• Prescribing Information
  • Patient Site
  • Medical Information
  • xalkori (crizotinib) logo
    xalkori (crizotinib) logo

    Pfizer Pledge Warranty Program

    For patients starting XALKORI® (crizotinib)

    xalkori (crizotinib) recommended dose​​​​​​​

    Pfizer stands by its commitment to patients

    As part of its commitment, Pfizer is proud to offer the Pfizer Pledge Warranty Program for XALKORI (the “Program”).* With the Program, eligible patients can get their out-of-pocket costs for XALKORI refunded. See below for requirements. The Pfizer Pledge Warranty Program is available to cash, commercial (those with employer-sponsored or private insurance), and Medicare Part D patients who discontinue XALKORI before the fourth 30-day supply is dispensed.

    *Terms and Conditions apply.

    Who is eligible for the Pfizer Pledge Warranty Program for XALKORI?

    Your patient is eligible if:

    • You prescribed XALKORI for him or her for an FDA-approved indication
    • He or she has commercial or Medicare Part D insurance, or paid cash for XALKORI
    • He or she used XALKORI according to the instructions you provided 
    • Due to a clinical decision to discontinue, your patient stopped taking XALKORI before the 4th bottle was dispensed
    • You have provided a signed Physician Attestation Form noting the clinical rationale for discontinuation
    ​​​​​​​Please refer to the Terms and Conditions to learn more.

    How does the Pfizer Pledge Warranty Program for XALKORI work?

    The Pfizer Pledge Warranty Program for XALKORI will refund eligible patients’ out-of-pocket costs as follows:

    Cash, commercial, or Medicare Part D patients are eligible for the warranty if they receive their first dispense of XALKORI during the period of June 1, 2021, through December 31, 2021.

    If the patient discontinues XALKORI for clinical reasons defined at your discretion before the pharmacy dispenses the fourth bottle (30-day supply) of XALKORI, the patient becomes eligible for a warranty claim payment.

    The patient can start the reimbursement process by downloading the Patient Warranty Claim Form and Patient Declarations and Authorizations Form or by calling 1-866-330-7902. The call center is open Monday-Friday, 7 AM-7 PM CT. The call center representative can walk the patient through the forms and provide instructions on how to complete them. If needed, someone who speaks the patient’s language may be able to help. The completed forms, together with the patient’s receipts for out-of-pocket costs for XALKORI, can be mailed, emailed, or sent by fax.

    You (the healthcare provider) complete the Physician Attestation Form and submit it with your patient’s consent. You may also give the signed form to your patient to submit.

    When the information provided is validated, the Program will reimburse the patient for what he or she paid out of pocket for XALKORI up to the first three 30-day supply bottles.

    Personal information will be kept confidential and will not be shared with anyone outside of the Program.

    What can your patient do in advance to prepare?

    If the first 30-day supply of XALKORI is dispensed on or after June 1, 2021, and the patient discontinues therapy before the fourth refill is dispensed, he or she may be eligible to receive a warranty payment. Following these 2 easy steps when purchasing XALKORI will make the process easier should your patient need to file a warranty claim:

    The patient should keep or use a smartphone to take photos of the first 3 pharmacy receipts to document what he or she paid for XALKORI.

    The patient should use a smartphone to take photos of the first 3 pill bottle labels for XALKORI to document the prescribing details.

    Although this documentation can be obtained after starting XALKORI, we suggest gathering it at the start of treatment.

    Downloadable document

    Physician Attestation Form

    If your patient is eligible for the warranty, please fill out and submit this form, or give the signed form to your patient to submit.

    Download

    Please remind your patient to carefully review the Terms and Conditions (available to patients at XALKORI.com/Pledge) before initiating the reimbursement process.

    Terms and Conditions

    Pfizer, Inc. (referred to as "us", "we" and similar terms) is proud to offer the Pfizer Pledge Warranty Program for XALKORI (the "Program") to each Patient (referred to as "you", "your" and similar terms) who meets the Eligibility Requirements and follows the Program Procedures described below, subject to all of the terms and conditions in this document (the "Terms"). You should carefully review these Terms.

    Overview of Program

    For Patients who meet the Eligibility Requirements, Pfizer will refund the out-of-pocket amount that you paid for up to the first three (3) bottles (30-day supply) of XALKORI, up to a maximum of $19,144 for each bottle (30-day supply) or an aggregate maximum of up to $57,432 (the “Maximum”). If your commercial insurance or Medicare and/or other payers (“Your Plan(s)”) paid for all or a portion of the cost of XALKORI, Pfizer will, on your behalf, refund to Your Plan(s) up to the Maximum that Your Plan(s) paid, less documented copayments provided by you. Payments to all parties must be equal to or less than the cost paid by each party and may reset Your Plan(s)’s out-of-pocket deductible and/or true out-of-pocket (“TrOOP”) cost in accordance with Your Plan(s)’s benefit design and Medicare requirements. The order of priority of warranty payments is first to you and then to Your Plan that is primary and then to Your Plan(s) that are secondary as determined by information provided by you and documented proof of payment that you provide to us. You are responsible for submitting proof of payment for you and for Your Plan(s). All claims payments will be reported to Your Plan(s) and to Medicare as required by law.

    Medication Eligible for the Program

    • XALKORI® (crizotinib) 200mg and 250mg

    Eligibility Requirements

    In order for you to be eligible to use the Program, you must satisfy all of the criteria listed below:

    1. You are a resident of the fifty (50) United States of America or the District of Columbia (the Program is void for any request made by anyone living outside the fifty (50) United States or the District of Columbia). 
    2. You were prescribed XALKORI by your physician for an FDA-approved indication.
    3. You used XALKORI according to the instructions provided by your physician.
    4. You discontinued XALKORI for clinical reasons defined at the discretion of the physician. Discontinuation solely due to patient choice or affordability does not qualify for the Program.
    5. You, or you and Your Plan(s), paid, in whole or in part, for XALKORI. Patients whose XALKORI was covered, in whole or in part, by Medicaid or other federal healthcare programs (other than Medicare) are not eligible to use the Program.
    6. Your first bottle (30-day supply) of XALKORI must be dispensed on or after June 1, 2021 and on or before December 31, 2021 (the “Coverage Period”).
    7. You must discontinue using XALKORI prior to a pharmacy dispensing your fourth bottle (30-day supply) of XALKORI.
    8. You must submit all receipts for the amount of money you paid for XALKORI and documentation showing what Your Plan(s) paid for XALKORI, including your primary insurance, secondary insurance, and any other third-party payers (including patient assistance programs) to ensure accurate payment of claims. It is your responsibility to submit proof of payment towards the cost of XALKORI from Your Plan(s) before any warranty payments are dispersed.
    9. You must submit all Claims Information (as described below) within one hundred and twenty (120) days following the dispense date of your last bottle (30-day supply) of XALKORI.​​​​​​​

    Benefit Request Process

    In order to be eligible for a refund under this Program, you must satisfy the requirements and submit the information below (the “Claims Information”), within one hundred and twenty (120) days following the dispense date of your last bottle (30-day supply) of XALKORI.

    1. Call 1-866-330-7902 and a representative will provide you with a Patient Warranty Claim Form, a Patient Declarations and Authorizations Form, and a Physician Attestation Form, or these forms may be downloaded from www.xalkori.com. 
    2. You will then need to return a fully completed and signed (i) Patient Warranty Claim Form, (ii) Patient Declarations and Authorizations Form, and (iii) Physician’s Attestation Form in accordance with their instructions, which will include the following information:
      1. Patient Warranty Claim Form:
        • Your name, date of birth, phone number, address, gender, and email address.
        • Prescribing physician name, phone number and address.
        • For each bottle (30-day supply), the dispensing pharmacy name, phone number and address.
        • For each bottle (30-day supply), Your Plan(s)’s information and amounts paid by Your Plan(s), including the following:
          1. For each primary insurer, secondary insurer and prescription Insurer, the insurance type, primary insurer name, phone number, address, policy/Medicare beneficiary ID#, group ID#, policyholder name, policyholder relationship, policyholder date 
            of birth.
          2. A photocopy of each respective insurance card.
        • Prescription information that includes: prescription #, Date of Dispense, Dose Dispensed (250mg or 200mg), number of pills dispensed, and days of supply. 
        • Proof of your out-of-pocket expense (e.g. receipts from your pharmacy)
        • Documents showing payments made by Your Plan(s) (e.g. Commercial or Medicare Part D) including any secondary and/or other third-party payers (e.g. patient assistance programs), if applicable.
      2. Patient Declarations and Authorizations Form which includes your:
        • Attestation that you have discontinued XALKORI before the 4th dispense date of your last bottle (30-day supply) of XALKORI.
        • Consent for the Pfizer Pledge. 
        • Consent to Receive Communication from our representative to process your claim. 
        • Authorization to share Health Information in order to process your claims. 
        • Acknowledgment of laws.
      3. Physician’s Attestation Form completed and signed by your prescribing physician which includes the following information:
        • Your name and date of birth.
        • Prescribing physician name, phone number and address.
        • Prescribing physician attestation that XALKORI was prescribed for on-label use, and the clinical rationale for discontinuance of XALKORI (no confirmatory documentation required).
    3. If your Claims Information passes the verification process, we will notify you via telephone or email that you have been approved for coverage. 
    4. If your Claims Information does not pass the verification process, we will notify you via email that your Request has been denied and the email will include the reason for the denial (such as, incomplete information, mismatched information, etc.). You will be given the opportunity to resubmit your Claims Information within thirty (30) days of the email notification.

    Additional Terms and Conditions

    By submitting your Claims Information under the Program, you are representing and warranting that you took the medication in accordance with the Instructions that were provided by your prescribing physician.

    1. We reserve the right to modify the processes, procedures, parameters, or other terms of the Program, or terminate the Program entirely, at any time, without prior notice to you. If we terminate the Program, we will: (i) continue to honor valid warranty claims related to initial doses of XALKORI, prescribed by your physician, dispensed during the Coverage Period. The current status of the Program and applicable terms are available at www.xalkori.com.
    2. We are refunding payments under this Program to you and Your Plan(s) based on the information provided by you. You are responsible for resolving any disagreements related to reimbursements made by us, on Your behalf, to Your Plan(s). ​​​​​​​
    3. LIMITATION OF LIABILITY

      IN NO EVENT, UNDER ANY CAUSE OF ACTION OF THEORY OF LIABILITY, SHALL PFIZER, ITS DISTRIBUTORS OR SUPPLIERS BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES, OF ANY NATURE WHATSOEVER, ARISING OUT OF OR IN CONNECTION WITH THE PROGRAM, EVEN IF PFIZER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 

      NOTWITHSTANDING ANY DAMAGES THAT YOU MIGHT INCUR FOR ANY REASON WHATSOEVER INCLUDING, WITHOUT LIMITATION, ALL DAMAGES REFERENCED HEREIN AND ALL DIRECT OR GENERAL DAMAGES IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, THE ENTIRE AGGREGATE LIABILITY OF PFIZER AND ANY OF ITS DISTRIBUTORS AND/OR SUPPLIERS SHALL BE LIMITED TO THE MAXIMUM AMOUNT SET FORTH ABOVE FOR THE PRODUCT THAT IS SUBJECT TO THE PROGRAM. SOME STATES AND/OR JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU. THE LIMITATIONS OF LIABILITY SET FORTH ABOVE SHALL APPLY TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAW. 

      ARBITRATION: Read the following arbitration provision (“Provision”) carefully. It limits certain of your rights, including your right to obtain relief or damages through court action. 

      To begin Arbitration, either you or we must make a written demand to the other party for arbitration for the applicable claim ("Claim"). The Arbitration will take place before a single arbitrator. It will be administered in keeping with the Expedited Procedures of the Commercial Arbitration Rules ("Rules") of the American Arbitration Association ("AAA") in effect when the Claim is filed. You may get a copy of these AAA's Rules by visiting www.adr.org. The filing fees to begin and carry out arbitration will be shared equally between you and us. This does not prohibit the arbitrator from giving the winning party their fees and expenses of the arbitration. Unless you and we agree, the arbitration will take place in the county and state where you live. The Federal Arbitration Act, 9 U.S.C. Ch. 1, et seq., will govern and not any state law on arbitration. YOU AGREE AND UNDERSTAND THAT this arbitration provision means that you give up your right to go to court on any Claim covered by this provision. You also agree that any arbitration proceeding will only consider your Claim. Claims by, or on behalf of, other individuals will not be arbitrated in any proceeding that is considering your Claims. THE DEGREE TO WHICH ARBITRATION CAN BE USED AS A DISPUTE RESOLUTION PROCESS FOR CONSUMER CLAIMS VARIES FROM STATE TO STATE, SO THIS ARBITRATION PROVISION MAY NOT APPLY TO YOU, DEPENDING ON YOUR STATE OF RESIDENCE. In the event this Arbitration provision is not approved by the appropriate state regulatory agency, and/or is stricken, severed, or otherwise deemed unenforceable by a court of competent jurisdiction, you and us specifically agree to waive and forever give up the right to a trial by jury. Instead, in the event any litigation arises between you and us, any such lawsuit will be tried before a judge, and a jury will not be impaneled or struck.

    Support & Resources

    Co-pay savings card

    Our co-pay savings program is available for eligible, commercially insured patients. Limits, terms, and conditions apply.

    Learn more

    XALKORI efficacy in ROS1+ metastatic NSCLC

    See ROS1+ efficacy data

    XALKORI safety profile

    See safety profile

    INDICATIONS

    XALKORI is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.

    Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of patients treated with XALKORI across clinical trials (n=1719). Increased transaminases generally occurred within the first 2 months. Monitor liver function tests, including ALT, AST, and total bilirubin, every 2 weeks during the first 2 months of treatment, then once a month, and as clinically indicated, with more frequent repeat testing for increased liver transaminases, alkaline phosphatase, or total bilirubin in patients who develop increased transaminases. Permanently discontinue for ALT/AST elevation >3 times ULN with concurrent total bilirubin elevation >1.5 times ULN (in the absence of cholestasis or hemolysis); otherwise, temporarily suspend and dose-reduce XALKORI as indicated.

    Interstitial Lung Disease/Pneumonitis: Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur. Across clinical trials (n=1719), 2.9% of XALKORI-treated patients had any grade ILD, 1.0% had Grade 3/4, and 0.5% had fatal ILD. ILD generally occurred within 3 months after initiation of treatment. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Exclude other potential causes and permanently discontinue XALKORI in patients with drug-related ILD/pneumonitis.

    QT Interval Prolongation: QTc prolongation can occur. Across clinical trials (n=1616), 2.1% of patients had QTcF (corrected QT by the Fridericia method) ≥500 ms and 5% of 1582 patients had an increase from baseline QTcF ≥60 ms by automated machine-read evaluation of ECGs. Avoid use in patients with congenital long QT syndrome. Monitor ECGs and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications that prolong the QT interval. Permanently discontinue XALKORI in patients who develop QTc >500 ms or ≥60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia. Withhold XALKORI in patients who develop QTc >500 ms on at least 2 separate ECGs until recovery to baseline or a QTc <481 ms, then resume at next lower dosage.

    Bradycardia: Symptomatic bradycardia can occur. Across clinical trials, bradycardia occurred in 13% of patients treated with XALKORI (n=1719). Avoid use in combination with other medications known to cause bradycardia. Monitor heart rate and blood pressure regularly. If bradycardia occurs, re-evaluate for the use of concomitant medications known to cause bradycardia. Permanently discontinue for life-threatening bradycardia due to XALKORI; however, if associated with concomitant medications known to cause bradycardia or hypotension, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If concomitant medications can be adjusted or discontinued, restart XALKORI at 250 mg once daily with frequent monitoring.

    Severe Visual Loss: Across clinical trials, the incidence of Grade 4 visual field defect with vision loss was 0.2% of 1719 patients. Optic atrophy and optic nerve disorder have been reported as potential causes of visual loss. Discontinue XALKORI in patients with new onset of severe visual loss (best corrected vision less than 20/200 in one or both eyes). Perform an ophthalmological evaluation. There is insufficient information to characterize the risks of resumption of XALKORI in patients with visual loss; a decision to resume should consider the potential benefits to the patient.

    Vision Disorders: Most commonly visual impairment, photopsia, blurred vision or vitreous floaters occurred in 63% of 1719 patients. The majority (95%) of these patients had Grade 1 visual adverse reactions. 0.8% of patients had Grade 3 and 0.2% had Grade 4 visual impairment. The majority of patients on the XALKORI arms in Studies 1 and 2 (>50%) reported visual disturbances which occurred at a frequency of 4-7 days each week, lasted up to 1 minute, and had mild or no impact on daily activities.

    Embryo-Fetal Toxicity: XALKORI can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to the fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 45 days (females) or 90 days (males) respectively, following the final dose of XALKORI.

    ROS1-positive Metastatic NSCLC: Safety was evaluated in 50 patients with ROS1-positive metastatic NSCLC from a single-arm study, and was generally consistent with the safety profile of XALKORI evaluated in patients with ALK-positive metastatic NSCLC. Vision disorders occurred in 92% of patients in the ROS1 study; 90% of patients had Grade 1 vision disorders and 2% had Grade 2.

    Adverse Reactions: Safety was evaluated in a phase 3 study in previously untreated patients with ALK-positive metastatic NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169). Serious adverse events were reported in 34% of patients treated with XALKORI, the most frequent were dyspnea (4.1%) and pulmonary embolism (2.9%). Fatal adverse events in XALKORI-treated patients occurred in 2.3% of patients, consisting of septic shock, acute respiratory failure, and diabetic ketoacidosis. Common adverse reactions (all grades) occurring in ≥25% and more commonly (≥5%) in patients treated with XALKORI vs chemotherapy were vision disorder (71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), vomiting (46% vs 36%), constipation (43% vs 30%), upper respiratory infection (32% vs 12%), dysgeusia (26% vs 5%), and abdominal pain (26% vs 12%). Grade 3/4 reactions occurring at a ≥2% higher incidence with XALKORI vs chemotherapy were QT prolongation (2% vs 0%), esophagitis (2% vs 0%), and constipation (2% vs 0%). In patients treated with XALKORI vs chemotherapy, the following occurred: elevation of ALT (any grade [79% vs 33%] or Grade 3/4 [15% vs 2%]); elevation of AST (any grade [66% vs 28%] or Grade 3/4 [8% vs 1%]); neutropenia (any grade [52% vs 59%] or Grade 3/4 [11% vs 16%]); lymphopenia (any grade [48% vs 53%] or Grade 3/4 [7% vs 13%]); hypophosphatemia (any grade [32% vs 21%] or Grade 3/4 [10% vs 6%]). Clinically relevant adverse reactions in <1% of patients who received XALKORI included photosensitivity (0.3%). In patients treated with XALKORI vs chemotherapy, renal cysts occurred (5% vs 1%). Nausea (56%), decreased appetite (30%), fatigue (29%), neuropathy (21%), and rash (11%) also occurred in patients taking XALKORI.

    Drug Interactions: Avoid concomitant use of XALKORI with strong CYP3A inhibitors as these increase XALKORI plasma concentrations. Avoid grapefruit or grapefruit juice which may also increase plasma concentrations of XALKORI. Use caution with concomitant use of moderate CYP3A inhibitors. Concomitant use of XALKORI with strong CYP3A inducers decreases XALKORI plasma concentrations which may decrease the efficacy of XALKORI. Avoid concomitant use of strong CYP3A inducers. Concomitant use of XALKORI increases plasma concentrations of CYP3A substrates. Avoid concomitant use of XALKORI with CYP3A substrates where minimal concentration changes may lead to serious adverse reactions. If concomitant use of XALKORI is unavoidable, decrease the CYP3A substrate dosage in accordance with approved product labeling.

    Lactation: Because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during treatment with XALKORI and for 45 days after the final dose.

    Hepatic Impairment: Crizotinib concentrations increased in patients with pre-existing moderate (any AST and total bilirubin >1.5x ULN and ≤3x ULN) or severe (any AST and total bilirubin >3x ULN) hepatic impairment. Reduce XALKORI dosage in patients with moderate or severe hepatic impairment. The recommended dose of XALKORI in patients with pre-existing moderate hepatic impairment is 200 mg orally twice daily or with pre-existing severe hepatic impairment is 250 mg orally once daily.

    Renal Impairment: Decreases in estimated glomerular filtration rate occurred in patients treated with XALKORI. Administer XALKORI at a starting dose of 250 mg taken orally once daily in patients with severe renal impairment (CLcr <30 mL/min) not requiring dialysis.

    Photosensitivity: Inform patients of the signs and symptoms of photosensitivity. Advise patients to avoid prolonged sun exposure and to use sunscreen or protective clothing during treatment with XALKORI.

    XALKORI is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.

    Please see Full Prescribing Information for XALKORI.