Sutent

DRUG DESCRIPTION

SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-l,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 • C4H6O5 and the molecular weight is 532.6 Daltons.

The chemical structure of sunitinib malate is:

SUTENT®
  (sunitinib malate) Structural Formula Illustration

Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2.

SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing sunitinib malate equivalent to 12.5 mg, 25 mg or 50 mg of sunitinib together with mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients.

The orange gelatin capsule shells contain titanium dioxide, and red iron oxide. The caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide and black iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide.

What are the possible side effects of sunitinib (Sutent)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sunitinib and call your doctor at once if you have any of these serious side effects:

  • chest pain, general ill feeling;
  • uneven heart rate;
  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • weakness, tired feeling, loss of appetite, weight loss;
  • sudden numbness or...

Read All Potential Side Effects and See Pictures of Sutent »

What are the precautions when taking sunitinib malate (Sutent)?

Before taking sunitinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart problems (e.g., congestive heart failure), high blood pressure, liver problems, thyroid disease.

Sunitinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may...

Read All Potential Precautions of Sutent »


Sutent Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, vomiting, diarrhea, change in taste, dry/cracked/thickened skin, watering eyes, swelling around eyes, numbness/tingling of arms/legs, or tiredness may occur. In some cases, drug therapy may be necessary to prevent or relieve nausea/vomiting/diarrhea. Eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may cause patchy or complete hair loss and changes in hair/skin color. These effects are not harmful.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: headache, rash/blisters on palms of hands/soles of feet, sores/pain on the tongue/mouth, easy bruising/bleeding, swelling ankles/feet, shortness of breath, seizures, unusual weight gain, cold intolerance, pain/redness/swelling of arms or legs, unusual tiredness, black/bloody stools, vomit that looks like coffee grounds.

Seek immediate medical attention if any of these rare but very serious side effects occur: trouble breathing, severe dizziness, fainting, fast/slow/irregular heartbeat.

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking sunitinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart problems (e.g., congestive heart failure), high blood pressure, liver problems, thyroid disease.

Sunitinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using sunitinib, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using sunitinib safely.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports.

If you need to have surgery, tell your doctor or dentist that you are using this medication.

Wash your hands well to prevent the spread of infections.

This drug is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. To avoid pregnancy, both males and females using the drug must use reliable form(s) of birth control during treatment.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Sutent Patient Information Including Side Effects

Brand Names: Sutent

Generic Name: sunitinib (Pronunciation: soo NIT in ib)

  • What is sunitinib (Sutent)?
  • What are the possible side effects of sunitinib (Sutent)?
  • What is the most important information I should know about sunitinib (Sutent)?
  • What should I discuss with my healthcare provider before using sunitinib (Sutent)?
  • How should I take sunitinib (Sutent)?
  • What happens if I miss a dose (Sutent)?
  • What happens if I overdose (Sutent)?
  • What should I avoid while taking sunitinib (Sutent)?
  • What other drugs will affect sunitinib (Sutent)?
  • Where can I get more information?

What is sunitinib (Sutent)?

Sunitinib is a cancer medicine that helps the body slow down the growth and reproduction of certain cells, including tumor cells.

Sunitinib is used to treat certain types of advanced or progressive tumors of the digestive system or the kidneys.

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

What are the possible side effects of sunitinib (Sutent)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sunitinib and call your doctor at once if you have any of these serious side effects:

  • chest pain, general ill feeling;
  • uneven heart rate;
  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • weakness, tired feeling, loss of appetite, weight loss;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet;
  • bloody, or black, tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • easy bruising or bleeding, unusual weakness; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • unusual or unpleasant taste in the mouth;
  • nausea, vomiting, stomach pain or upset;
  • diarrhea or constipation;
  • skin rash, hair loss, changes in skin or hair color; or
  • headache, joint or muscle pain.

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 is the most important information I should know about sunitinib (Sutent)?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before using sunitinib, tell your doctor if you have high blood pressure, a thyroid disorder, a heart rhythm disorder, or if you have ever had a heart attack, congestive heart failure, a stroke, or blood clots.

To be sure this medication is helping your condition and is not causing certain side effects, your blood and blood pressure may need to be tested at the beginning of each 4-week treatment cycle. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Stop using sunitinib and call your doctor at once if you have chest pain, shortness of breath, sudden numbness or weakness, sudden headache or vision problems, or any unusual bruising or bleeding.

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