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HomeFirst-line Advanced RCCFirst-line Advanced RCCOverviewEfficacy Measures: OS, PFS, & ORRSafety & Tolerability ProfileDosingTherapy Management StrategiesMOAs – INLYTA and pembrolizumabNCCN Recommendation  PublicationsHealthcare Professional VideosProfessional ResourcesSecond-line Advanced RCCSecond-line Advanced RCCOverviewEfficacy Measures: PFS, ORR, OS, & Subset AnalysesSafety & Tolerability ProfilePatient Characteristics & Treatment ConsiderationsOral DosingVEGFR Pathway & INLYTA® (axitinib) MOANCCN Recommendation  Patient Support and ResourcesPatient Support and ResourcesPfizer Oncology TogetherEventsMaterials
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Patient Financial Support & ResourcesPersonalized Support to Help Your Patients Access Their Prescribed Medications

At Pfizer Oncology Together™, we know how important it is that patients have access to their prescribed INLYTA® (axitinib) treatment. We’re here to help identify financial assistance options based on your patients’ insurance coverage. We offer support based on your patients’ needs—from access and reimbursement assistance to educational resources that may help them navigate the insurance process. When it comes to support, we’re in this together.

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Patient Financial Assistance

Pfizer Oncology Together can help patients understand their insurance benefits and connect them with financial assistance resources (if needed), regardless of their insurance coverage.

Employer-Sponsored Insurance

Resources for eligible patients with commercial, private, employer, or state health insurance marketplace coverage:

  • Co-pay assistance: Eligible, commercially insured patients may pay as little as $0 per month for their Pfizer Oncology treatment. Limits, terms, and conditions apply.* Patients may receive up to $10,000 per product in savings annually
ReferencesPatients 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.

Medicare/Government Insured

Help identifying resources for eligible patients with Medicare/Medicare Part D, Medicaid, or other government insurance plans who express a financial need:

  • We can assist patients with searching for financial support from alternate funding resources, which may include financial assistance through Extra Help, a Medicare Part D Low-Income Subsidy (LIS) program
  • If support from alternate funding resources or Medicare Extra Help is not available, Pfizer Oncology Together will see if your patient is eligible for the Pfizer Patient Assistance Program,† which can provide prescribed Pfizer Oncology medications for free

Medicare/Government insured
Help identifying resources for patients with Medicare/Medicare Part D, Medicaid, or other government insurance plans who express a financial need:

  • We can assist patients with searching for financial support from alternate funding resources, which may include financial assistance through Extra Help, a Medicare Part D Low-Income Subsidy (LIS) program
  • If support from alternate funding resources or Medicare Extra Help is not available, Pfizer Oncology Together will see if your patient is eligible for the Pfizer Patient Assistance Program,† which can provide prescribed Pfizer Oncology medications for free

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

  • We can check patient eligibility for Medicaid and help them understand how to apply
  • Patients who do not qualify for Medicaid may receive free medication through the Pfizer Patient Assistance Program.† Patients must be eligible and reapply as needed
ReferencesThe Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. Free medicines from Pfizer are provided through the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation™ is a separate legal entity from Pfizer Inc. with distinct legal restrictions.The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. Free medicines from Pfizer are provided through the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation™ is a separate legal entity from Pfizer Inc. with distinct legal restrictions.*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.
Access & Reimbursement Assistance

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

  • Benefits verification: We can help determine a patient’s coverage and out-of-pocket costs
  • Prior authorization (PA) assistance: We can coordinate with a patient’s insurer to determine the PA requirements. After your office submits a PA request, we can 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 can 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
  • Billing and coding assistance: For your patient claim submissions, we provide easy access to sample forms and template letters, along with billing and coding information for physicians’ offices and hospital outpatient settings of care
  • 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 Oncology Field Reimbursement Manager (FRM) in your area
  • Field Reimbursement Managers (FRMs): FRMs can help address specific access
    issues—in person or over the phone. They can help educate your staff on access and reimbursement resources and help address challenging or urgent Pfizer Oncology patient cases you have sent to Pfizer Oncology Together
Free Trial Voucher

Free 1-month (30-day) trial is available for new patients

  • To get patients started with a trial voucher, call 1-877-744-5675 or speak with your local INLYTA representative*
  • To obtain free samples, speak with your local INLYTA representative†

Voucher eligibility criteria
This 1-month (30-day) voucher is not a prescription for INLYTA.

To continue a patient on therapy, a separate prescription must be written to be filled at a participating pharmacy.

Limits, terms, and conditions apply. Please see above.Available at twice daily doses of 2 mg, 3 mg, 5 mg, 7 mg, and 10 mg.
Patient Support and Resources

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

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PP-MCL-USA-0367
INDICATIONSINLYTA® (axitinib) in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.
Important Safety Information

Hypertension including hypertensive crisis has been observed. Ensure that blood pressure is well controlled prior to initiating INLYTA. Monitor for hypertension and treat as needed. Withhold and then dose reduce INLYTA or permanently discontinue based on severity of hypertension.

Arterial and venous thrombotic events have been observed and can be fatal. Use with caution in patients who are at increased risk for, or who have a history of, these events. Permanently discontinue INLYTA if an arterial thromboembolic event occurs during treatment. Monitor for signs and symptoms of VTE and pulmonary embolism. Withhold INLYTA and then resume at same dose or permanently discontinue based on severity of VTE.

Hemorrhagic events, including fatal events, have been reported. INLYTA has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. Withhold and then dose reduce INLYTA or discontinue based on severity and persistence of hemorrhage.

Cardiac failure has been observed and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with INLYTA. Management of cardiac failure may require dose reduction, dose interruption or permanent discontinuation of INLYTA.

Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula. Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment.

Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiation of, and periodically throughout, treatment.

INLYTA has the potential to adversely affect wound healing. Withhold INLYTA for at least 2 days prior to elective surgery. Do not administer INLYTA for at least 2 weeks following major surgery and until adequate wound healing. Resume INLYTA at a reduced dose or discontinue based on severity and persistence of the impaired wound healing. The safety of resuming INLYTA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed. If signs or symptoms occur, permanently discontinue INLYTA.

Proteinuria has been observed. Monitor for proteinuria before initiation of, and periodically throughout, treatment. For moderate to severe proteinuria, withhold and then dose reduce INLYTA.

Liver enzyme elevation has occurred during treatment with INLYTA as a single agent. INLYTA in combination with pembrolizumab can cause hepatotoxicity with higher than expected frequencies of Grades 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Monitor ALT, AST, and bilirubin before initiation of, and periodically throughout, treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. Withhold INLYTA and/or pembrolizumab, initiate corticosteroid therapy as needed, and/or permanently discontinue the combination for severe or life-threatening hepatotoxicity.

For patients with moderate hepatic impairment, the starting dose of INLYTA should be decreased. INLYTA has not been studied in patients with severe hepatic impairment.

INLYTA can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception. When INLYTA is used in combination with pembrolizumab, refer to the full Prescribing Information of pembrolizumab for pregnancy and contraception information.

Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose of INLYTA. Grapefruit or grapefruit juice may also increase INLYTA plasma concentrations and should be avoided.

Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate CYP3A4/5 inducers.

Fatal adverse reactions (ARs) occurred in 3.3% of patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC. These included 3 cases of cardiac arrest, 2 cases of pulmonary embolism, and 1 case each of cardiac failure, death due to unknown cause, myasthenia gravis, myocarditis, Fournier’s gangrene, plasma cell myeloma, pleural effusion, pneumonitis, and respiratory failure.

The most common (≥20%) ARs (all grades, vs sunitinib) occurring in patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC were diarrhea (56% vs 45%), fatigue/asthenia (52% vs 51%), hypertension (48% vs 48%), hepatotoxicity (39% vs 25%), hypothyroidism (35% vs 32%), decreased appetite (30% vs 29%), palmar-plantar erythrodysesthesia (28% vs 40%), nausea (28% vs 32%), stomatitis/mucosal inflammation (27% vs 41%), dysphonia (25% vs 3.3%), rash (25% vs 21%), cough (21% vs 14%), and constipation (21% vs 15%).

The most common (≥20%) Grade 3/4 ARs (vs sunitinib) occurring in patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC were hypertension (24% vs 20%) and hepatotoxicity (20% vs 4.9%).

The most common (≥20%) lab abnormalities (all grades, vs sunitinib) occurring in patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC included hyperglycemia (62% vs 54%), increased ALT (60% vs 44%), increased AST (57% vs 56%), increased creatinine (43% vs 40%), hyponatremia (35% vs 29%), hyperkalemia (34% vs 22%), hypoalbuminemia (32% vs 34%), hypercalcemia (27% vs 15%), hypophosphatemia (26% vs 49%), increased alkaline phosphatase (26% vs 30%), hypocalcemia (22% vs 29%), increased blood bilirubin (22% vs 21%), prolonged activated partial thromboplastin time (22% vs 14%), lymphopenia (33% vs 46%), anemia (29% vs 65%), and thrombocytopenia (27% vs 78%).

The most common (≥20%) ARs (all grades, vs sorafenib) in patients receiving INLYTA as second-line treatment for advanced RCC were diarrhea (55% vs 53%), hypertension (40% vs 29%), fatigue (39% vs 32%), decreased appetite (34% vs 29%), nausea (32% vs 22%), dysphonia (31% vs 14%), palmar-plantar erythrodysesthesia syndrome (27% vs 51%), weight decreased (25% vs 21%), vomiting (24% vs 17%), asthenia (21% vs 14%), and constipation (20% vs 20%).

The most common (≥10%) Grade 3/4 ARs (vs sorafenib) occurring in patients receiving INLYTA as second-line treatment for advanced RCC were hypertension (16% vs 11%), diarrhea (11% vs 7%), and fatigue (11% vs 5%).

The most common (≥20%) lab abnormalities (all grades, vs sorafenib) occurring in patients receiving INLYTA as second-line treatment for advanced RCC included increased creatinine (55% vs 41%), decreased bicarbonate (44% vs 43%), hypocalcemia (39% vs 59%), decreased hemoglobin (35% vs 52%), decreased lymphocytes (absolute) (33% vs 36%), increased ALP (30% vs 34%), hyperglycemia (28% vs 23%), increased lipase (27% vs 46%), increased amylase (25% vs 33%), increased ALT (22% vs 22%), and increased AST (20% vs 25%).

IndicationS

INLYTA® (axitinib) in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.

Please see full Prescribing Information for INLYTA.