Warnings & Recalls for Sutent
Sutent Black Box Warning
Sutent has received a black bx warning due to its risk for causing hepatotoxicity, or liver damage, in patients. This condition can be lethal and patients should seek medical help right away if they suspect that they may have developed this condition.
Sutent and Pregnancy
Sutent has been assigned by the FDA as a
pregnancy Category D medicine. Women who are pregnant
should not take Sutent as it may cause harm to the fetus. It has not been confirmed if Sutent passes into breast-milk or if it could potentially cause harm to a nursing baby. Consult your doctor
before taking Sutent if you are
breastfeeding. Be sure to use an effective method of
birth control while taking Sutent and let your doctor know
immediately if you become pregnant.
General Warnings
Do not take Sutent if you are
allergic to sunitinib or any ingredients in the medicine. Let your doctor know about your
medical history, be sure to include information about the following:
- liver or kidney disease or failure
- seizures (convulsions)
- blood disorders, problems with blood-clotting, or if you have a blood clot
- high blood pressure
- thyroid problems
- heart disease, abnormal heart rythm, coronary artery disease, or if you have had bypass graft surgery
- "Long QT syndrome" (LQTS) or if anyone in your family has had "Long QT syndrome
- if you have ever had a stroke, heart attack or transient ischemic attack
Sutent may increase the risk of serious liver damage. Be aware of symptoms of liver problems, see "Side Effects" tab for details.
Sutent Drug Interactions
Avoid using products containing
St. John's wort, it may interact with Sutent.
Do not consume
grapefruit while using Sutent as a treatment, it may magnify the side effects of this drug. Tell your doctor about
all medicines you are currently taking, the following could have an effect on your use of Sutent:
- corticosteroid (steroid) drugs
- other cancer treatments
- medicines for tuberculosis
- anti-depressants
- antibiotics and antifungals
- barbiturates (depressants)
- drugs for treating heart or blood pressure conditions
- HIV or AIDS medications
- narcolepsy treatments
- medicines for preventing seizures
Sutent Treatment and Use
Sutent | Sunitinib is a multikinase inhibitor medicine marketed by Pfizer Inc. for treating advanced or worsening cancers and tumors. Sutent may be prescribed as a treatment for:
- gastrointestinal stromal tumors (GIST), including tumors of the stomach, intestines or bowels, and the esophagus, in patients who have not been successfully treated with imatinib
- advanced renal cell carcinoma (RCC or cancer of the kidneys)
- pancreatic neuroendocrine tumors (pNET or tumors of the pancreas) that cannot be treated with surgery
Sutent was approved by the U.S. Food and Drug Administration in May of 2011.
How Does Sutent Work?
Sutent works by interfering with proteins that trigger the multiplication of cancer cells. Sutent may prevent or decrease the reproduction of cancer and aids in reducing the size of tumors caused by cancer.
How to Take Sutent
Sutent is available in capsule form of 12.5 mg, 25 mg, and 50 mg doses to be taken orally with a full glass of water. Sutent may be taken with or without food. Swallow the capsule whole. Do not break or open the capsule. Dosage amounts vary, take only the amount prescribed to you by your doctor.
For patients treating gastrointestinal stromal tumors or advanced renal cell carcinoma, Sutent is typically prescribed to be taken once each day for a total of 4 weeks, with a 14 day interval break before beginning the next prescription cycle.
It is recommended to take Sutent once daily to treat pancreatic neuroendocrine tumors.
Be sure to keep all scheduled appointments. You may need to have your blood and blood pressure checked regularly to ensure your safety while taking Sutent. Your doctor may require you to have your heart function tested by using an electrocardiogram (ECG or EKG) frequently.