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Sunitinib Malate Oral capsule

It targets a specific protein within cancer cells and stops the cancer cells from growing

Generic Name: sunitinib  |  Brand Name: Sutent

Brand Names: Sutent

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 07/14/2008] Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving bevacizumab (Avastin) in combination with sunitinib malate (Sutent). Bevacizumab is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining bevacizumab and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of bevacizumab at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of bevacizumab. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for sunitinib malate to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

SUNITINIB (soo NI ti nib) is a chemotherapy drug. It targets a specific protein within cancer cells and stops the cancer cells from growing. It is used to treat specific digestive tract tumors called GISTs, advanced kidney cancer, and certain pancreatic neuroendocrine tumors.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • bleeding problems
  • dental disease
  • infection (especially a virus infection such as chickenpox, cold sores, or herpes)
  • heart disease
  • heart failure
  • high blood pressure
  • kidney disease (other than cancer)
  • liver disease
  • lung disease
  • seizures
  • an unusual or allergic reaction to sunitinib, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Tell your doctor if you miss a dose.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • cisapride
  • grapefruit juice
  • pimozide
  • St. John's Wort
  • thioridazine

This medicine may also interact with the following medications:

  • antiviral medicines for HIV or AIDS
  • barbiturates for sleep or seizures
  • carbamazepine
  • dexamethasone
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for fungal infections like ketoconazole and itraconazole
  • medicines for irregular heart beat like amiodarone, bepridil, dofetilide, encainide, flecainide, propafenone, quinidine
  • medicines for numbness or sleep during surgery
  • phenobarbital
  • phenytoin
  • rifabutin, rifampin, rifapentine
  • some antibiotics like clarithromycin, erythromycin, levofloxacin, mefloquine, telithromycin

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Talk to your doctor about any new or unusual health problems. You will need blood work done while you are taking this medicine.

If you have any dental work done, tell your dentist you are receiving this medicine.

Do not become pregnant while taking this medicine. Male and female patients should use effective birth control methods while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.


Last Updated: April 26, 2012
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