Nexavar
Stivarga

STIVARGA INDICATIONS

STIVARGA (regorafenib) is a prescription medicine used to treat people with:

  • colon or rectal cancer that has spread to other parts of the body and for which they have received previous treatment with certain chemotherapy medicines
  • a rare stomach, bowel, or esophagus cancer called GIST (gastrointestinal stromal tumor) that cannot be treated with surgery or that has spread to other parts of the body and for which they have received previous treatment with certain medicines
  • a type of liver cancer called hepatocellular carcinoma (HCC) in people who have been previously treated with sorafenib

It is not known if STIVARGA is safe and effective in children less than 18 years of age.

IMPORTANT SAFETY INFORMATION

STIVARGA (regorafenib) can cause liver problems, which can be serious and sometimes lead to death. Your healthcare provider will do blood tests to check your liver function before you start taking STIVARGA and during your treatment with STIVARGA to check for liver problems. Tell your healthcare provider right away if you experience yellowing of your skin or the white part of your eyes, nausea, vomiting, dark urine, or change in your sleep pattern.

Before taking STIVARGA, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems in addition to liver cancer
  • have bleeding problems
  • have high blood pressure
  • have heart problems or chest pain
  • plan to have surgery or have had a recent surgery. You should stop taking STIVARGA at least 2 weeks before planned surgery
  • are pregnant or plan to become pregnant. STIVARGA can harm your unborn baby. Females and males should use effective birth control during treatment with STIVARGA and for 2 months after their last dose of STIVARGA. Tell your healthcare provider right away if you or your partner becomes pregnant either while taking STIVARGA or within 2 months after your last dose of STIVARGA
  • are breast-feeding or plan to breast-feed. It is not known if STIVARGA passes into your breast milk. Do not breastfeed during treatment with STIVARGA and for 2 weeks after your final dose of STIVARGA.

Tell your healthcare provider about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Avoid drinking grapefruit juice and taking St. John’s Wort while taking STIVARGA.

STIVARGA may cause serious side effects, including:

  • infection. STIVARGA may lead to a higher risk of infections especially of the urinary tract, nose, throat and lung. STIVARGA may lead to a higher risk of fungal infections of the mucous membrane, skin or the body. Tell you healthcare provider right away if you get fever, severe cough with or without an increase in mucus (sputum) production, severe sore throat, shortness of breath, burning or pain when urinating, unusual vaginal discharge or irritation, redness, swelling or pain in any part of the body
  • severe bleeding. STIVARGA can cause bleeding, which can be serious and sometimes lead to death. Tell your healthcare provider if you have any signs of bleeding while taking STIVARGA, including: vomiting blood or if your vomit looks like coffee grounds, pink or brown urine, red or black (looks like tar) stools, coughing up blood or blood clots, menstrual bleeding that is heavier than normal, unusual vaginal bleeding, nose bleeds that happen often, bruising, and lightheadedness
  • a tear in your stomach or intestinal wall (bowel perforation). STIVARGA may cause a tear in your stomach or intestinal wall that can be serious and sometimes lead to death. Contact your healthcare provider immediately if you notice severe pains or swelling in your stomach area (abdomen), fever, chills, nausea, vomiting, or dehydration
  • a skin problem called hand-foot skin reaction and severe skin rash. Hand-foot skin reactions are common and sometimes can be severe. Tell your healthcare provider right away if you get redness, pain, blisters, bleeding, or swelling on the palms of your hands and soles of your feet, or a severe rash
  • high blood pressure. Your blood pressure should be checked every week for the first 6 weeks of starting STIVARGA. Your blood pressure should be checked regularly and any high blood pressure should be treated while you are receiving STIVARGA. Tell your healthcare provider if you have severe headaches, light-headedness, or changes in your vision
  • decreased blood flow to the heart and heart attack. Get emergency help if you have chest pain, have shortness of breath, feel dizzy, or feel like passing out
  • a condition called reversible posterior leukoencephalopathy syndrome (RPLS). Call your healthcare provider right away if you get severe headaches, seizure, confusion, change in vision, or problems thinking
  • risk of wound healing problems. Wounds may not heal properly during STIVARGA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with STIVARGA.
    • You should stop taking STIVARGA at least 2 weeks before planned surgery.
    • Your healthcare provider should tell you when you may start taking STIVARGA again after surgery.

The most common side effects with STIVARGA include pain including stomach-area (abdomen); tiredness, weakness, fatigue; diarrhea (frequent or loose bowel movements); decreased appetite; infection; voice change or hoarseness; increase in certain liver function tests; fever; swelling, pain, and redness of the lining in your mouth, throat, stomach, and bowel (mucositis); and weight loss

For Important risk and use information for STIVARGA, please see the full Prescribing Information.

What is NEXAVAR?

NEXAVAR is a prescription medicine used to treat:

  • a type of liver cancer called hepatocellular carcinoma (HCC) that cannot be removed by surgery
  • a type of kidney cancer called renal cell carcinoma (RCC)
  • a type of thyroid cancer called differentiated thyroid carcinoma (DTC) that can no longer be treated with radioactive iodine and is progressing

It is not known if NEXAVAR is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take NEXAVAR if you:

  • are allergic to sorafenib or any of the other ingredients in NEXAVAR.
  • have squamous cell lung cancer and receive carboplatin and paclitaxel.

Before taking NEXAVAR, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems including a condition called “congenital long QT syndrome”
  • have chest pain
  • have abnormal magnesium, potassium, or calcium blood levels
  • have bleeding problems
  • have high blood pressure
  • plan to have any surgical procedures or have had recent surgery
  • are pregnant or plan to become pregnant. NEXAVAR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treat- ment with NEXAVAR.

For females who are able to become pregnant:

  • Your healthcare provider should do a pregnancy test before you start treatment with NEXAVAR
  • Use effective birth control (contraception) during your treatment with NEXAVAR and for 6 months after the last dose of NEXAVAR.

For males with female partners who are able to become pregnant:

  • Use effective birth control (contraception) during your treatment with NEXAVAR and for 3 months after the last dose of NEXAVAR.
  • NEXAVAR may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.
  • are breastfeeding or plan to breastfeed. It is not known if NEXAVAR passes into your breast milk. Do not breastfeed during treatment with NEXAVAR and for 2 weeks after receiving the last dose of NEXAVAR.

Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take the medicine warfarin.

What are the possible side effects of NEXAVAR?

NEXAVAR may cause serious side effects, including:

  • decreased blood flow to the heart, heart attack and heart failure. Get emergency help right away if you get symptoms such as chest pain, shortness of breath, racing heartbeat, swelling in lower legs, feet and abdomen, feel lightheaded or faint, tiredness, nausea, vomiting, or sweat a lot.
  • increased risk of bleeding. Bleeding is a common side effect of NEXAVAR that can be serious and can lead to death. Tell your healthcare provider right away if you have any signs of bleeding during treatment with NEXAVAR:
    • vomiting blood or if your vomit looks like coffeegrounds
    • pink or brown urine
    • red or black (looks like tar) stools
    • coughing up blood or blood clots
    • heavier than normal menstrual cycle
    • unusual vaginal bleeding
    • frequent nose bleeds
    • bruising
  • 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 NEXAVAR. Your blood pressure should be checked regularly and any high blood pressure should be treated during treatment with NEXAVAR.
  • skin problems. A condition called hand-foot skin reactions and skin rash are common with NEXAVAR treatment and can be severe. NEXAVAR may also cause severe skin and mouth reactions that can be life threatening. Tell your healthcare provider if you have any of the following symptoms:
    • skin rash
    • pain or swelling
    • blistering and peeling of your skin
    • blistering and peeling on the inside of your mouth
    • blisters on the palms of your hand or soles of your feet
  • an opening in the wall of your stomach or intestines (gastrointestinal perforation). Tell your healthcare provider right away if you get fever, nausea, vomiting or severe stomach (abdominal) pain.
  • possible wound healing problems. If you need to have a surgical procedure, tell your healthcare provider that you are taking NEXAVAR. NEXAVAR may need to be stopped until your wound heals after some types of surgery
  • changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Your health- care provider may do tests during your treatment with NEXAVAR to check the levels of potassium, magnesium, and calcium in your blood, and check the elec- trical activity of your heart with an electrocardiogram (ECG). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy or feel your heart beating irregularly or fast during your treatment with NEXAVAR.
  • liver problems (drug-induced hepatitis). NEXAVAR may cause liver problems that may lead to liver failure and death. Your healthcare provider will do blood tests to check your liver function regularly during your treatment with NEXAVAR. Tell your healthcare provider right away if you develop any of the following symptoms:
    • yellowing of your skin or the whites of your eyes
    • dark “tea-colored” urine
    • light-colored bowel movements (stools)
    • worsening nausea or vomiting
    • pain on the right side of your stomach area
    • bleeding or bruising more easily than normal
    • loss of appetite
  • change in thyroid hormone levels. If you have differentiated thyroid cancer, you can have changes in your thyroid hormone levels during treatment with NEXAVAR. Your healthcare provider may need to change your dose of thyroid medicine during treatment with NEXAVAR. Your healthcare provider should check your thyroid hormone levels every month during treatment with NEXAVAR.

The most common side effects of NEXAVAR include:

  • diarrhea (frequent or loose bowel movements)
  • tiredness
  • infection
  • hair thinning or patchy hair loss
  • rash
  • weight loss
  • loss of appetite
  • nausea
  • stomach-area (abdomen) pain
  • low blood calcium levels in people with differentiated thyroid cancer

These are not all of the possible side effects of NEXAVAR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For Important risk and use information for NEXAVAR, please see the full Prescribing Information.