Description
Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma) that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body. Sorafenib is an antineoplastic (cancer) agent. It interferes with the growth of cancer cells, which are eventually destroyed by the body.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of sorafenib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sorafenib in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Bepridil
- Cisapride
- Dengue Tetravalent Vaccine, Live
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Levomethadyl
- Measles Virus Vaccine, Live
- Mesoridazine
- Mumps Virus Vaccine, Live
- Pimozide
- Piperaquine
- Posaconazole
- Rubella Virus Vaccine, Live
- Saquinavir
- Smallpox Monkeypox Vaccine
- Sparfloxacin
- Terfenadine
- Thioridazine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azathioprine
- Azithromycin
- Bedaquiline
- Buprenorphine
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cholera Vaccine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Crizotinib
- Dabrafenib
- Dasabuvir
- Dasatinib
- Degarelix
- Delamanid
- Desflurane
- Desipramine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Docetaxel
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Warfarin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding problems or
- Congestive heart failure or
- Heart attack, recent or
- Heart disease, unstable or
- Hypertension (high blood pressure) or
- Liver disease (eg, hepatitis) or
- Stomach or bowel perforation (tear or hole) or
- Thyroid problems—Use with caution. May make these conditions worse.
- Electrolyte imbalance (eg, high or low calcium, magnesium, or potassium levels in the blood) or
- Heart rhythm problems (eg, QT prolongation, slow heartbeat)—Use with caution. May increase risk for more serious side effects.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole with water. Do not crush, break, or chew it.
Take the tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For kidney, liver, or thyroid cancer:
- Adults—400 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For kidney, liver, or thyroid cancer:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Your blood pressure should be checked weekly, especially during the first 6 weeks after starting this medicine. Your doctor may need to treat you if you develop high blood pressure while you are using this medicine. Symptoms of high blood pressure include: blurred vision, dizziness, nervousness, headache, pounding in the ears, or a slow or fast heartbeat.
Serious skin reactions can occur with this medicine. 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 this medicine.
This medicine may cause serious heart problems, including heart failure or 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, troubled breathing, 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.
This medicine 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.
This medicine can cause changes in your heart rhythm, 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. Call your doctor right away if you have any symptoms of heart rhythm problems, such as a fast, pounding, or irregular heartbeat.
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 liver condition called hepatitis.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
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.
Side Effects
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:
More common
- Bleeding gums
- blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet
- 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
- 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
- stomach pain
- tightness in the chest
- vomiting
- vomiting of blood
- yellow eyes or skin
Less common
- Bone pain
- burning feeling in the chest or stomach
- chest pain or discomfort
- chills
- clammy skin
- confusion
- constipation
- cough
- decreased urine production
- depressed mood
- difficulty with moving
- dry skin and hair
- enlarged pupils (black part of the eye)
- fainting
- feeling cold
- fever
- hair loss
- hearing loss
- hives, itching, skin rash
- hoarseness or husky voice
- increase in heart rate
- increased sensitivity of the eyes to light
- increased sweating, possibly with fever or cold
- increased thirst
- indigestion
- joint pain or swelling
- lightheadedness
- loss of appetite
- loss of the ability to use or understand speech or language
- lower back or side pain
- muscle cramps, pain, or stiffness
- 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
- rapid breathing
- reddening of the skin, especially around the ears
- ringing, buzzing, or other unexplained noise in the ears that continues
- seizures
- severe chest pain
- severe headache
- shivering
- skin rash that is encrusted, scaly, and oozing
- 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
- trouble breathing with exertion
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- weight gain
Incidence not known
- Blistering, peeling, or loosening of the skin
- diarrhea
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- 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:
More common
- 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
- weight loss
Less common
- Acne
- belching
- burning, itching, and pain in hairy areas
- cracked lips
- cracks in the skin
- decreased appetite
- decreased interest in sexual intercourse
- discouragement
- dry mouth
- 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
- irritability
- lack or loss of strength
- loss in sexual ability, desire, drive, or performance
- loss of heat from the body
- loss of interest or pleasure
- mouth pain
- pus at the root of the hair
- red face, neck, arms, and occasionally, upper chest
- red, swollen skin
- runny nose
- scaly skin
- 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.
DRG-20068145
