Sutent

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/9/2021
Sutent Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Sutent?

Sutent (sunitinib malate) is a multi-kinase inhibitor indicated for the treatment of gastrointestinal stromal tumor after disease progression on, or intolerance to imatinib mesylate, for advanced renal cell carcinoma, and for progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable, locally advanced or metastatic disease. Sutent is available in generic form.

What Are Side Effects of Sutent?

Side effects of Sutent include:

  • unusual or unpleasant taste in the mouth
  • cough
  • nausea
  • vomiting
  • upset stomach
  • constipation
  • dry skin
  • changes in skin or hair color (yellow skin or lighter skin/hair)
  • hair loss
  • joint pain
  • back pain
  • fatigue
  • tiredness
  • weakness
  • fever
  • diarrhea
  • mouth pain/sores
  • abdominal pain
  • rash or other skin changes such as dry or cracked skin
  • blisters or rash on hands or feet
  • loss of appetite
  • pain or swelling in the arms or legs
  • numbness or tingling of the arms or legs
  • shortness of breath
  • bleeding
  • watery eyes
  • swelling around the eyes
  • chest pain
  • general ill feeling, or
  • uneven heart rate.

Tell your doctor if you have serious side effects of Sutent including:

  • headache,
  • easy bruising or bleeding,
  • swelling ankles or feet,
  • unusual weight changes,
  • cold or heat intolerance,
  • unusual tiredness,
  • black or bloody stools,
  • vomit that looks like coffee grounds,
  • coughing up blood,
  • slow wound healing,
  • jaw pain,
  • toe/joint/back pain,
  • painful urination,
  • cloudy/pink/bloody urine,
  • changes in the amount of urine,
  • muscle weakness/cramping/twitching,
  • signs of low blood sugar (such as hunger, shakiness, fast heartbeat, sweating),
  • mental/mood changes (such as decreased alertness, irritability, nervousness), or
  • vision changes (such as decreased vision).

Dosage for Sutent

The recommended dose of Sutent (strengths available are 12.5, 25 and 50mg tablets). Sutent may be taken without food. Dose modification depends on the type of cancer treated and is determined by the treating doctor. Severe side effects include hepatotoxicity.

What Drugs, Substances, or Supplements Interact with Sutent?

Sutent may interact with dexamethasone, imatinib, isoniazid, nefazodone, St. John's wort, antibiotics, antifungals, barbiturates, heart or blood pressure medications, HIV/AIDS medicines, medicines to treat narcolepsy, medications to treat osteoporosis or Paget's disease of bone, seizure medications, or grapefruit and grapefruit juice. Tell your doctor all medications and supplements you use.

Sutent During Pregnancy and Breastfeeding

Sutent is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Sutent passes into breast milk. Because of the possible risk to the infant, breastfeeding while using Sutent is not recommended

Additional Information

Our Sutent (sunitinib malate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Skin Cancer Symptoms, Types, Images See Slideshow
Sutent Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Sunitinib can cause severe or fatal effects on your liver. Call your doctor if you have loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Sunitinib may also cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Also call your doctor at once if you have:

  • pain, redness, numbness, and peeling skin on your hands or feet;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • painful skin sores, sores in your mouth or on your lips;
  • jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;
  • confusion, thinking problems, vision loss, seizure;
  • heart problems--swelling, rapid weight gain, fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (like you might pass out);
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, dizziness;
  • low blood sugar--headache, hunger, weakness, sweating, fast heart rate, feeling jittery;
  • signs of bleeding inside your body--change in your mental state, blood in your urine, pain and swelling in your stomach, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth; or
  • symptoms of a thyroid problem--severe and worsening tiredness, depression, fast heart rate, agitation, tremors, feeling nervous, sweating, nausea, vomiting, diarrhea, hair loss, weight changes, irregular menstrual periods.

Common side effects may include:

  • indigestion, decreased appetite, stomach pain, nausea, vomiting, diarrhea;
  • feeling weak or tired;
  • mouth sores or pain, altered sense of taste;
  • blisters or rash on your hands or feet;
  • bruising or bleeding; or
  • increased blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sutent (Sunitinib Malate)

Sutent Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling.

  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular Events [see WARNINGS AND PRECAUTIONS]
  • QT Interval Prolongation and Torsade de Pointes [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Hemorrhagic Events [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome (TLS) [see WARNINGS AND PRECAUTIONS]
  • Thrombotic Microangiopathy [see WARNINGS AND PRECAUTIONS]
  • Proteinuria [see WARNINGS AND PRECAUTIONS]
  • Dermatologic Toxicities [see WARNINGS AND PRECAUTIONS]
  • Thyroid Dysfunction [see WARNINGS AND PRECAUTIONS]
  • Hypoglycemia [see WARNINGS AND PRECAUTIONS]
  • Osteonecrosis of the Jaw (ONJ) [see WARNINGS AND PRECAUTIONS]
  • Wound Healing [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described in the Warnings and Precautions reflect exposure to SUTENT (N = 7527) in GIST, advanced RCC, adjuvant treatment of RCC, and pNET [see WARNINGS AND PRECAUTIONS]. In this database, 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.

The data below reflect exposure to SUTENT in 966 patients who participated in the treatment phase of randomized trials of GIST (n=202), advanced RCC (n=375), adjuvant treatment of RCC (n=306), and pNET (n=83) [see Clinical Studies].

Gastrointestinal Stromal Tumor (GIST)

The safety of SUTENT was evaluated in Study 1, a randomized, double-blind, placebo-controlled trial in which previously treated patients with GIST received SUTENT 50 mg daily on Schedule 4/2 (n=202) or placebo (n=102).

Median duration of blinded study treatment was 2 cycles for patients on SUTENT (mean: 3.0; range: 1-9) and 1 cycle (mean; 1.8; range: 1-6) for patients on placebo at the time of the interim analysis. Dose reductions occurred in 23 patients (11%) on SUTENT and none on placebo. Dose interruptions occurred in 59 patients (29%) on SUTENT and 31 patients (30%) on placebo. The rates of treatment-emergent, nonfatal adverse reactions resulting in permanent discontinuation were 7% and 6% in the SUTENT and placebo groups, respectively.

Most treatment-emergent adverse reactions in both study arms were Grade 1 or 2 in severity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 56% versus 51% of patients on SUTENT versus placebo, respectively, in the double-blind treatment phase of the trial. Table 1 compares the incidence of common (≥10%) treatment-emergent adverse reactions for patients receiving SUTENT and reported more commonly in patients receiving SUTENT than in patients receiving placebo.

Table 1. Adverse Reactions Reported in Study 1 in ≥10% of GIST Patients Who Received SUTENT in the Double-Blind Treatment Phase and More Commonly Than in Patients Given Placebo*

Adverse ReactionGIST
SUTENT (N=202)Placebo (N=102)
All Grades %Grade 3-4 %All Grades %Grade 3-4 %
Any Adverse Reaction94569751
Gastrointestinal
  Diarrhea404270
  Mucositis/stomatitis291182
  Constipation200142
Cardiac
  Hypertension154110
Dermatology
  Skin discoloration300230
  Rash14190
  Hand-foot syndrome144103
Neurology
  Altered taste210120
Musculoskeletal
  Myalgia/limb pain14191
Metabolism/Nutrition
  Anorexiaa331295
  Asthenia225113
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Abbreviations: GIST=gastrointestinal stromal tumor; N=number of patients.
a Includes decreased appetite.

In the double-blind treatment phase of GIST Study 1, oral pain other than mucositis/stomatitis occurred in 12 patients (6%) on SUTENT versus 3 (3%) on placebo. Hair color changes occurred in 15 patients (7%) on SUTENT versus 4 (4%) on placebo. Alopecia was observed in 10 patients (5%) on SUTENT versus 2 (2%) on placebo.

Table 2 provides common (≥10%) treatment-emergent laboratory abnormalities.

Table 2. Laboratory Abnormalities Reported in Study 1 in ≥10% of GIST Patients Who Received SUTENT or Placebo in the Double-Blind Treatment Phase*

Laboratory ParameterGIST
SUTENT (N=202)Placebo (N=102)
All Grades*
%
Grade 3-4*,a
%
All Grades*
%
Grade 3-4*,b
%
Any68 (34)22 (22)
Gastrointestinal
  AST/ALT392231
  Lipase2510177
  Alkaline phosphatase244214
  Amylase175123
  Total bilirubin16180
  Indirect bilirubin10040
Cardiac
  Decreased LVEF11130
Renal/Metabolic
  Creatinine12170
  Potassium decreased12140
  Sodium increased10041
Hematology
  Neutrophils531040
  Lymphocytes380160
  Platelets38540
  Hemoglobin263222
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; GIST=gastrointestinal stromal tumor; LVEF=left ventricular ejection fraction; N=number of patients.
a Grade 4 laboratory abnormalities in patients on SUTENT included alkaline phosphatase (1%), lipase (2%), creatinine (1%), potassium decreased (1%), neutrophils (2%), hemoglobin (2%), and platelets (1%).
b Grade 4 laboratory abnormalities in patients on placebo included amylase (1%), lipase (1%), and hemoglobin (2%).

After an interim analysis, the study was unblinded and patients on the placebo arm were given the opportunity to receive open-label SUTENT treatment [see Clinical Studies]. For 241 patients randomized to the SUTENT arm, including 139 who received SUTENT in both the double-blind and open-label treatment phases, the median duration of SUTENT treatment was 6 cycles (mean: 8.5; range: 1–44). For the 255 patients who ultimately received open-label SUTENT treatment, median duration of study treatment was 6 cycles (mean: 7.8; range: 1–37) from the time of the unblinding. A total of 118 patients (46%) required dosing interruptions, and a total of 72 patients (28%) required dose reductions. The incidence of treatment-emergent adverse reactions resulting in permanent discontinuation was 20%. The most common Grade 3 or 4 treatment-related adverse reactions experienced by patients receiving SUTENT in the open-label treatment phase were fatigue (10%), hypertension (8%), asthenia (5%), diarrhea (5%), hand-foot syndrome (5%), nausea (4%), abdominal pain (3%), anorexia (3%), mucositis (2%), vomiting (2%), and hypothyroidism (2%).

Advanced Renal Cell Carcinoma (RCC)

The safety of SUTENT was evaluated in Study 3, a double-blind, active-controlled trial in which previously untreated patients with locally advanced or metastatic RCC received SUTENT 50 mg daily on Schedule 4/2 (n=375) or IFN-α 9 million International Units (MIU) (n=360). The median duration of treatment was 11.1 months (range: 0.4-46.1) for SUTENT treatment and 4.1 months (range: 0.1–45.6) for IFN-α treatment. Dose interruptions occurred in 202 patients (54%) on SUTENT and 141 patients (39%) on IFN-α. Dose reductions occurred in 194 patients (52%) on SUTENT and 98 patients (27%) on IFN-α. Discontinuation rates due to adverse reactions were 20% for SUTENT and 24% for IFN-α. Most treatment-emergent adverse reactions in both study arms were Grade 1 or 2 in severity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 77% versus 55% of patients on SUTENT versus IFN-α, respectively.

Table 3 compares the incidence of common (≥10%) treatment-emergent adverse reactions for patients receiving SUTENT versus IFN-α.

Table 3. Adverse Reactions Reported in Study 3 in ≥10% of Patients With RCC Who Received SUTENT or IFN-α*

Adverse ReactionTreatment-Naive RCC
SUTENT (N=375)IFN-α (N=360)
All Grades
%
Grade 3-4a
%
All Grades
%
Grade 3-4b
%
Any Adverse Reaction99779955
Constitutional
  Fatigue62155615
  Asthenia2611226
  Fever22137<1
  Weight decreased16<1171
  Chills141310
  Chest Pain13271
  Influenza like illness5015<1
Gastrointestinal
  Diarrhea661021<1
  Nausea586412
  Mucositis/stomatitis4735<1
  Vomiting395171
  Dyspepsia34240
  Abdominal painc3051121
  Constipation23114<1
  Dry mouth1307<1
  GERD/reflux esophagitis12<110
  Flatulence14020
  Oral pain14<110
  Glossodynia11010
  Hemorrhoids10020
Cardiac
  Hypertension34134<1
  Edema peripheral24251
  Ejection fraction decreased16352
Dermatology
  Rash29211<1
  Hand-foot syndrome29810
  Skin discoloration/yellow skin25<100
  Dry skin23<170
  Hair color changes200<10
  Alopecia14090
  Erythema12<110
  Pruritus12<17<1
Neurology
  Altered tasted47<1150
  Headache231190
  Dizziness11<1141
Musculoskeletal
  Back pain285142
  Arthralgia303191
  Pain in extremity/limb discomfort405302
Endocrine
  Hypothyroidism16210
Respiratory
  Cough27114<1
  Dyspnea266204
  Nasopharyngitis14020
  Oropharyngeal pain14<120
  Upper respiratory tract infection11<120
Metabolism/Nutrition
  Anorexiae483422
Hemorrhage/Bleeding
  Bleeding, all sites374f101
Psychiatric
  Insomnia15<1100
  Depressiong110141
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Abbreviations: ARs=adverse reactions; IFN=interferon-α; N=number of patients; RCC=renal cell carcinoma.
a Grade 4 ARs in patients on SUTENT included back pain (1%), arthralgia (<1%), dyspnea (<1%), asthenia (<1%), fatigue (<1%), limb pain (<1%) and rash (<1%).
b Grade 4 ARs in patients on IFN-α included dyspnea (1%), fatigue (1%), abdominal pain (<1%), and depression (<1%).
c Includes flank pain.
d Includes ageusia, hypogeusia, and dysgeusia.
e Includes decreased appetite.
f Includes 1 patient with Grade 5 gastric hemorrhage.
g Includes depressed mood.

Treatment-emergent Grade 3-4 laboratory abnormalities are presented in Table 4.

Table 4. Laboratory Abnormalities Reported in Study 3 in ≥10% of Treatment-Naive RCC Patients Who Received SUTENT or IFN-α

Laboratory ParameterTreatment-Naive RCC
SUTENT (N=375)IFN-α (N=360)
All Grades*
%
Grade 3-4*,a
%
All Grades*
%
Grade 3-4*,b
%
Gastrointestinal
  AST562382
  ALT513402
  Lipase5618468
  Alkaline phosphatase462372
  Amylase356323
  Total bilirubin20120
  Indirect bilirubin13110
Renal/Metabolic
  Creatinine70<151<1
  Creatine kinase492111
  Uric acid4614338
  Calcium decreased421401
  Phosphorus316246
  Albumin281200
  Glucose increased236156
  Sodium decreased208154
  Glucose decreased17012<1
  Potassium increased163174
  Calcium increased13<1101
  Potassium decreased1312<1
  Sodium increased130100
Hematology
  Neutrophils7717499
  Hemoglobin798695
  Platelets689241
  Lymphocytes68186826
  Leukocytes788562
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; IFN=interferon-α; N=number of patients; RCC=renal cell carcinoma.
a Grade 4 laboratory abnormalities in patients on SUTENT included uric acid (14%), lipase (3%), neutrophils (2%), lymphocytes (2%), hemoglobin (2%), platelets (1%), amylase (1%), ALT (<1%), creatine kinase (<1%), creatinine (<1%), glucose increased (<1%), calcium decreased (<1%), phosphorous (<1%), potassium increased (<1%), and sodium decreased (<1%).
b Grade 4 laboratory abnormalities in patients on IFN-α included uric acid (8%), lymphocytes (2%), lipase (1%), neutrophils (1%), amylase (<1%), calcium increased (<1%), glucose decreased (<1%), potassium increased (<1%), and hemoglobin (<1%).

Long-Term Safety In RCC

The long-term safety of SUTENT in patients with metastatic RCC was analyzed across 9 completed clinical studies conducted in the first-line, bevacizumab-refractory, and cytokine-refractory treatment settings. The analysis included 5739 patients, of whom 807 (14%) were treated for at least 2 years and 365 (6%) for at least 3 years. Prolonged treatment with SUTENT did not appear to be associated with new types of adverse reactions. There appeared to be no increase in the yearly incidence of adverse reactions at later time points. Hypothyroidism increased during the second year of treatment with new cases reported up to year 4.

Adjuvant Treatment Of RCC

The safety of SUTENT was evaluated in S-TRAC, a randomized, double-blind, placebo-controlled trial in which patients who had undergone nephrectomy for RCC received SUTENT 50 mg daily (n=306) on Schedule 4/2 or placebo (n=304). The median duration of treatment was 12.4 months (range: 0.13-14.9) for SUTENT and 12.4 months (range: 0.03-13.7) for placebo. Permanent discontinuation due to an adverse reaction occurred in 28% of patients on SUTENT and 6% on placebo. Adverse reactions leading to permanent discontinuation in >2% of patients include hand-foot syndrome and fatigue/asthenia. Dosing interruptions or delays occurred in 166 (54%) and 84 (28%) patients on SUTENT and placebo, respectively. One hundred forty patients (45.8%) out of 306 patients in the SUTENT arm and 15 patients (5%) out of 304 patients in the placebo arm had dose reductions.

Table 5 compares the incidence of common (≥10%) treatment-emergent adverse reactions for patients receiving SUTENT versus placebo.

Table 5. Adverse Reactions Reported in S-TRAC in ≥10% of Patients With RCC Who Received SUTENT and More Commonly Than in Patients Given Placebo*

Adverse ReactionAdjuvant Treatment of RCC
SUTENT (N=306)Placebo (N=304)
All Grades
%
Grade 3-4
%
All Grades
%
Grade 3-4
%
Any Adverse Reaction99608815
Constitutional
  Fatigue/Asthenia578342
  Localized edemaa18<1<10
  Pyrexia12<160
Gastrointestinal
  Mucositis/Stomatitisb616150
  Diarrhea57422<1
  Nausea342150
  Dyspepsia27170
  Abdominal painc2529<1
  Vomiting19270
  Constipation120110
Cardiac
  Hypertensiond398141
  Edema/Peripheral edema10<170
Dermatology
  Hand-foot syndrome501610<1
  Hair color changes22020
  Rashe242120
  Skin discoloration /Yellow skin18010
  Dry skin14060
Neurology
  Altered tastef38<160
  Headache19<1120
Musculoskeletal
  Pain in extremity15<170
  Arthralgia11<1100
Endocrine
  Hypothyroidism/TSH increased24<140
Metabolism/Nutrition
  Anorexia/Decreased appetite19<150
Hemorrhage/Bleeding
  Bleeding events, all sitesg24<15<1

* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Abbreviations: ARs=adverse reactions; N=number of patients; RCC=renal cell carcinoma.
a Includes edema localized, face edema, eyelid edema, periorbital edema, swelling face, and eye edema.
b Includes mucosal inflammation, stomatitis apthous ulcer, mouth ulceration, tongue ulceration, oropharyngeal pain and oral pain.
c Includes abdominal pain, abdominal pain lower, and abdominal pain upper.
d Includes hypertension, blood pressure increased, blood pressure systolic increased, blood pressure diastolic increased, and hypertensive crisis.
e Includes dermatitis, dermatitis psoriasiform, exfoliative rash, genital rash, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculopapular, rash papular, and rash pruritic.
f Includes ageusia, hypogeusia, and dysgeusia.
g Includes epistaxis, gingival bleeding, rectal hemorrhage, hemoptysis, anal hemorrhage, upper gastrointestinal hemorrhage, hematuria.

Grade 4 adverse reactions in patients on SUTENT included hand-foot syndrome (1%), fatigue (<1%), abdominal pain (< 1%), stomatitis (<1%), and pyrexia (< 1%). Grade 4 adverse reactions in patients on placebo included asthenia (<1%) and hypertension (<1%).

Grade 3-4 laboratory abnormalities that occurred in ≥2% of patients receiving SUTENT include neutropenia (13%), thrombocytopenia (5%), leukopenia (3%), lymphopenia (3%), elevated alanine aminotransferase (2%), elevated aspartate aminotransferase (2%), hyperglycemia (2%), and hyperkalemia (2%).

Advanced Pancreatic Neuroendocrine Tumors (pNET)

The safety of SUTENT was evaluated in Study 6, a randomized, double-blind, placebo-controlled trial in which patients with progressive pNET received SUTENT 37.5 mg daily continuous dosing (n=83) or placebo (n=82). The median number of days on treatment was 139 days (range: 13-532 days) for patients on SUTENT and 113 days (range: 1-614 days) for patients on placebo. Nineteen patients (23%) on SUTENT and 4 patients (5%) on placebo were on study for >1 year. Dose interruptions occurred in 25 patients (30%) on SUTENT and 10 patients (12%) on placebo. Dose reductions occurred in 26 patients (31%) on SUTENT and 9 patients (11%) on placebo. Discontinuation rates due to adverse reactions were 22% for SUTENT and 17% for placebo.

Most treatment-emergent adverse reactions in both study arms were Grade 1 or 2 in severity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 54% versus 50% of patients on SUTENT versus placebo, respectively. Table 6 compares the incidence of common (≥10%) treatment-emergent adverse reactions for patients receiving SUTENT and reported more commonly in patients receiving SUTENT than in patients receiving placebo.

Table 6. Adverse Reactions Reported in the pNET Study 6 in ≥10% of Patients Who Received SUTENT and More Commonly Than in Patients Given Placebo*

Adverse ReactionpNET
SUTENT (N=83)Placebo (N=82)
All Grades
%
Grade 3-4a
%
All Grades
%
Grade 3-4b
%
Any Adverse Reaction99549550
Constitutional
  Asthenia345274
  Fatigue335279
  Weight decreased161110
Gastrointestinal
  Diarrhea595392
  Stomatitis/oral syndromesb486180
  Nausea451291
  Abdominal painc3953410
  Vomiting340312
  Dyspepsia15060
Cardiac
  Hypertension271051
Dermatology
  Hair color changes29110
  Hand-foot syndrome23620
  Rash18050
  Dry skin150110
Neurology
  Dysgeusia21050
  Headache180131
Musculoskeletal
  Arthralgia15060
Psychiatric
  Insomnia180120
Hemorrhage/Bleeding
  Bleeding eventsd220104
  Epistaxis21150
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Abbreviations: N=number of patients; pNET=pancreatic neuroendocrine tumors.
a Grade 4 adverse reactions in patients on SUTENT included fatigue (1%).
b Includes aphthous stomatitis, gingival pain, gingivitis, glossitis, glossodynia, mouth ulceration, oral discomfort, oral pain, tongue ulceration, mucosal dryness, mucosal inflammation, and dry mouth.
c Includes abdominal discomfort, abdominal pain, and abdominal pain upper.
d Includes hematemesis, hematochezia, hematoma, hemoptysis, hemorrhage, melena, and metrorrhagia.

Table 7 provides common (≥10%) treatment-emergent laboratory abnormalities.

Table 7. Laboratory Abnormalities Reported in the pNET Study 6 in ≥10% of Patients Who Received SUTENT

Laboratory ParameterpNET
SUTENTPlacebo
NAll Grades* %Grade 3-4*,a %NAll Grades* %Grade 3-4*,b %
  AST increased8272580703
  ALT increased8261480553
  Alkaline phosphatase increased826310807011
  Total bilirubin increased8237180284
  Amylase increased7420474101
  Lipase increased7517572114
Renal/Metabolic
  Glucose increased827112807818
  Albumin decreased8141179371
  Phosphorus decreased8136777225
  Calcium decreased8234080190
  Sodium decreased8229280343
  Creatinine increased8227580285
  Glucose decreased8222280154
  Potassium decreased8221480140
  Magnesium decreased5219039100
  Potassium increased8218180111
Hematology
  Neutrophils decreased82711680160
  Hemoglobin decreased8265080551
  Platelets decreased8260580150
  Lymphocytes decreased8256780354
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; N=number of patients; pNET=pancreatic neuroendocrine tumors.
a Grade 4 laboratory abnormalities in patients on SUTENT included creatinine (4%), lipase (4%), glucose decreased (2%), glucose increased (2%), neutrophils (2%), ALT (1%), AST (1%), platelets (1%), potassium increased (1%), and total bilirubin (1%).
b Grade 4 laboratory abnormalities in patients on placebo included creatinine (3%), alkaline phosphatase (1%), glucose increased (1%), and lipase (1%).

Venous Thromboembolic Events

In patients treated with SUTENT (N=7527) for GIST, advanced RCC, adjuvant treatment of RCC and pNET, 3.5% of patients experienced a venous thromboembolic event; 2.2% Grade 3-4.

Reversible Posterior Leukoencephalopathy Syndrome

There have been reports (<1%), some fatal, of patients presenting with seizures and radiological evidence of reversible posterior leukoencephalopathy syndrome (RPLS). Patients with seizures and signs/symptoms consistent with RPLS, such as hypertension, headache, decreased alertness, altered mental functioning, and visual loss, including cortical blindness, should be controlled with medical management including control of hypertension. Temporary suspension of SUTENT is recommended; following resolution, treatment may be resumed at the discretion of the treating healthcare provider.

Pancreatic Function

Pancreatitis was observed in 5 patients (1%) receiving SUTENT for treatment-naive RCC compared to 1 patient (<1%) receiving IFN-α. In a trial of patients receiving adjuvant treatment for RCC, 1 patient (<1%) on SUTENT and none on placebo experienced pancreatitis. Pancreatitis was observed in 1 patient (1%) receiving SUTENT for pNET and 1 patient (1%) receiving placebo.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SUTENT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: hemorrhage associated with thrombocytopenia*. Suspension of SUTENT is recommended; following resolution, treatment may be resumed at the discretion of the treating healthcare provider.

Gastrointestinal disorders: esophagitis.

Hepatobiliary disorders: cholecystitis, particularly acalculous cholecystitis.

Immune system disorders: hypersensitivity reactions, including angioedema.

Infections and infestations: serious infection (with or without neutropenia)*. The infections most commonly observed with SUTENT treatment include respiratory, urinary tract, skin infections, and sepsis/septic shock.

Musculoskeletal and connective tissue disorders: fistula formation, sometimes associated with tumor necrosis and/or regression*; myopathy and/or rhabdomyolysis with or without acute renal failure*. Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice.

Renal and urinary disorders: renal impairment and/or failure*.

Respiratory disorders: pulmonary embolism*, pleural effusion*.

Skin and subcutaneous tissue disorders: pyoderma gangrenosum, including positive dechallenges.

Vascular disorders: arterial (including aortic) aneurysms, dissections*, and rupture*; arterial thromboembolic events*. The most frequent events included cerebrovascular accident, transient ischemic attack, and cerebral infarction.

*including some fatalities.

Read the entire FDA prescribing information for Sutent (Sunitinib Malate)

© Sutent Patient Information is supplied by Cerner Multum, Inc. and Sutent Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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