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SUTENT
Bladder, kidney, and other urologic cancers
Colorectal and other GI cancers
Pancreatic, thyroid, and other endocrine cancers
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Drug Name:

SUTENT Rx

Generic Name and Formulations:
Sunitinib (as malate) 12.5mg, 25mg, 50mg; gelatin caps.

Company:
Pfizer Inc.



Therapeutic Use:

Indications for SUTENT:

Advanced renal cell carcinoma (RCC).

Adult Dose for SUTENT:

50mg once daily for 4 weeks, then 2 weeks off (see full labeling). May adjust dose in increments or decrements of 12.5mg. Concomitant strong CYP3A4 inhibitors (see Interactions): may reduce dose to 37.5mg daily. Concomitant strong CYP3A4 inducers (see Interactions): may increase to max 87.5mg daily.

Children's Dose for SUTENT:

Not established.

Pharmacological Class:

Multikinase inhibitor.

Warnings/Precautions:

Hepatotoxicity; may be severe or fatal. Monitor liver function tests before starting, during each cycle of treatment and as clinically needed; interrupt if Grade 3 or 4 hepatic adverse events occur and discontinue if no resolution; if severe liver function changes or signs/symptoms of failure, do not restart. Cardiovascular disease: monitor LVEF at baseline and periodically thereafter; interrupt or reduce dose if LVEF <50% and >20% below baseline; discontinue if CHF occurs. History of QT prolongation or proarrythmic conditions (eg, bradycardia, electrolyte disturbances); perform periodic ECG, monitor electrolytes. Monitor BP. Suspend therapy if severe hypertension, seizures, or pancreatitis develops. Obtain CBCs, platelets, serum chemistries at start of each cycle. Concomitant exposure to risk factors (eg, IV bisphosphonates therapy or dental disease) may increase the risk of osteonecrosis of the jaw; avoid or consider preventive dentistry prior to treatment. Risk of tumor lysis syndrome: monitor closely in RCC and GIST patients with high tumor burden. Monitor for thyroid dysfunction; obtain baseline levels prior to treatment. Undergoing major surgery. Stress (monitor for adrenal insufficiency). Renal or hepatic impairment. Pregnancy (Cat.D; avoid). Nursing mothers: not recommended.

Interactions:

May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole); grapefruit. May be antagonized by CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital); St. John's wort: not recommended.

Adverse Reactions:

Fatigue, asthenia, fever, diarrhea, nausea, vomiting, mucositis/stomatitis, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, skin discoloration, dry skin, hair color changes, altered taste, headache, back pain, arthralgia, extremity pain, cough, dyspnea, anorexia, bleeding; hepatotoxicity, left ventricular dysfunction, QT prolongation, hemorrhage, hypertension, osteonecrosis of the jaw, tumor lysis syndrome, thyroid dysfunction, impaired wound healing, others (see full labeling).

How Supplied:

Caps—28

SUTENT

  • 12.5mg capsules (Qty:28)
  • appx. price $3641.00
GoodRx

Indications for SUTENT:

Gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.

Adult Dose for SUTENT:

50mg once daily for 4 weeks, then 2 weeks off (see full labeling). May adjust dose in increments or decrements of 12.5mg. Concomitant strong CYP3A4 inhibitors (see Interactions): may reduce dose to 37.5mg daily. Concomitant strong CYP3A4 inducers (see Interactions): may increase to max 87.5mg daily.

Children's Dose for SUTENT:

Not established.

Pharmacological Class:

Multikinase inhibitor.

Warnings/Precautions:

Hepatotoxicity; may be severe or fatal. Monitor liver function tests before starting, during each cycle of treatment and as clinically needed; interrupt if Grade 3 or 4 hepatic adverse events occur and discontinue if no resolution; if severe liver function changes or signs/symptoms of failure, do not restart. Cardiovascular disease: monitor LVEF at baseline and periodically thereafter; interrupt or reduce dose if LVEF <50% and >20% below baseline; discontinue if CHF occurs. History of QT prolongation or proarrythmic conditions (eg, bradycardia, electrolyte disturbances); perform periodic ECG, monitor electrolytes. Monitor BP. Suspend therapy if severe hypertension, seizures, or pancreatitis develops. Obtain CBCs, platelets, serum chemistries at start of each cycle. Concomitant exposure to risk factors (eg, IV bisphosphonates therapy or dental disease) may increase the risk of osteonecrosis of the jaw; avoid or consider preventive dentistry prior to treatment. Risk of tumor lysis syndrome: monitor closely in RCC and GIST patients with high tumor burden. Monitor for thyroid dysfunction; obtain baseline levels prior to treatment. Undergoing major surgery. Stress (monitor for adrenal insufficiency). Renal or hepatic impairment. Pregnancy (Cat.D; avoid). Nursing mothers: not recommended.

Interactions:

May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole); grapefruit. May be antagonized by CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital); St. John's wort: not recommended.

Adverse Reactions:

Fatigue, asthenia, fever, diarrhea, nausea, vomiting, mucositis/stomatitis, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, skin discoloration, dry skin, hair color changes, altered taste, headache, back pain, arthralgia, extremity pain, cough, dyspnea, anorexia, bleeding; hepatotoxicity, left ventricular dysfunction, QT prolongation, hemorrhage, hypertension, osteonecrosis of the jaw, tumor lysis syndrome, thyroid dysfunction, impaired wound healing, others (see full labeling).

How Supplied:

Caps—28

SUTENT

  • 12.5mg capsules (Qty:28)
  • appx. price $3641.00
GoodRx

Indications for SUTENT:

Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.

Adult Dose for SUTENT:

37.5mg once daily continuously without a scheduled off-treatment period. May adjust dose in increments or decrements of 12.5mg. Concomitant strong CYP3A4 inhibitors (see Interactions): may reduce dose to 25mg daily. Concomitant strong CYP3A4 inducers (see Interactions): may increase to max 62.5mg daily.

Children's Dose for SUTENT:

Not established.

Pharmacological Class:

Multikinase inhibitor.

Warnings/Precautions:

Hepatotoxicity; may be severe or fatal. Monitor liver function tests before starting, during each cycle of treatment and as clinically needed; interrupt if Grade 3 or 4 hepatic adverse events occur and discontinue if no resolution; if severe liver function changes or signs/symptoms of failure, do not restart. Cardiovascular disease: monitor LVEF at baseline and periodically thereafter; interrupt or reduce dose if LVEF <50% and >20% below baseline; discontinue if CHF occurs. History of QT prolongation or proarrythmic conditions (eg, bradycardia, electrolyte disturbances); perform periodic ECG, monitor electrolytes. Monitor BP. Suspend therapy if severe hypertension, seizures, or pancreatitis develops. Obtain CBCs, platelets, serum chemistries at start of each cycle. Concomitant exposure to risk factors (eg, IV bisphosphonates therapy or dental disease) may increase the risk of osteonecrosis of the jaw; avoid or consider preventive dentistry prior to treatment. Risk of tumor lysis syndrome: monitor closely in RCC and GIST patients with high tumor burden. Monitor for thyroid dysfunction; obtain baseline levels prior to treatment. Undergoing major surgery. Stress (monitor for adrenal insufficiency). Renal or hepatic impairment. Pregnancy (Cat.D; avoid). Nursing mothers: not recommended.

Interactions:

May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole); grapefruit. May be antagonized by CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital); St. John's wort: not recommended.

Adverse Reactions:

Fatigue, asthenia, fever, diarrhea, nausea, vomiting, mucositis/stomatitis, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, skin discoloration, dry skin, hair color changes, altered taste, headache, back pain, arthralgia, extremity pain, cough, dyspnea, anorexia, bleeding; hepatotoxicity, left ventricular dysfunction, QT prolongation, hemorrhage, hypertension, osteonecrosis of the jaw, tumor lysis syndrome, thyroid dysfunction, impaired wound healing, others (see full labeling).

How Supplied:

Caps—28

SUTENT

  • 12.5mg capsules (Qty:28)
  • appx. price $3641.00
GoodRx

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