How does this medication work? What will it do for me?

Sorafenib belongs to a group of medications called multikinase inhibitors. This medication is an anticancer medication that interferes with enzymes needed by the cancer cells to grow and spread. This causes a slowing in the growth of cancer cells as well as delaying the growth of new blood vessels leading to the cancer cells. Sorafenib is used to treat liver cancer (hepatocellular carcinoma) that cannot be removed by surgery. It is used to treat kidney cancer (renal clear cell carcinoma) that is advanced or has spread to other areas of the body in adults who have not responded to or can't be treated with other therapies. It is also used to treat thyroid cancer when radioactive iodine is no longer effective.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each red, round, film-coated tablet, with the Bayer cross logo stamped on one side and "200" on the other, contains 200 mg of sorafenib. Nonmedicinal ingredients: croscarmellose sodium, microcrystalline cellulose, hydroxypropyl methylcellulose, sodium laurylsulfate, magnesium stearate, macrogol, titanium dioxide, and ferric oxide red.

How should I use this medication?

The recommended adult dose is 400 mg taken by mouth twice daily, with a large glass of water. Take sorafenib without food or with a meal that is low-to-moderate in fat content. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to sorafenib or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • acne
  • bone pain
  • changed sense of taste
  • constipation
  • decreased appetite
  • diarrhea
  • difficulty swallowing
  • dry skin
  • fatigue
  • flushing
  • hair loss
  • headache
  • hoarseness of voice
  • impotence (e.g., erection problems)
  • indigestion or heartburn
  • inflamed, dry, or scaly skin that peels
  • inflammation or sores of the mouth and tongue
  • joint pain
  • loss of appetite
  • muscle pain
  • muscle spasms
  • nausea
  • rash or itchiness
  • persistent runny nose
  • voice changes
  • vomiting
  • weakness
  • weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • dehydration
  • fever
  • increase in blood pressure
  • multiple skin rashes
  • shortness of breath
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood,  bleeding gums, cuts that don’t stop bleeding)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of heart failure (e.g., shortness of breath, fatigue, swelling in legs, ankles, feet)
  • signs of kidney failure (e.g., decreased urine production, swelling, fatigue, abdominal pain)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of skin reaction in the hands or feet (e.g., redness, pain, swelling or blistering of palms of hands or soles of feet)
  • skin cancer
  • symptoms of gall bladder problems – reduced bile flow (e.g., clay coloured stools, dark urine, itching, pain in the upper right abdomen, yellow skin or eyes)
  • symptoms of increased thyroid activity, e.g.:
    • anxiety
    • fast heartbeat
    • nervousness
    • sweating
    • weight loss
  • symptoms of low sodium levels in the blood (e.g., achy, stiff or uncoordinated muscles, confusion, tiredness, weakness)
  • symptoms of underactive thyroid gland (e.g., dry skin, constipation, weight gain, fatigue, aches, pains and stiffness, intolerance to cold, depression, memory problems)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • interstitial lung disease (e.g., shortness of breath, coughing)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of a serious allergic reaction, e.g.:
    • difficulty breathing or wheezing
    • hives
    • swelling of face or throat
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • symptoms of a heart attack, e.g.:
    • cold sweat
    • severe chest pain
    • shortness of breath
  • symptoms of an abnormal heart rhythm, e.g.:
    • dizziness
    • fainting
    • pounding or irregular heartbeat
    • seizures

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Bleeding problems: Sorafenib may increase your risk of bleeding. This risk may be greater if you are taking medications such as warfarin or if you have bleeding problems. If you develop unexplained bruising, nosebleeds, dark or tarry stools, or start coughing up blood, contact your doctor immediately or seek immediate medical attention.

Blood pressure: Sorafenib may increase blood pressure. The increase in blood pressure is usually mild-to-moderate and can be treated with blood-pressure-lowering medications. You and your doctor should monitor your blood pressure regularly while you are taking this medication.

Electrolyte imbalances: If you have electrolyte imbalances (e.g., low potassium, magnesium, or calcium), an eating disorder, or vomiting or diarrhea, you should discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Gastrointestinal problems: Rarely, sorafenib can cause perforation of the stomach or intestines. If you experience severe abdominal pain, fever, vomiting, or nausea, contact your doctor immediately.

Hand-foot skin reaction: A rash on the palms of your hands as well as the soles of your feet may occur, usually within the first 12 weeks of using sorafenib. It can vary in redness and itchiness, but it is possible that blistering and pain can develop. Speak to your doctor immediately if you develop a rash, pain, or blistering on your hands or feet.

Heart problems: Sorafenib may affect your heart function and cause heart problems such as heart attack, decreased oxygen supply to the heart, heart failure, and a slow heart rate. Get immediate medical attention if you experience shortness of breath, sudden chest pain, or an extremely slow heart rate. If you have a history of heart problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: As well as affecting cancer cells, sorafenib can affect other types of cells, including those that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver problems: Sorafenib has not been studied in people who have severe liver problems and may itself cause liver problems. If you have decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking this medication. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking sorafenib, contact your doctor immediately.

Pancreatitis: Sorafenib can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

QT prolongation: This medication can affect the electrical activity of the heart causing QT prolongation. You are more at risk for QT prolongation and its complications (e.g., abnormal heartbeat, fainting, or death) if you:

  • are female
  • are older than 65 years of age
  • are taking other medications that prolong the QT interval (e.g., quinidine, sotalol, amiodarone, disopyramide, haloperidol, amitriptyline, methadone, clarithromycin, erythromycin, moxifloxacin, fluconazole)
  • have a family history of sudden death related to heart problems
  • have a history of heart disease or abnormal hearth rhythms
  • have a slow heart rate
  • have congenital prolongation of the QT interval
  • have diabetes
  • have had a stroke
  • have low potassium, magnesium, or calcium levels
  • have nutritional deficiencies
  • have reduced liver function

If you have any of these risk factors you should discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience dizziness, fainting, a seizure, or a rapid and pounding or irregular heartbeat, get immediate medication attention.

Thyroid function: Sorafenib has been observed to cause changes to thyroid function. It can cause increased and decreased function of the thyroid gland. Your doctor will monitor your thyroid function with blood tests while you are using sorafenib.

Wound healing: Sorafenib may affect the way wounds heal. If you are having surgery, a dental procedure, or have recently had surgery, let your doctor know. You may need to temporarily stop taking sorafenib. Your doctor will suggest when you can restart the medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Sorafenib may reduce fertility in men and women. Effective contraception must be used while taking this medication and for at least 2 weeks after stopping this medication.

Breast-feeding: It is not known if sorafenib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between sorafenib and any of the following:

  • acetaminophen
  • alfuzosin
  • amantadine
  • amiodarone
  • amphotericin B
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • apomorphine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., phenobarbital)
  • BCG
  • bevacizumab
  • bisphosphonates (e.g., alendronate, etidronate)
  • boceprevir
  • bosentan
  • bosutinib
  • bupropion
  • capecitabine
  • carbamazepine
  • carboplatin
  • carvedilol
  • celecoxib
  • chloral hydrate
  • chloroquine
  • chlorpropamide
  • cisapride
  • corticosteroids (e.g., dexamethasone, prednisone, etc)
  • cyclophosphamide
  • dapsone
  • dabrafenib
  • dasatinib
  • dexamethasone
  • disopyramide
  • docetaxel
  • domperidone
  • doxorubicin
  • dronabinol
  • dronedarone
  • echinacea
  • famotidine
  • flecainide
  • fluouracil
  • formoterol
  • fosphenytoin
  • galantamine
  • glyburide
  • HIV nucleoside reverse transcriptase inhibitors (NRTIs; e.g., abacavir, didanosine, lamivudine, tenofovir, zidovudine)
  • irinotecan
  • ketamine
  • leflunomide
  • live vaccines (e.g., adenovirus, BCG, MMR, rotavirus, smallpox, yellow fever)
  • lithium
  • losartan
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • maprotiline
  • mestranol
  • methadone
  • mifepristone
  • mitotane
  • modafinil
  • montelukast
  • natalizumab
  • nateglinide
  • neomycin
  • nilotinib
  • octreotide
  • paclitaxel
  • paliperidone
  • pentamidine
  • phenytoin
  • pimecrolimus
  • pimozide
  • pioglitazone
  • piroxicam
  • procainamide
  • promethazine
  • propafenone
  • romidepsin
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • rifabutin
  • rifampin
  • ritonavir
  • roflumilast
  • St. John's wort
  • saquinavir
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • selegilene
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • sotalol
  • sulfonamide antibiotics
  • sulfonylureas
  • sunitinib
  • tacrolimus
  • tamoxifen
  • tetrabenazine
  • trazodone
  • trimethoprim
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • trimethoprim
  • warfarin
  • zafirlukast

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.