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SUTENT® (sunitinib malate) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SUTENT safely and effectively. See full prescribing information for SUTENT.

SUTENT® (sunitinib malate) capsules, for oral use
Initial U.S. Approval: 2006

WARNING: HEPATOTOXICITY

See full prescribing information for complete boxed warning.

Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1)].

RECENT MAJOR CHANGES

Dosage and Administration, Recommended Dosage for GIST and Advanced RCC (2.1)8/2020
Dosage and Administration, Recommended Dosage for pNET (2.3)8/2020
Dosage and Administration, Dosage Modifications for Adverse Reactions (2.4)8/2020
Warnings and Precautions (5)8/2020

INDICATIONS AND USAGE

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. (1.1)
  • treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2)
  • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3)
  • treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4)

DOSAGE AND ADMINISTRATION

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). (2.1)

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. (2.2)

pNET:

  • The recommended dosage is 37.5 mg orally once daily. (2.3)

DOSAGE FORMS AND STRENGTHS

Capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg sunitinib (3)

CONTRAINDICATIONS

None (4)

WARNINGS AND PRECAUTIONS

  • Hepatotoxicity: Fatal liver failure has been observed. Monitor liver function tests at baseline, during each cycle, and as clinically indicated. Interrupt SUTENT for Grade 3 or 4 hepatotoxicity until resolution; discontinue if no resolution. Discontinue SUTENT for subsequent severe changes in liver function tests or other signs and symptoms of liver failure. (5.1)
  • Cardiovascular Events: Myocardial ischemia, myocardial infarction, heart failure, cardiomyopathy, and decreased left ventricular ejection fraction (LVEF) to below the lower limit of normal including death have occurred. Monitor for signs and symptoms of congestive heart failure and consider monitoring LVEF at baseline and periodically during treatment. Discontinue SUTENT for clinical manifestations of congestive heart failure. Interrupt and/or dose reduce for decreased LVEF. (5.2)
  • QT Interval Prolongation and Torsade de Pointes: Monitor patients at higher risk for developing QT interval prolongation. Consider monitoring of electrocardiograms and electrolytes. (5.3)
  • Hypertension: Monitor blood pressure at baseline and as clinically indicated. Initiate and/or adjust antihypertensive therapy as appropriate. (5.4)
  • Hemorrhagic Events: Tumor-related hemorrhage and viscus perforation (both with fatal events) have occurred. Perform serial complete blood counts and physical examinations. (5.5)
  • Tumor Lysis Syndrome (TLS): TLS (some fatal) has been reported primarily in patients with RCC and GIST. Monitor these patients and treat as clinically indicated. (5.6)
  • Thrombotic microangiopathy (TMA): TMA, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, sometimes leading to renal failure or a fatal outcome, has been reported. Discontinue SUTENT for TMA. (5.7)
  • Proteinuria: Renal failure or a fatal outcome has occurred. Monitor urine protein. Interrupt treatment for 24-hour urine protein of 3 or more grams. Discontinue for repeat episodes of 24-hour urine protein of 3 or more grams despite dose reductions or nephrotic syndrome. (5.8)
  • Dermatologic Toxicities: Necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) (some fatal) have occurred. Discontinue SUTENT for these events. (5.9)
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS (some fatal) has been reported. Monitor for signs and symptoms of RPLS. Withhold SUTENT until resolution. (5.10)
  • Thyroid Dysfunction: Monitor thyroid function at baseline, periodically during treatment, and as clinically indicated. Initiate and/or adjust therapy for thyroid dysfunction as appropriate. (5.11)
  • Hypoglycemia: Check blood glucose levels regularly and assess if antidiabetic drug dose modifications are required. (5.12)
  • Osteonecrosis of the Jaw (ONJ): Withhold SUTENT for at least 3 weeks prior to invasive dental procedure and for development of ONJ until complete resolution. (5.13)
  • Impaired Wound Healing: Withhold SUTENT for at least 3 weeks prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of SUTENT after resolution of wound healing complications has not been established. (5.14)
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.15, 8.1, 8.3)

ADVERSE REACTIONS

  • The most common adverse reactions (≥25%) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • CYP3A4 Inhibitors: Consider dose reduction of SUTENT when administered with strong CYP3A4 inhibitors. (7.1)
  • CYP3A4 Inducers: Consider dose increase of SUTENT when administered with strong CYP3A4 inducers. (7.1)

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2020

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