Sutent

sunitinib malate
Dosage Form: capsule
FULL PRESCRIBING INFORMATION WARNING: HEPATOTOXICITY

 Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. [See Warnings and Precautions (5.1)]

Indications and Usage for Sutent Gastrointestinal Stromal Tumor (GIST)

Sutent is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.

Advanced Renal Cell Carcinoma (RCC)

Sutent is indicated for the treatment of advanced renal cell carcinoma.

Advanced Pancreatic Neuroendocrine Tumors (pNET)

 Sutent is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

Sutent Dosage and Administration Recommended Dose for GIST and RCC

The recommended dose of Sutent for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is one 50 mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). Sutent may be taken with or without food.

Recommended Dose for pNET

 The recommended dose of Sutent for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily continuously without a scheduled off-treatment period. Sutent may be taken with or without food.

Dose Modification

 Dose interruption and/or dose modification in 12.5 mg increments or decrements is recommended based on individual safety and tolerability. The maximum dose administered in the Phase 3 pNET study was 50 mg daily.

 Strong CYP3A4 inhibitors such as ketoconazole may increase sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended. A dose reduction for Sutent to a minimum of 37.5 mg (GIST and RCC) or 25 mg (pNET) daily should be considered if Sutent must be co-administered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

 CYP3A4 inducers such as rifampin may decrease sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme induction potential is recommended. A dose increase for Sutent to a maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily should be considered if Sutent must be co-administered with a CYP3A4 inducer. If dose is increased, the patient should be monitored carefully for toxicity [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Dosage Forms and Strengths

12.5 mg capsules
Hard gelatin capsule with orange cap and orange body, printed with white ink "Pfizer" on the cap and "STN 12.5 mg" on the body.

25 mg capsules
Hard gelatin capsule with caramel cap and orange body, printed with white ink "Pfizer" on the cap and "STN 25 mg" on the body.

50 mg capsules
Hard gelatin capsule with caramel top and caramel body, printed with white ink "Pfizer" on the cap and "STN 50 mg" on the body.

Contraindications

None

Warnings and Precautions Hepatotoxicity

 Sutent has been associated with hepatotoxicity, which may result in liver failure or death. Liver failure has been observed in clinical trials (7/2281 [0.3%]) and post-marketing experience. Liver failure signs include jaundice, elevated transaminases and/or hyperbilirubinemia in conjunction with encephalopathy, coagulopathy, and/or renal failure. Monitor liver function tests (ALT, AST, bilirubin) before initiation of treatment, during each cycle of treatment, and as clinically indicated. Sutent should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution. Do not restart Sutent if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.

 Safety in patients with ALT or AST >2.5 ? ULN or, if due to liver metastases, >5.0 ? ULN has not been established.

Pregnancy

 Sutent can cause fetal harm when administered to a pregnant woman. As angiogenesis is a critical component of embryonic and fetal development, inhibition of angiogenesis following administration of Sutent should be expected to result in adverse effects on pregnancy. In animal reproductive studies in rats and rabbits, sunitinib was teratogenic, embryotoxic, and fetotoxic. There are no adequate and well-controlled studies of Sutent in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Sutent.

Left Ventricular Dysfunction

In the presence of clinical manifestations of congestive heart failure (CHF), discontinuation of Sutent is recommended. The dose of Sutent should be interrupted and/or reduced in patients without clinical evidence of CHF but with an ejection fraction <50% and >20% below baseline.

 Cardiovascular events, including heart failure, myocardial disorders and cardiomyopathy, some of which were fatal, have been reported through post-marketing experience. For GIST and RCC, more patients treated with Sutent experienced decline in left ventricular ejection fraction (LVEF) than patients receiving either placebo or interferon-? (IFN-?). In the double-blind treatment phase of GIST Study A, 22/209 patients (11%) on Sutent and 3/102 patients (3%) on placebo had treatment-emergent LVEF values below the lower limit of normal (LLN). Nine of 22 GIST patients on Sutent with LVEF changes recovered without intervention. Five patients had documented LVEF recovery following intervention (dose reduction: one patient; addition of antihypertensive or diuretic medications: four patients). Six patients went off study without documented recovery. Additionally, three patients on Sutent had Grade 3 reductions in left ventricular systolic function to LVEF <40%; two of these patients died without receiving further study drug. No GIST patients on placebo had Grade 3 decreased LVEF. In the double-blind treatment phase of GIST Study A, 1 patient on Sutent and 1 patient on placebo died of diagnosed heart failure; 2 patients on Sutent and 2 patients on placebo died of treatment-emergent cardiac arrest.

In the treatment-na?ve RCC study, 103/375 (27%) and 54/360 (15%) patients on Sutent and IFN-?, respectively, had an LVEF value below the LLN. Twenty-six patients on Sutent (7%) and seven on IFN-? (2%) experienced declines in LVEF to >20% below baseline and to below 50%. Left ventricular dysfunction was reported in four patients (1%) and CHF in two patients (<1%) who received Sutent.

 In the Phase 3 pNET study, cardiac failure leading to death was reported in 2/83 (2%) patients on Sutent and no patients on placebo.

Patients who presented with cardiac events within 12 months prior to Sutent administration, such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic CHF, cerebrovascular accident or transient ischemic attack, or pulmonary embolism were excluded from Sutent clinical studies. It is unknown whether patients with these concomitant conditions may be at a higher risk of developing drug-related left ventricular dysfunction. Physicians are advised to weigh this risk against the potential benefits of the drug. These patients should be carefully monitored for clinical signs and symptoms of CHF while receiving Sutent. Baseline and periodic evaluations of LVEF should also be considered while these patients are receiving Sutent. In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.

QT Interval Prolongation and Torsade de Pointes

Sutent has been shown to prolong the QT interval in a dose dependent manner, which may lead to an increased risk for ventricular arrhythmias including Torsade de Pointes. Torsade de Pointes has been observed in <0.1% of Sutent-exposed patients.

Sutent should be used with caution in patients with a history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. When using Sutent, periodic monitoring with on-treatment electrocardiograms and electrolytes (magnesium, potassium) should be considered. Concomitant treatment with strong CYP3A4 inhibitors, which may increase sunitinib plasma concentrations, should be used with caution and dose reduction of Sutent should be considered [see Dosage and Administration (2.2)].

Hypertension

Patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy. In cases of severe hypertension, temporary suspension of Sutent is recommended until hypertension is controlled.

 Of patients receiving Sutent for treatment-na?ve RCC, 127/375 patients (34%) receiving Sutent compared with 13/360 patients (4%) on IFN-? experienced hypertension. Grade 3 hypertension was observed in 50/375 treatment-na?ve RCC patients (13%) on Sutent compared to 1/360 patients (<1%) on IFN-?. While all-grade hypertension was similar in GIST patients on Sutent compared to placebo, Grade 3 hypertension was reported in 9/202 GIST patients on Sutent (4%), and none of the GIST patients on placebo. Of patients receiving Sutent in the Phase 3 pNET study, 22/83 patients (27%) on Sutent and 4/82 patients (5%) on placebo experienced hypertension. Grade 3 hypertension was reported in 8/83 pNET patients (10%) on Sutent, and 1/82 patient (1%) on placebo. No Grade 4 hypertension was reported. Sutent dosing was reduced or temporarily delayed for hypertension in 21/375 patients (6%) on the treatment-naive RCC study and 7/83 pNET patients (8%). Four treatment-na?ve RCC patients, including one with malignant hypertension, one patient with pNET, and no GIST patients discontinued treatment due to hypertension. Severe hypertension (>200 mmHg systolic or 110 mmHg diastolic) occurred in 8/202 GIST patients on Sutent (4%), 1/102 GIST patients on placebo (1%), in 32/375 treatment-na?ve RCC patients (9%) on Sutent, in 3/360 patients (1%) on IFN-?, and in 8/80 pNET patients (10%) on Sutent and 2/76 pNET patients (3%) on placebo.

Hemorrhagic Events

 Hemorrhagic events reported through post-marketing experience, some of which were fatal, have included GI, respiratory, tumor, urinary tract and brain hemorrhages. In patients receiving Sutent in a clinical trial for treatment-na?ve RCC, 140/375 patients (37%) had bleeding events compared with 35/360 patients (10%) receiving IFN-?. Bleeding events occurred in 37/202 patients (18%) receiving Sutent in the double-blind treatment phase of GIST Study A, compared to 17/102 patients (17%) receiving placebo. Epistaxis was the most common hemorrhagic adverse event reported. Bleeding events, excluding epistaxis, occurred in 18/83 patients (22%) receiving Sutent in the Phase 3 pNET study, compared to 8/82 patients (10%) receiving placebo. Epistaxis was reported in 17/83 patients (20%) receiving Sutent for pNET and 4 patients (5%) receiving placebo. Less common bleeding events in GIST, RCC and pNET patients included rectal, gingival, upper gastrointestinal, genital, and wound bleeding. In the double-blind treatment phase of GIST Study A, 14/202 patients (7%) receiving Sutent and 9/102 patients (9%) on placebo had Grade 3 or 4 bleeding events. In addition, one patient in GIST Study A taking placebo had a fatal gastrointestinal bleeding event during Cycle 2. Most events in RCC patients were Grade 1 or 2; there was one Grade 5 event of gastric bleed in a treatment-na?ve patient. In the pNET study, 1/83 patients (1%) receiving Sutent had Grade 3 epistaxis, and no patients had other Grade 3 or 4 bleeding events. In pNET patients receiving placebo, 3/82 patients (4%) had Grade 3 or 4 bleeding events.

Tumor-related hemorrhage has been observed in patients treated with Sutent. These events may occur suddenly, and in the case of pulmonary tumors may present as severe and life-threatening hemoptysis or pulmonary hemorrhage. Fatal pulmonary hemorrhage occurred in 2 patients receiving Sutent on a clinical trial of patients with metastatic non-small cell lung cancer (NSCLC). Both patients had squamous cell histology. Sutent is not approved for use in patients with NSCLC. Treatment-emergent Grade 3 and 4 tumor hemorrhage occurred in 5/202 patients (3%) with GIST receiving Sutent on Study A. Tumor hemorrhages were observed as early as Cycle 1 and as late as Cycle 6. One of these five patients received no further drug following tumor hemorrhage. None of the other four patients discontinued treatment or experienced dose delay due to tumor hemorrhage. No patients with GIST in the Study A placebo arm were observed to undergo intratumoral hemorrhage. Clinical assessment of these events should include serial complete blood counts (CBCs) and physical examinations.

Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation, have occurred rarely in patients with intra-abdominal malignancies treated with Sutent.

Thyroid Dysfunction

Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of Sutent treatment. All patients should be observed closely for signs and symptoms of thyroid dysfunction on Sutent treatment. Patients with signs and/or symptoms suggestive of thyroid dysfunction should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice.

 Treatment-emergent acquired hypothyroidism was noted in eight GIST patients (4%) on Sutent versus one (1%) on placebo. Hypothyroidism was reported as an adverse reaction in sixty-one patients (16%) on Sutent in the treatment-na?ve RCC study and in three patients (1%) in the IFN-? arm. Hypothyroidism was reported as an adverse reaction in 6/83 patients (7%) on Sutent in the Phase 3 pNET study and in 1/82 patients (1%) in the placebo arm.

Cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience.

Wound Healing

 Cases of impaired wound healing have been reported during Sutent therapy. Temporary interruption of Sutent therapy is recommended for precautionary reasons in patients undergoing major surgical procedures. There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention. Therefore, the decision to resume Sutent therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery.

Adrenal Function

Physicians prescribing Sutent are advised to monitor for adrenal insufficiency in patients who experience stress such as surgery, trauma or severe infection.

Adrenal toxicity was noted in non-clinical repeat dose studies of 14 days to 9 months in rats and monkeys at plasma exposures as low as 0.7 times the AUC observed in clinical studies. Histological changes of the adrenal gland were characterized as hemorrhage, necrosis, congestion, hypertrophy and inflammation. In clinical studies, CT/MRI obtained in 336 patients after exposure to one or more cycles of Sutent demonstrated no evidence of adrenal hemorrhage or necrosis. ACTH stimulation testing was performed in approximately 400 patients across multiple clinical trials of Sutent. Among patients with normal baseline ACTH stimulation testing, one patient developed consistently abnormal test results during treatment that are unexplained and may be related to treatment with Sutent. Eleven additional patients with normal baseline testing had abnormalities in the final test performed, with peak cortisol levels of 12–16.4 mcg/dL (normal >18 mcg/dL) following stimulation. None of these patients were reported to have clinical evidence of adrenal insufficiency.

Laboratory Tests

CBCs with platelet count and serum chemistries including phosphate should be performed at the beginning of each treatment cycle for patients receiving treatment with Sutent.

Adverse Reactions

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 (14.1)], an active-controlled trial (n=375) for the treatment of RCC [see Clinical Studies (14.2)] or a placebo-controlled trial (n=83) for the treatment of pNET [see Clinical Studies (14.3)]. 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 (5). 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 * Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 † Includes decreased appetite 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   Anorexia† 67 (33) 1 (1) 30 (29) 5 (5)   Asthenia 45 (22) 10 (5) 11 (11) 3 (3)

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*† All Grades* Grade 3/4*‡ LVEF=Left ventricular ejection fraction * 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 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)

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 (14.1)]. 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-?. 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-? treatment. Dose interruptions occurred in 202 patients (54%) on Sutent and 141 patients (39%) on IFN-?. Dose reductions occurred in 194 patients (52%) on Sutent and 98 patients (27%) on IFN-?. Discontinuation rates due to adverse reactions were 20% for Sutent and 24% for IFN-?. 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-?, respectively.

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

Table 3. Adverse Reactions Reported in at Least 10% of Patients with RCC Who Received Sutent or IFN-?* Adverse Reaction,
n (%) Treatment-Na?ve RCC Sutent (n=375) IFN-? (n=360) All Grades Grade 3/4† All Grades Grade 3/4‡ * 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 IFN-? included dyspnea (1%), fatigue (1%), abdominal pain (<1%) and depression (<1%). § Includes flank pain ¶ Includes ageusia, hypogeusia and dysgeusia # Includes decreased appetite ? Includes one patient with Grade 5 gastric hemorrhage ? Includes depressed mood 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 (16) 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 pain§ 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 taste¶ 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

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sunitinib

Generic Name: sunitinib (soo NIT in ib)
Brand Names: Sutent

What is sunitinib?

Sunitinib is a cancer medicine that helps the body slow down the growth and reproduction of certain cells, including tumor cells.

Sunitinib is used to treat certain types of advanced or progressive tumors of the digestive system, the pancreas, or the kidneys.

Sunitinib may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sunitinib? Do not use sunitinib if you are pregnant. It could harm the unborn baby.

Before using sunitinib, tell your doctor if you have liver or kidney disease, high blood pressure, seizures, a bleeding or blood-clotting disorder, a thyroid disorder, heart disease, heart rhythm disorder, or if you have ever had a heart attack, congestive heart failure, a stroke, blood clots, coronary artery disease, bypass graft surgery, or transient ischemic attack (TIA).

To be sure this medication is helping your condition and is not causing certain side effects, your blood and blood pressure may need to be tested at the beginning of each 4-week treatment cycle. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis. Do not miss any follow-up visits to your doctor.

Stop using sunitinib and call your doctor at once if you have chest pain, severe dizziness, fast or pounding heartbeat, swelling, feeling short of breath, fainting, sudden numbness or weakness, severe headache, weight changes, tiredness, missed menstrual periods, blood in your urine or stools, coughing up blood, easy bruising or bleeding, upper stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).

Tell your doctor about all other medicines you use.

What should I discuss with my healthcare provider before using sunitinib? You should not use this medication if you are allergic to it.

To make sure you can safely take sunitinib, tell your doctor if you have any of these other conditions:

liver or kidney disease;

high blood pressure;

seizures;

a bleeding or blood-clotting disorder;

a thyroid disorder;

heart disease, heart rhythm disorder;

a personal or family history of "Long QT syndrome";

a history of heart attack or congestive heart failure; or

a history of stroke, blood clots, coronary artery disease, bypass graft surgery, or transient ischemic attack (TIA).

FDA pregnancy category D. Do not use sunitinib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known if sunitinib passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take sunitinib?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Sunitinib is usually taken once per day. Sunitinib is sometimes taken for 4 weeks followed by 2 weeks off the drug. Your doctor will determine how many complete treatment cycles you need based on your condition.

Sunitinib may be taken with or without food.

Take this medicine with a full glass of water. Do not crush, chew, or open a sunitinib capsule. Swallow it whole. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water and rinse thoroughly.

To be sure this medication is helping your condition and is not causing certain side effects, your blood and blood pressure may need to be tested at the beginning of each 4-week treatment cycle. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis. Do not miss any follow-up visits to your doctor.

If you need surgery, tell the surgeon ahead of time that you are using sunitinib. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.

See also: Sunitinib dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include muscle weakness, shaking or chills, and stomach pain.

What should I avoid while taking sunitinib?

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking sunitinib.

Grapefruit and grapefruit juice may interact with sunitinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Sunitinib 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:

chest pain, general ill feeling;

severe dizziness, fainting, fast or pounding heartbeat;

swelling of your ankles or feet, feeling short of breath (even with mild exertion);

sudden numbness or weakness, especially on one side of the body;

sudden and severe headache, confusion, problems with vision, speech, or balance;

feeling very weak or tired, loss of appetite, weight gain or loss, hair loss, increased sensitivity to heat;

missed menstrual periods;

feeling agitated, depressed, or nervous;

redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet;

change in your mental state, blood in your urine or stools, black or tarry stools;

pain and swelling in your stomach, coughing up blood or vomit that looks like coffee grounds;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

fever, white patches or sores inside your mouth or on your lips; or

nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

unusual or unpleasant taste in the mouth;

cough;

mild nausea, vomiting, stomach pain or upset;

diarrhea or 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.

Sunitinib Dosing Information

Usual Adult Dose for Renal Cell Carcinoma:

50 mg orally once a day with or without food.
Sunitinib is given on a schedule of four weeks on treatment followed by two weeks off treatment.

Usual Adult Dose for Gastrointestinal Stromal Tumor:

50 mg orally once a day with or without food.
Sunitinib is given on a schedule of four weeks on treatment followed by two weeks off treatment.

Usual Adult Dose for Pancreatic Cancer:

Pancreatic neuroendocrine tumors (pNET): 37.5 mg orally once daily continuously without a scheduled off treatment period.

What other drugs will affect sunitinib?

Tell your doctor about all other medications you are using, especially:

dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

nefazodone;

St. John's wort;

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

heart or blood pressure medication such as nicardipine (Cardene), quinidine (Quin-G), or verapamil (Calan, Covera, Isoptin, Verelan), and others;

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra);

medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil); or

seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with sunitinib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More sunitinib resources Sunitinib Side Effects (in more detail) Sunitinib Dosage Sunitinib Use in Pregnancy & Breastfeeding Sunitinib Drug Interactions Sunitinib Support Group 7 Reviews for Sunitinib - Add your own review/rating sunitinib Advanced Consumer (Micromedex) - Includes Dosage Information Sunitinib MedFacts Consumer Leaflet (Wolters Kluwer) Sunitinib Malate Monograph (AHFS DI) Sutent Prescribing Information (FDA) Compare sunitinib with other medications Gastrointestinal Stromal Tumor Pancreatic Cancer Renal Cell Carcinoma Where can I get more information? Your pharmacist can provide more information about sunitinib.

See also: sunitinib side effects (in more detail)

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sunitinib malate

soo-NI-ti-nib MAL-ate

Oral route(Capsule)

Hepatotoxicity has been observed in clinical trials and postmarketing experience. This hepatotoxicity may be severe, and deaths have been reported .

Commonly used brand name(s)

In the U.S.

Sutent

Available Dosage Forms:

Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Sunitinib

Uses For sunitinib malate

Sunitinib belongs to the group of medicines known as antineoplastics. It is used to treat a gastrointestinal stromal tumor (GIST) after a medicine called imatinib did not work very well. It may also be used when patients are not able to take imatinib. GIST is a group of cancer cells that start growing in the wall of the stomach, intestines, or rectum. Sunitinib is also used to treat advanced (late-stage) kidney cancer.

Sunitinib is also used to treat a type of pancreatic cancer called pancreatic neuroendocrine tumor (pNET), that cannot be surgically removed and is locally advanced or metastatic (cancer that has spread).

Sunitinib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by sunitinib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with sunitinib, you and your doctor should talk about the benefits sunitinib malate will do as well as the risks of using it.

sunitinib malate is available only with your doctor's prescription.

Before Using sunitinib malate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sunitinib malate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sunitinib malate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sunitinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sunitinib in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sunitinib malate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using sunitinib malate with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dronedarone Fluconazole Mesoridazine Pimozide Posaconazole Sparfloxacin Thioridazine

Using sunitinib malate with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfuzosin Amiodarone Amitriptyline Amoxapine Apomorphine Arsenic Trioxide Asenapine Astemizole Atazanavir Azithromycin Boceprevir Bretylium Carbamazepine Chloroquine Chlorpromazine Ciprofloxacin Cisapride Citalopram Clarithromycin Clomipramine Clozapine Conivaptan Crizotinib Dasatinib Desipramine Dexamethasone Disopyramide Dofetilide Dolasetron Droperidol Erythromycin Flecainide Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Ibutilide Iloperidone Imipramine Indinavir Itraconazole Ketoconazole Lapatinib Levofloxacin Lopinavir Lumefantrine Mefloquine Methadone Mitotane Moxifloxacin Nefazodone Nelfinavir Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Pazopanib Perflutren Lipid Microsphere Phenobarbital Phenytoin Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Ranolazine Rifabutin Rifampin Rifapentine Ritonavir Salmeterol Saquinavir Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol St John's Wort Telavancin Telithromycin Terfenadine Tetrabenazine Toremifene Trazodone Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of sunitinib malate. Make sure you tell your doctor if you have any other medical problems, especially:

Bleeding problems or Bradycardia (very slow heart beat), history of or Congestive heart failure, history of or Heart disease (e.g., cardiomyopathy), history of or Heart rhythm problems (e.g., QT prolongation), history of or Hypertension (high blood pressure) or Hyperthyroidism (overactive thyroid) or Hypothyroidism (underactive thyroid) or Kidney problems (other than cancer) or Liver problems or Seizures or Stomach ulcers—Use with caution. May make these conditions worse. Hypokalemia (low potassium in the blood) or Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse. Infection, severe or Surgery or Trauma—These conditions may cause adrenal gland problems. Proper Use of sunitinib malate

Your doctor will tell you how much of sunitinib malate to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

You may take sunitinib malate with or without food. Do not open the capsules.

sunitinib malate comes with a Medication Guide and a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of sunitinib malate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sunitinib malate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules): For the treatment of GIST and kidney cancer: Adults—50 milligrams (mg) once a day for 4 weeks. This is followed by 2 weeks without medicine. Your doctor may tell you to repeat this cycle. Children—Use and dose must be determined by your doctor. For advanced pancreatic cancer or pancreatic neuroendocrine tumor (pNET): Adults—37.5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day. Children—Use and dose must be determined by your doctor. Missed Dose

sunitinib malate needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using sunitinib malate

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting sunitinib treatment.

Using sunitinib malate while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Before you have any medical tests, tell the medical doctor in charge that you are using sunitinib malate. The results of some tests may be affected by sunitinib malate.

Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.

Sunitinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you are rapidly gaining weight or have shortness of breath; chest pain or discomfort; extreme tiredness or weakness; irregular breathing; uneven heartbeats; or excessive swelling of the hands, wrist, ankles, or feet. These may be symptoms of a heart problem.

sunitinib malate can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or dizziness. Call your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

sunitinib malate may also increase your risk of bleeding and cause delay in wound healing. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.

Make sure any doctor or dentist who treats you knows that you are using sunitinib malate. You may need to stop using sunitinib malate several days before having surgery or medical tests.

Grapefruit and grapefruit juice may cause you to have too much of sunitinib malate in the blood. You should not eat grapefruit or drink grapefruit juice while you are taking sunitinib malate.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's Wort) or vitamin supplements.

sunitinib malate Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Bleeding gums bloating or swelling of the face, arms, hands, fingers, lower legs, or feet blurred vision chest pain chills confusion coughing up blood cracked lips decreased urination decreased urine output diarrhea difficulty with breathing or swallowing dilated neck veins dizziness dry mouth extreme fatigue fainting fast, slow, or irregular heartbeat fever headache increase in heart rate increased menstrual flow or vaginal bleeding irregular breathing labored breathing lightheadedness nervousness nosebleeds paralysis pounding in the ears prolonged bleeding from cuts rapid breathing rapid weight gain red or black, tarry stools red or dark brown urine shortness of breath sores, ulcers, or white spots on the lips, tongue, or inside the mouth sunken eyes swelling or inflammation of the mouth thirst tightness in the chest tingling of the hands or feet troubled breathing unusual tiredness or weakness unusual weight gain or loss wheezing wrinkled skin yellow eyes or skin Less common Constipation depressed mood dry skin and hair feeling cold hair loss hoarseness or husky voice indigestion loss of appetite muscle cramps and stiffness nausea pain in the chest, groin, or legs, especially the calves pain in the stomach, side, or abdomen, possibly radiating to the back severe, sudden headache slurred speech sudden loss of coordination sudden, severe weakness or numbness in the arm or leg sudden, unexplained shortness of breath vision changes vomiting Rare Back pain chest discomfort cloudy or bloody urine convulsions darkening of the skin drowsiness general feeling of tiredness or weakness irregular or slow heart rate light-colored stools mental depression skin rash stomach pain, continuing swelling of the face, feet, or lower legs Incidence not known Cough dark-colored urine decreased frequency or amount of urine increased thirst lower back or side pain muscle cramps or spasms muscular pain, tenderness, wasting, or weakness painful or difficult urination pale skin sore throat sudden, severe chest pain unusual bleeding or bruising weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal or stomach pain acid or sour stomach belching blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet change in color of the treated skin change in taste difficulty with moving discouragement excess air or gas in the stomach or intestines feeling sad or empty full feeling hair color changes hair loss or thinning of the hair heartburn irritability joint pain lack of appetite lack or loss of strength loss of interest or pleasure muscle aches or pains numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet pain or burning in the throat passing gas sleeplessness stomach discomfort, upset, or pain swollen joints trouble concentrating trouble sleeping unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: sunitinib malate side effects (in more detail)

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More sunitinib malate resources Sunitinib malate Side Effects (in more detail) Sunitinib malate Dosage Sunitinib malate Use in Pregnancy & Breastfeeding Sunitinib malate Drug Interactions Sunitinib malate Support Group 7 Reviews for Sunitinib malate - Add your own review/rating Compare sunitinib malate with other medications Gastrointestinal Stromal Tumor Pancreatic Cancer Renal Cell Carcinoma

Read More:

sunitinib malate

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