Pronunciation:

soe-RAF-e-nib

Brand Names:

• NexAVAR
• APO-SORAfenib

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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.

• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Levomethadyl
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• 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
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Buprenorphine
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasabuvir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Erythromycin
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Ifosfamide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Methotrexate
• Metronidazole
• Mifepristone
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Neomycin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pitolisant
• Ponesimod
• Prednisolone
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Telavancin
• Telithromycin
• Tetrabenazine
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Zuclopenthixol

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 of This Medicine:

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.

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 While Using This Medicine:

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 of This Medicine:

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.