)
- Infections
- Decreased appetite (anorexia)
- Constipation
- Joint pain (arthralgia)
- Fever
- Weight loss
- Dry skin
Common
May affect up to 1 in 10 patients
- Flu-like illness
- Indigestion (dyspepsia) and difficulty swallowing (dysphagia)
- Inflamed or dry mouth, tongue pain (stomatitis, mucositis)
- Low blood calcium (hypocalcemia), potassium (hypokalemia), or sodium (hyponatremia)
- Low blood sugar (hypoglycemia)
- Muscle pain (myalgia) and muscle spasms
- Peripheral neuropathy (tingling and numbness in fingers and toes)
- Depression
- Erectile dysfunction
- Voice changes (dysphonia)
- Acne, dermatitis, dry or flaking skin
- Heart failure, heart attack (myocardial infarction), chest pain
- Tinnitus (ringing in the ears)
- Kidney failure, abnormal protein in urine (proteinuria)
- Decreased white blood cells, red blood cells, or platelets
- Underactive thyroid (hypothyroidism)
- Taste changes (dysgeusia)
- Flushing, runny nose, heartburn (GERD)
- Skin cancer (keratoacanthoma, squamous cell carcinoma)
- Folliculitis (inflammation of hair follicles)
Uncommon
May affect up to 1 in 100 patients
- Gastritis (stomach inflammation)
- Pancreatitis, cholecystitis, or cholangitis
- Jaundice (hyperbilirubinemia)
- Allergic reactions including urticaria (hives)
- Dehydration
- Gynecomastia (breast enlargement in males)
- Breathing difficulties (pulmonary disease)
- Eczema
- Overactive thyroid (hyperthyroidism)
- Erythema multiforme (skin rash with blisters)
- Hypertensive crisis
- Gastrointestinal perforation (hole in bowel wall)
- Reversible posterior leukoencephalopathy (brain swelling)
- Anaphylactic reaction
Rare
May affect up to 1 in 1,000 patients
- Angioedema (swelling of face, tongue; difficulty breathing or swallowing)
- QT prolongation (abnormal heart rhythm)
- Drug-induced hepatitis (liver inflammation)
- Radiation recall dermatitis
- Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin reactions)
- Rhabdomyolysis (abnormal muscle breakdown that may cause kidney damage)
- Nephrotic syndrome (kidney damage with protein loss)
- Leukocytoclastic vasculitis (inflammation of blood vessels in the skin)
Not Known
Frequency cannot be estimated from available data
- Encephalopathy (impaired brain function with drowsiness, behavioral changes, or confusion)
- Aneurysms and arterial dissections (weakening or tearing of blood vessel walls)
- Tumor lysis syndrome (rapid breakdown of cancer cells causing metabolic complications)
If you experience any side effects, talk to your doctor, pharmacist, or oncology nurse. This includes any side effects not listed above. You can also report suspected side effects directly to your national medicines regulatory authority. Reporting helps provide continuous monitoring of the benefit-risk balance of medicines.
How Should You Store Nexavar?
Proper storage of Nexavar is essential to ensure the medication remains effective and safe throughout its shelf life. Follow these guidelines carefully:
- Temperature: Store at no more than 25°C (77°F). Avoid exposing the tablets to excessive heat or direct sunlight. Brief exposure to temperatures up to 30°C during transport is generally acceptable.
- Original packaging: Keep the tablets in their original blister packs until ready to take. The blister packaging protects the tablets from moisture and light.
- Out of reach of children: Keep this medicine out of the sight and reach of children at all times. As a cancer medication, accidental ingestion by a child could be extremely dangerous.
- Expiration date: Do not use Nexavar after the expiry date stated on the carton and blister pack after "EXP." The expiry date refers to the last day of the stated month.
- Disposal: Do not dispose of unused medication in household waste or down the drain. Return any unused tablets to your pharmacist for safe disposal. This protects the environment from pharmaceutical contamination.
Nexavar is supplied in calendar packs containing 112 film-coated tablets: four transparent blister packs with 28 tablets each. The tablets are red, round, and biconvex, with the Bayer cross on one side and "200" on the other.
What Does Nexavar Contain?
Understanding the composition of your medication is important, especially if you have known allergies to any pharmaceutical excipients. Each Nexavar film-coated tablet contains:
Active Substance
Sorafenib 200 mg (as sorafenib tosylate). Sorafenib tosylate is the salt form of sorafenib, chosen for its improved bioavailability and stability compared to the free base form. The molecular formula is C21H16ClF3N4O3·C7H8SO3.
Inactive Ingredients
Tablet core: Croscarmellose sodium (disintegrant), microcrystalline cellulose (filler), hypromellose (binder), sodium lauryl sulfate (wetting agent), magnesium stearate (lubricant).
Film coating: Hypromellose (film-forming agent), macrogol (plasticizer), titanium dioxide E171 (white color), red iron oxide E172 (gives the tablet its characteristic red color).
Appearance
Nexavar 200 mg tablets are red, round, biconvex, film-coated tablets with beveled edges. They are marked with the Bayer cross on one side and "200" on the other side. Each calendar pack contains 112 tablets in four transparent blister packs of 28 tablets each.
Known Brand Names
Sorafenib is available under several brand names globally:
- Nexavar (Bayer AG) – the originator brand
- Sorafenib Sandoz (Sandoz/Novartis)
- Sorafenib Accord (Accord Healthcare)
- Sorafenib STADA (STADA Arzneimittel)
- Sorafenib Viatris (Viatris)
- Sorafenib Teva (Teva Pharmaceutical)
All these products contain the same active substance and dosage. Generic versions have been approved by regulatory authorities such as the EMA and FDA as bioequivalent to the originator Nexavar. Your pharmacist may dispense a generic version; this is therapeutically equivalent.
Frequently Asked Questions About Nexavar
Nexavar is the original brand name product manufactured by Bayer AG. Generic versions of sorafenib (such as Sorafenib Sandoz, Sorafenib Accord, Sorafenib STADA, Sorafenib Viatris, and Sorafenib Teva) contain the same active ingredient at the same dose and have been shown to be bioequivalent to Nexavar through rigorous regulatory evaluation. This means they are absorbed into the body at the same rate and to the same extent. Your doctor or pharmacist may prescribe or dispense a generic version, which is therapeutically interchangeable with Nexavar.
You should avoid taking Nexavar with high-fat meals, as fat reduces the absorption of the drug by approximately 29%. Take your tablets either on an empty stomach or with a low-to-moderate-fat meal. If you plan to eat a high-fat meal, take your tablets at least 1 hour before or 2 hours after eating. There are no other specific dietary restrictions, but maintaining good nutrition is important during cancer treatment. Speak with a dietitian if you experience appetite loss or weight changes.
Nexavar treatment typically continues for as long as you are benefiting from the medication and the side effects remain tolerable. Your oncologist will regularly assess your response through imaging scans (usually every 6-8 weeks) and blood tests. Treatment may be discontinued if the cancer progresses, if side effects become unacceptable despite dose modifications, or if you and your doctor decide together that it is appropriate to stop. There is no predetermined maximum duration of treatment.
Hand-foot skin reaction (also called palmar-plantar erythrodysesthesia) is one of the most common side effects of Nexavar. It typically appears within the first 6 weeks of treatment. Preventive measures include using thick moisturizing creams on hands and feet, wearing comfortable shoes and cotton gloves/socks, avoiding hot water and friction, and using padded insoles. If the reaction becomes severe (painful blisters, peeling, difficulty walking or using hands), contact your oncologist promptly. They may reduce your dose temporarily or interrupt treatment until the skin has recovered. Grade 3 hand-foot reactions typically require treatment interruption.
You must be very cautious with supplements and herbal medicines while taking Nexavar. St. John's Wort (Hypericum perforatum) is strictly contraindicated as it can dramatically reduce sorafenib blood levels, making the treatment ineffective. Other herbal products may also interact. Always discuss any supplements, vitamins, or herbal remedies with your oncologist before taking them. Some common supplements like vitamin D and calcium are generally safe, but always confirm with your treatment team first.
Nexavar is not typically considered a curative treatment. It is a targeted therapy designed to slow the growth and spread of cancer, control the disease, and extend survival. In clinical trials, Nexavar has demonstrated significant improvements in overall survival and progression-free survival compared to placebo. For hepatocellular carcinoma, the SHARP trial showed a median overall survival improvement of approximately 2.8 months. For thyroid cancer, the DECISION trial showed improved progression-free survival. While not curative in most cases, Nexavar can provide meaningful clinical benefit and improved quality of life for many patients.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have been verified against evidence level 1A sources where available.
- European Medicines Agency (EMA). Nexavar Summary of Product Characteristics (SmPC). Updated 2025. Available at: EMA – Nexavar
- U.S. Food and Drug Administration (FDA). Nexavar (sorafenib) Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Available at: FDA Nexavar Label
- Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in Advanced Hepatocellular Carcinoma (SHARP Trial). New England Journal of Medicine. 2008;359(4):378-390. doi:10.1056/NEJMoa0708857
- Brose MS, Nutting CM, Jarzab B, et al. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer (DECISION Trial). The Lancet. 2014;384(9940):319-328. doi:10.1016/S0140-6736(14)60421-9
- Escudier B, Eisen T, Stadler WM, et al. Sorafenib for treatment of renal cell carcinoma (TARGET Trial). New England Journal of Medicine. 2007;356(2):125-134. doi:10.1056/NEJMoa060655
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hepatocellular Carcinoma. Version 2.2025.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Hepatocellular Carcinoma. Updated 2024.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List. 2023.
- British National Formulary (BNF). Sorafenib. National Institute for Health and Care Excellence (NICE). Updated 2025.
Editorial Team
This article was written by the iMedic Medical Editorial Team and reviewed by specialist physicians in oncology and clinical pharmacology. Our editorial process follows international medical standards and the GRADE evidence framework.
iMedic Medical Editorial Team – specialists in oncology, pharmacology, and evidence-based medicine with extensive experience in patient education.
iMedic Medical Review Board – independent panel of board-certified oncologists and clinical pharmacologists who verify accuracy against current international guidelines.
All content on iMedic is based on peer-reviewed research and international clinical guidelines (EMA, FDA, WHO, ESMO, NCCN). We have no commercial funding and accept no pharmaceutical sponsorship. Our goal is to provide accurate, accessible, and evidence-based medical information for patients and caregivers worldwide. Read our full editorial standards.