Sorafenib

What is sorafenib used for?

• Sorafenib is used to treat cancer.

Before taking sorafenib, tell your doctor:

• If you are allergic to sorafenib; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a long QT on ECG.
• If you have a certain type of lung cancer (squamous cell) and are getting either carboplatin with paclitaxel or cisplatin with gemcitabine.
• If you are taking any of these drugs: Carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampin, or St. John's wort.
• If you are breast-feeding. Do not breast-feed while you take sorafenib and for 2 weeks after your last dose.

This is not a list of all drugs or health problems that interact with sorafenib.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take sorafenib with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take sorafenib?

• Tell all of your health care providers that you take sorafenib. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor. Rarely, some bleeding problems have been deadly.
• Very bad and sometimes deadly liver problems have happened with sorafenib. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Holes in the GI (gastrointestinal) tract may rarely happen.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Heart problems like a type of abnormal heartbeat (prolonged QT interval) have happened with sorafenib. Call your doctor right away if you have chest pain or pressure, a fast or abnormal heartbeat, shortness of breath, a big weight gain, swelling in the arms or legs, or very bad dizziness or passing out.
• This medicine may affect being able to father a child. Talk with the doctor.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during treatment and for 3 months after your last dose.
• If you are a man and your sex partner gets pregnant while you take sorafenib or within 3 months after your last dose, call your doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting sorafenib. Talk with your doctor.
• Use birth control that you can trust to prevent pregnancy while taking sorafenib and for 6 months after stopping sorafenib.
• If you get pregnant while taking sorafenib or within 6 months after your last dose, call your doctor right away.

How is sorafenib best taken?

Use sorafenib as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach. Take 1 hour before or 2 hours after meals.
• Keep taking sorafenib as you have been told by your doctor or other health care provider, even if you feel well.
• If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• This medicine may affect how wounds heal. If you have surgery, you may need to stop sorafenib before surgery. Start taking it again after surgery as you are told by your doctor.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of sorafenib that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of thyroid problems like change in weight; feeling nervous, excitable, restless, or weak; hair thinning; depression; neck swelling; not able to focus; trouble with heat or cold; menstrual changes; shakiness; or sweating.
• Sweating a lot.
• Very bad belly pain.
• Very upset stomach or throwing up.
• Pain in arms or legs.
• Feeling very tired or weak.
• A burning, numbness, or tingling feeling that is not normal.
• Redness or irritation of the palms of hands or soles of feet.
• Low mood (depression).
• Not able to get or keep an erection.

What are some other side effects of sorafenib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Hair loss.
• Feeling tired or weak.
• Diarrhea.
• Constipation.
• Dry skin.
• Not hungry.
• Itching.
• Weight loss.
• Belly pain.
• Muscle or joint pain.
• Muscle spasm.
• Headache.
• Change in taste.
• Mouth irritation or mouth sores.
• Pimples (acne).
• Flushing.
• Runny nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out sorafenib?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about sorafenib, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take sorafenib or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sorafenib. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.