Possible side effects

NEXAVAR may cause serious side effects, including:

  • Decreased blood flow to the heart and heart attack. Get emergency help right away and call your doctor if you have chest pain, shortness of breath, feel lightheaded or faint, have nausea or vomiting, or you are sweating a lot
  • Bleeding problems. Bleeding is a common side effect of NEXAVAR that can be serious and sometimes lead to death. Tell your doctor if you have any bleeding while taking NEXAVAR
  • High blood pressure. High blood pressure is a common side effect of NEXAVAR and can be serious. Your blood pressure should be checked every week during the first 6 weeks of starting therapy and then regularly, thereafter. If your blood pressure is high, it should be treated
  • A skin problem called hand-foot skin reaction. This causes redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. If you get this side effect, your doctor may change your dose or stop treatment for a while
  • Serious skin and mouth reactions. NEXAVAR can cause serious skin reactions which can be life-threatening. Tell your doctor if you have:
    • Skin rash
    • Blistering and peeling of the skin
    • Blistering and peeling on the inside of your mouth
  • An opening in the wall of your stomach or intestines (perforation of the bowel). Tell your doctor right away if you get high fever, nausea, vomiting, or severe stomach (abdominal) pain
  • Wound healing problems. If you have a surgical or dental procedure, tell your doctor you are taking NEXAVAR. Your treatment may be stopped until after your surgery or until your wound heals
  • Changes in the electrical activity of your heart called "QT prolongation." QT prolongation can cause irregular heartbeats that can be life threatening. Your doctor may do tests during your treatment with NEXAVAR to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an ECG. Tell your doctor right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast while taking NEXAVAR
  • Inflammation of your liver (drug-induced hepatitis). NEXAVAR may cause liver problems that may lead to liver failure and death. Your doctor may stop your treatment with NEXAVAR if you develop changes in certain liver function tests. Call your doctor right away if you develop:
    • Yellowing of the skin or white part of your eyes (jaundice)
    • Dark "tea-colored" urine
    • Light-colored bowel movements (stools)
    • Worsening nausea
    • Worsening vomiting
    • Abdominal pain
  • Birth defects or death of an unborn baby. Avoid becoming pregnant while taking NEXAVAR and for at least 2 weeks after stopping your treatment. Men and women should use birth control during and at least 2 weeks after NEXAVAR therapy. Talk with your doctor about effective birth control methods. Call your doctor right away if you become pregnant
  • Change in thyroid hormone levels. If you have differentiated thyroid cancer, you can have changes in your thyroid hormone levels when taking NEXAVAR. Your doctor should monitor thyroid hormone levels every month and may need to increase your dose of thyroid medicine

Here are some of the most common side effects people get when they take NEXAVAR:

Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Diarrhea
(frequent or loose
bowel movements)
Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Infection
Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Rash
Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Loss of
appetite
Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Stomach
(abdominal)
pain
Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Tiredness
Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Hair thinning or
patchy hair loss
Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Weight loss
Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Nausea
Graphic icons depicting the common side effects of NEXAVAR, including diarrhea, tiredness, infection, thinning hair, rash, weight loss, loss of appetite, nausea, and stomach pain. Low blood calcium
levels in people
with thyroid cancer

Tell your doctor if you have any side effects that bother you or do not go away. These are not all the possible side effects of NEXAVAR. Ask your doctor or pharmacist for more information.

If you experience any symptom that bothers you or does not go away, contact your doctor or healthcare team, or seek medical attention as soon as possible.

These are not all the side effects of NEXAVAR. Ask your doctor or pharmacist for more information. Please talk to your doctor about how to help manage your side effects.

Remember: Your healthcare team is the best source of information regarding you and your health.

Indications

NEXAVAR is an anticancer medicine used to treat a certain type of liver, kidney or thyroid cancer called:

  • Hepatocellular carcinoma (HCC, a type of liver cancer), when it cannot be treated with surgery
  • Renal cell carcinoma (RCC, a type of kidney cancer)
  • Differentiated thyroid carcinoma (DTC, a type of thyroid cancer) that can no longer be treated with radioactive iodine and is progressing

    • NEXAVAR has not been studied in children.

Important Safety Information

Do not take NEXAVAR if you have a specific type of lung cancer (squamous cell) and receive carboplatin and paclitaxel or if you are allergic to sorafenib or any of the other ingredients in NEXAVAR.

Before starting NEXAVAR, tell your doctor if you have: allergies, heart problems (including a problem called "congenital long QT syndrome") or chest pain, bleeding or bruising problems, high blood pressure, any planned surgical procedures, lung cancer or are being treated for lung cancer, kidney problems in addition to kidney cancer, or liver problems in addition to liver cancer.

Tell your doctor if you are pregnant or plan to become pregnant and if you are breast-feeding or plan to breast-feed. It is not known if NEXAVAR passes into your breast milk. You and your doctor should decide if you will take NEXAVAR or breast-feed. You should not do both.

NEXAVAR may interact with certain other medicines and cause serious side effects so tell your doctor about all medicines you take including prescription and over-the-counter (OTC) medicines, vitamins, or herbal supplements. Especially tell your doctor if you are taking the following medicines: warfarin (Coumadin, Jantoven®), neomycin, St. Johns Wort, dexamethasone, phenytoin (Fosphenytoin sodium, Dilantin, Phenytek), carbamazepine (Carbatrol, Equetro, Tegretol, Teril, Epitol), rifampin (Rifater, Rifamate, Rifadin, Rimactane), rifabutin (Mycobutin), phenobarbital.

NEXAVAR may cause serious side effects, including:

  • decreased blood flow to the heart and heart attack. Get emergency help right away and call your doctor if you have chest pain, shortness of breath, feel lightheaded or faint, have nausea or vomiting, or you are sweating a lot.
  • bleeding problems. Bleeding is a common side effect of NEXAVAR that can be serious and sometimes lead to death. Tell your doctor if you have any bleeding or easy bruising while taking NEXAVAR.
  • high blood pressure. High blood pressure is a common side effect of NEXAVAR and can be serious. Your blood pressure should be checked every week during the first 6 weeks of starting therapy and then regularly, thereafter. If your blood pressure is high, it should be treated.
  • a skin problem called hand-foot skin reaction. This causes redness, pain, swelling, or blisters on the palms of your hands and soles of your feet. Your doctor may change your dose or stop treatment for a while.
  • serious skin and mouth reactions. NEXAVAR can cause serious skin and mouth reactions which can be life-threatening. Tell your doctor if you have skin rash, blistering and peeling of the skin, blistering and peeling on the inside of your mouth.
  • an opening in the wall of your stomach or intestines (perforation of the bowel). Tell your doctor right away if you get high fever, nausea, vomiting or abdominal (stomach) pain.
  • wound healing problems. If you have a surgical or dental procedure, tell your doctor you are taking NEXAVAR. Your treatment may be stopped until after your surgery or until your wound heals.
  • changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your doctor may do tests during your treatment with NEXAVAR to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an ECG. Tell your doctor right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast while taking NEXAVAR.
  • inflammation of your liver (drug-induced hepatitis). NEXAVAR may cause liver problems that may lead to liver failure and death. Your doctor may stop your treatment with NEXAVAR if you develop changes in certain liver function tests. Call your doctor right away if you develop yellowing of the skin or white part of your eyes (jaundice), dark "tea-colored" urine, light-colored bowel movements (stools), worsening nausea, worsening vomiting, abdominal pain.
  • birth defects or death of an unborn baby. Avoid becoming pregnant while taking NEXAVAR and for at least 2 weeks after stopping your treatment. Men and women should use birth control during and at least 2 weeks after NEXAVAR therapy. Talk with your doctor about effective birth control methods. Call your doctor right away if you become pregnant.
  • change in thyroid hormone levels. If you have differentiated thyroid carcinoma, you can have changes in your thyroid hormone levels when taking NEXAVAR. Your doctor should monitor thyroid hormone levels every month and may need to increase your dose of thyroid medicine.

The most common side effects with NEXAVAR include: diarrhea (frequent or loose bowel movements); tiredness; infection; hair thinning or patchy hair loss; rash; weight loss; loss of appetite; nausea; stomach (abdominal) pain; low blood calcium levels in people with differentiated thyroid cancer.

Tell your doctor if you have any side effects that bother you or do not go away. These are not all the possible side effects of NEXAVAR. Ask your doctor or pharmacist for more information.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information about NEXAVAR, please see the full Prescribing Information.

©2018 Bayer. All Rights Reserved. 100 Bayer Boulevard, PO Box 915, Whippany NJ 07981 USA.

BAYER, the Bayer Cross, NEXAVAR, and REACH are registered trademarks of Bayer.

Last Modified 03/2018

©2018 Bayer. All Rights Reserved. 100 Bayer Boulevard, PO Box 915, Whippany NJ 07981 USA.

BAYER, the Bayer Cross, NEXAVAR, and REACH are registered trademarks of Bayer.

Last Modified 03/2018

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When it comes to cancer and cancer treatment, there are a lot of technical terms. Below is a list of words that you will find on our website, along with definitions to help ensure you understand the information we are providing.

  • adrenal [uh-DREE-nul] gland

    • a small gland that sits on top of each kidney and produces certain hormones for the body to use

  • advanced kidney cancer

    • term that means the cancer has spread to more than one part of the kidney and possibly other parts of the body, and cannot be cured by surgery or other treatments

  • advanced liver cancer

    • term that means the cancer has spread to more than one part of the liver and possibly other parts of the body, and cannot be cured by surgery or other treatments

  • curative [KYOO-re-tiv] treatment

    • treatment aimed at getting rid of all signs of cancer (an example is surgery)

  • follicular cells

    • a cell in the thyroid, or to a type of cancer that starts in follicular cells. It can also refer to a type of non-Hodgkin lymphoma that tends to grow in follicles

  • hepatitis [HEH-puh-TY-tis]

    • a disease causing inflammation of the liver

  • immune [ih-MYOON] system

    • a group of organs and cells that help protect your body from infection and disease

  • immunotherapy (ih-MYOO-no-THAYR-uh-pee)

    • treatments that use the body's immune system to fight cancer

  • immunotherapy biologic therapy

    • treatments that use the body's immune system to fight cancer. This is done by boosting the patient's own immune system or giving man-made immune system proteins

  • kidney cancer

    • cancer that forms in tissues of the kidneys

  • laparoscope

    • a long, flexible, thin tube with a lens on the end that's put into the belly (abdomen) through a very small cut. The laparoscope lets the surgeon see organs and lymph nodes inside the abdomen, and remove them using special surgical tools that fit through the laparoscope

  • laparoscopic nephrectomy [LA-puh-ruh-SKAH-pik neh-FREK-toh-mee]

    • a type of surgery to remove a kidney, or part of a kidney in which small incisions, or cuts, are made and a small laparoscope (a thin, tubelike instrument with a light and a lens for viewing) is inserted into one incision to see the kidney and small surgical tools are inserted into the other small incisions. The surgeon looks into the laparoscope to guide the removal of the kidney using the surgical tools

  • locoregional therapy

    • treatment of cancer at its site, so that the rest of the body is not affected. Surgery and radiation are examples of local therapy

  • lymph [limf] nodes

    • filter lymph (lymphatic fluid) and store lymphocytes [LIM-foh-sites] (white blood cells). Lymph nodes are part of the immune system

  • metastases [meh-TAS-tuh-sis]

    • the spread of cancer from one part of the body to other parts of the body. New tumors, which are called "metastatic tumors" or "metastases," contain cells that are like those in the original (primary) tumor

  • metastatic [meh-tah-sta-tik]

    • cancer that has spread from the place where it first started to another place in the body

  • nephrectomy [neh-FREK-toh-mee]

    • a surgery to remove a kidney

  • noncurative care

    • treatment that can make symptoms better and keep the cancer from getting worse for as long as possible but will not cure the cancer. Also called palliative [pa-lee-uh-tiv] care

  • partial nephrectomy [PAR-shul neh-FREK-toh-mee]

    • a surgery to remove part of one kidney or a kidney tumor, but not an entire kidney

  • percutaneous ethanol injection (PEI) [per-kyoo-TAY-nee-us EH-thuh-nol in-JEK-shun]

    • a process that destroys tumors by injecting them with a form of alcohol (ethanol)

  • perforated bowel [pur-FOR-A-tid BOW-ul]

    • a hole directly in the wall of the stomach, small intestine, or large intestine. A perforated bowel requires surgery, as food and other substances can leak into the abdomen, causing severe infection

  • radiation therapy

    • treatment with high-energy rays or particles to kill cancer cells and shrink tumors. The radiation may come from outside the body (external radiation) or from radioactive materials placed in the body (brachytherapy or internal radiation)

  • radical nephrectomy [RA-dih-kul neh-FREK-toh-mee]

    • a surgery that removes the entire kidney along with the adrenal gland and some tissue around the kidney

  • radiofrequency ablation [RAY-dee-oh-FREE-kwen-see uh-BLAY-shun]

    • a procedure that uses radio waves to heat and destroy abnormal cells. The radio waves travel through electrodes (small devices that carry electricity). Radiofrequency ablation may be used to treat cancer and other conditions

  • radiotherapy [RAY-dee-oh-THAYR-uh-pee]

    • a ray or beam of high-energy particles that is used to kill cancer cells and shrink tumors

  • regional lymphadenectomy [LIMF-a-de-NEK-toh-mee]

    • Sometimes performed when cancers are removed by surgery, such as in the case of a radical nephrectomy, a regional lymphadenectomy removes nearby lymph nodes to see whether the cancer has spread to them

  • specialty pharmacy

    • a special pharmacy that fills prescriptions and deliver medications that are not available in local or chain pharmacies

  • staging

    • the use of exams and tests to learn the extent of the cancer within the body, especially how far the disease has spread. Staging usually takes into account the size and location of tumor(s)

  • systemic therapy

    • treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body

  • transarterial chemoembolization (TACE) [trans-ar-TEER-ee-ul KEE-moh-EM-boh-lih-ZAY-shun]

    • a procedure in which chemotherapy drugs are injected into the blood vessels that feed the tumors. This delivers a high dose of chemotherapy to the tumor while lowering the blood supply that feeds the tumor

  • unresectable (UN-ree-SEK-tuh-bul)

    • a cancer tumor that cannot be removed by surgery