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Sorafenib (Oral route)

Pronunciation:

soe-RAF-e-nib

Brand Names:

  • Nexavar

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma), and thyroid cancer (metastatic, progressive, differentiated thyroid carcinoma). It is an antineoplastic (cancer) agent. Sorafenib 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 likely to be sensitive and may require a lower dose.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

  • Amifampridine
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Levomethadyl
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Saquinavir
  • Sparfloxacin
  • 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.

  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Apomorphine
  • Aprepitant
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azithromycin
  • Bupropion
  • Carbamazepine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Dabrafenib
  • Dasatinib
  • Desipramine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Erythromycin
  • Eslicarbazepine Acetate
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Fosaprepitant
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Ifosfamide
  • Iloperidone
  • Imipramine
  • Ivabradine
  • Lapatinib
  • Levofloxacin
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Mifepristone
  • Mitotane
  • Moxifloxacin
  • Neomycin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Paliperidone
  • Pazopanib
  • Perflutren Lipid Microsphere
  • Primidone
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Salmeterol
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sotalol
  • Sunitinib
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vinflunine
  • Voriconazole

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
  • Irinotecan
  • Thiotepa
  • 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
  • Heart disease (eg, angina, chest pain) or
  • Hepatitis or
  • Hypertension (high blood pressure) or
  • Stomach or bowel perforation (hole in the gut)—Use with caution. May make these conditions worse.
  • Congestive heart failure or
  • 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.

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.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

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 cancer:
      • Adults—400 milligrams (mg) two times per day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For liver cancer:
      • Adults—400 milligrams (mg) two times per day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For thyroid cancer:
      • Adults—400 milligrams (mg) two times per day. Your doctor may adjust your dose as needed.
      • 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:

If you will be taking this medicine 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 this medicine.

Using this medicine 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 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 are 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 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.

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 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 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 taking 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
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
Less common
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
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 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:

More common
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
Less common
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.


Last Updated: 4/4/2014

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