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 SlideshowGet 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.
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.
Health Solutions From Our Sponsors