Sutent

Generic Name: sunitinib malate (Oral route)

Commonly used brand name(s):

In the U.S.

• Sutent

Available Dosage Forms:

• Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Sunitinib

Uses For Sutent

Sunitinib malate belongs to the group of medicines known as antineoplastics. It is used to treat patients with gastrointestinal stromal tumor (GIST) when the medicine imatinib mesylate did not stop the cancer from growing or when the patient cannot take imatinib mesylate. GIST is a group of cancer cells that start growing in the wall of the stomach, intestines, or rectum. Sunitinib malate is also used to treat advanced (late-stage) kidney cancer.

Sunitinib malate interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by sunitinib malate, 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 malate, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Importance of Diet

Grapefruit and grapefruit juice may change the amount of Sutent in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sunitinib malate 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 malate in the elderly.

Pregnancy

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 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.

• Pimozide
• 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.

• Amiodarone
• Arsenic Trioxide
• Astemizole
• Atazanavir
• Bretylium
• Carbamazepine
• Cisapride
• Clarithromycin
• Dexamethasone
• Disopyramide
• Dofetilide
• Halofantrine
• Indinavir
• Itraconazole
• Ketoconazole
• Lapatinib
• Levofloxacin
• Lumefantrine
• Methadone
• Moxifloxacin
• Nefazodone
• Nelfinavir
• Nilotinib
• Pazopanib
• Phenobarbital
• Phenytoin
• Procainamide
• Quinidine
• Quinine
• Ranolazine
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• Sodium Phosphate
• Sotalol
• St John's Wort
• Telavancin
• Telithromycin
• Terfenadine
• Tetrabenazine
• 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. 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
• High blood pressure or
• Hyperthyroidism (overactive thyroid) or
• Hypothyroidism (underactive thyroid) or
• Kidney function problems (other than cancer) or
• Liver problems or
• Seizures or
• Stomach ulcers—Use with caution. May make these conditions worse.

• Electrolyte imbalance (e.g., low magnesium or potassium in the blood) or
• Heart disease or
• Heart rhythm problems (e.g., QT prolongation or slow heartbeat), history of—Patients with these conditions should be monitored closely when using sunitinib malate.

• Infection, recent or
• Surgery, recent or
• Trauma or injury, recent—Your chances of having serious side effects may be increased.

Proper Use of Sutent

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 late-stage kidney cancer:
    • Adults—50 milligrams (mg) once a day for four weeks (28 days) then stop for two weeks (14 days). The cycle may be repeated as long as your doctor tells you.
    • 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 Sutent

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 malate therapy.

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.

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.

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

Sunitinib malate can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Do not take St. John's Wort while taking this medicine.

Sutent 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:

• 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 in 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

• Constipation
• depressed mood
• dry skin and hair
• feeling cold
• hair loss
• indigestion
• hoarseness or husky voice
• 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, 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

• 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
• swelling of the face, feet, or lower legs

• Cough
• dark-colored urine
• decreased frequency or amount of urine
• increased thirst
• lower back or side pain
• muscle cramps or spasms
• muscular pain, tenderness, wasting, or weakness
• 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:

• Abdominal pain
• acid or sour stomach
• belching
• blistering, peeling, redness, and/or swelling of the palms, hands, or bottoms of the feet
• change in color of treated skin
• change in taste
• difficulty in moving
• discouragement
• excess air or gas in 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 hands or bottoms of 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.

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