ACCESS

ORDERING

Ordering Xofigo® is a simple 3-step process

Xofigo is ordered and distributed exclusively through Xofigo® Access Services, your one source for ordering Xofigo and treatment support.

Number 1 in purple circle

CONTACT XOFIGO ACCESS SERVICES

  • Submit the appropriate form, including signed Patient Authorization, via phone, fax, or online:
  • If an insurance benefit verification is needed, submit the Xofigo Access Services Provider Referral Form via the contact information above
  • Xofigo Access Services completes benefits investigation, if requested

Please have the following information available when you call Xofigo Access Services to place an order:

  • Patient name
  • Patient weight
  • Dosage
  • Facility shipment address
  • Planned date and time of administration

What you’ll need:

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 services enrollment form for the VA and Department of Defense (DoD).

Xofigo Enrollment Form for VA/DoD PDF

Order Xofigo for your Veterans Affairs (VA)/Department of Defense (DoD) patients through Xofigo Access Services.
Number 2 in purple circle

RECEIVE CONFIRMATION VIA FAX

  • Provides completed insurance benefit verification and written summary of patient’s benefits, if requested
  • Confirms patient treatment date

NOTE:

Xofigo Access Services will fax you a confirmation receipt of your request. If the form is submitted online, you will receive a confirmation once submitted.

Number 3 in purple circle

ORDER XOFIGO

  • Call Xofigo Access Services up to 7 days prior to each scheduled treatment date
  • Your call will be transferred to Cardinal Health Nuclear Pharmacy Services for actual order placement
  • Cardinal Health Nuclear Pharmacy Services will ship the patient-ready dose to your facility

NOTE:

For future doses, Xofigo Access Services will call you to process the order if it has not been placed a minimum of 3 business days prior to the scheduled treatment date.

Comprehensive support right when you need it

Xofigo® access services logo

Counselors are available from 9:00 AM to 7:00 PM ET, Monday through Friday:

See Licensing Requirements Here

Xofigo is ordered and distributed exclusively through Xofigo® Access Services, your one source for ordering Xofigo and treatment support.

 

 

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Contact Xofigo Access Services

  • Submit the appropriate form, including signed Patient Authorization, via phone, fax, or online:
  • If an insurance benefit verification is needed, submit the Xofigo Access Services Provider Referral Form via the contact information above
  • Xofigo Access Services completes benefits investigation, if requested

 

Please have the following information available when you call Xofigo Access Services to place an order:

  • Patient name
  • Patient weight
  • Dosage
  • Facility shipment address
  • Planned date and time of administration

 

What you’ll need:

Alt text

Xofigo Enrollment Form PDF

Alt text

Xofigo Enrollment Form for VA/DoD PDF

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Receive confirmation via fax

  • Provides completed insurance benefit verification and written summary of patient’s benefits, if requested
    • Confirms patient treatment date

Note:

Xofigo Access Services will fax you a confirmation receipt of your request.

Alt tag

Order Xofigo

  • Call Xofigo Access Services up to 7 days prior to each scheduled treatment date
  • Your call is transferred to Cardinal Health Nuclear Pharmacy Services for actual order placement
  • Cardinal Health Nuclear Pharmacy Services will ship the patient-ready dose to your facility

Note:

Xofigo Access Services will call you to process the order if it has not been placed a minimum of 3 business days prior to the scheduled treatment date.

Comprehensive support right when you need it

Alt tag

Counselors are available from 9:00 AM to 7:00 PM ET, Monday through Friday:

DoD=Department of Defense; VA=Department of Veterans Affairs.

 

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Licensing requirements
Open link

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.

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