SIMPLE DOSING WITH XOFIGO1

Xofigo should be received, used, and administered only by authorized persons in designated clinical settings.

1 minute intravenous injection every 4 weeks for 6 treatments over as little as 5 months

Injections take place every 4 weeks.

XOFIGO IS DELIVERED IN A CONVENIENT, PATIENT-READY DOSE

  • A patient-ready dose with the requested activity will be provided in a syringe by Cardinal Health Nuclear Pharmacy Services2
  • The patient-ready dose is 1.49 microcurie (55 kBq) per kg body weight1a

The volume to be administered to a given patient is calculated as follows1a:

Note: This is for your information only. Cardinal Health will perform all calculations for your convenience.

Xofigo® administration

  • The shelf life of Xofigo in the patient-ready syringe is 96 hours1
  • Xofigo is a ready-to-use solution and should not be diluted or mixed with any other solutions1

ADMINISTRATION STEPS

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Assay the dose immediately before treatment, and set up the infusion environment by placing absorbent materials in the area where the injection will take place1

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Insert the IV cannula required by your institution for injection. Connect a 2- or 3-way stopcock to the IV device, and then open the stopcock to flush the infusion set with isotonic saline to confirm IV patency

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If IV patency is confirmed, remove the red cap from the Xofigo syringe and attach the open port of the stopcock. Then, turn the stopcock so that it is closed to the saline syringe and open from the Xofigo syringe to the patient

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Administer Xofigo by slow IV injection over 1 minute. When complete, turn the stopcock to shut off the Xofigo syringe and open the saline syringe. Flush the infusion system thoroughly with isotonic saline, remove the syringes and injection setup, and assay immediately for residual activity. Dispose of according to institutional policies1

After administration of Xofigo, the patient should remain in the office for a period of time determined by institutional policies to ensure there are no complications from administration. Fill out the Xofigo Patient Release Card and give it to him before he leaves.

FOLLOW APPROPRIATE DRUG HANDLING1

  • Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The receipt, storage, use, transfer, and disposal of Xofigo are subject to the regulations and/or appropriate licenses of the competent official organization
  • Follow normal working procedures for the handling of radiopharmaceuticals, and use universal precautions, such as gloves and barrier gowns, when handling blood and bodily fluids to avoid contamination
  • In case of contact with skin or eyes, flush immediately with water
  • If spillage occurs, contact the local radiation safety officer immediately to initiate necessary measurements and required procedures to decontaminate
    • 0.01 M EDTA solution is recommended to remove contamination

 

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

EDTA=Ethylene-Diamine-Tetraacetic Acid; IV=Intravenous.

aBased on the 2015 standard set by National Institute of Standards and Technology (NIST), the numerical description of the patient dose has been adjusted from 50 kBq/kg to 55 kBq/kg of body weight and the numerical description of the radioactivity in the vial has been changed from 1000 kBq/mL to 1100 kBq/mL.2

References
  • Xofigo® (radium Ra 223 dichloride) injection [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; December 2019. Return to content
  • United States Nuclear Regulatory Commission. Revision to the National Institute of Standards and Technology standard for radium-223 and impact on dose calibration for the medical use of radium-223 dichloride. http://pbadupws.nrc.gov/docs/ML1526/ML15264B095.pdf. Accessed March 11, 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.