Description and Brand Names

US Brand Name

  1. NexAVAR

Descriptions


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.

  • Amisulpride
  • Bepridil
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Ketoconazole
  • 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.

  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azithromycin
  • Buprenorphine
  • Buserelin
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Dabrafenib
  • Dasabuvir
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Droperidol
  • Efavirenz
  • Encorafenib
  • Entrectinib
  • Enzalutamide
  • Erythromycin
  • Escitalopram
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Foscarnet
  • Fosphenytoin
  • Gatifloxacin
  • Gemifloxacin
  • Glasdegib
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Ifosfamide
  • Iloperidone
  • Imipramine
  • Inotuzumab Ozogamicin
  • Ivabradine
  • Ivosidenib
  • Lapatinib
  • Lenvatinib
  • Leuprolide
  • Levofloxacin
  • Lofexidine
  • Lopinavir
  • Lumefantrine
  • Macimorelin
  • Mefloquine
  • Methadone
  • Metronidazole
  • Mifepristone
  • Moxifloxacin
  • Nafarelin
  • Neomycin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Osimertinib
  • Paliperidone
  • Panobinostat
  • Pasireotide
  • Pazopanib
  • Phenytoin
  • Pimavanserin
  • Pitolisant
  • Prednisolone
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Rifabutin
  • Rifampin
  • Rifapentine
  • 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
  • Vinflunine
  • 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

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

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

  1. Bleeding gums
  2. blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet
  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
  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. stomach pain
  24. tightness in the chest
  25. vomiting
  26. vomiting of blood
  27. yellow eyes or skin

Less common

  1. Bone pain
  2. burning feeling in the chest or stomach
  3. chest pain or discomfort
  4. chills
  5. clammy skin
  6. confusion
  7. constipation
  8. cough
  9. decreased urine production
  10. depressed mood
  11. difficulty with moving
  12. dry skin and hair
  13. enlarged pupils (black part of the eye)
  14. fainting
  15. feeling cold
  16. fever
  17. hair loss
  18. hearing loss
  19. hives, itching, skin rash
  20. hoarseness or husky voice
  21. increase in heart rate
  22. increased sensitivity of the eyes to light
  23. increased sweating, possibly with fever or cold
  24. increased thirst
  25. indigestion
  26. joint pain or swelling
  27. lightheadedness
  28. loss of appetite
  29. loss of the ability to use or understand speech or language
  30. lower back or side pain
  31. muscle cramps, pain, or stiffness
  32. pain or discomfort in the arms, jaw, back, or neck
  33. painful or difficult urination
  34. pains in the stomach, side, or abdomen, possibly radiating to the back
  35. pale skin
  36. pinpoint red spots on the skin
  37. rapid breathing
  38. reddening of the skin, especially around the ears
  39. ringing, buzzing, or other unexplained noise in the ears that continues
  40. seizures
  41. severe chest pain
  42. severe headache
  43. shivering
  44. skin rash that is encrusted, scaly, and oozing
  45. sore throat
  46. sores, ulcers, or white spots on the lips or in the mouth
  47. stiff or sore neck
  48. stomach discomfort or upset
  49. sweating
  50. swelling of the ankles or hands
  51. swelling of the eyes, face, or inside of the nose
  52. swollen glands
  53. trouble breathing with exertion
  54. unpleasant breath odor
  55. unusual bleeding or bruising
  56. unusual tiredness or weakness
  57. 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 genitals
  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. Burning, tingling, numbness or pain in the hands, arms, feet, or legs
  2. numbness, pain, tingling, or unusual sensations in palms of the hands or bottom of the feet
  3. sensation of pins and needles
  4. stabbing pain
  5. thinning of the hair
  6. weight loss

Less common

  1. Acne
  2. belching
  3. burning, itching, and pain in hairy areas
  4. cracked lips
  5. cracks in the skin
  6. decreased appetite
  7. decreased interest in sexual intercourse
  8. discouragement
  9. dry mouth
  10. feeling of warmth
  11. feeling sad or empty
  12. flushing or red skin
  13. gas
  14. general feeling of discomfort or illness
  15. heartburn
  16. inability to have or keep an erection
  17. irritability
  18. lack or loss of strength
  19. loss in sexual ability, desire, drive, or performance
  20. loss of heat from the body
  21. loss of interest or pleasure
  22. mouth pain
  23. pus at the root of the hair
  24. red face, neck, arms, and occasionally, upper chest
  25. red, swollen skin
  26. runny nose
  27. scaly skin
  28. sunken eyes
  29. swelling of the breasts or breast soreness in both men and women
  30. swelling or inflammation of the mouth
  31. tenderness in the stomach area
  32. thirst
  33. trouble concentrating
  34. trouble sleeping
  35. unusually warm skin
  36. 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.