Sorafenib

Pronunciation

Generic Name: sorafenib (soe-RAF-e-nib)
Brand Name: Nexavar

Sorafenib is used for:

Treating certain types of kidney, liver or thyroid cancer. It may also be used for other conditions as determined by your doctor.

Sorafenib is a multikinase inhibitor. It works by helping to stop cancer cells from growing.

Do NOT use sorafenib if:

  • you are allergic to any ingredient in sorafenib
  • you have a certain type of irregular heartbeat (congenital long QT syndrome)
  • you have a certain type of lung cancer (squamous cell) and are taking carboplatin and paclitaxel

Contact your doctor or health care provider right away if any of these apply to you.

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Before using sorafenib:

Some medical conditions may interact with sorafenib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • you have heart failure or other heart problems (eg, irregular heartbeat, disease of the blood vessels in the heart, a recent heart attack)
  • if you have chest pain; high blood pressure; bleeding problems; blood electrolyte problems (eg, low blood calcium, magnesium, or potassium levels); stomach or bowel problems (eg, tearing); or liver, kidney, or thyroid problems
  • if you have or are being treated for lung cancer
  • if you have recently had or will be having surgery
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with sorafenib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Warfarin because risk of bleeding may be increased
  • Carbamazepine, dexamethasone, hydantoins (eg, fosphenytoin, phenytoin), nevirapine, oral neomycin, phenobarbital, primidone, rifamycins (eg, rifabutin, rifampin), or St. John's wort because they may decrease sorafenib's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if sorafenib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use sorafenib:

Use sorafenib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with sorafenib. Talk to your pharmacist if you have questions about this information.
  • Take sorafenib on an empty stomach at least 1 hour before or 2 hours after eating.
  • Swallow sorafenib whole. Do not break, crush, or chew before swallowing.
  • Take sorafenib with a full glass of water (8 oz [240 mL]).
  • Continue to take sorafenib even if you feel well. Do not miss any doses.
  • If you miss a dose of sorafenib, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use sorafenib.

Important safety information:

  • Sorafenib may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Sorafenib may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Tell your doctor or dentist that you take sorafenib before you receive any medical or dental care, emergency care, or surgery.
  • High blood pressure has been reported in patients who take sorafenib. If this occurs, it is usually seen early in the course of treatment. However, it may occur at any time during treatment. Contact your doctor if you develop symptoms of high blood pressure (eg, severe or persistent headache or dizziness, vision changes).
  • 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.
  • Women who may become pregnant should use effective birth control while they are taking sorafenib and for 2 weeks after they stop taking it. Check with your doctor if you have questions about effective birth control.
  • Men who may father a child should use effective birth control while taking sorafenib and for 2 weeks after they stop taking it. Check with your doctor if you have questions about effective birth control. If your partner becomes pregnant while you are taking sorafenib, contact your doctor right away.
  • Severe and sometimes fatal bleeding has been reported in patients taking sorafenib. Contact your doctor right away if you develop blood in the urine, coughing or spitting up blood, menstrual bleeding that is heavier than normal, nosebleeds that happen often, pink or brown urine, unusual vaginal bleeding, or other unusual bruising or bleeding.
  • Severe stomach or bowel problems (eg, tearing) have rarely occurred in patients taking sorafenib. Contact your doctor right away if you develop severe or persistent stomach pain, black tarry or bloody stools, or vomiting blood or a substance that looks like coffee grounds.
  • Sorafenib may rarely cause severe and sometimes fatal liver problems. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite, nausea, or stomach pain; unusual tiredness).
  • Tell your doctor if you have a wound that does not heal.
  • Lab tests, including blood pressure, blood electrolyte levels, liver function, thyroid hormone levels, and electrocardiograms (ECGs), may be performed while you use sorafenib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Sorafenib should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Sorafenib may cause harm to the fetus. Avoid becoming pregnant while you are taking it and for at least 2 weeks after you stop taking it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of taking sorafenib while you are pregnant. It is not known if sorafenib is found in breast milk. Do not breast-feed while taking sorafenib.

Possible side effects of sorafenib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dry skin; hair thinning or loss; headache; loss of appetite; mouth, bone, muscle, stomach, or joint pain; nausea; taste changes; tiredness; voice changes; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); black, tarry, or bloody stools; blood in the urine; chest pain; confusion; coughing or spitting up blood; decreased sexual ability; decreased urination; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent cough or sore throat; menstrual bleeding that is heavier than normal; muscle pain, cramps, or weakness; nosebleeds that happen often; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; redness, pain, swelling, numbness, tingling, ulcers, or blisters on the palms of hands or soles of feet; seizures; severe or persistent dizziness, headache, or light-headedness; severe stomach pain, vomiting, or nausea; shortness of breath; speech changes; sudden increased sweating; sudden weight gain; swelling, sores, pain, or redness in the mouth or throat; swelling of the ankles, hands, or feet; unusual bruising or bleeding; unusual tiredness or weakness; unusual vaginal bleeding; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of sorafenib:

Store sorafenib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep sorafenib out of the reach of children and away from pets.

General information:

  • If you have any questions about sorafenib, please talk with your doctor, pharmacist, or other health care provider.
  • Sorafenib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take sorafenib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 sorafenib. 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 your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sorafenib.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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