Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Nexavar

Descriptions


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.

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 likely to be sensitive and may require a lower dose.

Pregnancy

Information about this sorafenib-oral-route
Pregnancy Category Explanation
All Trimesters D Studies 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.

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.

  • 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
  • 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
  • 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

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

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

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

  1. Abdominal or stomach pain
  2. bleeding gums
  3. bloating of the abdomen or stomach
  4. blood in the urine or stools
  5. blurred vision
  6. clay-colored stools
  7. coughing up blood
  8. dark urine
  9. difficulty with breathing or swallowing
  10. dizziness
  11. headache
  12. increased menstrual flow or vaginal bleeding
  13. light-colored stools
  14. nausea and vomiting
  15. nervousness
  16. nosebleeds
  17. paralysis
  18. pounding in the ears
  19. prolonged bleeding from cuts
  20. red or black, tarry stools
  21. red or dark brown urine
  22. slow or fast heartbeat
  23. vomiting of blood
  24. yellow eyes or skin

Less common

  1. Bone pain
  2. chest pain or discomfort
  3. chills
  4. clammy skin
  5. confusion
  6. constipation
  7. convulsions (seizures)
  8. cough
  9. decreased urine production
  10. depressed mood
  11. difficulty with moving
  12. dry skin and hair
  13. enlarged pupils
  14. feeling cold
  15. fever
  16. hair loss
  17. hearing loss
  18. hives
  19. hoarseness or husky voice
  20. increased sensitivity of the eyes to light
  21. increased sweating, possibly with fever or cold
  22. increased thirst
  23. indigestion
  24. itching
  25. joint pain
  26. loss of appetite
  27. lower back or side pain
  28. muscle cramps and stiffness
  29. muscle pain
  30. pain or discomfort in the arms, jaw, back, or neck
  31. painful or difficult urination
  32. pains in the stomach, side, or abdomen, possibly radiating to the back
  33. pale skin
  34. pinpoint red spots on the skin
  35. reddening of the skin, especially around the ears
  36. ringing, buzzing, or other unexplained noise in the ears that continues
  37. severe chest pain
  38. severe headache
  39. sore throat
  40. sores, ulcers, or white spots on the lips or in the mouth
  41. stiff or sore neck
  42. stomach discomfort or upset
  43. sweating
  44. swelling of the ankles or hands
  45. swelling of the eyes, face, or inside of the nose
  46. swollen glands
  47. swollen joints
  48. trouble breathing with exertion
  49. unpleasant breath odor
  50. unusual bleeding or bruising
  51. unusual tiredness or weakness
  52. weight gain

Incidence not known

  1. Blistering, peeling, or loosening of the skin
  2. diarrhea
  3. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  4. red skin lesions, often with a purple center
  5. 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

  1. Blistering, peeling, redness, and/or swelling of the palms of the hands or bottom of the feet
  2. burning, tingling, numbness or pain in the hands, arms, feet, or legs
  3. numbness, pain, tingling, or unusual sensations in palms of the hands or bottom of the feet
  4. sensation of pins and needles
  5. stabbing pain
  6. thinning of the hair
  7. tightness in the chest
  8. weight loss

Less common

  1. Acid or sour stomach
  2. acne
  3. belching
  4. blistering, peeling, or loosening of the skin
  5. burning feeling in the chest or stomach
  6. burning, itching, and pain in hairy areas
  7. cracked lips
  8. cracks in the skin
  9. decreased appetite
  10. decreased interest in sexual intercourse
  11. discouragement
  12. dry mouth
  13. fainting
  14. feeling of warmth
  15. feeling sad or empty
  16. flushing or red skin
  17. gas
  18. general feeling of discomfort or illness
  19. heartburn
  20. inability to have or keep an erection
  21. increase in heart rate
  22. irritability
  23. lack or loss of strength
  24. lightheadedness
  25. loss in sexual ability, desire, drive, or performance
  26. loss of ability to use or understand speech or language
  27. loss of heat from the body
  28. loss of interest or pleasure
  29. mouth pain
  30. pus at the root of the hair
  31. rapid breathing
  32. red face, neck, arms, and occasionally, upper chest
  33. red, swollen skin
  34. runny nose
  35. scaly skin
  36. shivering
  37. skin rash that is encrusted, scaly, and oozing
  38. sunken eyes
  39. swelling of the breasts or breast soreness in both men and women
  40. swelling or inflammation of the mouth
  41. tenderness in the stomach area
  42. thirst
  43. trouble concentrating
  44. trouble sleeping
  45. unusually warm skin
  46. 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.