Generic name: Sunitinib

Trade name: Sutent ^®

Other name:  SU11248

Sutent is the trade name for sunitinib. In some cases, health care professionals may use the trade name Sutent when referring to the generic drug name sunitinib. 

Drug type: Sunitinib is a targeted therapy and is a receptor protein-tyrosine kinase inhibitor.  It inhibits the actions of vascular endothelial growth factor (VEGF) and is an angiogenesis inhibitor.  (For more detail, see "How this drug works," below.)

What This Drug Is Used For:

• Treatment of gastrointestinal stromal tumor (GIST)
• Treatment of advanced renal cell cancer

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How This Drug Is Given:

• As a capsule taken by mouth.
• May be taken with or without food.  Avoid grapefruit juice.  
• The amount of sunitinib that you will receive depends on several factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.

Side Effects:

Important things to remember about the side effects of sunitinib:

• You will not get all of the side effects mentioned below.
• Side effects are often predictable in terms of their onset, duration, and severity.
• Side effects are almost always reversible and will go away after therapy is complete.
• Side effects are quite manageable. There are many options to minimize or prevent them.

The following side effects are common (occurring in greater than 30%) for patients taking sunitinib:

• Fatigue 
• Diarrhea 
• Nausea and vomiting 
• Heartburn 
• Taste changes
• Hypertension (high blood pressure)
• Low blood counts. Your white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia and/or bleeding.
• Skin discoloration (possibly due to the drug color - yellow) 

The following side effects are less common (occurring in 29-10%) for patients receiving sunitinib:

• Poor Appetite
• Headache 
• Increased liver enzymes
• Weakness
• Constipation
• Abdominal pain
• Bleeding 
• Fever
• Dry skin 
• Swelling of ankles and feet 
• Dizziness 
• Increased amylase and lipase levels
• Shortness of breath
• Generalized aches and pains
• Rash
• Flatulence 
• Hand –foot syndrome (Palmar-plantar erythrodysesthesia or PPE) –skin rash, swelling, redness, pain and/or peeling of the skin on the palms of hands and soles of feet. 
• Dehydration 
• Low potassium levels 
• Increased bilirubin levels
• Hair color changes 
• Cough
• Hypothyroid
• Hair loss

Rare (2-3%) but serious side effects may include problems with blood clots. Blood clots can lead to pulmonary embolus or stroke – potentially life-threatening conditions.

This list includes common and less common side effects for those taking sunitinib.  Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C) or higher, chills (possible signs of infection)

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Nausea (interferes with ability to eat and unrelieved with prescribed medication).
• Vomiting (vomiting more than 4-5 times in a 24 hour period).
• Diarrhea (4-6 episodes in a 24-hour period).
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decreased amount of urine, or dizziness.
• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools.
• Blood in the urine.
• Pain or burning with urination.
• Extreme fatigue (unable to carry on self-care activities).
• Mouth sores (painful redness, swelling or ulcers).
• Swelling, redness and/or pain in one leg or arm and not the other (may be signs and symptoms of blood clot)

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting sunitinib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
• Avoid the herbal preparation St. John's wort (may increase metabolism and decrease sunitinib concentrations). 
• Do not receive any kind of immunization or vaccination without your doctor’s approval while taking sunitinib.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
• For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking sunitinib. Barrier methods of contraception, such as condoms, are recommended.
• Do not breast feed while taking this medication.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
• Use an electric razor and a soft toothbrush to minimize bleeding.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• Prevention of hand-foot syndrome. Modification of normal activities of daily living to reduce friction and heat exposure to hands and feet, for about a week after treatment. (for more information see - Managing side effects: hand foot syndrome)
• Keep palms of hands and soles of feet moist using emollients.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your doctor while you are taking sunitinib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) the function of other organs (such as your kidneys and liver) as well as your thyroid function.  These will also be ordered by your doctor.

How This Drug Works:

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells.  To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that divide rapidly.  Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects. 

Targeted therapy is about identifying other features of cancer cells.  Scientists look for specific differences in the cancer cells and the normal cells.  This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects.  Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells. 

There are different types of targeted therapies, defined in three broad categories.  Some targeted therapies focus on the internal components and function of the cancer cell.  These use small molecules that can get into the cell and disrupt the function of the cells, causing them to die.  There are several types of targeted therapy that focus on the inner parts of the cells.   The second variety target receptors that are on the outside or surface of the cell.   This form of targeted treatment includes the monoclonal antibodies.  Finally, antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cancer cells, ultimately causing the cells to starve and die.

Researchers agree that targeted therapies are not a replacement for traditional therapies, but may best be used in combination.  More research is needed to identify which cancers may be best treated in this way and to identify additional targets for more types of cancer.

Sunitinib is designed to block tumor cell growth in several ways.  Sunitinib targets several enzymes on blood vessel cells and tumor cells.  Several of these targets are thought to be involved in angiogenesis (making of blood vessels).   

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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