Sorafenib

Oral Administration

Take 1 hr before or 2 hr after meals

Although partially metabolized by CYP3A4, dose modification appears to be unnecessary if coadministered with CYP3A4 inhibitors

Monitor: BP

Sorafenib is a prescription medication used to treat adults with certain types of liver, kidney, and thyroid cancers. Sorafenib belongs to a group of drugs called kinase inhibitors, which work by blocking proteins called kinases that are needed for cell growth.

This medication comes in tablet form and is taken twice a day, without food.

Common side effects include rash or itching of the skin, hair thinning, diarrhea, and weight loss.

Sorafenib may cause serious side effects. See "Drug Precautions" section.

Common side effects include:

• rash, redness, itching or peeling of your skin 
• hair thinning or patchy hair loss 
• diarrhea (frequent or loose bowel movements) 
• nausea or vomiting 
• mouth sores 
• weakness 
• loss of appetite 
• numbness, tingling or pain in your hands and feet 
• abdominal pain 
• tiredness 
• weight loss


Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the side effects with sorafenib. Ask your doctor or pharmacist for more information.

Sorafenib may cause serious side effects, including:

• decreased blood flow to the heart and heart attack. Get emergency help right away and call your doctor if you get symptoms such as chest pain, shortness of breath, feel lightheaded or faint, nausea, vomiting, sweating a lot. 
• bleeding problems. Sorafenib may increase your chance of bleeding. Tell your doctor if you have any bleeding while taking sorafenib. 
• high blood pressure. Your blood pressure should be checked every week during the first 6 weeks of starting sorafenib. Your blood pressure should be checked regularly and any high blood pressure should be treated while you are receiving sorafenib. 
• a skin problem called hand-foot skin reaction. This causes redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. If you get this side effect, your doctor may change your dose or stop treatment for some time. 
• perforation of the bowel. Tell your doctor right away if you get high fever, nausea, vomiting, severe abdominal pain. 
• possible wound healing problems. If you need to have a surgical or dental procedure, tell your doctor that you are taking sorafenib. sorafenib may need to be stopped until your wound heals after some types of surgery. 
• birth defects or death of an unborn baby. 


Do not take sorafenib if you: 

Store sorafenib tablets at room temperature between 59° to 86° F (15° to 30° C), in a dry place.

Keep sorafenib and all medicines out of the reach of children.

Sorafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Sorafenib is used to treat liver cancer, thyroid cancer, or a type of kidney cancer called advanced renal cell carcinoma.

Sorafenib may also be used for purposes not listed in this medication guide.

If you will be taking sorafenib for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by sorafenib.

Using sorafenib while you are pregnant can harm your unborn baby. Men and women should use an effective form of birth control during therapy and for at least 2 weeks after the last dose. If you think you have become pregnant while using sorafenib, tell your doctor right away.

Your blood pressure should be checked weekly, especially during the first 6 weeks after starting sorafenib. Your doctor may need to treat you if you develop high blood pressure while you are using sorafenib. Symptoms of high blood pressure are blurred vision, dizziness, nervousness, headache, pounding in the ears, or a slow or fast heartbeat.

Serious skin reactions can occur with sorafenib. Check with your doctor right away if you have redness, blistering, peeling, or loosening of the skin, red skin lesions, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using sorafenib.

sorafenib may cause serious heart problems, including a heart attack. Check with your doctor right away if you are having chest pain or discomfort, nausea, pain or discomfort in your arms, jaw, back, or neck, shortness of breath, sweating, or vomiting.

Check with your doctor right away if you have severe burning, cramps, or pain in the stomach area, bloody or black, tarry stools, trouble breathing, heartburn, indigestion, nausea, or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.

sorafenib may increase your chance of bleeding and cause a delay in wound healing. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

sorafenib can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious condition called hepatitis.

Make sure any doctor who treats you knows that you are using sorafenib. You may need to stop using sorafenib several days before having surgery.

Before you have any medical tests, tell the medical doctor in charge that you are taking sorafenib. The results of some tests may be affected by sorafenib.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• bleeding gums
• bloating of the abdomen or stomach
• blood in the urine or stools
• blurred vision
• clay-colored stools
• coughing up blood
• dark urine
• difficulty with breathing or swallowing
• dizziness
• headache
• increased menstrual flow or vaginal bleeding
• light-colored stools
• nausea and vomiting
• nervousness
• nosebleeds
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• slow or fast heartbeat
• vomiting of blood
• yellow eyes or skin

• Bone pain
• chest pain or discomfort
• chills
• clammy skin
• confusion
• constipation
• convulsions (seizures)
• cough
• decreased urine production
• depressed mood
• difficulty with moving
• dry skin and hair
• enlarged pupils
• feeling cold
• fever
• hair loss
• hearing loss
• hives
• hoarseness or husky voice
• increased sensitivity of the eyes to light
• increased sweating, possibly with fever or cold
• increased thirst
• indigestion
• itching
• joint pain
• loss of appetite
• lower back or side pain
• muscle cramps and stiffness
• muscle pain
• pain or discomfort in the arms, jaw, back, or neck
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• reddening of the skin, especially around the ears
• ringing, buzzing, or other unexplained noise in the ears that continues
• severe chest pain
• severe headache
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiff or sore neck
• stomach discomfort or upset
• sweating
• swelling of the ankles or hands
• swelling of the eyes, face, or inside of the nose
• swollen glands
• swollen joints
• trouble breathing with exertion
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain

• Blistering, peeling, or loosening of the skin
• diarrhea
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• red skin lesions, often with a purple center
• red, irritated eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blistering, peeling, redness, and/or swelling of the palms of the hands or bottom of the feet
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• numbness, pain, tingling, or unusual sensations in palms of the hands or bottom of the feet
• sensation of pins and needles
• stabbing pain
• thinning of the hair
• tightness in the chest
• weight loss

• Acid or sour stomach
• acne
• belching
• blistering, peeling, or loosening of the skin
• burning feeling in the chest or stomach
• burning, itching, and pain in hairy areas
• cracked lips
• cracks in the skin
• decreased appetite
• decreased interest in sexual intercourse
• discouragement
• dry mouth
• fainting
• feeling of warmth
• feeling sad or empty
• flushing or red skin
• gas
• general feeling of discomfort or illness
• heartburn
• inability to have or keep an erection
• increase in heart rate
• irritability
• lack or loss of strength
• lightheadedness
• loss in sexual ability, desire, drive, or performance
• loss of ability to use or understand speech or language
• loss of heat from the body
• loss of interest or pleasure
• mouth pain
• pus at the root of the hair
• rapid breathing
• red face, neck, arms, and occasionally, upper chest
• red, swollen skin
• runny nose
• scaly skin
• shivering
• skin rash that is encrusted, scaly, and oozing
• sunken eyes
• swelling of the breasts or breast soreness in both men and women
• swelling or inflammation of the mouth
• tenderness in the stomach area
• thirst
• trouble concentrating
• trouble sleeping
• unusually warm skin
• wrinkled skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• Take on an empty stomach. Take 1 hour before or 2 hours after meals.

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.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience constipation, dry skin, hair loss, lack of appetite, itching, weight loss, muscle pain, or joint pain. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of bleeding (vomiting blood or vomit that looks like coffee grounds, coughing up blood, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, bruises without a reason or that get bigger, or any bleeding that is very bad or that will not stop), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), shortness of breath, sweating a lot, confusion, vision changes, tachycardia, severe dizziness, passing out, angina, severe headache, severe abdominal pain, severe nausea, severe vomiting, severe diarrhea, swelling of arms or legs, painful extremities, severe loss of strength and energy, burning or numbness feeling, redness or irritation of palms of hands or soles of feet, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Applies to sorafenib: oral tablet

Gastrointestinal

Gastrointestinal (GI) side effects including diarrhea (43%), increased lipase (41%), increased amylase (30%), nausea (23%), anorexia (16%), vomiting (16%), and constipation (15%) have been reported. Common side effects have included mucositis, stomatitis, (including dry mouth and glossodynia), dyspepsia, and dysphagia. Uncommon side effects have included pancreatitis, GI reflux, and gastritis. In addition, GI perforation has been reported in less than 1% of patients receiving sorafenib and not always associated with apparent intra- abdominal tumor.[Ref]

Dermatologic

Dermatologic side effects including rash/desquamation (40%), Hand-foot skin reaction (30%), alopecia (27%), pruritus (19%), and dry skin (11%) have been reported. Very common side effects have included erythema. Common side effects have included exfoliative dermatitis, acne, and flushing. Scalp dysesthesia and subungual splinter hemorrhages (characterized by straight black or red lines under the nails) have been reported. Uncommon side effects have included folliculitis, eczema, Stevens-Johnson syndrome, and erythema multiforme. Three cases of keratoacanthomas and two cases of sorafenib-induced eruptive melanocytic lesions have been reported. Postmarketing reports of Stevens-Johnson syndrome and toxic epidermal necrolysis have been received.[Ref]

Endocrine

Endocrine side effects have included hyperthyroidism.[Ref]

Cardiovascular

Cardiovascular side effects including hypertension (17%), angioedema, and congestive heart failure have been reported. Uncommon side effects have included hypertensive crisis, myocardial ischemia, and/or infarction. Cardiac failure, thromboembolism, and arrhythmia have been reported infrequently.[Ref]

Hematologic

Hematologic side effects including Hypoalbuminemia (49%), hemorrhage (15%) (i.e., gastrointestinal, respiratory tract and rarely cerebral hemorrhage) have been reported. Common side effects have included anemia and thrombocytopenia. Uncommon side effects have included abnormal international normalized ratio (INR) results. Cases of erythrocytosis have also been reported.[Ref]

Respiratory

Respiratory side effects including dyspnea (14%) and cough (13%) have been reported. Common side effects have included hoarseness. Uncommon side effects have included rhinorrhea and interstitial lung disease-like events.[Ref]

Nervous system

Nervous system side effects including sensory neuropathy (13%) and headache (10%) have been reported. Common side effects have included tinnitus. Cerebral hemorrhage, transient ischemic attack, and reversible posterior leukoencephalopathy have also been reported infrequently.[Ref]

Musculoskeletal

Musculoskeletal side effects including joint pain (10%) have been reported. Common side effects have included arthralgia and myalgia. Postmarketing reports of rhabdomyolysis and osteonecrosis of the jaw have been received.[Ref]

Immunologic

Immunologic side effects have very commonly included leukopenia and lymphopenia. Common side effects have included neutropenia.[Ref]

Hypersensitivity

Hypersensitivity side effects including skin reactions and urticaria have been reported. Postmarketing reports of angioedema and anaphylactic reaction have been received.[Ref]

Metabolic

Metabolic side effects including hypocalcemia, weight loss (10%), transient increases in transaminases, and hypophosphatemia have been commonly reported. Uncommon side effects have included dehydration, hyponatremia, hypokalemia, transient increases in alkaline phosphatase, increased bilirubin (including jaundice), and hypothyroidism.[Ref]

Psychiatric

Psychiatric side effects have commonly included depression.[Ref]

Genitourinary

Genitourinary side effects have commonly included erectile dysfunction. Uncommon side effects have included gynecomastia and proteinuria.[Ref]

Renal

Renal side effects including acute renal failure and nephrotic syndrome have been reported infrequently.[Ref]

Hepatic

Hepatic side effects including liver dysfunction have been reported in at least 10% of patients. Drug-induced hepatitis, including reports of hepatic failure and death, has been reported during postmarketing surveillance.[Ref]

Other

Other side effects including fatigue (37%) and abdominal pain (11%) have been reported. Very common side effects have included asthenia and pain (including mouth, bone, and tumor pain). Common side effects have included decreased appetite, influenza-like illness, and pyrexia. Uncommon side effects have included infection.[Ref]

Some side effects of sorafenib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Child-Pugh A and B hepatic impairment: No adjustment recommended.

Child-Pugh C hepatic impairment: Data not available.

Data not available