Sutent®

Posted on October 19th, 2010 by

Class: Targeted therapy

Generic Name: Sunitinib malate (soo-NI-too-nib MA-late)
Trade Name: Sutent®

For what conditions is this drug used? Sunitinib malate is FDA approved for the treatment of gastrointestinal stromal tumors (GIST) after cancer progression or for patients intolerant of imatinib mesylate (Gleevec®); for the treatment of advanced renal cell carcinoma (kidney cancer); and for the treatment of progressive (worsening) pancreatic neuroendocrine tumors (PNET) that cannot be treated with surgery. If your doctor has prescribed this drug for a different condition, keep in mind that doctors have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA; you should discuss this issue with your doctor.

What is the mechanism of action? Sunitinib is classified as a multi-kinase inhibitor. It inhibits pathways of a cell that are involved in growth and replication of a cell; these pathways are also implicated in the spread of cancer in the body.

How is sunitinib malate given (administered)? Sunitinib is given in the form of a capsule and is taken orally.  You should not drink grapefruit juice or eat grapefruit during treatment with Sutent.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while being treated with sunitinib malate. Physical examinations, scans, or other measures may be performed to assess side effects and response to therapy. Blood may be drawn to monitor functions of some organs, such as the liver.

What are the common (occur in 20% or more of patients) side effects of treatment with sunitinib?

  • Fatigue
  • Weakness
  • Fever
  • Diarrhea
  • Nausea and vomiting
  • Constipation
  • High blood pressure
  • Pain or swelling in arms or legs
  • Altered taste
  • Rash
  • Skin discoloration
  • Heartburn
  • Abdominal pain
  • Hand-foot syndrome
  • Dry skin
  • Hair color changes
  • Headache
  • Cough
  • Difficulty breathing/shortness of breath
  • Loss of appetite
  • Mouth sores
  • Bleeding

What are the less common but potentially serious side effects of treatment with sunitinib?

  • Liver problems
  • Heart problems
  • Severe bleeding
  • Hormone problems, including problems with the thyroid and adrenal glands

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to the physician’s instructions and inform the physician of any side effects.
  • Drink plenty of fluid. Patients should ask their physician about the amount of liquid to consume per day.
  • Maintain adequate rest and nutrition.
  • Eat small meals frequently to help alleviate nausea and heartburn.
  • Avoid extreme heat, cold, or friction with palms of hands or soles of feet.

Are there any special precautions patients should be aware of before starting treatment?

  • Patients should tell their physician if they are pregnant, breastfeeding, or planning a family in the near future. This drug may cause birth defects.
  • It is important that patients inform their physician about all medical conditions, including heart problems, high blood pressure, thyroid problems, plans to have surgery, kidney problems, liver problems, bleeding problems, and seizures.
  • Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
  • Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor if you experience any of the following:

  • Signs or symptoms of liver problems: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area.
  • Signs or symptoms of heart problems: feeling very tired, shortness of breath, or swelling of the feet and ankles
  • Signs or symptoms of heart rhythm changes: dizziness, faintness, or abnormal heartbeats
  • Signs or symptoms of a serious bleeding problem: painful swollen stomach, vomiting blood, black sticky stools, bloody urine, or headache or change in mental status.
  • Signs or symptoms of a hormone problem: tiredness that worsens and does not go away, loss of appetite, heat intolerance, feeling nervous or agitated, tremors, sweating, nausea or vomiting, diarrhea, fast heart rate, weight gain or weight loss, feeling depressed, irregular menstrual periods or no menstrual periods, headache, hair loss.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics, and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

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