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sunitinib

Pronunciation: soo NIT in ib

Brand: Sutent

Sutent

slide 1 of 3, Sutent,

12.5 mg, capsule, orange, imprinted with Pfizer, STN 12.5 mg

 Image of Sutent
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Sutent

slide 2 of 3, Sutent,

25 mg, capsule, brown/orange, imprinted with Pfizer, STN 25 mg

 Image of Sutent
slide 2 of 3
    

Sutent

slide 3 of 3, Sutent,

50 mg, capsule, brown, imprinted with Pfizer, STN 50 mg

 Image of Sutent
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What is the most important information I should know about sunitinib?

Sunitinib can cause severe or fatal effects on your liver. You will need frequent blood tests to check your liver function during treatment. Call your doctor if you have any signs of a liver problem, such as right-sided upper stomach pain, itching, dark urine, or jaundice (yellowing of the skin or eyes).

What is sunitinib?

Sunitinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Sunitinib is used to treat certain types of advanced or progressive tumors of the stomach, intestines, esophagus, pancreas, or kidneys.

Sunitinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using sunitinib?

You should not use sunitinib if you are allergic to it.

To make sure sunitinib is safe for you, tell your doctor if you have ever had:

  • kidney problems other than cancer;
  • liver disease;
  • heart disease, high blood pressure;
  • low blood sugar, or diabetes;
  • a seizure;
  • a bleeding or blood-clotting disorder;
  • a thyroid disorder; or
  • long QT syndrome (in you or a family member).

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. You may be more likely to develop this condition if you also use medicine to treat osteoporosis or Paget's disease.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

You may need to have a negative pregnancy test before starting this treatment.

Sunitinib can harm an unborn baby. Do not use this medicine if you are pregnant. Use effective birth control to prevent pregnancy, whether you are a man or a woman. The use of this medicine by either parent may cause birth defects.

If you are a woman, keep using birth control for at least 4 weeks after your last dose of sunitinib. If you are a man, keep using birth control for at least 7 weeks after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using sunitinib.

It is not known whether sunitinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using sunitinib and for at least 4 weeks after your last dose.

How should I take sunitinib?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your blood pressure and liver function may need to be tested at the beginning of each 4-week treatment cycle.

Sunitinib is usually taken once per day. Sunitinib is sometimes taken for 4 weeks followed by 2 weeks off the drug. Your doctor will determine how many complete treatment cycles you need based on your condition.

You may take sunitinib with or without food.

Do not crush, chew, or open a sunitinib capsule. Swallow it whole. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water and rinse thoroughly.

To be sure this medicine is not causing harmful effects, you will need frequent blood and urine tests. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis, and you may also need frequent dental exams. Do not miss any follow-up visits to your doctor.

If you need surgery or a dental procedure, tell the surgeon or dentist ahead of time that you are using sunitinib. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sunitinib?

Grapefruit and grapefruit juice may interact with sunitinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking sunitinib.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of sunitinib?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Sunitinib can cause severe or fatal effects on your liver. Call your doctor if you have:

  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

  • feeling short of breath (even with mild exertion), swelling in your ankles or feet;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet;
  • unusual bruising or bleeding, pale skin;
  • increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, dizziness;
  • low blood sugar --headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
  • signs of bleeding inside your body --change in your mental state, blood in your urine, pain and swelling in your stomach, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • signs of tumor cell breakdown --muscle cramps, tiredness, confusion, fast or slow heart rate, vomiting, diarrhea, decreased urination, tingling in your hands or feet, tingling around your mouth; or
  • symptoms of a thyroid problem --severe and worsening tiredness, depression, fast heart rate, agitation, tremors, feeling nervous, sweating, nausea, vomiting, diarrhea, hair loss, weight changes, irregular menstrual periods.

Common side effects may include:

  • indigestion, decreased appetite, stomach pain, nausea, vomiting, diarrhea;
  • feeling weak or tired;
  • blisters or ulcers in your mouth, red or swollen gums, altered sense of taste, trouble swallowing;
  • pain and redness in your hands or feet;
  • increased blood pressure;
  • bleeding; or
  • skin rash or dryness, changes in skin or hair color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sunitinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with sunitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about sunitinib.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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