• Prescribing Information, including BOXED WARNING
  • Indications
  • Medical Information
  • Efficacy
    Adjuvant treatment
    of RCC
    ​​​​​​​ Imatinib-resistant or
    -intolerant GIST

    Support and Financial Assistance

    Pfizer Oncology Together™

    Making your patients’ support needs a priority. Together.

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    ​​​​​​​At Pfizer Oncology Together™, patient support is at the core of everything we do. We’ve gathered resources and developed tools to help patients and their loved ones throughout SUTENT treatment. From helping to identify financial assistance options to connecting patients to resources for emotional support, your patients’ needs are our priority.

    Visit PfizerOncology Together.com

    Patient financial assistance

    ​​​​​​​Pfizer Oncology Together can help patients understand their insurance benefits and connect them with financial assistance.

    Commercially insured

    ​​​​​​​Resources are available for eligible patients with commercial, private, employer, and state health insurance marketplace coverage.

    Co-pay assistance

    Eligible, commercially insured patients may pay as little as $0 per month for SUTENT. Limits, terms, and conditions apply.*

    Get the card now

    *Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico. Patients may receive up to $25,000 in savings annually. The offer will be accepted only at participating pharmacies. This offer is not health insurance. No membership fees apply. Pfizer reserves the right to rescind, revoke, or amend this offer without notice. For any questions, please call 1-877-744-5675, visit PfizerOncologyTogether.com/terms or write: Pfizer Oncology Together Co-Pay Savings Program, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. For full Terms and Conditions, please see PfizerOncologyTogether.com/terms.

    Medicare/Government insured

    Help identifying resources for eligible patients with Medicare/Medicare Part D, Medicaid, and other government insurance plans:

    • Assistance for patients with searching for financial support that may be available from independent charitable foundations. These foundations exist independently of Pfizer and have their own eligibility criteria and application processes. Availability of support from the foundations is determined solely by the foundations 
    • Financial assistance through Extra Help, a Medicare Part D Low-Income Subsidy (LIS) program 
    • Free medication

    Uninsured

    Help identifying resources for eligible patients without any form of healthcare coverage:

    • Help finding coverage 
    • Free medication through the Pfizer Patient Assistance Program, or at a savings through the Pfizer Savings Program 

    If support from independent charitable foundations or Medicare Extra Help is not available, Pfizer Oncology Together will provide eligible patients with medication for free through the Pfizer Patient Assistance Program. The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions.

    The Pfizer Savings Program is not health insurance. For more information, call the toll-free number 1-877-744-5675. There are no membership fees to participate in this program. Estimated savings are 50% and depend on such factors as the particular drug purchased, amount purchased, and the pharmacy where purchased.
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    Access & reimbursement support 

    If patients prescribed SUTENT need access or reimbursement support, Pfizer Oncology Together is here to help with:

    Benefits verification

    We can help determine a patient’s coverage and out-of-pocket costs.

    ​​​​​​​PA assistance

    ​​​​​​​We can coordinate with a patient’s insurer to determine the PA requirements. After your office submits a PA request, we’ll follow up with the payer until a final outcome is determined.

    Appeals assistance

    ​​​​​​​​​​​​​​We can review the reasons for a denied claim and provide information on payer requirements. After your office submits an appeal, we’ll follow up with the payer until a final outcome is determined.

    Specialty pharmacy coordination

    To help your patients access the medication you’ve prescribed, we can identify specialty pharmacy options. If you prefer, you and your staff can also continue to work directly with specialty pharmacies.

    Dedicated local support

    Pfizer Oncology Account Specialists can provide detailed information on Pfizer Oncology medications and access resources. In addition, they can help you and your office staff contact a Pfizer Field Reimbursement Manager (FRM) in your area.

    FRMs are trained to help address specific access issues—in person or over the phone. They can help educate your staff on our access and reimbursement resources and help address challenging or urgent Pfizer Oncology patient cases you have sent to Pfizer Oncology Together.

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    Personalized patient support

    When your patients need support for their day-to-day challenges, we want to be a place they can turn to for help. At Pfizer Oncology Together, our Care Champions, who have social work experience, can connect patients prescribed SUTENT to resources that may help with some of their daily needs.*

    Emotional support 

    ​​​​​​​We can connect patients to diagnosis-specific support groups, an independent organization that offers short-term counseling, and a free app, developed by Pfizer Oncology, to help patients connect with loved ones and ask for the support they need.

    Educational support

    ​​​​​​​To help support patients’ overall health and well-being, we’ve created resources about physical and mental health, as well as nutritional tips and healthy recipes developed in partnership with dietitians who specialize in oncology nutrition. We can also provide patients with information to help them understand their prescribed SUTENT. 

    Practical support 

    If patients need assistance with transportation or lodging for treatment-related appointments, we’ll connect them to independent organizations that offer these services for free to qualifying patients.

    And if your patients are leaving work for a period of time during treatment, or preparing to return to work, we can send them information to help make the transition easier.

     

    DAW=dispense as written; FRM=Field Reimbursement Manager; PA=prior authorization; RCC=renal cell carcinoma.
    ​​​​​​​*Some services are provided through third-party organizations that operate independently and are not controlled by Pfizer. Availability of services and eligibility requirements are determined solely by these organizations.

     Terms and Conditions for the Pfizer Oncology Together Co-Pay Savings Plan ​​​​​​​

    By using this co-pay card, you acknowledge that you currently meet the eligibility criteria and will comply with the Terms and Conditions described below: ​​​​​​​

    • Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”). 
    • Patient must have private insurance. Offer is not valid for cash-paying patients.
    • With this card, eligible patients will pay a $0 co-pay per eligible monthly prescription, subject to a maximum amount of $25,000 per product per calendar year. The amount of any benefit is the difference between your co-pay and $0. After the annual maximum of $25,000 per product is reached, you will be responsible for the remaining monthly out-of-pocket costs. This card may not be redeemed more than once per 30 days. 
    • This co-pay card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs. 
    • You must deduct the value of this co-pay card from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
    • You are responsible for reporting use of the co-pay card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the co-pay card or which the patient receives a rebate, as may be required. You should not use the co-pay card if your private insurer or health plan prohibits use of manufacturer coupons, co-pay cards, debit cards or similar savings programs.
    • You must be 18 years of age or older to redeem the co-pay card under this program.
    • This co-pay card is not valid where prohibited by law. 
    • This card cannot be combined with any other savings, free trial, or similar offer for the specified prescription. 
    • Card will be accepted only at participating pharmacies. 
    • This card is not health insurance. 
    • Offer good only in the U.S. and Puerto Rico. 
    • For SUTENT patients, this copay card is not valid for Massachusetts or California residents whose prescriptions are covered in whole or in part by third party insurance.
    • Card is limited to 1 per person during this offering period and is not transferable. 
    • No other purchase is necessary. 
    • Data related to your redemption of the co-pay card may be collected, analyzed, and shared with Pfizer for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other co-pay card redemptions and will not identify you. 
    • Pfizer reserves the right to rescind, revoke, or amend this offer without notice. 
    • Offer expires 12/31/2023. 
    • If your pharmacy does not participate in the co-pay program, you may be able to submit a request for a rebate in connection with this offer:  
      ​​​​​​​
      • ​​​​​​​​​​​​​​Mail a copy of the patient’s original pharmacy receipt indicating patient name, name of medication purchased, price paid, and date purchased, accompanying your prescription, as proof of purchase, along with a copy of the patient’s Pfizer Oncology Together Co-Pay Savings Card, to: Pfizer Oncology Together Co-Pay Savings Program, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560.  Receipt will not be returned.  ​​​​​​​
      • ​​​​​​​The patient will receive a maximum of $25,000 per product per calendar year or the amount of the co-pay paid, whichever is less.
      • ​​​​​​​Rebate will be mailed to patients approximately 6 to 8 weeks after receipt of required documentation or earlier, as required by law.

    Prevent generic substitution by including Dispense As Written (DAW), Brand Medically Necessary, or No Substitutions on your prescription. See your state's requirements.

    Boxed Warning/Hepatotoxicity: Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended. Fatal liver failure has been observed. Monitor liver function tests at baseline, during each cycle, and as clinically indicated. Interrupt SUTENT for Grade 3 or 4 hepatotoxicity until resolution; discontinue if no resolution. Discontinue SUTENT for subsequent severe changes in liver function tests or other signs and symptoms of liver failure. Safety in patients with ALT or AST >2.5 x upper limit of normal (ULN) or with >5 x ULN and liver metastases has not been established.

    Cardiovascular events: Myocardial ischemia, myocardial infarction, heart failure, cardiomyopathy, and decreased left ventricular ejection fraction (LVEF) to below the lower limit of normal, including death, have occurred. Monitor for signs and symptoms of congestive heart failure and consider monitoring LVEF at baseline and periodically during treatment, as clinically indicated. Discontinue SUTENT for clinical manifestations of congestive heart failure. Interrupt and/or dose reduce for decreased LVEF.

    SUTENT can cause QT interval prolongation in a dose-dependent manner, which may lead to an increased risk for ventricular arrhythmias including Torsades de Pointes. Monitor patients at higher risk of developing QT interval prolongation, including patients with a history of QT interval prolongation, patients who are taking antiarrhythmics, and patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. Consider periodic monitoring of electrocardiograms and electrolytes during treatment with SUTENT. Monitor QT interval more frequently when SUTENT is concomitantly administered with strong CYP3A4 inhibitors or drugs known to prolong QT interval. Consider dose reducing SUTENT.

    Hypertension may occur. Monitor blood pressure at baseline and as clinically indicated. Initiate and/or adjust antihypertensive therapy as appropriate. In cases of hypertension, withhold SUTENT until hypertension is controlled.

    Hemorrhagic events, including tumor-related hemorrhage and viscus perforation (both with fatal events) have occurred. Hemorrhagic events have involved the gastrointestinal tract, respiratory tract, tumor, urinary tract, and brain. These events may occur suddenly, and in the case of pulmonary tumors may present as severe and life-threatening hemoptysis or pulmonary hemorrhage. Perform serial complete blood counts (CBCs) and physical examinations with the clinical assessment of hemorrhagic events.

    Tumor lysis syndrome (TLS) (some fatal) has been reported. Patients generally at risk of TLS are those with high tumor burden prior to treatment. Monitor these patients and treat as clinically indicated.

    Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, sometimes leading to renal failure or a fatal outcome, has been reported in patients who received SUTENT. Discontinue SUTENT for TMA. Reversal of the effects of TMA has been observed after treatment was discontinued.

    Proteinuria and nephrotic syndrome have been reported. Some of these cases have resulted in renal failure and fatal outcomes. Monitor patients for the development or worsening of proteinuria. Perform baseline and periodic urinalysis during treatment, with follow-up measurement of 24-hour urine protein as clinically indicated. Interrupt treatment for 24-hour urine protein of 3 or more grams. Discontinue for repeat episodes of 24-hour urine protein of 3 or more grams despite dose reductions or nephrotic syndrome.

    Dermatologic toxicities: Severe cutaneous reactions have been reported, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), some of which were fatal. Necrotizing fasciitis, including fatal cases, has been reported, including of the perineum and secondary to fistula formation. Permanently discontinue SUTENT for these severe cutaneous adverse reactions.

    Reversible Posterior Leukoencephalopathy Syndrome (RPLS) (some fatal) has been reported. Monitor for signs and symptoms of RPLS. Patients can present with hypertension, headache, decreased alertness, altered mental functioning, and visual loss, including cortical blindness. Withhold SUTENT until resolution. The safety of reinitiating SUTENT in patients with RPLS is unknown.

    Thyroid dysfunction may occur. Monitor thyroid function at baseline, periodically during treatment, and as clinically indicated. Monitor patients closely for signs and/or symptoms of thyroid dysfunction, including hypothyroidism, hyperthyroidism, and thyroiditis during treatment with SUTENT. Initiate and/or adjust therapy for thyroid dysfunction as appropriate.

    Hypoglycemia may occur. SUTENT can result in symptomatic hypoglycemia, which may lead to a loss of consciousness or require hospitalization. Reductions in blood glucose levels may be worse in patients with diabetes. Check blood glucose levels at baseline, regularly during treatment, as clinically indicated, and after discontinuation of SUTENT. In patients with diabetes, assess if antidiabetic drug dosage needs to be adjusted to minimize the risk of hypoglycemia.

    Osteonecrosis of the Jaw (ONJ) occurred in patients treated with SUTENT. Concomitant exposure to other risk factors, such as bisphosphonates or dental disease/invasive dental procedures, may increase the risk of ONJ. Perform an oral examination prior to initiation of SUTENT and periodically during SUTENT therapy. Advise patients regarding good oral hygiene practices. Withhold SUTENT treatment for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold SUTENT for development of ONJ until complete resolution.

    Impaired wound healing has been reported in patients who received SUTENT. Withhold SUTENT for at least 3 weeks prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of SUTENT after resolution of wound healing complications has not been established.

    Embryofetal toxicity and reproductive potential
    Females: SUTENT can cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with SUTENT and for 4 weeks following the final dose.
    Males: Based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with SUTENT and for 7 weeks after the last dose.
    Male and female infertility: Based on findings in animals, male and female fertility may be compromised by treatment with SUTENT.

    Lactation: Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with SUTENT and for at least 4 weeks after the last dose.

    Venous thromboembolic events: In pooled safety population, 3.5% of patients experienced a venous thromboembolic event, including Grade 3-4 in 2.2% of patients.

    Pancreatic function: Pancreatitis was observed in 5 patients (1%) receiving SUTENT for treatment-naïve RCC compared to 1 patient (<1%) receiving interferon alfa. In a trial of patients receiving adjuvant treatment for RCC, 1 patient (<1%) on SUTENT and none on placebo experienced pancreatitis. Pancreatitis was observed in 1 patient (1%) receiving SUTENT for pNET and 1 patient (1%) receiving placebo.

    CYP3A4 Inhibitors and Inducers: Dose adjustments are recommended when SUTENT is administered with CYP3A4 inhibitors or inducers. During treatment with SUTENT, patients should not drink grapefruit juice, eat grapefruit, or take St. John’s Wort.

    Most common ARs & most common grade 3/4 ARs (advanced RCC): The most common ARs reported in ≥20% of patients receiving SUTENT for treatment-naïve metastatic RCC (all grades, vs interferon alfa) were diarrhea (66% vs 21%), fatigue (62% vs 56%), nausea (58% vs 41%), anorexia (48% vs 42%), altered taste (47% vs 15%), mucositis/stomatitis (47% vs 5%), pain in extremity/limb discomfort (40% vs 30%), vomiting (39% vs 17%), bleeding, all sites (37% vs 10%), hypertension (34% vs 4%), dyspepsia (34% vs 4%), arthralgia (30% vs 19%), abdominal pain (30% vs 12%), rash (29% vs 11%), hand-foot syndrome (29% vs 1%), back pain (28% vs 14%), cough (27% vs 14%), asthenia (26% vs 22%), dyspnea (26% vs 20%), skin discoloration/yellow skin (25% vs 0%), peripheral edema (24% vs 5%), headache (23% vs 19%), constipation (23% vs 14%), dry skin (23% vs 7%), fever (22% vs 37%), and hair color changes (20% vs <1%). The most common grade 3/4 ARs reported in ≥5% of patients with RCC receiving SUTENT (vs interferon alfa) were fatigue (15% vs 15%), hypertension (13% vs <1%), asthenia (11% vs 6%), diarrhea (10% vs <1%), hand-foot syndrome (8% vs 0%), dyspnea (6% vs 4%), nausea (6% vs 2%), back pain (5% vs 2%), pain in extremity/limb discomfort (5% vs 2%), vomiting (5% vs 1%), and abdominal pain (5% vs 1%).

    Most common grade 3/4 lab abnormalities (advanced RCC): The most common grade 3/4 lab abnormalities (occurring in ≥5% of patients with RCC receiving SUTENT vs Interferon alfa) included lymphocytes (18% vs 26%), lipase (18% vs 8%), neutrophils (17% vs 9%), uric acid (14% vs 8%), platelets (9% vs 1%), hemoglobin (8% vs 5%), sodium decreased (8% vs 4%), glucose increased (6% vs 6%), phosphorus (6% vs 6%), and amylase (6% vs 3%).

    Most common ARs & most common grade 3/4 ARs (adjuvant RCC): The most common ARs reported in ≥20% of patients receiving SUTENT for adjuvant treatment of RCC and more commonly than in patients given placebo (all grades, vs placebo) were mucositis/stomatitis (61% vs 15%), diarrhea (57% vs 22%), fatigue/asthenia (57% vs 34%), hand-foot syndrome (50% vs 10%), hypertension (39% vs 14%), altered taste (38% vs 6%), nausea (34% vs 15%), dyspepsia (27% vs 7%), abdominal pain (25% vs 9%), hypothyroidism/TSH increased (24% vs 4%), rash (24% vs 12%), bleeding events, all sites (24% vs 5%), and hair color changes (22% vs 2%). The most common grade 3/4 ARs reported in ≥5% of patients receiving SUTENT for adjuvant treatment of RCC and more commonly than in patients given placebo (vs placebo) were hand-foot syndrome (16% vs <1%), fatigue/asthenia (8% vs 2%), hypertension (8% vs 1%), and mucositis/stomatitis (6% vs 0%).

    Most common grade 3/4 lab abnormalities (adjuvant RCC): The most common grade 3/4 lab abnormalities (occurring in ≥2% of patients receiving SUTENT) included neutropenia (13%), thrombocytopenia (5%), leukopenia (3%), lymphopenia (3%), elevated alanine aminotransferase (2%), elevated aspartate aminotransferase (2%), hyperglycemia (2%), and hyperkalemia (2%).

    Most common ARs & most common grade 3/4 ARs (imatinib-resistant or ‑intolerant GIST): The most common ARs reported in ≥20% of patients with GIST and more commonly with SUTENT than placebo (all grades, vs placebo) were diarrhea (40% vs 27%), anorexia (33% vs 29%), skin discoloration (30% vs 23%), mucositis/stomatitis (29% vs 18%), asthenia (22% vs 11%), altered taste (21% vs 12%), and constipation (20% vs 14%). The most common grade 3/4 ARs reported in ≥4% of patients with GIST receiving SUTENT (vs placebo) were asthenia (5% vs 3%), hand-foot syndrome (4% vs 3%), diarrhea (4% vs 0%), and hypertension (4% vs 0%).

    Most common grade 3/4 lab abnormalities (imatinib-resistant or ‑intolerant GIST): The most common grade 3/4 lab abnormalities (occurring in ≥5% of patients with GIST receiving SUTENT vs placebo) included lipase (10% vs 7%), neutrophils (10% vs 0%), amylase (5% vs 3%), and platelets (5% vs 0%).

    Most common ARs & most common grade 3/4 ARs (advanced pNET): The most common ARs reported in ≥20% of patients with advanced pNET and more commonly with SUTENT than placebo (all grades, vs placebo) were diarrhea (59% vs 39%), stomatitis/oral syndromes (48% vs 18%), nausea (45% vs 29%), abdominal pain (39% vs 34%), vomiting (34% vs 31%), asthenia (34% vs 27%), fatigue (33% vs 27%), hair color changes (29% vs 1%), hypertension (27% vs 5%), hand-foot syndrome (23% vs 2%), bleeding events (22% vs 10%), epistaxis (21% vs 5%), and dysgeusia (21% vs 5%). The most common grade 3/4 ARs reported in ≥5% of patients with advanced pNET receiving SUTENT (vs placebo) were hypertension (10% vs 1%), hand-foot syndrome (6% vs 0%), stomatitis/oral syndromes (6% vs 0%), abdominal pain (5% vs 10%), fatigue (5% vs 9%), asthenia (5% vs 4%), and diarrhea (5% vs 2%).

    Most common grade 3/4 lab abnormalities (advanced pNET): The most common grade 3/4 lab abnormalities (occurring in ≥5% of patients with advanced pNET receiving SUTENT vs placebo) included decreased neutrophils (16% vs 0%), increased glucose (12% vs 18%), increased alkaline phosphatase (10% vs 11%), decreased phosphorus (7% vs 5%), decreased lymphocytes (7% vs 4%), increased creatinine (5% vs 5%), increased lipase (5% vs 4%), increased AST (5% vs 3%), and decreased platelets (5% vs 0%).

    SUTENT® (sunitinib malate) is indicated for:

    • the treatment of adult patients with advanced renal cell carcinoma (RCC)
    • the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy
    • the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate
    • the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease

    Indications 

    SUTENT® (sunitinib malate) is indicated for:

          •     the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate

          •     the treatment of adult patients with advanced renal cell carcinoma (RCC)

          •     the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy

          •     the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease