SUTENT® (sunitinib malate) 6 ADVERSE REACTIONS

(sunitinib malate)

Prescribing Information

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling.

•: Hepatotoxicity [see Warnings and Precautions (5.1)]
•: Cardiovascular Events [see Warnings and Precautions (5.2)]
•: QT Interval Prolongation and Torsade de Pointes [see Warnings and Precautions (5.3)]
•: Hypertension [see Warnings and Precautions (5.4)]
•: Hemorrhagic Events [see Warnings and Precautions (5.5)]
•: Tumor Lysis Syndrome [see Warnings and Precautions (5.6)]
•: Thrombotic Microangiopathy [see Warnings and Precautions (5.7)]
•: Proteinuria [see Warnings and Precautions (5.8)]
•: Dermatologic Toxicities [see Warnings and Precautions (5.9)]
•: Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.10)]
•: Thyroid Dysfunction [see Warnings and Precautions (5.11)]
•: Hypoglycemia [see Warnings and Precautions (5.12)]
•: Osteonecrosis of the Jaw [see Warnings and Precautions (5.13)]
•: Impaired Wound Healing [see Warnings and Precautions (5.14)]

6.1 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 %
Abbreviations: GIST=gastrointestinal stromal tumor; N=number of patients.
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. † Includes decreased appetite.
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
Anorexia†	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

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*,† %	All Grades* %	Grade 3–4*,‡ %
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; GIST=gastrointestinal stromal tumor; LVEF=left ventricular ejection fraction; N=number of patients.
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. † 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%). ‡ Grade 4 laboratory abnormalities in patients on placebo included amylase (1%), lipase (1%), and hemoglobin (2%).
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

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 (14.1)]. 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-Naïve RCC
	SUTENT (N=375)		Interferon Alfa (N=360)
	All Grades %	Grade 3–4† %	All Grades %	Grade 3–4‡ %
Abbreviations: ARs=adverse reactions; N=number of patients; RCC=renal cell carcinoma.
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. † 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%). ‡ Grade 4 ARs in patients on interferon alfa included dyspnea (1%), fatigue (1%), abdominal pain (<1%), and depression (<1%). § Includes flank pain. ¶ Includes decreased appetite. # Includes ageusia, hypogeusia, and dysgeusia. Þ Includes 1 patient with Grade 5 gastric hemorrhage. ß Includes depressed mood.
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 pain§	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
Anorexia¶	48	3	42	2
Neurology
Altered taste#	47	<1	15	0
Headache	23	1	19	0
Dizziness	11	<1	14	1
Hemorrhage/Bleeding
Bleeding, all sites	37	4Þ	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
Depressionß	11	0	14	1

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-Naïve RCC
	SUTENT (N=375)		Interferon Alfa (N=360)
	All Grades* %	Grade 3–4*,† %	All Grades* %	Grade 3–4*,‡ %
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; N=number of patients; RCC=renal cell carcinoma.
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. † 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%). ‡ 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%).
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

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 %
Abbreviations: ARs=adverse reactions; N=number of patients; RCC=renal cell carcinoma.
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. † Includes mucosal inflammation, stomatitis aphthous ulcer, mouth ulceration, tongue ulceration, oropharyngeal pain, and oral pain. ‡ Includes abdominal pain, abdominal pain lower, and abdominal pain upper. § Includes edema localized, face edema, eyelid edema, periorbital edema, swelling face, and eye edema. ¶ Includes dermatitis, dermatitis psoriasiform, exfoliative rash, genital rash, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculopapular, rash papular, and rash pruritic. # Includes hypertension, blood pressure increased, blood pressure systolic increased, blood pressure diastolic increased, and hypertensive crisis. Þ Includes ageusia, hypogeusia, and dysgeusia. ß Includes epistaxis, gingival bleeding, rectal hemorrhage, hemoptysis, anal hemorrhage, upper gastrointestinal hemorrhage, and hematuria.
Any Adverse Reaction	99	60	88	15
Gastrointestinal
Mucositis/Stomatitis†	61	6	15	0
Diarrhea	57	4	22	<1
Nausea	34	2	15	0
Dyspepsia	27	1	7	0
Abdominal pain‡	25	2	9	<1
Vomiting	19	2	7	0
Constipation	12	0	11	0
Constitutional
Fatigue/Asthenia	57	8	34	2
Localized edema§	18	<1	<1	0
Pyrexia	12	<1	6	0
Dermatology
Hand-foot syndrome	50	16	10	<1
Rash¶	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
Hypertension#	39	8	14	1
Edema/Peripheral edema	10	<1	7	0
Neurology
Altered tasteÞ	38	<1	6	0
Headache	19	<1	12	0
Endocrine
Hypothyroidism/TSH increased	24	<1	4	0
Hemorrhage/Bleeding
Bleeding events, all sitesß	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

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 3–4† %	All Grades %	Grade 3–4 %
Abbreviations: N=number of patients; pNET=pancreatic neuroendocrine tumors.
* Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. † Grade 4 adverse reactions in patients on SUTENT included fatigue (1%). ‡ Includes aphthous stomatitis, gingival pain, gingivitis, glossitis, glossodynia, mouth ulceration, oral discomfort, oral pain, tongue ulceration, mucosal dryness, mucosal inflammation, and dry mouth. § Includes abdominal discomfort, abdominal pain, and abdominal pain upper. ¶ Includes hematemesis, hematochezia, hematoma, hemoptysis, hemorrhage, melena, and metrorrhagia.
Any Adverse Reaction	99	54	95	50
Gastrointestinal
Diarrhea	59	5	39	2
Stomatitis/oral syndromes‡	48	6	18	0
Nausea	45	1	29	1
Abdominal pain§	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 events¶	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

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
	pNET
Laboratory Abnormality	SUTENT		Placebo
	All Grades* %	Grade 3–4*,† %	All Grades* %	Grade 3–4*,‡ %
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; N=number of patients; pNET=pancreatic neuroendocrine tumors.
* 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. † 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%). ‡ Grade 4 laboratory abnormalities in patients on placebo included creatinine (3%), alkaline phosphatase (1%), glucose increased (1%), and lipase (1%).
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

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-naïve RCC study, and 1 patient (<1%) in the adjuvant treatment for RCC study on SUTENT.

6.2 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 thrombocytopenia1.
•: 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)1. 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 regression1; myopathy and/or rhabdomyolysis with or without acute renal failure1.
•: Renal and urinary disorders: renal impairment and/or failure1.
•: Respiratory disorders: pulmonary embolism1, pleural effusion1.
•: Skin and subcutaneous tissue disorders: pyoderma gangrenosum, including positive de-challenges.
•: Vascular disorders: arterial (including aortic) aneurysms, dissections1, and rupture1; arterial thromboembolic events1. The most frequent events included cerebrovascular accident, transient ischemic attack, and cerebral infarction.
•: General disorders and administration site conditions: impaired wound healing.

1: including some fatalities

Medication Guide

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: October 2025
MEDICATION GUIDE SUTENT® (su TENT) (sunitinib malate) capsules
What is the most important information I should know about SUTENT? SUTENT can cause serious side effects including: • Severe liver problems, that can lead to death. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with SUTENT: o itching o yellow eyes or skin o dark urine o pain or discomfort in the right upper stomach area Your healthcare provider should do blood tests to check your liver function before you start taking and during treatment with SUTENT. Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with SUTENT if you develop liver problems. See “What are the possible side effects of SUTENT?” for more information about side effects.
What is SUTENT? SUTENT is a prescription medicine used to treat: • a rare cancer of the stomach, bowel, or esophagus called gastrointestinal stromal tumor (GIST) and when: o you have taken the medicine imatinib mesylate and it did not stop the cancer from growing, or o you cannot take imatinib mesylate. • advanced kidney cancer (advanced renal cell carcinoma or RCC). • adults with kidney cancer that has not spread (localized), and who are at high risk of RCC coming back again after having kidney surgery. • a type of pancreatic cancer called pancreatic neuroendocrine tumors (pNET), that has progressed and cannot be treated with surgery. It is not known if SUTENT is safe and effective in children.
Before taking SUTENT tell your healthcare provider about all of your medical conditions, including if you: • have any heart problems • have high blood pressure • have thyroid problems • have a history of low blood sugar or diabetes • have kidney function problems (other than cancer) • have liver problems • have any bleeding problem • plan to have surgery or have had a recent surgery. You should stop taking SUTENT at least 3 weeks before planned surgery. See "What are the possible side effects of SUTENT?" • have seizures • have or have had pain in the mouth, teeth or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth • are pregnant or plan to become pregnant. SUTENT can harm your unborn baby. Females who are able to become pregnant: o Your healthcare provider should do a pregnancy test before you start treatment with SUTENT. o You should use effective birth control (contraception) during treatment and for at least 4 weeks after your last dose of SUTENT. o Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with SUTENT. Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 7 weeks after your last dose of SUTENT. SUTENT may cause fertility problems in males and females. Tell your healthcare provider if this is a concern for you. • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with SUTENT and for at least 4 weeks (1 month) after the last dose. Tell all of your healthcare providers and dentists that you are taking SUTENT. They should talk to the healthcare provider who prescribed SUTENT for you, before you have any surgery, or medical or dental procedure. Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. Using SUTENT with certain other medicines can cause serious side effects. You may have an increased risk of severe jawbone problems (osteonecrosis) if you take SUTENT and a bisphosphonate medicine. Especially tell your healthcare provider if you are taking or have taken an osteoporosis medicine. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take SUTENT? • Take SUTENT exactly the way your healthcare provider tells you. • Take SUTENT 1 time each day with or without food. • If you take SUTENT for GIST or RCC, you will usually take your medicine for 4 weeks (28 days) and then stop for 2 weeks (14 days). This is 1 cycle of treatment. You will repeat this cycle for as long as your healthcare provider tells you to. • If you take SUTENT for pNET, take it 1 time each day until your healthcare provider tells you to stop. • Do not drink grapefruit juice or eat grapefruit during your treatment with SUTENT. They may cause you to have too much SUTENT in your body. • Your healthcare provider may do blood tests before each cycle of treatment to check you for side effects. • If you miss a dose of SUTENT by less than 12 hours, take the missed dose right away. If you miss a dose of SUTENT by more than 12 hours, just take your next dose at your regular time. Do not make up the missed dose. Tell your healthcare provider about any missed dose. • Call your healthcare provider right away, if you take too much SUTENT.
What are possible side effects of SUTENT? SUTENT may cause serious side effects, including: • See “What is the most important information I should know about SUTENT?” • Heart problems. Heart problems may include heart failure, heart attack and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles. • Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heart beats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider right away if you feel dizzy, faint, or have abnormal heartbeats during your treatment with SUTENT
	o you feel faint or lightheaded, or you pass out o dizziness	o feel your heart beat is irregular or fast
• High blood pressure. High blood pressure is common with SUTENT and may sometimes be severe. Follow your healthcare provider’s instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high, or if you have any of the following signs or symptoms of high blood pressure:
	o severe headache o lightheadedness	o dizziness o change in vision
	Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed.
• Bleeding problems. Bleeding is common with SUTENT, but SUTENT can also cause severe bleeding problems that can lead to death. Your healthcare provider will monitor you for bleeding and may do blood tests if needed. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including:
	o painful, swollen stomach (abdomen) o vomiting blood o coughing up blood o black, sticky stools	o bloody urine o headache o change in your mental status
• Serious stomach and intestinal problems, that can sometimes lead to death. Some people have had tears in their stomach or intestine (perforation), or have developed an abnormal opening between the stomach and intestine (fistula). Get medical help right away if you get stomach-area (abdominal) pain that does not go away or is severe during treatment with SUTENT. • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS. • Abnormal changes in the brain (Reversible Posterior Leukoencephalopathy Syndrome [RPLS]). RPLS can cause a collection of symptoms including headache, confusion, and vision loss. Some people who have taken SUTENT have developed RPLS that can lead to death. • Thrombotic microangiopathy (TMA) including thrombotic thrombocytopenia purpura (TTP) and hemolytic uremic syndrome (HUS). TMA is a condition that involves injury to the smallest blood vessels, and blood clots that can happen while taking SUTENT. TMA is accompanied by a decrease in red cells and cells that are involved with clotting. TMA may harm your body’s organs such as the brain and kidneys, and can sometimes lead to death. • Protein in your urine. Some people who have taken SUTENT have developed protein in their urine, and in some cases, kidney problems that can lead to death. Your healthcare provider will check you for this problem. • Serious skin and mouth reactions. Treatment with SUTENT has caused severe skin reactions that can lead to death, including: o severe rash with blisters or peeling of the skin. o painful sores or ulcers on the skin, lips or inside the mouth. o tissue damage (necrotizing fasciitis). If you have any signs or symptoms of severe skin reactions, stop taking SUTENT and call your healthcare provider or get medical help right away. • Thyroid problems. Your healthcare provider may do tests to check your thyroid function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms during your treatment with SUTENT:
	o tiredness that gets worse and does not go away o loss of appetite o problems with heat o feeling nervous or agitated, tremors o sweating o nausea or vomiting o diarrhea	o fast heat rate o weight gain or weight loss o feeling depressed o irregular menstrual periods or no menstrual periods o headache o hair loss
• Low blood sugar (hypoglycemia). Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take antidiabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your antidiabetic medicines. Call your healthcare provider right away if you have any of the following signs or symptoms of low blood sugar during your treatment with SUTENT:
	o headache o drowsiness o weakness o dizziness o confusion	o irritability o hunger o fast heart beat o sweating o feeling jittery
• Jawbone problems (osteonecrosis). Severe jawbone problems have happened in some people who take SUTENT. Certain risk factors such as taking a bisphosphonate medicine or having dental disease may increase your risk of getting osteonecrosis. Your healthcare provider may tell you to see your dentist before you start taking SUTENT. Your healthcare provider may tell you to avoid dental procedures, if possible, during your treatment with SUTENT, especially if you are receiving a bisphosphonate medicine into a vein (intravenous). Tell your healthcare provider if you plan to have any dental procedures before or during treatment with SUTENT. o You should stop taking SUTENT at least 3 weeks before planned dental procedures. o Your healthcare provider should tell you when you may start taking SUTENT again after dental procedures. • Wound healing problems. Wound healing problems have happened in some people who take SUTENT. Tell your healthcare provider if you plan to have any surgery before or during treatment with SUTENT. o You should stop taking SUTENT at least 3 weeks before planned surgery. o Your healthcare provider should tell you when you may start taking SUTENT again after surgery. Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with SUTENT if you develop serious side effects. Common side effects of SUTENT include:
• tiredness • weakness • diarrhea • pain, swelling or sores inside of your mouth • nausea • loss of appetite • indigestion		• vomiting • stomach-area (abdominal) pain • blisters or rash on the palms of your hands and soles of your feet • high blood pressure • taste changes • low platelet counts
The medicine in SUTENT is yellow, and it may make your skin look yellow. Your skin and hair may get lighter in color. SUTENT may also cause other skin problems including: dryness, thickness or cracking of the skin. These are not all of the possible side effects of SUTENT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How do I store SUTENT? • Store SUTENT at room temperature, between 68°F to 77°F (20°C to 25°C). Keep SUTENT and all medicines out of the reach of children.
General information about the safe and effective use of SUTENT. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SUTENT for a condition for which it was not prescribed. Do not give SUTENT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about SUTENT that is written for health professionals.
What are the ingredients in SUTENT? Active ingredient: sunitinib malate Inactive ingredients: mannitol, croscarmellose sodium, povidone (K-25), and magnesium stearate. Orange gelatin capsule shells: titanium dioxide, and red iron oxide. Caramel gelatin capsule shells: titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. Yellow gelatin capsule shells: titanium dioxide and yellow iron oxide. White printing ink: shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide. Black printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide. LAB-0361-13.0 For more information go to www.SUTENT.com or call 1-877-5-SUTENT.

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