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Sunitinib: Drug information

Sunitinib: Drug information
(For additional information see "Sunitinib: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Hepatotoxicity:

Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib as recommended.

Brand Names: US
  • Sutent
Brand Names: Canada
  • Sutent;
  • TARO-Sunitinib
Pharmacologic Category
  • Antineoplastic Agent, Tyrosine Kinase Inhibitor;
  • Antineoplastic Agent, Vascular Endothelial Growth Factor (VEGF) Inhibitor;
  • Vascular Endothelial Growth Factor (VEGF) Inhibitor
Dosing: Adult

Note: Withhold sunitinib for at least 3 weeks prior to elective surgery; do not administer sunitinib for at least 2 weeks after major surgery and until adequate wound healing. If possible, withhold sunitinib for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures.

Gastrointestinal stromal tumor

Gastrointestinal stromal tumor: Oral: 50 mg once daily for 4 weeks of a 6-week treatment cycle (4 weeks on, 2 weeks off) until disease progression or unacceptable toxicity (Demetri 2006).

Off-label dosing: Oral: 37.5 mg once daily, continuous daily dosing until disease progression or unacceptable toxicity (George 2009a).

Pancreatic neuroendocrine tumors, advanced

Pancreatic neuroendocrine tumors, advanced: Oral: 37.5 mg once daily, continuous daily dosing until disease progression or unacceptable toxicity (Raymond 2011).

Renal cell carcinoma, adjuvant treatment

Renal cell carcinoma, adjuvant treatment:

Note: Sunitinib is no longer recommended as adjuvant treatment (Atkins 2022). Although approved for adjuvant therapy based on improved disease-free survival in patients with high-risk disease, sunitinib has not shown an overall survival benefit and is associated with increased toxicity (Motzer 2018; Ravaud 2016).

Oral: 50 mg once daily for 4 weeks of a 6-week treatment cycle (4 weeks on, 2 weeks off) for 9 cycles (Motzer 2018; Ravaud 2016); the minimum daily dose used in clinical trials was 37.5 mg.

Renal cell carcinoma, advanced

Renal cell carcinoma, advanced:

Note: May be used as initial therapy for patients with limited-burden, favorable-risk disease who desire a more aggressive initial approach, for those with favorable-risk disease who are ineligible for immunotherapy-based combinations, or for those with progression after initial immunotherapy and who have not received prior VEGF treatment (George 2022; Motzer 2006a; Motzer 2006b; Motzer 2009).

3-week cycle (off-label dosing): Note: Dosing on a 3-week cycle may be associated with improved tolerability. Oral: 50 mg once daily for 2 weeks of a 3-week treatment cycle (2 weeks on, 1 week off) until disease progression or unacceptable toxicity (Bracarda 2015).

6-week cycle: Oral: 50 mg once daily for 4 weeks of a 6-week treatment cycle (4 weeks on, 2 weeks off) until disease progression or unacceptable toxicity (Motzer 2006a; Motzer 2006b; Motzer 2009).

Soft tissue sarcoma, non-GIST

Soft tissue sarcoma, non-GIST (off-label use): Oral: 37.5 mg once daily, continuous daily dosing (George 2009b).

Thyroid cancer, refractory

Thyroid cancer, refractory (off-label use): Oral: 50 mg once daily for 4 weeks of a 6-week treatment cycle (4 weeks on, 2 weeks off) until disease progression or unacceptable toxicity (Cohen 2008; Ravaud 2017).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥30 mL/minute: No dosage adjustment required.

CrCl <30 mL/minute (not on hemodialysis): No dosage adjustment required.

End-stage renal disease on hemodialysis: No initial dosage adjustment required. Subsequent doses may be increased gradually (up to 2-fold) based on safety and tolerability (due to lower systemic exposure).

Renal toxicity during treatment:

Nephrotic syndrome: Permanently discontinue sunitinib.

Proteinuria:

Urine protein ≥3 g per 24 hours (in the absence of nephrotic syndrome): Interrupt sunitinib until resolution to ≤ grade 1 or baseline, then resume at a reduced dose.

Recurrent urine protein ≥3 g per 24 hours despite dose reductions: Permanently discontinue sunitinib.

Dosing: Hepatic Impairment: Adult

Preexisting hepatic impairment:

Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling.

Hepatotoxicity during treatment:

Grade 3: Withhold sunitinib until resolution to ≤ grade 1 or baseline, then resume at a reduced dose. Permanently discontinue sunitinib for recurrent grade 3 hepatotoxicity.

Grade 4: Permanently discontinue sunitinib.

Discontinue sunitinib if grade 3 hepatotoxicity does not resolve or in patients with subsequent severe changes in LFTs or other signs/symptoms of liver failure.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Adjustment for Toxicity: Adult
Recommended Sunitinib Dose Reduction Levels for Adverse Reactions

GISTa

RCCa, b

Pancreatic neuroendocrine tumors

Advanced RCC

Adjuvant RCC

a Refer to "Dosing: Adult" for dosing/treatment cycle schedule. GIST = gastrointestinal stromal tumor.

b RCC = Renal cell carcinoma.

Initial (usual) dose

50 mg once daily

50 mg once daily

50 mg once daily

37.5 mg once daily

First dose reduction

37.5 mg once daily

37.5 mg once daily

37.5 mg once daily

25 mg once daily

Second dose reduction

25 mg once daily

25 mg once daily

-

-

Recommended Sunitinib Dose Modifications for Adverse Reactions

Adverse reaction

Severity

Sunitinib dose modification

a Prior to treatment initiation, a pedicure is recommended to remove hyperkeratotic areas/calluses, which may predispose to HFSR; avoid vigorous exercise/activities that may stress hands or feet. During therapy, patients should reduce exposure to hot water (may exacerbate hand-foot symptoms); avoid constrictive footwear and excessive skin friction. Patients may also wear thick cotton gloves or socks and should wear shoes with padded insoles (Lacouture 2008). Refer to Lacouture 2008 for additional dermatologic toxicity management information.

b HFSR = Hand-foot skin reaction.

c ONJ = osteonecrosis of the jaw.

Cardiovascular event

Asymptomatic cardiomyopathy (left ventricular ejection fraction <50% but >20% below baseline or below the lower limit of normal [if baseline ejection fraction is not available])

Withhold sunitinib until resolution to ≤ grade 1 or baseline, then resume at a reduced dose.

Clinical manifestations of heart failure

Permanently discontinue sunitinib.

Dermatologic adverse reactions (eg, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrotizing fasciitis)

Any grade

Permanently discontinue sunitinib.

HFSRa,b

Therapy interruption and dose reductions may be necessary (Lacouture 2008a).

Grade 1

Moisturizing creams, cotton gloves and socks (at night), and/or keratolytic creams such as urea (20% to 40%) or salicylic acid (6%) may be utilized (Lacouture 2008).

Grade 2

Apply topical steroid (eg, clobetasol ointment) twice daily to erythematous areas; topical anesthetics (eg, lidocaine 2%) and then systemic analgesics (if appropriate) may be used for pain control (Lacouture 2008).

Hemorrhage

Grade 3 or 4

Withhold sunitinib until resolution to ≤ grade 1 or baseline, then resume at a reduced dose or discontinue (depending on severity and persistence). Discontinue sunitinib if grade 3 or 4 hemorrhagic events do not resolve.

Hypertension

If indicated, initiate appropriate antihypertensive treatment to reduce the risk for cardiotoxicity (ASCO [Armenian 2017]). Adjust antihypertensive therapy as appropriate.

Grade 3

Withhold sunitinib until resolution to ≤ grade 1 or baseline, then resume at a reduced dose.

Grade 4

Permanently discontinue sunitinib.

Hypoglycemia

Any grade

Dose modifications of antihyperglycemic medications may be necessary to minimize the risk of hypoglycemia.

ONJc

Any grade

Withhold sunitinib until complete resolution, then either resume at a reduced dose or discontinue (depending on severity and persistence). Patients developing ONJ during therapy should receive care by an oral surgeon (AAOMS [Ruggiero 2014]). The safety of resuming sunitinib after ONJ has not been established.

Reversible posterior leukoencephalopathy syndrome

Any grade

Permanently discontinue sunitinib.

Thrombotic microangiopathy

Any grade

Permanently discontinue sunitinib.

Wound healing complications

Any grade

Withhold sunitinib until resolution, then either resume at a reduced dose or discontinue (depending on severity and persistence). The safety of resuming sunitinib has not been established.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Sutent: 12.5 mg, 25 mg, 37.5 mg, 50 mg

Generic: 12.5 mg, 25 mg, 37.5 mg, 50 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Sutent: 12.5 mg, 25 mg, 37.5 mg, 50 mg

Generic: 25 mg, 50 mg

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021938s039lbledt.pdf#page=34, must be dispensed with this medication.

Administration: Adult

Oral: May be administered with or without food.

Note: Administration schedules vary by indication; some treatment regimens are continuous daily dosing and other treatment schedules are daily dosing for 4 weeks of a 6-week cycle (4 weeks on, 2 weeks off); other treatment schedules have also been reported off label.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Use: Labeled Indications

Gastrointestinal stromal tumor: Treatment of gastrointestinal stromal tumor (GIST) in adults after disease progression on or intolerance to imatinib.

Pancreatic neuroendocrine tumors, advanced: Treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in adults with unresectable locally advanced or metastatic disease.

Renal cell carcinoma: Adjuvant treatment of adults at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy; treatment of advanced RCC in adults.

Use: Off-Label: Adult

Soft tissue sarcoma (non-gastrointestinal stromal tumor); Thyroid cancer

Medication Safety Issues
Sound-alike/look-alike issues:

SUNItinib may be confused with axitinib, dasatinib, enasidenib, erlotinib, gefitinib, imatinib, lapatinib, neratinib, nilotinib, PAZOPanib, regorafenib, ripretinib, selpercatinib, selumetinib, SORAfenib, sotorasib, tivozanib, vandetanib

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Administration issues:

Dosing schedules vary by indication; some treatment regimens are continuous daily dosing; other treatment schedules are daily dosing for 4 weeks of a 6-week cycle (4 weeks on, 2 weeks off)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

>10%:

Cardiovascular: Chest pain (13%), decreased left ventricular ejection fraction (11% to 16%), hypertension (15% to 39%), increased serum creatine kinase (49%), peripheral edema (≤24%)

Dermatologic: Alopecia (5% to 14%), erythema of skin (12%), hair discoloration (7% to 29%), palmar-plantar erythrodysesthesia (14% to 50%), pruritus (12%), skin discoloration (18% to 30%; yellow color), skin rash (14% to 29%), xeroderma (14% to 23%)

Endocrine & metabolic: Decreased serum albumin (28% to 41%), decreased serum calcium (34% to 42%), decreased serum magnesium (19%), decreased serum phosphate (31% to 36%), decreased serum potassium (12% to 21%), decreased serum sodium (20%), hypothyroidism (≤24%), increased serum calcium (13%), increased serum sodium (10% to 13%), increased uric acid (46%), weight loss (16%)

Gastrointestinal: Abdominal pain (25% to 39%), anorexia (≤48%), constipation (12% to 23%), decreased appetite (≤19%), diarrhea (40% to 66%; grades 3/4: 4% to 10%), dysgeusia (21% to 47%), dyspepsia (15% to 34%), flatulence (14%), gastroesophageal reflux disease (12%), glossalgia (11%), increased serum amylase (17% to 35%), increased serum lipase (17% to 56%), nausea (34% to 58%; grades 3/4: 2% to 6%), stomatitis (29% to 61%; grades 3/4: 3% to 6%; grade 4: <1%), vomiting (19% to 39%; grades 3/4: 2% to 5%), xerostomia (13%)

Hematologic & oncologic: Decreased hemoglobin (26% to 79%; grades 3/4: 3% to 8%; grade 4: 2%), hemorrhage (22% to 37%; grades 3/4: ≤4%), lymphocytopenia (38% to 68%; grades 3/4: 3% to 18%, grade 4: 2%), neutropenia (grades 3/4: 13%)

Hepatic: Increased indirect serum bilirubin (10% to 13%), increased serum alanine aminotransferase (≤61%), increased serum alkaline phosphatase (24% to 46%), increased serum aspartate aminotransferase (≤72%), increased serum bilirubin (16% to 37%)

Local: Localized edema (18%)

Nervous system: Chills (14%), depression (11%), dizziness (11%), fatigue (≤62%), headache (18% to 23%), insomnia (15% to 18%), mouth pain (6% to 14%)

Neuromuscular & skeletal: Arthralgia (11% to 30%), asthenia (≤57%), back pain (28%), limb pain (≤40%), myalgia (≤14%)

Renal: Increased serum creatinine (12% to 70%)

Respiratory: Cough (27%), dyspnea (26%), epistaxis (21%), nasopharyngitis (14%), oropharyngeal pain (14%), upper respiratory tract infection (11%)

Miscellaneous: Fever (12% to 22%)

1% to 10%:

Cardiovascular: Cardiac failure (3%), edema (≤10%), venous thromboembolism (4%)

Endocrine & metabolic: Hyperglycemia (grades 3/4: 2%), hyperkalemia (grades 3/4: 2%), hypoglycemia (2% to 10%)

Gastrointestinal: Hemorrhoids (10%), pancreatitis (1%)

Hematologic & oncologic: Leukopenia (grades 3/4: 3%), thrombocytopenia (grades 3/4: 5%)

Respiratory: Flu-like symptoms (5%)

<1%:

Cardiovascular: Torsades de pointes

Hepatic: Hepatic failure

Nervous system: Reversible posterior leukoencephalopathy syndrome

Frequency not defined:

Cardiovascular: Prolonged QT interval on ECG

Endocrine & metabolic: Hyperthyroidism

Gastrointestinal: Gastrointestinal hemorrhage

Genitourinary: Urinary tract hemorrhage

Hematologic & oncologic: Hematoma, hemolytic-uremic syndrome, thrombotic microangiopathy, thrombotic thrombocytopenic purpura, tumor hemorrhage, tumor lysis syndrome

Hepatic: Hepatotoxicity

Nervous system: Cerebral hemorrhage

Neuromuscular & skeletal: Osteonecrosis of the jaw

Respiratory: Respiratory tract hemorrhage

Postmarketing

Cardiovascular: Acute myocardial infarction, aneurysm (arterial), aortic aneurysm, aortic dissection, arterial thrombosis, cardiomyopathy, cerebral infarction, cerebrovascular accident, coronary artery dissection, ischemic heart disease, myocardial rupture (arterial rupture and aortic rupture), pre-eclampsia (like syndrome with proteinuria and reversible hypertension) (Gallucci 2013; Patel 2008), pulmonary embolism, septic shock

Dermatologic: Erythema multiforme, pyoderma gangrenosum (including positive dechallenges), skin infection, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Thyroiditis (Feldt 2012)

Gastrointestinal: Cholecystitis (particularly acalculous), esophagitis, gastrointestinal perforation

Genitourinary: Nephrotic syndrome, proteinuria, urinary tract infection

Hypersensitivity: Angioedema, hypersensitivity reaction

Infection: Necrotizing fasciitis (including of the perineum), sepsis, serious infection

Neuromuscular & skeletal: Myopathy, rhabdomyolysis

Renal: Acute renal failure, renal insufficiency

Respiratory: Pleural effusion, respiratory tract infection

Miscellaneous: Fistula (sometimes associated with tumor necrosis and/or regression), wound healing impairment

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to sunitinib or any component of the formulation; pregnancy

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular events: Cardiovascular events (some fatal), including heart failure, cardiomyopathy, myocardial ischemia, and myocardial infarction (MI) have been reported. A majority of patients with heart failure recovered. Grade 2 ejection fraction decrease has been observed. Patients with cardiac events (MI [including severe/unstable angina], bypass graft, symptomatic heart failure, cerebrovascular accident, transient ischemic attack, and pulmonary embolism) within the previous 12 months were excluded from clinical trials, and patients with prior anthracycline use or cardiac radiation were also excluded from some clinical trials; it is not known if the risk for left ventricular dysfunction is increased in patients with these conditions.

• Dermatologic toxicities: Severe cutaneous adverse reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported (some fatal). Necrotizing fasciitis (with fatalities) has been reported with sunitinib, including perineum necrotizing fasciitis and fasciitis secondary to fistula formation. Sunitinib may cause skin and/or hair depigmentation or discoloration.

• GI complications: Serious and fatal GI complications, including GI perforation, have occurred (rarely) in patients with intra-abdominal malignancies treated with sunitinib.

• Hand-foot skin reaction: Hand-foot skin reaction (HFSR) observed with tyrosine kinase inhibitors (TKIs), including sunitinib, and is distinct from hand-foot syndrome (palmar-plantar erythrodysesthesia) associated with traditional chemotherapy agents; HFSR due to TKIs is localized with defined hyperkeratotic lesions; symptoms include burning, dysesthesia, paresthesia, or tingling on the palms/soles, and generally occur within the first 2 to 4 weeks of treatment; pressure and flexor areas may develop blisters (callus-like), dry/cracked skin, edema, erythema, desquamation, or hyperkeratosis (Appleby 2011).

• Hemorrhage: Hemorrhagic events (some fatal) have been reported with sunitinib. Events (including grades 3 and 4 toxicity) have included GI tract, respiratory tract, tumor, urinary tract, and brain hemorrhages. Epistaxis was the most common hemorrhagic event, while GI hemorrhage was the most common ≥ grade 3 event. Tumor-related hemorrhage has been reported and may occur suddenly. Pulmonary tumor hemorrhage may present as severe or life-threatening hemoptysis or pulmonary hemorrhage; cases of pulmonary hemorrhage with some fatalities have been reported.

• Hepatotoxicity: Hepatotoxicity may be severe and sometimes fatal. Liver failure included jaundice, elevated transaminases, and/or hyperbilirubinemia, in conjunction with encephalopathy, coagulopathy, and/or renal failure. Safety has not been established in patients with ALT or AST >2.5 times ULN (or >5 times ULN and liver metastases).

• Hypertension: Sunitinib may cause hypertension, including grade 3 and 4 hypertension.

• Hypoglycemia: Symptomatic hypoglycemia has been associated with sunitinib; may result in loss of consciousness or require hospitalization. Hypoglycemia occurred infrequently in patients with renal cell cancer (RCC) and gastrointestinal stromal tumors (GIST); however, the incidence is higher (~10%) in patients with pancreatic neuroendocrine tumors (PNET); preexisting glucose homeostasis abnormalities were not always present in patients who experienced hypoglycemia. Blood glucose decreases may be worse in patients with diabetes.

• Osteonecrosis of the jaw: Osteonecrosis of the jaw (ONJ), also referred to as medication-related osteonecrosis of the jaw (MRONJ), has been reported with sunitinib. Concurrent bisphosphonate use or dental disease/invasive dental procedures may increase the risk for ONJ. According to a position paper by the American Association of Maxillofacial Surgeons (AAOMS), MRONJ has been associated with bisphosphonates and other antiresorptive agents (denosumab) and antiangiogenic agents (eg, bevacizumab, sunitinib) used for the treatment of osteoporosis or malignancy. Antiangiogenic agents, when given concomitantly with antiresorptive agents, are associated with an increased risk of ONJ. Other risk factors for MRONJ include dentoalveolar surgery (eg, tooth extraction, dental implants), preexisting inflammatory dental disease, and concomitant corticosteroid use. If possible, avoid invasive dental procedures in patients with current or prior bisphosphonate use (particularly IV bisphosphonate use). The AAOMS suggests that if medically permissible, initiation of antiangiogenic agents for cancer therapy should be delayed until optimal dental health is attained (if extractions are required, antiangiogenesis therapy should delayed until the extraction site has mucosalized or until after adequate osseous healing). Once antiangiogenic therapy for oncologic disease is initiated, procedures that involve direct osseous injury and placement of dental implants should be avoided.

• Proteinuria/nephrotic syndrome: Proteinuria and nephrotic syndrome have been reported; some cases have led to renal failure and fatal outcomes. The safety of continuing treatment with sunitinib in patients with moderate to severe proteinuria has not been evaluated.

• QT prolongation: Sunitinib may cause dose-dependent QT interval prolongation, which may increase the risk for ventricular arrhythmias, including torsades de pointes (which has been observed rarely).

• Reversible posterior leukoencephalopathy syndrome: Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported rarely (some cases were fatal). RPLS may present with altered mental status, decreased alertness, headache, hypertension, and/or visual loss (including blindness). MRI is necessary to confirm RPLS.

• Thyroid disorders: Hyperthyroidism, sometimes followed by hypothyroidism, has been reported with sunitinib.

• Thrombotic microangiopathy: Thrombotic microangiopathy (including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome), sometimes leading to renal failure or fatality, has been reported with sunitinib, both as monotherapy and in combination with bevacizumab. Thrombotic microangiopathy effects may be reversible after sunitinib discontinuation.

• Tumor lysis syndrome: Tumor lysis syndrome (TLS), including fatalities, has been reported, predominantly in patients with RCC or GIST. The risk for TLS is higher in patients with a high tumor burden prior to treatment.

• Wound healing complications: Impaired wound healing has been reported with sunitinib. The safety of resuming sunitinib treatment after resolution of wound healing complications has not been established.

Disease-related concerns:

• Renal insufficiency: An increased incidence of fatigue, thyroid dysfunction, and treatment-induced hypertension was reported in patients with renal insufficiency (CrCl ≤60 mL/minute) who received sunitinib for the treatment of metastatic RCC (Gupta 2011).

Special populations:

• Older adult: Patients ≥65 years of age experienced a higher incidence of grade 3 or 4 adverse reactions (compared to younger patients).

Metabolism/Transport Effects

Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Amisulpride (Oral): May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk C: Monitor therapy

Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Androgens: Hypertension-Associated Agents may enhance the hypertensive effect of Androgens. Risk C: Monitor therapy

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Azithromycin (Systemic): QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of Azithromycin (Systemic). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Bevacizumab: SUNItinib may enhance the adverse/toxic effect of Bevacizumab. Specifically, the risk for a specific form of anemia, microangiopathic hemolytic anemia (MAHA), may be increased. Bevacizumab may enhance the hypertensive effect of SUNItinib. Risk X: Avoid combination

Bisphosphonate Derivatives: Angiogenesis Inhibitors (Systemic) may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CloZAPine: May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of SUNItinib. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of SUNItinib. Management: Avoid when possible. If combined, increase sunitinib dose to a max of 87.5 mg daily when treating GIST or RCC. Increase sunitinib dose to a max of 62.5 mg daily when treating PNET. Monitor patients for both reduced efficacy and increased toxicities. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of SUNItinib. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of SUNItinib. Management: Avoid when possible. If combined, decrease sunitinib dose to a minimum of 37.5 mg daily when treating GIST or RCC. Decrease sunitinib dose to a minimum of 25 mg daily when treating PNET. Monitor patients for both reduced efficacy and increased toxicities. Risk D: Consider therapy modification

Dabrafenib: May enhance the QTc-prolonging effect of SUNItinib. Dabrafenib may decrease the serum concentration of SUNItinib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced sunitinib efficacy. Risk C: Monitor therapy

Domperidone: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Dronedarone: May enhance the QTc-prolonging effect of SUNItinib. Dronedarone may increase the serum concentration of SUNItinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider therapy modification

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fluorouracil Products: May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Haloperidol: QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of Haloperidol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Herbal Products with Glucose Lowering Effects: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Itraconazole: May increase the serum concentration of SUNItinib. Management: Avoid when possible. If combined, decrease sunitinib dose to a minimum of 37.5 mg daily when treating GIST or RCC. Decrease sunitinib dose to a minimum of 25 mg daily when treating PNET. Monitor patients for both reduced efficacy and increased toxicities. Risk D: Consider therapy modification

Lefamulin: May enhance the QTc-prolonging effect of QT-prolonging CYP3A4 Substrates. Management: Do not use lefamulin tablets with QT-prolonging CYP3A4 substrates. Lefamulin prescribing information lists this combination as contraindicated. Risk X: Avoid combination

Levoketoconazole: May enhance the QTc-prolonging effect of SUNItinib. Levoketoconazole may increase the serum concentration of SUNItinib. Risk X: Avoid combination

Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Midostaurin: May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

NiCARdipine: May increase the serum concentration of SUNItinib. Risk C: Monitor therapy

OLANZapine: May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Ondansetron: May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

PAZOPanib: QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of PAZOPanib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Pentamidine (Systemic): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination

Posaconazole: May increase the serum concentration of QT-prolonging CYP3A4 Substrates. Such increases may lead to a greater risk for proarrhythmic effects and other similar toxicities. Risk X: Avoid combination

Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of SUNItinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider therapy modification

QT-prolonging Antidepressants (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Antipsychotics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-Prolonging Inhalational Anesthetics (Moderate Risk): QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of QT-Prolonging Inhalational Anesthetics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Kinase Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of other QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Miscellaneous Agents (Moderate Risk): QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of SUNItinib. QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of SUNItinib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Quinolone Antibiotics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): May enhance the QTc-prolonging effect of SUNItinib. QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk) may increase the serum concentration of SUNItinib. Management: Avoid when possible. If combined, decrease sunitinib dose to a minimum of 37.5 mg daily when treating GIST or RCC. Decrease sunitinib dose to a minimum of 25 mg daily when treating PNET. Monitor patients for both reduced efficacy and increased toxicities. Risk D: Consider therapy modification

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of SUNItinib. QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of SUNItinib. Management: Avoid when possible. If combined, decrease sunitinib dose to a minimum of 37.5 mg daily when treating GIST or RCC. Decrease sunitinib dose to a minimum of 25 mg daily when treating PNET. Monitor patients for both reduced efficacy and increased toxicities. Risk D: Consider therapy modification

Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

RisperiDONE: QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of RisperiDONE. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Saquinavir: May increase the serum concentration of SUNItinib. Risk X: Avoid combination

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Sertindole: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination

Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Risk C: Monitor therapy

St John's Wort: May decrease the serum concentration of SUNItinib. Risk X: Avoid combination

Temsirolimus: May enhance the adverse/toxic effect of SUNItinib. Risk X: Avoid combination

Food Interactions

Grapefruit juice may increase the levels/effects of sunitinib. Management: Avoid grapefruit juice.

Reproductive Considerations

Evaluate pregnancy status prior to treatment initiation in patients who may become pregnant. Patients who may become pregnant should use effective contraception during treatment and for at least 4 weeks after the last sunitinib dose. Patients with partners who may become pregnant should use effective contraception during treatment and for 7 weeks after the last sunitinib dose.

Pregnancy Considerations

Based on data from animal reproduction studies and its mechanism of action, in utero exposure to sunitinib may cause fetal harm. Because sunitinib inhibits angiogenesis, a critical component of fetal development, adverse effects on pregnancy would be expected.

Breastfeeding Considerations

It is not known if sunitinib is present in human milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for at least 4 weeks after the last sunitinib dose.

Dietary Considerations

Avoid grapefruit juice.

Monitoring Parameters

LFTs (baseline, during each cycle, and as clinically indicated), serum chemistries including magnesium, phosphate, calcium, and potassium (prior to each treatment cycle), blood glucose levels (baseline, regularly during treatment, as clinically indicated, and following sunitinib discontinuation), urinalysis for proteinuria (baseline and periodic; follow up with 24-hour urine protein if clinically indicated). Monitor BP at baseline and as clinically indicated. Obtain dental exam prior to treatment initiation and perform preventative dentistry, if indicated. Consider periodic monitoring of ECGs and electrolytes (eg, magnesium, potassium) during sunitinib treatment (monitor QT interval more frequently when administered concomitantly with strong CYP3A4 inhibitors or medications known to prolong the QT interval). Monitor patients who are at higher risk of developing QT interval prolongation, including those with a history of QTc prolongation, patients taking antiarrhythmics, or who have preexisting (relevant) cardiac disease, bradycardia, or electrolyte imbalance. Serial CBC and physical exam as clinically necessary for hemorrhage. Consider left ventricular ejection fraction evaluation at baseline and periodically as indicated. Evaluate pregnancy status prior to treatment in patients who may become pregnant. Monitor for signs/symptoms of bleeding/hemorrhage, heart failure, hypoglycemia, severe cutaneous adverse reactions, hand-foot skin reaction, GI complications (eg, perforation), reversible posterior leukoencephalopathy syndrome (confirm with MRI), thrombotic microangiopathy, thyroid disorders (hypothyroidism, hyperthyroidism, or thyroiditis), tumor lysis syndrome, and/or wound healing complications. Assess patients for good oral hygiene practices. Monitor adherence.

Thyroid function testing: Monitor thyroid function at baseline, periodically during treatment, and as clinically indicated. Patients not receiving thyroid hormone replacement therapy at sunitinib initiation should be monitored (thyroid-stimulating hormone [TSH]) every 4 weeks for 4 months and then every 2 to 3 months; those patients already receiving levothyroxine prior to initiating sunitinib should have TSH monitored every 4 weeks until levels and levothyroxine dose are stable, then monitor every 2 months (Hamnvik 2011).

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Sunitinib exhibits antitumor and antiangiogenic properties by inhibiting multiple receptor tyrosine kinases, including platelet-derived growth factors (PDGFRα and PDGFRβ), vascular endothelial growth factors (VEGFR1, VEGFR2, and VEGFR3), FMS-like tyrosine kinase-3 (FLT3), colony-stimulating factor type 1 (CSF-1R), and glial cell-line-derived neurotrophic factor receptor (RET).

Pharmacokinetics

Distribution: Vd/F: 2,230 L.

Protein binding: Sunitinib: 95%; SU12662: 90%.

Metabolism: Hepatic; primarily metabolized by CYP3A4 to the primary active metabolite, SU12662.

Half-life elimination: Terminal: Sunitinib: 40 to 60 hours; SU12662: 80 to 110 hours.

Time to peak, plasma: 6 to 12 hours.

Excretion: Feces (~61%); urine (16%).

Clearance: 34 to 62 L/hour.

Pharmacokinetics: Additional Considerations

Altered kidney function: Although sunitinib is not eliminated through hemodialysis, sunitinib systemic exposure was 47% lower in patients with end-stage renal disease on hemodialysis compared to patients with normal renal function.

Pricing: US

Capsules (SUNItinib Malate Oral)

12.5 mg (per each): $217.47 - $230.39

25 mg (per each): $434.95 - $460.78

37.5 mg (per each): $652.42 - $691.17

50 mg (per each): $757.18 - $802.15

Capsules (Sutent Oral)

12.5 mg (per each): $255.85

25 mg (per each): $511.70

37.5 mg (per each): $767.56

50 mg (per each): $890.81

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Alsuni (TW);
  • Sunitix (BD);
  • Sutene (KR);
  • Sutent (AE, AR, AT, AU, BB, BE, BG, BH, BR, BZ, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IS, IT, JO, JP, KW, LB, LK, LT, LU, LV, MT, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, UY, VE, VN)


For country code abbreviations (show table)
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  29. Sutent (sunitinib) [prescribing information]. New York, NY: Pfizer Labs; August 2021.
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