sunitinib malate - TheGIConnection

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, for patients intolerant of imatinib mesylate (Gleevec®), and for the treatment of advanced renal cell carcinoma (kidney cancer). 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. It is typically taken once per day for four weeks followed by two weeks of not taking the drug.

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 30% or more of patients) side effects of treatment with sunitinib?

Fatigue
Diarrhea
Nausea and vomiting
Constipation
Altered taste
Rash
Skin discoloration
Heartburn
Inflammation, ulceration of the lining of the mouth
Weight loss
Low levels of immune cells – increases risk of infection
Low levels of platelets – increases risk of bleeding

What are the less common (occur in 10% to 29% of patients) side effects of treatment with sunitinib?

High blood pressure
Cough
Bleeding
Alterations in liver enzymes as determined by laboratory tests
Alterations in kidney enzymes as determined by laboratory test
Low levels of red blood cells – increases risk of anemia
Fever
Headache
Dizziness
Pain – muscles, joints, limb, abdominal, and back
Dry skin
Hair color changes
Loss of hair
Dehydration
Flatulence
Pain, blistering, redness, swelling of the palms of hands and soles of feet

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

Patients should inform their doctors of any side effects.
Wear sunscreen and protective clothing; try to minimize sun exposure.
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.
Wash hands frequently to reduce risk of infection.
Avoid contact with individuals who are known to be sick; avoid large crowds if possible.
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 to use some form of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future since some drugs may cause fertility problems.
It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney stones, liver disease, lung disease, etc.) as they may worsen with this drug.
Patients should let their physician know of any other medication they are taking (whether prescription or over the counter, including vitamins, herbs, etc.) as they may interfere with treatment.
If an oral dose is missed, do not double up on doses. Patients should contact their doctor in this event.
Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.

When should patients notify their physician?

Sudden onset of shortness of breath, cough, and/or fever
Persistent or extreme diarrhea
Persistent or extreme nausea and vomiting
Fever, sore throat, cough
Excessive bleeding, blood in urine or stool
Persistent or extreme constipation
Extreme pain
Extreme weight loss
Dizziness
Ulcers, pain, or inflammation of the lining of the mouth
Ulcers, pain, redness, or inflammation of the palms of hands or soles of feet

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.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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