RESOURCES

RESOURCES FOR EVERY STEP OF THE JOURNEY

All your patient and practice resources

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Xofigo^® Access Services Forms

Use the following forms to order Xofigo^® and register your patients for support services.

Xofigo® access services enrollment form for providers

Xofigo Enrollment Form PDF

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

Xofigo® access service enrollment form for VA DoD

Xofigo 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 Medical Necessity PDF

An example of how to ask for Xofigo to be covered by insurance for your patient

Xofigo Sample Letter of Appeal PDF

An example of how to respond to a denied claim

Cardinal Health Holiday Delivery Schedule 2024 PDF

Information about when Cardinal Health makes holiday deliveries throughout the year

Patient education resources

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

Xofigo Patient Symptom Sheet PDF

A summary that helps patients recognize the symptoms of mCRPC that have spread to the bones and reviews important facts and safety information about Xofigo treatment

Xofigo Patient-Doctor Discussion Guide PDF

A guide for patients to help talk with their doctors about their disease, Xofigo, and their treatment journey

Xofigo Patient Brochure PDF

A guide that helps patients understand Xofigo: how it works, how it fits into the treatment journey, and its benefits and risks

Xofigo Patient Brochure (Spanish) PDF

A guide that helps patients understand Xofigo: how it works, how it fits into the treatment journey, and its benefits and risks

Xofigo Access Support for Patients Brochure PDF

Information about patient access programs available for patients taking Xofigo

Xofigo Patient Treatment Guide PDF

Information about how Xofigo is given, with space to track administration dates

ADMINISTRATION AND HOT LAB RESOURCES

Use the following resources to understand the dosing and administration procedures for Xofigo^®.

Dose Calibrator Dial Setting Procedure for Xofigo PDF

How to calibrate the dose for Xofigo

Xofigo Administration Guide PDF

A step-by-step guide on how to administer Xofigo

Xofigo General Decontamination Procedures PDF

What to do in the event of a spill

Xofigo Dial Setting

Establishing a dial setting for Radium 223 using a patient dose

Patient Release Card

Keep track of Xofigo doses

Patient Release Card (Spanish)

How to calibrate the dose for Xofigo

Routine Monitoring Requirements

Understand the routine monitoring requirements for Xofigo patients

NIST Form

Request a calibration standard for Xofigo

Storage and Handling Guide

How to store and handle Xofigo

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® brochure for healthcare professionals

Xofigo Comprehensive Early-Use Brochure for Healthcare Professionals PDF

An in-depth overview of Xofigo, including data on efficacy and safety, and information on where Xofigo fits in the overall treatment journey

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.