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sunitinib (Oral route)

soo-NI-ti-nib MAL-ate

Oral route(Capsule)

Hepatotoxicity has been observed in clinical trials and postmarketing experience. This hepatotoxicity may be severe, and deaths have been reported .

Commonly used brand name(s)

In the U.S.

  • Sutent

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Sunitinib

Uses For sunitinib

Sunitinib belongs to the group of medicines known as antineoplastics. It is used to treat a gastrointestinal stromal tumor (GIST) after a medicine called imatinib did not work very well. It may also be used when patients are not able to take imatinib. GIST is a group of cancer cells that start growing in the wall of the stomach, intestines, or rectum. Sunitinib is also used to treat advanced (late-stage) kidney cancer.

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Sunitinib is also used to treat a type of pancreatic cancer called pancreatic neuroendocrine tumor (pNET), that cannot be surgically removed and is locally advanced or metastatic (cancer that has spread).

Sunitinib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by sunitinib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with sunitinib, you and your doctor should talk about the benefits sunitinib will do as well as the risks of using it.

sunitinib is available only with your doctor's prescription.

Before Using sunitinib

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 sunitinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sunitinib 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 sunitinib 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 sunitinib in the elderly.

Pregnancy

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.

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

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 sunitinib, 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 sunitinib 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
  • Dronedarone
  • Fluconazole
  • Ketoconazole
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Sparfloxacin
  • Thioridazine

Using sunitinib 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
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Boceprevir
  • Bretylium
  • Carbamazepine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Cisapride
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Desipramine
  • Dexamethasone
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Formoterol
  • Fosaprepitant
  • Fosphenytoin
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Lapatinib
  • Levofloxacin
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Mifepristone
  • Mitotane
  • Moxifloxacin
  • Nefazodone
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Paliperidone
  • Pasireotide
  • Pazopanib
  • Perflutren Lipid Microsphere
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Salmeterol
  • Saquinavir
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Tacrolimus
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Tizanidine
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Ziprasidone

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of sunitinib. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Bradycardia (very slow heart beat), history of or
  • Congestive heart failure, history of or
  • Heart disease (e.g., cardiomyopathy), history of or
  • Heart rhythm problems (e.g., QT prolongation), history of or
  • Hypertension (high blood pressure) or
  • Hyperthyroidism (overactive thyroid) or
  • Hypothyroidism (underactive thyroid) or
  • Kidney problems (other than cancer) or
  • Liver problems or
  • Seizures or
  • Stomach ulcers—Use with caution. May make these conditions worse.
  • Dental or tooth problems or
  • Dental procedures or
  • Dental surgery—May increase risk for severe jaw problems.
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse.
  • Infection, severe or
  • Surgery or
  • Trauma—These conditions may cause adrenal gland problems.

Proper Use of sunitinib

Your doctor will tell you how much of sunitinib to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

You may take sunitinib with or without food. Do not open the capsules.

sunitinib comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of sunitinib 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 sunitinib. 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 (capsules):
    • For the treatment of GIST and kidney cancer:
      • Adults—50 milligrams (mg) once a day for 4 weeks. This is followed by 2 weeks without medicine. Your doctor may tell you to repeat this cycle.
      • Children—Use and dose must be determined by your doctor.
    • For the treatment of advanced pancreatic cancer or pancreatic neuroendocrine tumor (pNET):
      • Adults—37.5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

sunitinib needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

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 sunitinib

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting sunitinib treatment.

Using sunitinib while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you are rapidly gaining weight or have shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, uneven heartbeats, or excessive swelling of the hands, wrist, ankles, or feet. These may be symptoms of a heart problem.

sunitinib can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or dizziness. Call your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

sunitinib may also increase your risk of bleeding and cause delay in wound healing. Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

It is important that you check with your doctor before having any dental procedures or surgeries done, or are receiving bisphosphonates (e.g., alendronate, ibandronate, risedronate, Actonel®, Boniva®, Fosamax®, or Zometa®) while you are receiving sunitinib. Tell your doctor right away if you have jaw tightness, swelling, numbing, or pain or a loose tooth. This could be symptoms of a severe problem of your jaw.

sunitinib may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Make sure any doctor or dentist who treats you knows that you are using sunitinib. You may need to stop using sunitinib several days before having surgery or medical tests.

Grapefruit and grapefruit juice may cause you to have too much of sunitinib in the blood. You should not eat grapefruit or drink grapefruit juice while you are taking sunitinib.

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 (e.g., St. John's wort) or vitamin supplements.

sunitinib 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
  • Bleeding gums
  • bloating or swelling of the face, arms, hands, fingers, lower legs, or feet
  • blurred vision
  • chest pain
  • chills
  • confusion
  • coughing up blood
  • cracked lips
  • decreased urination
  • decreased urine output
  • diarrhea
  • difficulty with breathing or swallowing
  • dilated neck veins
  • dizziness
  • dry mouth
  • extreme fatigue
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • headache
  • increase in heart rate
  • increased menstrual flow or vaginal bleeding
  • irregular breathing
  • labored breathing
  • lightheadedness
  • nervousness
  • nosebleeds
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • rapid breathing
  • rapid weight gain
  • red or black, tarry stools
  • red or dark brown urine
  • shortness of breath
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • sunken eyes
  • swelling or inflammation of the mouth
  • thirst
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • wheezing
  • wrinkled skin
  • yellow eyes or skin
Less common
  • Bleeding from the rectum
  • bleeding from wounds
  • constipation
  • depressed mood
  • dry skin and hair
  • feeling cold
  • hair loss
  • hoarseness or husky voice
  • indigestion
  • loss of appetite
  • muscle cramps and stiffness
  • nausea
  • pain in the chest, groin, or legs, especially the calves
  • pain in the stomach, side, or abdomen, possibly radiating to the back
  • severe stomach pain
  • severe, sudden headache
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • vision changes
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
Rare
  • Back pain
  • chest discomfort
  • cloudy or bloody urine
  • convulsions
  • darkening of the skin
  • drowsiness
  • general feeling of tiredness or weakness
  • irregular or slow heart rate
  • light-colored stools
  • mental depression
  • skin rash
  • stomach pain, continuing
Incidence not known
  • Cough
  • coughing up blood
  • dark-colored urine
  • heavy jaw feeling
  • increased thirst
  • joint pain, stiffness, or swelling
  • loosening of a tooth
  • lower back or side pain
  • muscle cramps or spasms
  • muscular pain, tenderness, wasting, or weakness
  • pain, swelling, or numbness in the mouth or jaw
  • painful or difficult urination
  • pale skin
  • sore throat
  • sudden, severe chest pain
  • unusual bleeding or bruising
  • 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
  • Acid or sour stomach
  • belching
  • blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
  • change in color of the treated skin
  • change in taste
  • difficulty with moving
  • discouragement
  • excess air or gas in the stomach or intestines
  • feeling sad or empty
  • full feeling
  • hair color changes
  • hair loss or thinning of the hair
  • heartburn
  • irritability
  • joint pain
  • lack of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • muscle aches or pains
  • numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
  • pain or burning in the throat
  • passing gas
  • sleeplessness
  • stomach discomfort, upset, or pain
  • swollen joints
  • trouble concentrating
  • trouble sleeping
  • unable to sleep

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.

See also: Side effects (in more detail)

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