Important Safety Information

  • Contraindications: Xofigo® is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman Continue reading below. »
  • 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. Continue reading below. »

Help your patients understand treatment with Xofigo

Your patients have questions about Xofigo, and you have the answers

Whether you are a part of the multidisciplinary team that decided to prescribe Xofigo or you are administering patients’ injections, it is important to manage patients’ and caregivers’ expectations of treatment with Xofigo. It is also important to ensure that the prescribing and administering physicians are aligned on the goals of therapy prior to discussing Xofigo with patients.

For your convenience, we’ve included patient-friendly language below to assist you in answering patients’ and caregivers’ questions, and educating them about what to expect during Xofigo treatment. You can also share the Xofigo Patient Brochure with your patients, available to download at the bottom of this page.

Common questions your patients may have:

  • What is Xofigo used for?1

    • Xofigo is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body
  • How does Xofigo help men with prostate cancer in the bones?

    • Xofigo helps extend life by more than 30%—14.9 months in Xofigo-treated men vs 11.3 months in placebo-treated men, in an updated analysis1,2
    • Xofigo was studied in a clinical trial with 921 men with mCRPC. In addition to any other medication they were taking, some of the men in the study were given Xofigo. Others were given an injection that did not contain an active drug2
  • How does Xofigo work?1

    • When prostate cancer goes to the bone, so does Xofigo. Xofigo gives off radiation that helps kill cancer cells
    • Xofigo contains the radioactive material radium 223. It goes to areas in your bones that are growing quickly, just like calcium does. Bone metastases are one of those rapidly growing areas
    • Even though Xofigo gives off a strong energy, it has a short range that does limited damage to healthy cells around it
      • Xofigo can be absorbed by other organs, primarily the bone marrow and digestive system, which may result in side effects in those healthy tissues
  • What are the serious risks I should know about?1

    • Xofigo is not indicated for women. Women who are pregnant or may become pregnant should not receive Xofigo and should practice safe sex, such as having their partner wear a condom and using effective birth control, as Xofigo can harm unborn babies. People who are handling fluids such as urine, feces, or vomit of a man taking Xofigo should wear gloves and wash their hands as precaution
    • Xofigo can cause your blood cells counts to go down, including red blood cells, white blood cells, and/or platelets. In a clinical trial, some patients had to permanently discontinue therapy because of bone marrow problems. In addition, there were some deaths and blood transfusions that occurred due to severe bone marrow problems. Your healthcare provider will do blood tests before and during treatment with Xofigo
    • Before taking Xofigo, tell your healthcare provider if you are receiving any chemotherapy or another extensive radiation therapy, are taking Zytiga® (also known as abiraterone) with prednisone/prednisolone, as this may increase the risk of bone fractures (breaks) and death or have any other medical conditions
  • What are the most common side effects of Xofigo?1

    • The most common side effects of Xofigo include:

      • Nausea
      • Diarrhea
      • Vomiting
      • Swelling of the arms or legs (peripheral edema)
      • Low blood cell counts
  • What should I know while I am on Xofigo?

    • Make sure you keep your blood cell count monitoring appointments and tell your healthcare provider about any symptoms or signs of low blood cell counts. Report symptoms or signs of shortness of breath, tiredness, bleeding (such as bruising), or infection (such as fever)
    • Stay well hydrated and report any signs of dehydration (such as dry mouth and increased thirst), or urinary or kidney problems (such as burning when urinating)
    • There are no restrictions regarding contact with other people after receiving Xofigo
    • Follow good hygiene practices in order to minimize radiation exposure from spills of bodily fluids to household members and caregivers for a period of one week after each injection
    • Use condoms and make sure female partners who may become pregnant use highly effective birth control methods during and for a minimum of six months after treatment with Xofigo
  • Is financial support available to help me pay for Xofigo?

    • Xofigo Access Services can help you pay for Xofigo, if you qualify. A $0 copay* is available for eligible privately insured patients. Contact an Access Counselor to learn more at 1-855-6XOFIGO (1-855-696-3446)
    • If you are uninsured or lack coverage for Xofigo, Access Counselors can research potential alternate sources of funding, such as Medicaid or other state and local assistance programs. If you are eligible for one of these programs, your Access Counselor can provide information about the program and how to apply

    *Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the co-payment support provided under this program, e.g., co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payors of any benefits they receive and the value of this program, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Patients enrolled in Bayer’s Patient Assistance Program are not eligible. Bayer may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the Xofigo Access Services at any time, including but not limited to this commercial co-pay assistance program. Only patients not currently enrolled in the Xofigo Access Services are eligible; current participants may enroll upon their annual renewal date.

  • How will I receive Xofigo treatment?

    • Before each treatment you will get a blood test, so your doctor can be sure your blood counts are normal and it is okay for you to receive your injection1
    • You will receive a 1-minute injection in a vein every 4 weeks, for a total of 6 injections1
      • You will receive your injection at a location where healthcare providers or technicians are qualified to give Xofigo
    • Once the injection is finished, you can leave the office and go about your daily activities1,8

    Locate a treatment site near your patient

mCRPC=Metastatic Castration-Resistant Prostate Cancer.

Helpful Resources

View all patient resources

Indication

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

Important Safety Information

Contraindications: Xofigo® is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman

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

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.

References: 1. Xofigo® (radium Ra 223 dichloride) injection [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; August 2018. 2. Parker C, Nilsson S, Heinrich D, et al; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369(3):213-223. 3. National Institutes of Health: National Heart, Lung, and Blood Institute. What are the signs and symptoms of anemia? https://www.nhlbi.nih.gov/health/health-topics/topics/anemia/signs. Accessed January 28, 2017. 4. National Institutes of Health: National Heart, Lung, and Blood Institute. What are the signs and symptoms of lymphocytopenia? https://www.nhlbi.nih.gov/health/health-topics/topics/lym/signs. Accessed January 30, 2017. 5. National Institutes of Health: National Heart, Lung, and Blood Institute. What are the signs and symptoms of thrombocytopenia? https://www.nhlbi.nih.gov/health/health-topics/thcp/signs. Accessed January 30, 2017. 6. eMedicineHealth. Dehydration in adults: symptoms and signs of dehydration in adults. http://www.emedicinehealth.com/dehydration_in_adults/page3_em.htm. Accessed January 30, 2017. 7. Mayo Clinic. Kidney infection symptoms. http://www.mayoclinic.org/diseases-conditions/kidney-infection/basics/symptoms/con-20032448. Accessed January 30, 2017. 8. United States Nuclear Regulatory Commission. Release of individuals containing unsealed byproduct material or implants containing byproduct material. Title 10: Energy. Electronic Code of Federal Regulations (eCFR), Part 35.75. US Government Publishing Office. http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0075.html. Accessed October 12, 2016.