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Treatment Name: Sorafenib (Nexavar®)

Sorafenib (Nexavar®) is a Chemotherapy Regimen for Renal Cell Carcinoma - Kidney Cancer

How does sorafenib work?
Sorafenib is designed to slow the growth of cancer cells by inhibiting proteins inside the cell uses to grow and survive. Sorafenib is in a class of medications called Tyrosine Kinase Inhibitors, often referred to as "TKIs."

Goals of therapy:
Sorafenib is taken to shrink kidney tumors and decrease symptoms of renal cell carcinoma (RCC). Sorafenib is not commonly given with the goal of cure.

Schedule

Usual starting dose: 400 mg (two x 200 mg oral capsules) by mouth twice daily

Sorafenib is taken by mouth once daily continuously. Sorafenib is usually taken at home.

Typically, therapy with sorafenib is continued until the drug no longer works or unacceptable toxicity is experienced.

Side Effects

In clinical studies, the most commonly reported side effects with sorafenib are shown here. Side effects sometimes have percentage ranges [example 43 – 55%] because they differed between in clinical studies:

  • Diarrhea (43 - 55%)
  • Skin rash (41%)
  • Rash and blistering on soles of hands and feet (30 - 60%)
  • Fatigue (29 - 43%)
  • Hair loss (27 - 41%)
  • Nausea (19 - 23%)
  • High blood pressure (17 - 23%)
  • Decreased appetite (14 - 30%)
  • Trouble breathing (14%)
  • Itching (13 - 19%)
  • Cough (13%)
  • Dry skin (13%)
  • Vomiting (12 - 16%)
  • Weight loss (8 - 14%)
  • Constipation (7 - 15%)
  • Mouth sores (5 - 17%)

Roughly 4 - 11% of patients discontinue sorafenib due to unacceptable side effects.

Side effect videos Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue Hair LossHair LossConstipationConstipation

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment and periodically during treatment, most commonly before a new cycle is started. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), urinalysis, and thyroid stimulating hormone (TSH).

How often is imaging needed?

Imaging may be checked before treatment and every 8 weeks until the end of treatment. Imaging may include: computerized tomography (CT) scans and magnetic resonance imaging (MRI)

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue sorafenib as planned, or delay or switch therapy

ChemoExperts Tips

  • Sorafenib can possibly impair your body’s ability to heal wounds. Talk to your oncologist about any planned surgeries and let your surgeon know that you are taking sorafenib
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • You can tell if a medication is a TKI if the name ends in "nib," such as sorafenib. TKIs are usually oral medications taken by mouth
  • Clinical trials may exist for renal cell carcinoma. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Sorafenib (Nexavar®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Sorafenib (Nexavar®). Depending upon your income, they may be able to help cover the cost of:

  • Sorafenib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Sorafenib (Nexavar®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Sorafenib (Nexavar®)

Individual Drug Label Information

Sorafenib (Nexavar®)

  • Sorafenib ​is an oral tablet
  • Sorafenib should be taken on an empty stomach, 1 hour before eating or 2 hours after eating. Food increases blood levels of sorafenib and can increase your risk of experiencing side effects
  • Tablets should be swallowed whole and never chewed, crushed, or opened
  • If you miss a dose, take the dose as soon as possible on the same day, then return to the normal schedule. If it is already the next day, do not take an extra dose. Wait until your next dose is due
  • Sorafenib should be stored at room temperature in a cool, dry place
  • Dosage adjustments may be required for liver function, kidney function, or if severe skin reactions occur during treatment
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions
  • May interact with grapefruit and grapefruit juice, causing increased blood levels of sorafenib. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment
  • Avoid therapy with St. Johns Wort as it will decrease blood levels of sorafenib. This could decrease the effectiveness of sorafenib
General Sorafenib (Nexavar) Side Effects
  • May increase your risk of heart attack. Get help immediately if you experience symptoms such as chest pain, shortness of breath, lightheadedness, nausea, vomiting, and sweating
  • Can cause changes in heart rhythm. Electrocardiograms may be done to monitor for any heart rhythm changes
  • May cause injury to your liver. Liver function tests will be monitored periodically throughout treatment
  • Thyroid and adrenal gland problems can occur. You doctor may do tests to monitor your thyroid and adrenal glands during therapy
  • Various gastrointestinal side effects can occur such as nausea, vomiting, abdominal pain, mouth sores, and diarrhea. Talk to your doctor or pharmacist for ways to manage these side effects
  • May cause blisters or a rash on the palms of your hands and soles of your feet. Use a non-alcoholic moisturizer on your hands and feet to help prevent this from occurring
  • Can cause high blood pressure. Consider keeping a blood pressure monitor at home. Your doctor may prescribe a medication to help lower your blood pressure if needed
  • Can cause an opening in the wall of your stomach or intestines. Seek help immediately if you experience severe abdominal pain with fever, nausea, or vomiting
  • Click on the sorafenib (Nexavar) package insert link below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue ConstipationConstipation

See DailyMed package insert.

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References

1. Escudier B, Szczylik C, Hutson TE, et al. Randomized Phase II Trial of First-Line Treatment With Sorafenib Verus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2009;27:1280-1289.

2. Escudier B, Eisen T, Stadler WM, et al. Sorafenib for Treatment of Renal Cell Carcinoma: Final Efficacy and Safety Results of the Phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. J Clin Oncol. 2009;27:3312-3318.

3. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in Advanced Clear-Cell Renal-Cell Carcinoma. N Engl J Med. 2007;356:125-134.

Created: August 16, 2015 Updated: September 5, 2018

What is Renal Cell Carcinoma - Kidney Cancer?

A malignant disease of the cells found in the kidney. Renal cell carcinoma (RCC) is a rare condition and is the most commonly diagnosed type of kidney cancer. Known causes of RCC include smoking, obesity, hypertension, family history of RCC, and a genetic disease known as Von Hippel-Lindau disease. The stage of RCC can vary at diagnosis and throughout treatment. RCC uses the TNM (Tumor, Node, Metastasis) staging system and is grouped into stages I, II, III, and IV. The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1. Escudier B, Szczylik C, Hutson TE, et al. Randomized Phase II Trial of First-Line Treatment With Sorafenib Verus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2009;27:1280-1289.

2. Escudier B, Eisen T, Stadler WM, et al. Sorafenib for Treatment of Renal Cell Carcinoma: Final Efficacy and Safety Results of the Phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. J Clin Oncol. 2009;27:3312-3318.

3. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in Advanced Clear-Cell Renal-Cell Carcinoma. N Engl J Med. 2007;356:125-134.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.