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PRESCRIBING INFORMATION

Xofigo full Prescribing Information

CONTACT US

Phone: 1-855-6XOFIGO

(1-855-696-3446)

Fax: 1-855-963-4463

Hours: Monday through Friday
9:00 A.M. to 7:00 P.M ET

Contact Address:

Xofigo Access Services
PO Box 220009
Charlotte, NC 28222-0009

Xofigo Access Services

Program Forms and Resources

The list below are our most common forms for patient needs

Xofigo® Quick Start Guide

Xofigo® Patient Authorization Form

Submit this form with any initial patient request. The patient's signature on this form authorizes the use and/or disclosure of PHI. This form is required to complete the Patient Assistance Program and Commercial Copay Assistance applications.

Xofigo® Access Services Brochure

This brochure is designed to give you an overview of Xofigo Access Services, your single point of contact for assistance with product ordering, confirming patient scheduling and shipments reimbursement support, and patient assistance.

Xofigo Access Services Referral Form

Use this form to request insurance coverage benefits verification for your patients through Xofigo Access Services

Xofigo® Access Services Enrollment Form for Administering Providers

Use this form to request benefit verification, set a treatment schedule, or place an order

Xofigo® Access Services Enrollment Form for VA/DoD

Use this form to set a treatment schedule or place an order

Xofigo® Access Services Application for Patient Assistance/Commercial Copay Assistance

Use this form to apply for patient assistance of commercial copay assistance for your patients on Xofigo

Quick Reference Reimbursement Guide for Freestanding Centers

This guide is designed to provide you with coding and reimbursement information to support healthcare professionals and office staff in prescribing Xofigo.

Quick Reference Reimbursement Guide for Hospital Outpatient Departments

This guide is designed to provide you with coding and reimbursement information to support healthcare professionals and office staff in prescribing Xofigo.

Xofigo® Access Support for Patients Brochure

This brochure is designed to provide your patients with information about patient access programs available for patients taking Xofigo including the patient assistance program, commercial copay assistance program and copay assistance program for uninsured patients.

Get Started With Xofigo® Guide for Referring Providers

This guide is intended to give you an overview of Xofigo Access Services can help patients get started with Xofigo.

Ordering Xofigo Guide for Administering Providers

This guide is intended to give you an overview of the 3 step process to get your patient started in Xofigo.

Sample letter of Medical Necessity

This sample letter is intended to provide physicians with language that can be used in their correspondence with insurance companies to justify coverage for Xofigo for their patients.

Sample letter of Appeal

This sample letter is intended to provide physicians with language that can be used in their correspondence with insurance companies to respond to queries regarding coverage for Xofigo for their patients.

Patient Assistance Application

Please use this form if you are applying for the Patient Assistance Program

Get Started with Xofigo for Administering Providers

This guide is intended to give administering providers an overview of Xofigo Access Services and how to get your patients started on Xofigo

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.

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