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LICENSING REQUIREMENTS

OBTAINING YOUR LICENSE

Getting licensed to administer Xofigo®

On January 10, 2013, the Nuclear Regulatory Commission (NRC) posted a notice of licensing decision regarding Xofigo, which states that licensing under Title 10, Code of Federal Regulations (10 CFR), Part 35, Subpart E (which includes 35.300) is appropriate for Xofigo.

The NRC staff also determined that under current regulations, the following can be authorized for the medical use of Xofigo:

  • Physicians who are approved for the use of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV under 10 CFR 35.390(b)(1)(ii)(G)(3) Training for Use of Unsealed Byproduct Material for Which a Written Directive Is Required

OR

  • 10 CFR 35.396(d)(2) Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive

For each NRC region/Agreement State, information is provided on radioactive materials, licensing regulations, and regulatory personnel contact information.

View State Information at NRC.gov

If you’re an Authorized User (AU) and looking to get proctored for Xofigo, please reach out to your Radiotherapy Specialist.

If you have questions, you can request assistance from a Bayer representative below.

Contact a Radiotherapy Specialist

MAINTAINING YOUR LICENSE

Considerations

Please refer to the checklist below for items to consider when evaluating your license for use of Xofigo. You may not need an amendment if your license is written with the following conditions. Some Agreement States may require a line-item amendment for individual radiopharmaceuticals. Please refer to your local regulatory authority for specific information on state requirements.

Broad-scope license:

  • Z# of 88 allowed or “any radioactive material permitted by 10 CFR 35.300” (if not, a line-item amendment may be needed)
  • Authorized user for parenteral administration under 35.390 or 35.396, or state equivalent

Limited-scope license:

  • Licensed under 35.300 or state equivalent as any radioactive material, any form (if not, a line-item amendment may be needed)
  • Authorized user for parenteral administration under 35.390 or 35.396, or state equivalent
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Getting licensed to administer Xofigo

On January 10, 2013, the Nuclear Regulatory Commission (NRC) posted a notice of licensing decision regarding Xofigo that states that licensing under Title 10, Code of Federal Regulations (10 CFR), Part 35, Subpart E (which includes 35.300) is appropriate for Xofigo.1,2

 

The NRC staff also determined that under current regulations, the following can be authorized for the medical use of Xofigo1:

  • Physicians who are approved for the use of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV under 10 CFR 35.390(b)(1)(ii)(G)(3) Training for Use of Unsealed Byproduct Material for Which a Written Directive Is Required3

OR

  • 10 CFR 35.396(d)(2) Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive4

 

For each NRC region/Agreement State, information is provided on radioactive materials, licensing regulations, and regulatory personnel contact information.

 

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View State Information on NRC.gov
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Register for more information

Registering gives you access to the following:      

  • Specialists who can answer your licensing questions      
  • Updates on changes in requirements as they become available
  • Assurance that the information you provide remains private and safe

 

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Register to learn more
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If you have questions, you can request assistance from a Bayer representative below.

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References
  • United States Regulatory Commission. Notice of Licensing Decision on Radium-223 Dichloride (FSME-13-002). http://www.nrc.gov/docs/ML1300/ML13008A149.pdf. Accessed September 12, 2016. Return to content
  • United States Nuclear Regulatory Commission. Unsealed Byproduct Material—Written Directive Required. Title 10: Energy. Electronic Code of Federal Regulations (eCFR), Part 35, Subpart E. US Government Publishing Office. http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=92ea438f1e4e96431e1e2436b22fef88&mc=true&n=sp10.1.35.e&r=SUBPART&ty=HTML. Accessed September 26, 2016. Return to content
  • United States Nuclear Regulatory Commission. Training for use of unsealed byproduct material for which a written directive is required. Title 10: Energy. Electronic Code of Federal Regulations (eCFR), Part 35.390. US Government Publishing Office. http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0390.html. Accessed September 26, 2016. Return to content
  • United States Nuclear Regulatory Commission. Training for the parenteral administration of unsealed byproduct material requiring a written directive. Title 10: Energy. Electronic Code of Federal Regulations (eCFR), Part 35.396. US Government Publishing Office. http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0396.html. Accessed September 26, 2016. Return to content

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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