RESOURCES FOR EVERY STEP OF THE JOURNEY

    Xofigo® Access Services Forms
    Use the following forms to order Xofigo and register your patients for support services.
    Xofigo patient treatment guide thumbnail

    Xofigo Access Services Enrollment Form for Providers PDF

    Request insurance benefit verification services for your patients or order Xofigo through Xofigo Access Services
    Xofigo Access Services Brochure PDF

    Xofigo Sample Letter of Medical Necessity PDF

    An example of how to ask for Xofigo to be covered by insurance for your patient
    Xofigo Access Services Brochure PDF

    Xofigo Access Services Brochure PDF

    An overview of Xofigo Access Services and the support it offers
    Reimbursement guidance for freestanding centers

    Xofigo Quick Reference Reimbursement Guide—Freestanding Centers PDF

    Reimbursement guidance for freestanding centers
    Xofigo Get Started Guide for Referring Providers PDF

    Xofigo Get Started Guide for Referring Providers PDF

    How to help patients get started on Xofigo, including guidance on the Xofigo Access Services Provider Referral Form
    Xofigo ICD-10 Flashcard PDF

    Xofigo ICD-10 Flashcard PDF

    Codes to use when billing for Xofigo
    Cardinal Health Holiday Delivery Schedule 2021 PDF

    Cardinal Health Holiday Delivery Schedule 2021 PDF

    Information about when Cardinal Health makes deliveries during the holidays
    Xofigo access support for patients brochure thumbnail

    Xofigo Access Services Enrollment Form for VA/DoD PDF

    Order Xofigo for your Veterans Affairs (VA)/Department of Defense (DoD) patients through Xofigo Access Services
    Xofigo Sample Letter of Appeal PDF

    Xofigo Sample Letter of Appeal PDF

    An example of how to respond to a denied claim
    Alt text

    Xofigo Quick Reference Reimbursement Guide—Hospital Outpatient Settings PDF

    Reimbursement guidance for hospital outpatient settings
    Xofigo Get Started Guide for Administering Providers PDF

    Xofigo Get Started Guide for Administering Providers PDF

    How to order Xofigo, including guidance on the Enrollment Form for Administering Providers
    Xofigo fact sheet thumbnail

    Xofigo Access Services Enrollment Form for Providers PDF

    Request insurance benefit verification services for your patients or order Xofigo through Xofigo Access Services
    Xofigo Split Billing in Separate Sites of Care Flashcard PDF

    Xofigo Split Billing in Separate Sites of Care Flashcard PDF

    Guidance for how to bill for Xofigo injection and administration in separate sites of care
      Patient education resources

      Share these resources with your patients to educate them about Xofigo treatment and support services available through Xofigo Access Services.

      Xofigo fact sheet thumbnail

      Xofigo Fact Sheet PDF

      Information on how patients can take an active role in their health while on Xofigo treatment
      Xofigo patient treatment guide thumbnail

      Xofigo Patient Brochure PDF

      A comprehensive guide to the risks and benefits of Xofigo
      Information about patient access programs available for patients taking Xofigo

      Xofigo Access Support for Patients Brochure PDF

      Information about patient access programs available for patients taking Xofigo
      Xofigo access support for patients brochure thumbnail

      Xofigo Access Services Brochure PDF

      An overview of Xofigo Access Services and the support it offers
      Xofigo Patient Brochure (Spanish) PDF

      Xofigo Patient Brochure (Spanish) PDF

      A comprehensive Spanish-language guide to the risks and benefits of Xofigo
      Xofigo Patient Treatment Guide PDF

      Xofigo Patient Treatment Guide PDF

      Information about how Xofigo is given, with space to track administration dates
        Dosing and administration resources
        Use the following resources to understand the dosing and administration procedures for Xofigo.
        Xofigo fact sheet thumbnail

        Xofigo Lookup Table for Prescribed Ra 223 Activity PDF

        Helps assess the Xofigo dose based on patient weight
        Xofigo patient treatment guide thumbnail

        Xofigo Administration Guide PDF

        A step-by-step guide on how to administer Xofigo
        Xofigo Patient Release Card (Spanish) PDF

        Xofigo Patient Release Card (Spanish) PDF

        Fill out this card and give it to Spanish-speaking patients prior to their release after administration of Xofigo
        Xofigo Overview of Radionuclide Properties PDF

        Xofigo Overview of Radionuclide Properties PDF

        A summary of the properties of Xofigo
        Xofigo Secondary NIST Traceable Source Request Form PDF

        Xofigo Secondary NIST Traceable Source Request Form PDF

        How to make a request for a calibration standard for Xofigo
        Xofigo Dial Setting

        Xofigo Dial Setting

        Establishing a dial setting for Radium 223 using a patient dose
        Xofigo access support for patients brochure thumbnail

        Dose Calibrator Dial Setting Procedure for Xofigo PDF

        How to calibrate the dose for Xofigo
        Xofigo Patient Release Card PDF

        Xofigo Patient Release Card PDF

        Fill out this card and give it to patients prior to their release after administration of Xofigo
        Xofigo Storage and Handling Guide PDF

        Xofigo Storage and Handling Guide PDF

        A guide for persons authorized to handle radiopharmaceuticals in designated clinical settings
        Xofigo General Decontamination Procedures PDF

        Xofigo General Decontamination Procedures PDF

        What to do in the event of a spill
        Xofigo Routine Monitoring Requirements PDF

        Xofigo Routine Monitoring Requirements PDF

        Information about standard hematologic evaluations required before and during treatment with Xofigo
          Hot lab maintenance resources

          Use the following resources to help you set up and maintain a hot lab in your practice for the administration of Xofigo.

          Xofigo fact sheet thumbnail

          Therapeutic Use of Xofigo Procedure Checklist PDF

          Outlines the therapeutic administration of Xofigo protocol established by the facility’s Radioactive Materials License (RML)
          Xofigo patient treatment guide thumbnail

          Xofigo Quick Reference Reimbursement Guide—Hospital Outpatient Settings PDF

          Reimbursement guidance for hospital outpatient settings
          Dose Calibrator Dial Setting Procedure for Xofigo PDF

          Dose Calibrator Dial Setting Procedure for Xofigo PDF

          How to calibrate the dose for Xofigo
          Xofigo Administration Guide PDF

          Xofigo Administration Guide PDF

          A step-by-step guide on how to administer Xofigo
          Xofigo Patient Release Card PDF

          Xofigo Patient Release Card PDF

          Fill out this card and give it to patients prior to their release after administration of Xofigo
          Xofigo Overview of Radionuclide Properties PDF

          Xofigo Overview of Radionuclide Properties PDF

          A summary of the properties of Xofigo
          Xofigo Secondary NIST Traceable Source Request Form PDF

          Xofigo Secondary NIST Traceable Source Request Form PDF

          How to make a request for a calibration standard for Xofigo
          Xofigo access support for patients brochure thumbnail

          Xofigo Quick Reference Reimbursement Guide—Freestanding Centers PDF

          Reimbursement guidance for freestanding centers
          Xofigo Lookup Table for Prescribed Ra 223 Activity PDF

          Xofigo Lookup Table for Prescribed Ra 223 Activity PDF

          Helps assess the Xofigo dose based on patient weight
          Xofigo Get Started Guide for Administering Providers PDF

          Xofigo Get Started Guide for Administering Providers PDF

          How to order Xofigo, including guidance on the Enrollment Form for Administering Providers
          Xofigo Storage and Handling Guide PDF

          Xofigo Storage and Handling Guide PDF

          A guide for persons authorized to handle radiopharmaceuticals in designated clinical settings
          Xofigo Patient Release Card (Spanish) PDF

          Xofigo Patient Release Card (Spanish) PDF

          Fill out this card and give it to Spanish-speaking patients prior to their release after administration of Xofigo
          Xofigo General Decontamination Procedures PDF

          Xofigo General Decontamination Procedures PDF

          What to do in the event of a spill
            Xofigo clinical data resources

            Use the following resources to learn more about Xofigo, including efficacy and safety data, dosing, and information about identifying appropriate patients.

            Xofigo fact sheet thumbnail

            Xofigo Brochure for Healthcare Professionals PDF

            A comprehensive overview of Xofigo, including efficacy and safety data and information on how Xofigo works
            Xofigo patient treatment guide thumbnail

            Xofigo Mechanism of Action (MOA) Video

            An animated video demonstrating the MOA for Xofigo

            Xofigo Radiobiology Brochure

            Xofigo Radiobiology Brochure

            Understanding key aspects of radiotherapies employed in mCRPC
            Xofigo access support for patients brochure thumbnail

            Xofigo Patient Identification Tool PDF

            Learn how to identify patients as soon as they become eligible for Xofigo
            Xofigo Switch Brochure for Healthcare Professionals PDF

            Xofigo Switch Brochure for Healthcare Professionals PDF

            Learn about introducing a different mechanism of action when metastatic castration-resistant prostate cancer (mCRPC) spreads to the bone with no known visceral metastases

            Indication

            Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

            Important Safety Information

            Warnings and Precautions:
            • Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo.

              Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure

             

            • Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care

             

            • Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued

             

            • Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established

             

            • Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo

             

            Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations

            Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia

            Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo

            Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial

            Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy

            Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%)

            For important risk and use information about Xofigo, please see the Full Prescribing Information.

            You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.

            © 2021 Bayer. All rights reserved. January 2021

            Bayer, the Bayer Cross, Xofigo, and the Xofigo Access Services logo are registered trademarks of Bayer.

            Site Last Modified: 01/21

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