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Drugs reference index «sorafenib»

sorafenib


sorafenib (Oral route)

soe-RAF-e-nib

Commonly used brand name(s):

In the U.S.

  • Nexavar

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Uses For sorafenib

Sorafenib is an anticancer medicine that is used to treat adults with kidney cancer (advanced renal cell carcinoma) and liver cancer that cannot be treated with surgery .

sorafenib is available only with your doctor's prescription .

Before Using sorafenib

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 sorafenib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sorafenib 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 geriatrics-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.

Interactions with Medicines

Using sorafenib 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
  • Irinotecan

Interactions with Food/Tobacco/Alcohol

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 sorafenib. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Heart disease or
  • High blood pressure—May make these conditions worse .
  • Kidney disease, severe (requires dialysis) or
  • Liver disease, severe—Use with caution. sorafenib has not been studied in patients with these conditions .

Proper Use of sorafenib

Swallow the tablet whole with water .

Take the tablet on an empty stomach, at least 1 hour before or 2 hours after a meal .

Dosing

The dose of sorafenib 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 sorafenib. 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):
    • Kidney cancer:
      • Adults—400 milligrams (mg) two times a day.
      • Children—Use and dose must be determined by your doctor .
    • Liver cancer:
      • Adults—400 milligrams (mg) two times a day.
      • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of sorafenib, take it as soon as possible. However, if it is almost time for your next dose, 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 sorafenib

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.

Your blood pressure should be checked weekly, especially during the first six weeks of 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 .

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

sorafenib may cause a serious skin problem called hand-foot syndrome. Check with your doctor right away if you have a skin rash or any redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet. If you get this skin problem, your doctor may adjust the dose or stop treatment for a short time .

Sorafenib may cause serious heart problems. 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 start having severe abdominal or stomach burning, cramps, or pains; 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. 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 .

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 .

sorafenib 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
  • Abdominal pain
  • bleeding gums
  • bloating of the abdomen
  • 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
  • shortness of breath
  • 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
  • feeling cold
  • enlarged pupils
  • fever
  • hair loss
  • hearing loss
  • hives
  • hoarseness or husky voice
  • increased sensitivity of 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, upset, or pain
  • 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

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 palms of the hands or bottom of the feet
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • diarrhea
  • difficulty having a bowel movement (stool)
  • 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 hair
  • tightness in the chest
  • weight loss
  • wheezing
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, irritated eyes
  • 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 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.

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  • Sorafenib Professional Patient Advice (Wolters Kluwer)
  • Sorafenib MedFacts Consumer Leaflet (Wolters Kluwer)
  • Nexavar Prescribing Information (FDA)
  • Nexavar Consumer Overview

See Also...