Sutent Side Effects Center

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

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.

Sutent Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in 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 [see WARNINGS AND PRECAUTIONS]
  • Thrombotic Microangiopathy [see WARNINGS AND PRECAUTIONS]
  • Proteinuria [see WARNINGS AND PRECAUTIONS]
  • Dermatologic Toxicities [see WARNINGS AND PRECAUTIONS]
  • Reversible Posterior Leukoencephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
  • Thyroid Dysfunction [see WARNINGS AND PRECAUTIONS]
  • Hypoglycemia [see WARNINGS AND PRECAUTIONS]
  • Osteonecrosis of the Jaw [see WARNINGS AND PRECAUTIONS]
  • Impaired 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 pooled safety population described in the Warnings and Precautions reflect exposure to SUTENT in 7527 patients with GIST, RCC (advanced and adjuvant), or pNET. In this pooled safety population, the most common adverse reactions (≥25%) were fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia.

Gastrointestinal Stromal Tumor

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.

Permanent discontinuation due to an adverse reaction occurred in 7% of patients in the SUTENT arm. Dose reductions occurred in 11% and dose interruptions occurred in 29% of patients who received SUTENT.

Table 3 summarizes the adverse reactions for Study 1.

Table 3: Adverse Reactions Reported in ≥10% of GIST Patients Who Received SUTENT in the Double-Blind Treatment Phase and More Commonly Than in Patients Given Placebo* in Study 1

Adverse Reaction GIST
SUTENT
(N=202)
Placebo
(N=102)
All Grades % Grade 3-4 % All Grades % Grade 3-4 %
Any Adverse Reaction 94 56 97 51
Gastrointestinal
Diarrhea 40 4 27 0
Mucositis/stomatitis 29 1 18 2
Constipation 20 0 14 2
Metabolism/Nutrition
Anorexiaa 33 1 29 5
Asthenia 22 5 11 3
Dermatology Skin discoloration 30 0 23 0
Rash 14 1 9 0
Hand-foot syndrome 14 4 10 3
Neurology Altered taste 21 0 12 0
Cardiac
Hypertension 15 4 11 0
Musculoskeletal
Myalgia/limb pain 14 1 9 1
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Abbreviations: GIST=gastrointestinal stromal tumor; N=number of patients.
a Includes decreased appetite.

Other clinically relevant adverse reactions included oral pain other than mucositis/stomatitis in 6%; hair color changes in 7%; alopecia in 5% of patients who received SUTENT.

Table 4 summarizes the laboratory abnormalities in Study 1.

Table 4: Laboratory Abnormalities Reported in ≥10% of GIST Patients Who Received SUTENT or Placebo in the Double-Blind Treatment Phase* in Study 1

Laboratory Abnormality GIST
SUTENT
(N=202)
Placebo
(N=102)
All Grades*% Grade 3-4*,a% All Grades*% Grade 3-4*,b%
Any Laboratory Abnormality 34 22
Hematology
Neutrophils decreased 53 10 4 0
Lymphocytes decreased 38 0 16 0
Platelets decreased 38 5 4 0
Hemoglobin decreased 26 3 22 2
Gastrointestinal
AST/ALT increased 39 2 23 1
Lipase increased 25 10 17 7
Alkaline phosphatase increased 24 4 21 4
Amylase increased 17 5 12 3
Total bilirubin increased 16 1 8 0
Indirect bilirubin increased 10 0 4 0
Renal/Metabolic
Creatinine increased 12 1 7 0
Potassium decreased 12 1 4 0
Sodium increased 10 0 4 1
Cardiac
Decreased LVEF 11 1 3 0
* 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 [see Clinical Studies]. For 241 patients randomized to the SUTENT arm, including 139 who received SUTENT in both the double-blind and open-label 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 treatment was 6 cycles (mean: 7.8; range: 1-37) from the time of the unblinding.

Permanent discontinuation due to an adverse reaction occurred in 20% of patients who received SUTENT. Dosage interruption occurred in 46% and dose reduction occurred in 28% of patients who received SUTENT.

The most common Grade 3 or 4 adverse reactions in patients who received SUTENT in the open-label 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

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 interferon alfa 9 million International Units (MIU) (n=360). The median duration of treatment was 11.1 months (range: 0.4 to 46.1) for SUTENT treatment and 4.1 months (range: 0.1 to 45.6) for interferon alfa treatment.

Permanent discontinuation due to an adverse reaction occurred in 20% of patients in the SUTENT arm. Dose interruptions occurred in 54% and dose reductions occurred in 52% of patients who received SUTENT.

Table 5 summarizes the adverse reactions for Study 3.

Table 5: Adverse Reactions Reported in ≥10% of Patients With RCC Who Received SUTENT or Interferon Alfa* in Study 3

Adverse Reaction Treatment-Naive RCC
SUTENT
(N=375)
Interferon Alfa
(N=360)
All Grades % Grade 3-4a % All Grades % Grade 3-4b %
Any Adverse Reaction 99 77 99 55
Gastrointestinal
Diarrhea 66 10 21 <1
Nausea 58 6 41 2
Mucositis/stomatitis 47 3 5 <1
Vomiting 39 5 17 1
Dyspepsia 34 2 4 0
Abdominal painc 30 5 12 1
Constipation 23 1 14 <1
Dry mouth 13 0 7 <1
Oral pain 14 <1 1 0
Flatulence 14 0 2 0
GERD/reflux esophagitis 12 <1 1 0
Glossodynia 11 0 1 0
Hemorrhoids 10 0 2 0
Constitutional
Fatigue 62 15 56 15
Asthenia 26 11 22 6
Fever 22 1 37 <1
Weight decreased 16 <1 17 1
Chills 14 1 31 0
Chest Pain 13 2 7 1
Influenza like illness 5 0 15 <1
Metabolism/Nutrition
Anorexiad 48 3 42 2
Neurology
Altered tastee 47 <1 15 0
Headache 23 1 19 0
Dizziness 11 <1 14 1
Hemorrhage/Bleeding
Bleeding, all sites 37 4f 10 1
Cardiac
Hypertension 34 13 4 <1
Edema peripheral 24 2 5 1
Ejection fraction decreased 16 3 5 2
Dermatology
Rash 29 2 11 <1
Hand-foot syndrome 29 8 1 0
Skin discoloration/yellow skin 25 <1 0 0
Dry skin 23 <1 7 0
Hair color changes 20 0 <1 0
Alopecia 14 0 9 0
Erythema 12 <1 1 0
Pruritus 12 <1 7 <1
Musculoskeletal
Pain in extremity/limb discomfort 40 5 30 2
Arthralgia 30 3 19 1
Back pain 28 5 14 2
Respiratory
Cough 27 1 14 <1
Dyspnea 26 6 20 4
Nasopharyngitis 14 0 2 0
Oropharyngeal pain 14 <1 2 0
Upper respiratory tract infection 11 <1 2 0
Endocrine
Hypothyroidism 16 2 1 0
Psychiatric
Insomnia 15 <1 10 0
Depressiong 11 0 14 1
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Abbreviations: ARs=adverse reactions; 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 interferon alfa included dyspnea (1%), fatigue (1%), abdominal pain (<1%), and depression (<1%).
CIncludes flank pain.
d Includes decreased appetite.
e Includes ageusia, hypogeusia, and dysgeusia.
f Includes 1 patient with Grade 5 gastric hemorrhage.
g Includes depressed mood.

Table 6 summarizes the laboratory abnormalities in Study 3.

Table 6: Laboratory Abnormalities Reported in ≥10% of RCC Patients Who Received SUTENT or Interferon Alfa in Study 3

Laboratory Abnormality Treatment-Naive RCC
SUTENT (N=375) Interferon Alfa (N=360)
All Grades* % Grade 3-4*,a % All Grades* % Grade 3-4*,b %
Hematology
Hemoglobin decreased 79 8 69 5
Neutrophils decreased 77 17 49 9
Platelets decreased 68 9 24 1
Lymphocytes decreased 68 18 68 26
Renal/Metabolic
Creatinine increased 70 <1 51 <1
Creatine kinase increased 49 2 11 1
Uric acid increased 46 14 33 8
Calcium decreased 42 1 40 1
Phosphorus decreased 31 6 24 6
Albumin decreased 28 1 20 0
Glucose increased 23 6 15 6
Sodium decreased 20 8 15 4
Glucose decreased 17 0 12 <1
Potassium increased 16 3 17 4
Calcium increased 13 <1 10 1
Potassium decreased 13 1 2 <1
Sodium increased 13 0 10 0
Gastrointestinal
AST increased 56 2 38 2
Lipase increased 56 18 46 8
ALT increased 51 3 40 2
Alkaline phosphatase increased 46 2 37 2
Amylase increased 35 6 32 3
Total bilirubin increased 20 1 2 0
Indirect bilirubin increased 13 1 1 0
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; 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 interferon alfa 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 on Schedule 4/2 (n=306) or placebo (n=304). The median duration of treatment was 12.4 months (range: 0.13 to 14.9) for SUTENT and 12.4 months (range: 0.03 to 13.7) for placebo.

Permanent discontinuation due to an adverse reaction occurred in 28% of patients in the SUTENT arm. Adverse reactions leading to permanent discontinuation in >2% of patients include hand-foot syndrome and fatigue/asthenia. Dosing interruptions occurred in 54% and dose reductions occurred in 46% of patients who received SUTENT.

Table 7 summarizes the adverse reactions in S-TRAC.

Table 7: Adverse Reactions Reported in ≥10% of Patients With RCC Who Received SUTENT and More Commonly Than in Patients Given Placebo* in S-TRAC

Adverse Reaction Adjuvant Treatment of RCC
SUTENT
(N=306)
Placebo
(N=304)
All Grades % Grade 3-4 % All Grades % Grade 3-4 %
Any Adverse Reaction 99 60 88 15
Gastrointestinal
Mucositis/Stomatitisa 61 6 15 0
Diarrhea 57 4 22 <1
Nausea 34 2 15 0
Dyspepsia 27 1 7 0
Abdominal painb 25 2 9 <1
Vomiting 19 2 7 0
Constipation 12 0 11 0
Constitutional
Fatigue/Asthenia 57 8 34 2
Localized edemac 18 <1 <1 0
Pyrexia 12 <1 6 0
Dermatology
Hand-foot syndrome 50 16 10 <1
Rashd 24 2 12 0
Hair color changes 22 0 2 0
Skin discoloration/Yellow skin 18 0 1 0
Dry skin 14 0 6 0
Cardiac
Hypertensione 39 8 14 1
Edema/Peripheral edema 10 <1 7 0
Neurology
Altered tastef 38 <1 6 0
Headache 19 <1 12 0
Endocrine
Hypothyroidism/TSH increased 24 <1 4 0
Hemorrhage/Bleeding
Bleeding events, all sitesg 24 <1 5 <1
Metabolism/Nutrition
Anorexia/Decreased appetite 19 <1 5 0
Musculoskeletal
Pain in extremity 15 <1 7 0
Arthralgia 11 <1 10 0
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Abbreviations: ARs=adverse reactions; N=number of patients; RCC=renal cell carcinoma.
a Includes mucosal inflammation, stomatitis aphthous ulcer, mouth ulceration, tongue ulceration, oropharyngeal pain, and oral pain.
b Includes abdominal pain, abdominal pain lower, and abdominal pain upper.
cIncludes edema localized, face edema, eyelid edema, periorbital edema, swelling face, and eye edema.
d Includes dermatitis, dermatitis psoriasiform, exfoliative rash, genital rash, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculopapular, rash papular, and rash pruritic.
e Includes hypertension, blood pressure increased, blood pressure systolic increased, blood pressure diastolic increased, and  hypertensive crisis.
f Includes ageusia, hypogeusia, and dysgeusia.
g Includes epistaxis, gingival bleeding, rectal hemorrhage, hemoptysis, anal hemorrhage, upper gastrointestinal hemorrhage, and  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 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

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 once daily (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.

Permanent discontinuation due to an adverse reaction occurred in 22% in the SUTENT arm. Dose interruptions occurred in 30% and dose reductions occurred in 31% of patients who received SUTENT.

Table 8 summarizes the adverse reactions in Study 6.

Table 8: Adverse Reactions Reported in ≥10% of Patients With pNET Who Received SUTENT and More Commonly Than in Patients Given Placebo* in Study 6

Adverse Reaction pNET
SUTENT
(N=83)
Placebo
(N=82)
All Grades % Grade 3-4a % All Grades % Grade 3-4 %
Any Adverse Reaction 99 54 95 50
Gastrointestinal
Diarrhea 59 5 39 2
Stomatitis/oral syndromesb 48 6 18 0
Nausea 45 1 29 1
Abdominal painc 39 5 34 10
Vomiting 34 0 31 2
Dyspepsia 15 0 6 0
Constitutional
Asthenia 34 5 27 4
Fatigue 33 5 27 9
Weight decreased 16 1 11 0
Dermatology
Hair color changes 29 1 1 0
Hand-foot syndrome 23 6 2 0
Rash 18 0 5 0
Dry skin 15 0 11 0
Cardiac
Hypertension 27 10 5 1
Hemorrhage/Bleeding
Bleeding eventsd 22 0 10 4
Epistaxis 21 1 5 0
Neurology
Dysgeusia 21 0 5 0
Headache 18 0 13 1
Psychiatric
Insomnia 18 0 12 0
Musculoskeletal
Arthralgia 15 0 6 0
* 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.
cIncludes abdominal discomfort, abdominal pain, and abdominal pain upper.
d Includes hematemesis, hematochezia, hematoma, hemoptysis, hemorrhage, melena, and metrorrhagia.

Table 9 summarizes the laboratory abnormalities in Study 6.

Table 9: Laboratory Abnormalities Reported in ≥10% of Patients With pNET Who Received SUTENT in Study 6

Laboratory Abnormality pNET
SUTENT Placebo
All Grades*% Grade 3-4*,a % All Grades* % Grade 3-4*,b %
Gastrointestinal
AST increased 72 5 70 3
Alkaline phosphatase increased 63 10 70 11
ALT increased 61 4 55 3
Total bilirubin increased 37 1 28 4
Amylase increased 20 4 10 1
Lipase increased 17 5 11 4
Hematology
Neutrophils decreased 71 16 16 0
Hemoglobin decreased 65 0 55 1
Platelets decreased 60 5 15 0
Lymphocytes decreased 56 7 35 4
Renal/Metabolic
Glucose increased 71 12 78 18
Albumin decreased 41 1 37 1
Phosphorus decreased 36 7 22 5
Calcium decreased 34 0 19 0
Sodium decreased 29 2 34 3
Creatinine increased 27 5 28 5
Glucose decreased 22 2 15 4
Potassium decreased 21 4 14 0
Magnesium decreased 19 0 10 0
Potassium increased 18 1 11 1
* The denominator used to calculate the rate varied from 52 to 82 for SUTENT and 39 to 80 for Placebo based on the number of patients with a baseline value and at least one post-treatment value. 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 pooled safety population, 3.5% of patients experienced a venous thromboembolic event, including Grade 3-4 in 2.2% of patients.

Pancreatic Function

Pancreatitis was observed in 1 patient (1%) in the pNET study, 5 patients (1%) in the treatment-naive RCC study, and 1 patient (<1%) in the adjuvant treatment for RCC study on SUTENT.

Postmarketing Experience

The following adverse reactions have been identified during postapproval 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*.
  • 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 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*.
  • Renal and urinary disorders: renal impairment and/or failure*.
  • Respiratory disorders: pulmonary embolism*, pleural effusion*.
  • Skin and subcutaneous tissue disorders: pyoderma gangrenosum, including positive de-challenges.
  • 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.
  • General disorders and administration site conditions: impaired wound healing. *including some fatalities

DRUG INTERACTIONS

Effect Of Other Drugs On SUTENT

Strong CYP3A4 Inhibitors

Co-administration with strong CYP3A4 inhibitors may increase sunitinib plasma concentrations [see CLINICAL PHARMACOLOGY]. Select an alternate concomitant medication with no or minimal enzyme inhibition potential. Consider a dose reduction for SUTENT when it is co-administered with strong CYP3A4 inhibitors [see DOSAGE AND ADMINISTRATION].

Strong CYP3A4 Inducers

Co-administration with strong CYP3A4 inducers may decrease sunitinib plasma concentrations [see CLINICAL PHARMACOLOGY]. Select an alternate concomitant medication with no or minimal enzyme induction potential. Consider a dose increase for SUTENT when it must be co-administered with CYP3A4 inducers [see DOSAGE AND ADMINISTRATION].

Drugs That Prolong QT Interval

SUTENT is associated with QTc interval prolongation [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. Monitor the QT interval with ECGs more frequently in patients who require treatment with concomitant medications known to prolong the QT interval.

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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