What is NEXAVAR (Sorafenib)?
NEXAVAR is a prescription medicine used to treat:
- A type of liver cancer called hepatocellular carcinoma (HCC) that cannot be removed by surgery
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A type of kidney cancer called renal cell carcinoma (RCC)
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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.
What is the most important information I should know about NEXAVAR?
NEXAVAR can cause serious side effects. These serious side effects include:
- 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 coffee-grounds
- Pink or brown urine
- Red or black (looks like tar) stools
- Coughing up blood or blood clots
- Heavier than normal menstrual
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Frequent nose bleeds
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Unusual vaginal bleeding
- 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
- Skin redness
- Blisters on the palms of your hand or soles of your feet
- pain or swelling
- Blistering and peeling of your skin
- Blistering and peeling on the inside of your mouth
- 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 healthcare provider 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 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
How should I take NEXAVAR?
- Take NEXAVAR exactly as your healthcare provider tells you to take it.
- Take NEXAVAR 2 times a day. Your healthcare provider may change your dose, temporarily stop treatment or completely stop treatment with NEXAVAR if you have side effects.
- Take NEXAVAR without food (at least 1 hour before or 2 hours after a meal).
- If you miss a dose of NEXAVAR, skip the missed dose, and take your next dose at your regular time. Do not double your dose of NEXAVAR.
- If you take too much NEXAVAR call your doctor or go to the nearest hospital emergency room right away.
Important Safety Information
- Use effective birth control (contraception) during your treatment with NEXAVAR and for 6 months after the last dose of NEXAVAR.
- NEXAVAR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with NEXAVAR.
- Do not take NEXAVAR if you are allergic to sorafenib or any of the other ingredients in NEXAVAR.
- Do not take NEXAVAR if you have squamous cell lung cancer and receive carboplatin and paclitaxel.
- 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
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider 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 treatment with NEXAVAR
- 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.
- Especially tell your healthcare provider if you take the medicine warfarin
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter
medicines, vitamins, and herbal supplements
General information about NEXAVAR
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NEXAVAR for a condition for which it is not prescribed. Do not give NEXAVAR to other people even if they have the same symptoms you have. It may harm them
What are the ingredients in NEXAVAR?
Active ingredient: Sorafenib tosylate
Other ingredient: Croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium lauryl sulphate, magnesium stearate, polyethylene glycol, titanium dioxide and ferric oxide red