sunitinib

Generic Name: sunitinib (soo NIT in ib)
Brand Name: Sutent

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 digestive system, the pancreas, or the kidneys.

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

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 upper stomach pain, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Slideshow: The Ferocity of Chemotherapy - Does The End Justify The Means?

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:

  • liver or kidney disease;

  • heart disease, high blood pressure, heart rhythm disorder;

  • seizures;

  • a bleeding or blood-clotting disorder;

  • a disorder of your thyroid or adrenal gland;

  • a personal or family history of Long QT syndrome; or

  • a history of stroke, heart attack, congestive heart failure, a blood clot, or coronary artery disease.

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.

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.

FDA pregnancy category D. Do not use sunitinib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

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.

How should I take sunitinib?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. 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. Skip the missed dose if it is almost time for your next scheduled 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?

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up 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.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

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

Sunitinib side effects

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.

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;

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet;

  • unusual bleeding (nose, mouth, vagina, or rectum);

  • signs of bleeding inside your body--change in your mental state, easy bruising, 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--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting;

  • dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats, seizure;

  • symptoms of a hormone problem--severe tiredness, depression, fast heart rate, agitation, tremors, feeling nervous, sweating, feeling hot, nausea, vomiting, diarrhea, hair loss, irregular menstrual periods; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • indigestion, decreased appetite, stomach pain, nausea, vomiting, diarrhea, constipation;

  • muscle or joint pain, headache, feeling weak or tired;

  • blisters or ulcers in your mouth, red or swollen gums, altered sense of taste, trouble swallowing;

  • increased blood pressure;

  • bleeding;

  • swelling in your hands or feet;

  • cough, trouble breathing; 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.

See also: Side effects (in more detail)

Sunitinib dosing information

Usual Adult Dose for Renal Cell Carcinoma:

50 mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

Comment: May be taken with or without food.

Uses:
-For the treatment of advanced renal cell carcinoma (RCC)
-For the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib.

Usual Adult Dose for Gastrointestinal Stromal Tumor:

50 mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

Comment: May be taken with or without food.

Uses:
-For the treatment of advanced renal cell carcinoma (RCC)
-For the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib.

Usual Adult Dose for Pancreatic Cancer:

37.5 mg orally once daily

Comments:
-To be taken continuously without a scheduled off-treatment period; may be taken with or without food.

Use: For the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.

What other drugs will affect sunitinib?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with sunitinib, especially medicines to treat osteoporosis or Paget's disease, such as:

  • risedronate (Actonel);

  • pamidronate (Aredia);

  • ibandronate (Boniva);

  • etidronate (Didronel);

  • alendronate (Fosamax);

  • tiludronate (Skelid); or

  • zoledronic acid (Reclast, Zometa).

This list is not complete. Other drugs may interact with sunitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.03. Revision Date: 2014-11-12, 4:14:22 PM.

Hide
(web4)