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Sunitinib (Oral route)

Pronunciation:

soo-NI-ti-nib MAL-ate

Brand Names:

  • Sutent

Dosage Forms:

  • Capsule

Warnings:

Oral route(Capsule)

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

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Sunitinib

Uses of This Medicine:

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.

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 this medicine will do as well as the risks of using it.

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 sunitinib 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 sunitinib in the elderly.

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
  • Dronedarone
  • Fluconazole
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Sparfloxacin
  • Thioridazine

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
  • 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
  • Eslicarbazepine Acetate
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Formoterol
  • Fosaprepitant
  • Fosphenytoin
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • 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
  • 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

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. 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 this medicine. 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 This Medicine:

Your doctor will tell you how much of this medicine 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 this medicine with or without food. Do not open the capsules.

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

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 (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—

This medicine 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 This Medicine:

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 this medicine 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.

This medicine 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.

This medicine 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.

This medicine 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 this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Grapefruit and grapefruit juice may cause you to have too much of this medicine in the blood. You should not eat grapefruit or drink grapefruit juice while you are taking 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 (e.g., 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
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.


Last Updated: 4/4/2014

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