Sorafenib

Sorafenib is used in adults to treat liver cancer, thyroid cancer, or kidney cancer.

Sorafenib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take on an empty stomach, at least 1 hour before or 2 hours after a meal.

Your blood pressure will need to be checked often.

You will need frequent medical tests while taking this medicine.

If you need surgery, tell the surgeon or dentist ahead of time that you are using sorafenib. You should stop taking this medicine at least 10 days before having surgery. Follow your doctor's instructions about when to start taking the medicine again.

Store at room temperature away from moisture and heat.

You should not use sorafenib if you have squamous cell lung cancer and are being treated with carboplatin and paclitaxel.

Sorafenib can cause heart problems. Get emergency medical help if you have chest pain, fast heartbeats, trouble breathing, or swelling around your midsection or in your lower legs.

Sorafenib can also cause severe bleeding. Call your doctor if you have blood in your urine or stools, abnormal vaginal bleeding, severe stomach pain, a cough with bloody mucus, or any bleeding that will not stop.

You should not use sorafenib if you are allergic to it, or if you have squamous cell lung cancer and you are being treated with carboplatin and paclitaxel.

Tell your doctor if you have or have ever had:

• heart problems, chest pain, or a heart attack;
• long QT syndrome (in you or a family member);
• high blood pressure;
• thyroid disorder;
• an electrolyte imbalance (such as abnormal levels of calcium, magnesium, or potassium in your blood);
• slow wound healing, bleeding problems; or
• surgery.

Sorafenib can harm an unborn baby if the mother or the father is using sorafenib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

It may be harder for you to get a woman pregnant while you are using this medicine.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Get emergency medical help if you notice signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have symptoms of a heart attack or heart failure: chest pain, fast heartbeats, sweating, nausea, trouble breathing, feeling light-headed, or swelling around your abdomen or in your lower legs.

Sorafenib may cause serious side effects. Call your doctor immediately if you experience:

• fast or pounding heartbeats, fluttering in your chest;
• shortness of breath, sudden dizziness (feeling like you might faint);
• pain, redness, swelling, rash, blisters or peeling on the palms of your hands or the soles of your feet;
• fever with nausea, vomiting, severe stomach pain, or changes in bowel habits;
• a surgical incision or wound that does not heal;
• liver problems—loss of appetite, upper right stomach pain, nausea, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or
• signs of bleeding inside your body—easy bruising or bleeding (such as nosebleeds or bleeding gums), pink or brown urine, abnormal vaginal bleeding or heavy menstrual periods, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Your cancer treatments may be delayed or stopped permanently if you experience certain side effects.

Common side effects of sorafenib may include:

• bleeding;
• feeling tired;
• vomiting, diarrhea, nausea, stomach pain;
• low calcium level;
• infections;
• high blood pressure;
• hair loss, thinning hair;
• rash; or
• loss of appetite, weight loss.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Renal Cell Carcinoma:

400 mg orally 2 times a day Duration of therapy: Until the patient is no longer benefiting from therapy or until unacceptable toxicity occursComments:-This drug should be taken on an empty stomach, at least 1 hour before or 2 hours after food. -The tablets should be swallowed with a glass of water.Uses:-Hepatocellular Carcinoma (HCC): For patients with unresectable HCC-Renal Cell Carcinoma (RCC): For patients with advanced RCC-Differentiated Thyroid Carcinoma (DTC): For patients with locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine treatment

Usual Adult Dose for Thyroid Cancer:

400 mg orally 2 times a day Duration of therapy: Until the patient is no longer benefiting from therapy or until unacceptable toxicity occursComments:-This drug should be taken on an empty stomach, at least 1 hour before or 2 hours after food. -The tablets should be swallowed with a glass of water.Uses:-Hepatocellular Carcinoma (HCC): For patients with unresectable HCC-Renal Cell Carcinoma (RCC): For patients with advanced RCC-Differentiated Thyroid Carcinoma (DTC): For patients with locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine treatment

Usual Adult Dose for Hepatocellular Carcinoma:

400 mg orally 2 times a day Duration of therapy: Until the patient is no longer benefiting from therapy or until unacceptable toxicity occursComments:-This drug should be taken on an empty stomach, at least 1 hour before or 2 hours after food. -The tablets should be swallowed with a glass of water.Uses:-Hepatocellular Carcinoma (HCC): For patients with unresectable HCC-Renal Cell Carcinoma (RCC): For patients with advanced RCC-Differentiated Thyroid Carcinoma (DTC): For patients with locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine treatment

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes, it is not safe to take certain medicines together. Some drugs can change how much of another drug is in your blood, which can lead to more side effects or make the medicines work less effectively.

Sorafenib can lead to a serious heart problem. Your risk may be higher if you are also using certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all the other medicines you are taking, especially:

• warfarin; or
• neomycin.

This list is not complete. Other drugs may affect sorafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.