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Sutent

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Sutent

Sutent Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Sutent (sunitinib malate) is a multi-kinase inhibitor and is available in generic form. Sutent is 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. Side effects include chest pain, general ill feeling, and uneven heart rate.

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. Strong CYP3A4 inhibitors such as ketoconazole may increase sunitinib plasma concentrations. Grapefruit may also increase plasma concentrations of sunitinib. Sutent can cause fetal harm when administered to pregnant women and has not been studied in pediatric populations.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sutent in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sunitinib and call your doctor at once if you have a serious side effect such as:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • feeling short of breath (even with mild exertion), swelling in your ankles or feet;
  • sudden numbness or weakness, problems with vision, speech, or balance;
  • numbness or tingly feeling around your mouth;
  • slow heart rate, weak pulse, confusion;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
  • lower back pain, blood in your urine;
  • urinating less than usual or not at all;
  • pain and swelling in your stomach, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • missed menstrual periods;
  • feeling depressed or very tired, loss of appetite, diarrhea, weight gain or loss, hair loss, sweating, increased sensitivity to heat.
  • fever, white patches or sores inside your mouth or on your lips; or
  • redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet.

Less serious side effects may include:

  • unusual or unpleasant taste in the mouth;
  • cough;
  • mild nausea, vomiting, upset stomach;
  • constipation;
  • dry skin, changes in skin or hair color; or
  • joint pain, back pain.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sutent Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, vomiting, diarrhea, change in taste, decreased appetite, dry/cracked/thickened skin, watering eyes, swelling around eyes, numbness/tingling of arms/legs, or tiredness may occur. In some cases, drug therapy may be necessary to prevent or relieve nausea/vomiting/diarrhea. Eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may cause patchy or complete hair loss and changes in hair/skin color. These effects are not harmful.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: headache, rash/blisters on palms of hands/soles of feet, sores/pain on the tongue/mouth, easy bruising/bleeding, swelling ankles/feet, shortness of breath, seizures, unusual weight changes, cold/heat intolerance, pain/redness/swelling of arms or legs, unusual tiredness, black/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, change in the amount of urine, muscle weakness/cramping/twitching, mental/mood changes (such as decreased alertness), vision changes (such as decreased vision).

Get medical help right away if you have any very serious side effects, including: trouble breathing, severe dizziness, fainting, fast/slow/irregular heartbeat.

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sutent (Sunitinib Malate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sutent FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The data described below reflect exposure to SUTENT in 660 patients who participated in the double-blind treatment phase of a placebo-controlled trial (n=202) for the treatment of GIST [see Clinical Studies], an active-controlled trial (n=375) for the treatment of RCC [see Clinical Studies] or a placebo-controlled trial (n=83) for the treatment of pNET [see Clinical Studies]. The GIST and RCC patients received a starting oral dose of 50 mg daily on Schedule 4/2 in repeated cycles, and the pNET patients received a starting oral dose of 37.5 mg daily without scheduled off-treatment periods.

The most common adverse reactions ( ≥ 20%) in patients with GIST, RCC or pNET are fatigue, asthenia, fever, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, skin discoloration, dry skin, hair color changes, altered taste, headache, back pain, arthralgia, extremity pain, cough, dyspnea, anorexia, and bleeding. The potentially serious adverse reactions of hepatotoxicity, left ventricular dysfunction, QT interval prolongation, hemorrhage, hypertension, thyroid dysfunction, and adrenal function are discussed in WARNINGS AND PRECAUTIONS. Other adverse reactions occurring in GIST, RCC and pNET studies are described below.

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.

Adverse Reactions in GIST Study A

Median duration of blinded study treatment was two cycles for patients on SUTENT (mean 3.0, range 1-9) and one 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, non-fatal 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 A in at Least 10% of GIST Patients who Received SUTENT in the Double-Blind Treatment Phase and More Commonly Than in Patients Given Placebo*

Adverse Reaction, n (%) GIST
SUTENT
(n=202)
Placebo
(n=102)
All Grades Grade 3/4 All Grades Grade 3/4
Any 114 (56) 52 (51)
Gastrointestinal
  Diarrhea 81 (40) 9 (4) 27 (27) 0 (0)
  Mucositis/stomatitis 58 (29) 2 (1) 18 (18) 2 (2)
  Constipation 41 (20) 0 (0) 14 (14) 2 (2)
Cardiac
  Hypertension 31 (15) 9 (4) 11 (11) 0 (0)
Dermatology
  Skin discoloration 61 (30) 0 (0) 23 (23) 0 (0)
  Rash 28(14) 2 (1) 9 (9) 0 (0)
  Hand-foot syndrome 28 (14) 9 (4) 10 (10) 3 (3)
Neurology
  Altered taste 42 (21) 0 (0) 12 (12) 0 (0)
Musculoskeletal
  Myalgia/limb pain 28(14) 1 (1) 9 (9) 1 (1)
Metabolism/Nutrition
  Anorexiaa 67 (33) 1 (1) 30 (29) 5 (5)
  Asthenia 45 (22) 10 (5) 11 (11) 3 (3)
*Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
a Includes decreased appetite

In the double-blind treatment phase of GIST Study A, 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 A in at Least 10% of GIST Patients Who Received SUTENT or Placebo in the Double-Blind Treatment Phase*

Laboratory Parameter, n (%) GIST
SUTENT
(n=202)
Placebo
(n=102)
All Grades* Grade 3/4*a All Grades* Grade 3/4*b
Any 68 (34) 22 (22)
Gastrointestinal
  AST / ALT 78 (39) 3 (2) 23 (23) 1 (1)
  Lipase 50 (25) 20 (10) 17 (17) 7 (7)
  Alkaline phosphatase 48 (24) 7 (4) 21 (21) 4 (4)
  Amylase 35 (17) 10 (5) 12 (12) 3 (3)
  Total bilirubin 32 (16) 2 (1) 8 (8) 0 (0)
  Indirect bilirubin 20 (10) 0 (0) 4 (4) 0 (0)
Cardiac
  Decreased LVEF 22 (11) 2 (1) 3 (3) 0 (0)
Renal/Metabolic
  Creatinine 25(12) 1 (1) 7 (7) 0 (0)
  Potassium decreased 24 (12) 1 (1) 4 (4) 0 (0)
  Sodium increased 20 (10) 0 (0) 4 (4) 1 (1)
Hematology
  Neutrophils 107 (53) 20 (10) 4 (4) 0 (0)
  Lymphocytes 76 (38) 0 (0) 16 (16) 0 (0)
  Platelets 76 (38) 10 (5) 4 (4) 0 (0)
  Hemoglobin 52 (26) 6 (3) 22 (22) 2 (2)
LVEF=Left ventricular ejection fraction
*Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
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%).

Adverse Reactions in the Treatment-Na´ve RCC Study

The as-treated patient population for the treatment-naive RCC study included 735 patients, 375 randomized to SUTENT and 360 randomized to IFN-α. 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 at Least 10% of Patients with RCC Who Received SUTENT or IFN-α*

Adverse Reaction, n (%) Treatment-Naive RCC
SUTENT
(n=375)
IFN-α
(n=360)
All Grades Grade 3/4a All Grades Grade 3/4b
Any 372 (99) 290 (77) 355 (99) 197 (55)
Constitutional
  Fatigue 233 (62) 55 (15) 202 (56) 54 (15)
  Asthenia 96 (26) 42 (11) 81 (22) 21 (6)
  Fever 84 (22) 3 (1) 134 (37) 1 ( < 1)
  Weight decreased 60 (l6) 1 ( < 1) 60 (17) 3 (1)
  Chills 53 (14) 3 (1) 111 (31) 0 (0)
  Chest Pain 50 (13) 7 (2) 24 (7) 3 (1)
  Influenza like illness 18 (5) 0 (0) 54 (15) 1 ( < 1)
Gastrointestinal
  Diarrhea 246 (66) 37 (10) 76 (21) 1 ( < 1)
  Nausea 216 (58) 21 (6) 147 (41) 6 (2)
  Mucositis/stomatitis 178 (47) 13 (3) 19 (5) 2 ( < 1)
  Vomiting 148 (39) 19 (5) 62 (17) 4 (1)
  Dyspepsia 128 (34) 8 (2) 16 (4) 0 (0)
  Abdominal painc 113 (30) 20 (5) 42 (12) 5 (1)
  Constipation 85 (23) 4 (1) 49 (14) 1 ( < 1)
  Dry mouth 50 (13) 0 (0) 27 (7) 1 ( < 1)
  GERD/reflux esophagitis 47 (12) 1 ( < 1) 3 (1) 0(0)
  Flatulence 52 (14) 0 (0) 8 (2) 0 (0)
  Oral pain 54 (14) 2 ( < 1) 2 (1) 0 (0)
  Glossodynia 40 (11) 0 (0) 2 (1) 0 (0)
  Hemorrhoids 38 (10) 0 (0) 6 (2) 0 (0)
Cardiac
  Hypertension 127 (34) 50 (13) 13 (4) 1 ( < 1)
  Edema, peripheral 91 (24) 7 (2) 17 (5) 2 (1)
  Ejection fraction decreased 61 (16) 10 (3) 19 (5) 6 (2)
Dermatology
  Rash 109 (29) 6 (2) 39 (11) 1 ( < 1)
  Hand-foot syndrome 108 (29) 32 (8) 3 (1) 0 (0)
  Skin discoloration/ yellow skin 94 (25) 1 ( < 1) 0 (0) 0 (0)
  Dry skin 85 (23) 1 ( < 1) 26 (7) 0 (0)
  Hair color changes 75 (20) 0 (0) 1 ( < 1) 0 (0)
  Alopecia 51 (14) 0 (0) 34 (9) 0 (0)
  Erythema 46 (12) 2 ( < 1) 5 (1) 0 (0)
  Pruritus 44 (12) 1 ( < 1) 24 (7) 1 ( < 1)
Neurology
  Altered tasted 178 (47) 1 ( < 1) 54 (15) 0 (0)
  Headache 86 (23) 4 (1) 69 (19) 0 (0)
  Dizziness 43 (11) 2 ( < 1) 50 (14) 2 (1)
Musculoskeletal
  Back pain 105 (28) 19 (5) 52 (14) 7 (2)
  Arthralgia 111 (30) 10 (3) 69 (19) 4 (1)
  Pain in extremity/ limb discomfort 150 (40) 19 (5) 107 (30) 7 (2)
Endocrine
  Hypothyroidism 61 (16) 6 (2) 3 (1) 0 (0)
Respiratory
  Cough 100 (27) 3 (1) 51(14) 1 ( < 1)
  Dyspnea 99 (26) 24 (6) 71 (20) 15 (4)
  Nasopharyngitis 54 (14) 0 (0) 8 (2) 0 (0)
  Oropharyngeal Pain 51(14) 2 ( < 1) 9 (2) 0 (0)
  Upper respiratory tract infection 43 (11) 2 ( < 1) 9 (2) 0 (0)
Metabolism/Nutrition
  Anorexiae 182 (48) 11 (3) 153 (42) 7 (2)
Hemorrhage/Bleeding
  Bleeding, all sites 140 (37) 16 (4)f 35 (10) 3 (1)
Psychiatric
  Insomnia 57 (15) 3 ( < 1) 37 (10) 0 (0)
  Depressiong 40 (11) 0 (0) 51(14) 5 (1)
*Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
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 one 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 at Least 10% of Treatment-Na´ve RCC Patients Who Received SUTENT or IFN-α

Laboratory Parameter, n (%) Treatment-Naive RCC
SUTENT
(n=375)
IFN-α
(n=360)
All Grades* Grade 3/4*a All Grades* Grade 3/4*b
Gastrointestinal
  AST 211 (56) 6 (2) 136 (38) 8 (2)
  ALT 192 (51) 10 (3) 144 (40) 9 (2)
  Lipase 211 (56) 69 (18) 165(46) 29 (8)
  Alkaline phosphatase 171 (46) 7 (2) 132 (37) 6 (2)
  Amylase 130 (35) 22 (6) 114 (32) 12 (3)
  Total bilirubin 75 (20) 3 (1) 8 (2) 0 (0)
  Indirect bilirubin 49(13) 4 (1) 3 (1) 0 (0)
Renal/Metabolic
  Creatinine 262 (70) 2 (<1) 183 (51) 1 (<1)
  Creatine kinase 183 (49) 9 (2) 40 (11) 4 (1)
  Uric acid 173 (46) 54 (14) 119 (33) 29 (8)
  Calcium decreased 156 (42) 4 (1) 145 (40) 4 (1)
  Phosphorus 116 (31) 22 (6) 87 (24) 23 (6)
  Albumin 106 (28) 4 (1) 72 (20) 0 (0)
  Glucose increased 86 (23) 21 (6) 55 (15) 22 (6)
  Sodium decreased 75 (20) 31 (8) 55 (15) 13 (4)
  Glucose decreased 65 (17) 0 (0) 43 (12) 1 (<1)
  Potassium increased 61 (16) 13 (3) 61 (17) 15 (4)
  Calcium increased 50 (13) 2 (<1) 35 (10) 5 (1)
  Potassium decreased 49 (13) 3 (1) 7 (2) 1 (<1)
  Sodium increased 48 (13) 0 (0) 38 (10) 0 (0)
Hematology
  Neutrophils 289 (77) 65 (17) 178(49) 31 (9)
  Hemoglobin 298 (79) 29 (8) 250 (69) 18 (5)
  Platelets 255 (68) 35 (9) 85 (24) 2 (1)
  Lymphocytes 256 (68) 66 (18) 245 (68) 93 (26)
  Leukocytes 293 (78) 29 (8) 202 (56) 8 (2)
*Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
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%).

Adverse Reactions in the Phase 3 pNET Study

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 5 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 5: Adverse Reactions Reported in the Phase 3 pNET Study in at Least 10% of Patients who Received SUTENT and More Commonly Than in Patients Given Placebo*

Adverse Reaction, n (%) pNET
SUTENT
(n=83)
Placebo
(n=82)
All Grades Grade 3/4a All Grades Grade 3/4
Any 82 (99) 45 (54) 78 (95) 41 (50)
Constitutional
  Asthenia 28 (34) 4 (5) 22 (27) 3 (4)
  Fatigue 27(33) 4 (5) 22 (27) 7 (9)
  Weight decreased 13 (16) 1(1) 9 (11) 0 (0)
Gastrointestinal
  Diarrhea 49 (59) 4 (5) 32 (39) 2 (2)
  Stomatitis/oral 40 (48) 5 (6) 15 (18) 0 (0)
  Syndromesb Nausea 37 (45) 1 (1) 24 (29) 1 (1)
  Abdominal painc 32 (39) 4 (5) 28 (34) 8 (10)
  Vomiting 28 (34) 0 (0) 25 (31) 2 (2)
  Dyspepsia 12 (15) 0 (0) 5 (6) 0 (0)
Cardiac
  Hypertension 22 (27) 8 (10) 4 (5) 1 (1)
Dermatology
  Hair color changes 24 (29) 1 (1) 1 (1) 0 (0)
  Hand-foot syndrome 19(23) 5 (6) 2 (2) 0 (0)
  Rash 15 (18) 0 (0) 4 (5) 0 (0)
  Dry skin 12 (15) 0 (0) 9 (11) 0 (0)
Neurology
  Dysgeusia 17 (21) 0 (0) 4 (5) 0 (0)
  Headache 15 (18) 0 (0) 11 (13) 1 (1)
Musculoskeletal
  Arthralgia 12 (15) 0 (0) 5 (6) 0 (0)
Psychiatric
  Insomnia 15 (18) 0 (0) 10 (12) 0 (0)
Hemorrhage/Bleeding
  Bleeding eventsd 18(22) 0 (0) 8 (10) 3 (4)
  Epistaxis 17 (21) 1 (1) 4 (5) 0 (0)
*Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
a Grade 4 ARs 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 6 provides common ( ≥ 10%) treatment-emergent laboratory abnormalities.

Table 6: Laboratory Abnormalities Reported in the Phase 3 pNET Study in at Least 10% of Patients Who Received SUTENT

Laboratory Parameter, n (%) pNET
SUTENT Placebo
N All Grades* Grade 3/4*a N All Grades* Grade 3/4*b
Gastrointestinal
  AST increased 82 59 (72) 4 (5) 80 56 (70) 2 (3)
  ALT increased 82 50 (61) 3 (4) 80 44 (55) 2 (3)
  Alkaline phosphatase increased  82 52 (63) 8 (10) 80 56 (70) 9 (11)
  Total bilirubin increased 82 30 (37) 1 (1) 80 22 (28) 3 (4)
  Amylase increased 74 15 (20) 3 (4) 74 7 (10) 1 (1)
  Lipase increased 75 13 (17) 4 (5) 72 8 (11) 3 (4)
Renal/Metabolic
  Glucose increased 82 58 (71) 10 (12) 80 62 (78) 14 (18)
  Albumin decreased 81 33 (41) 1 (1) 79 29 (37) 1 (1)
  Phosphorus decreased 81 29 (36) 6 (7) 77 17 (22) 4 (5)
  Calcium decreased 82 28 (34) 0 (0) 80 15 (19) 0 (0)
  Sodium decreased 82 24 (29) 2 (2) 80 27 (34) 2 (3)
  Creatinine increased 82 22 (27) 4 (5) 80 22 (28) 4 (5)
  Glucose decreased 82 18 (22) 2 (2) 80 12 (15) 3 (4)
  Potassium decreased 82 17 (21) 3 (4) 80 11(14) 0 (0)
  Magnesium decreased 52 10 (19) 0 (0) 39 4 (10) 0 (0)
  Potassium increased 82 15 (18) 1 (1) 80 9 (11) 1 (1)
Hematology
  Neutrophils decreased 82 58 (71) 13 (16) 80 13 (16) 0 (0)
  Hemoglobin decreased 82 53 (65) 0 (0) 80 44 (55) 1 (1)
  Platelets decreased 82 49 (60) 4 (5) 80 12 (15) 0 (0)
  Lymphocytes decreased 82 46 (56) 6 (7) 80 28 (35) 3 (4)
*Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
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

Seven patients (3%) on SUTENT and none on placebo in the double-blind treatment phase of GIST Study A experienced venous thromboembolic events; five of the seven were Grade 3 deep venous thrombosis (DVT), and two were Grade 1 or 2. Four of these seven GIST patients discontinued treatment following first observation of DVT.

Thirteen (3%) patients receiving SUTENT for treatment-na´ve RCC had venous thromboembolic events reported. Seven (2%) of these patients had pulmonary embolism, one was Grade 2 and six were Grade 4, and six (2%) patients had DVT, including three Grade 3. One patient was permanently withdrawn from SUTENT due to pulmonary embolism; dose interruption occurred in two patients with pulmonary embolism and one with DVT. In treatment-na´ve RCC patients receiving IFN-α, six (2%) venous thromboembolic events occurred; one patient ( < 1%) experienced a Grade 3 DVT and five patients (1%) had pulmonary embolism, all Grade 4. One patient (1%) receiving SUTENT for pNET had a venous thromboembolic event reported compared to 5 patients (6%) receiving placebo. The SUTENT patient had Grade 2 thrombosis. Two placebo patients had DVT, one was Grade 3, two placebo patients had pulmonary embolism, one was Grade 3 and one was Grade 4, and one placebo patient had Grade 3 jugular thrombosis.

Reversible Posterior Leukoencephalopathy Syndrome

There have been reports ( < 1%), some fatal, of subjects 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 physician.

Pancreatic and Hepatic Function

If symptoms of pancreatitis or hepatic failure are present, patients should have SUTENT discontinued. Pancreatitis was observed in 5 (1%) patients receiving SUTENT for treatment-na´ve RCC compared to 1 ( < 1%) patient receiving IFN-α. Pancreatitis was observed in 1 (1%) patient receiving SUTENT for pNET and 1 (1%) patient receiving placebo. Hepatotoxicity was observed in patients receiving SUTENT [See BOXED WARNING and WARNINGS AND PRECAUTIONS].

Post-marketing 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: thrombotic microangiopathy; hemorrhage associated with thrombocytopenia*. Suspension of SUTENT is recommended; following resolution, treatment may be resumed at the discretion of the treating physician.

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)*; necrotizing fasciitis, including of the perineum*. The infections most commonly observed with sunitinib treatment include respiratory, urinary tract, skin infections,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*; proteinuria; rare cases of nephritic syndrome. Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria. The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated. Discontinue SUTENT in patients with nephrotic syndrome.

Respiratory disorders: pulmonary embolism*.

Skin and subcutaneous tissue disorders: pyoderma gangrenosum, including positive dechallenges; erythema multiforme and Stevens-Johnson syndrome.

Vascular disorders: 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) »

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