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Sutent is the brand name for sunitinib malate oral capsules.

Sutent is available as 12.5 mg, 25 mg, 37.5 mg, or 50 mg oral capsule

Sutent is a kinase inhibitor indicated for:

• Treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate
• Treatment of adult patients with advanced renal cell carcinoma (RCC)
• Adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy
• Treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease

Sutent targets proteins in cancer cells and stops the cancer cells from growing.

Sutent is dosed as follows:

GIST and Advanced RCC:

• The recommended dosage is 50 mg orally once daily for the first 4 weeks of each 6-week cycle (Schedule 4/2)

Adjuvant Treatment of RCC:

• The recommended dosage is 50 mg orally once daily for the first 4 weeks of a 6-week cycle (Schedule 4/2) for a maximum of 9 cycles

pNET:

• The recommended dosage is 37.5 mg orally once daily

Sutent is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Sutent:

• Tiredness
• Weakness
• Diarrhea
• Pain, swelling or sores inside of your mouth
• Nausea
• Loss of appetite
• Indigestion
• Vomiting
• Stomach-area (abdominal) pain
• Blisters or rash on the palms of your hands and soles of your feet
• High blood pressure
• Taste changes
• Low platelet counts

Serious side effects are rare with Sutent. Contact your doctor if you experience any of the following.

• Heart problems
• Abnormal heart rhythm changes
• Bleeding problems
• Serious stomach and intestinal problems
• Tumor lysis syndrome (TLS)
• Abnormal changes in the brain
• Blood clots
• Serious skin and mouth reactions
• Thyroid problems
• Jawbone problems (osteonecrosis)
  Wound healing problems

The following medications may interact with Sutent:

• CYP3A4 Inhibitors: Consider dose reduction of Sutent when administered with strong CYP3A4 inhibitors
• CYP3A4 Inducers: Consider dose increase of Sutent when administered with strong CYP3A4 inducers

Pfizer

Sutent can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Sutent
• You should use effective birth control (contraception) during treatment and for at least 4 weeks after your last dose of Sutent
• Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Sutent
• Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 7 weeks after your last dose of Sutent
• Sutent may cause fertility problems in males and females. Tell your healthcare provider if this is a concern for you

• Sunitinib