Version May 2024
Note: Calculate administration volume using patient weight, radioactivity content (at the reference date), and decay correction factor; determine net patient dose immediately before and after administration with an appropriate radioisotope dose calibrator; refer to product labeling for further details. Prior to initial dose, ANC should be ≥1,500/mm3, platelets ≥100,000/mm3, and hemoglobin ≥10 g/dL.
Prostate cancer, castration resistant with symptomatic bone metastases: IV: 55 kBq/kg (1.49 microcurie/kg) every 4 weeks for 6 doses.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl 30 to 89 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling, (has not been studied).
Mild impairment: No dosage adjustment necessary.
Moderate to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, dosage adjustment is not likely needed because not metabolized hepatically or eliminated in bile.
ANC <1,000/mm3 or platelets <50,000/mm3 (prior to subsequent doses): Withhold treatment until hematologic recovery; if recovery does not occur within 6 to 8 weeks from the last dose (despite supportive care), discontinue radium Ra 223 treatment.
Compromised bone marrow reserve: Closely monitor; discontinue if life-threatening complications occur despite supportive care
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Cardiovascular: Peripheral edema (13%)
Gastrointestinal: Diarrhea (25%; grades 3/4: 2%), nausea (36%; grades 3/4: 2%), vomiting (19%; grades 3/4: 2%)
Hematologic & oncologic: Anemia (93%; grades 3/4: 6%), leukopenia (35%; grades 3/4: 3%), lymphocytopenia (72%; grades 3/4: 20%), neutropenia (18%; grades 3/4: 1% to 3%), thrombocytopenia (31%; grades 3/4: 1% to 6%)
1% to 10%:
Endocrine & metabolic: Dehydration (3%)
Hematologic & oncologic: Pancytopenia (2%; grades 3/4: 1%)
Local: Injection-site reaction (1%; including erythema at injection site, pain at injection site, swelling at injection site)
Renal: Renal insufficiency (3%; including renal failure syndrome)
Postmarketing: Hematologic & oncologic: Aplastic anemia (Parker 2018)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Bone marrow suppression: Hematologic toxicity, including anemia, lymphocytopenia, thrombocytopenia, leukopenia, and neutropenia commonly occur. Bone marrow failure occurred in 2% of patients receiving radium Ra 223 dichloride in clinical studies (did not occur in patients who received placebo). Bone marrow failure may be prolonged and fatal (rare); may require blood transfusion support. Vascular hemorrhage due to thrombocytopenia has been reported. Infection may occur due to neutropenia. Neutrophils and platelet nadirs typically occurred 2 to 3 weeks after administration; recovery generally occurred ~6 to 8 weeks after administration.
• Dehydration: Dehydration may occur due to GI adverse events (diarrhea, nausea, vomiting).
• Secondary malignancies: Although fewer malignancies were reported for radium Ra 223 dichloride than for placebo (from clinical studies), long-term cumulative radiation exposure may increase the risk for malignancies (onset may be delayed).
Concurrent drug therapy issues:
• Abiraterone acetate: Concurrent use with abiraterone acetate plus prednisone/prednisolone outside of a clinical trial is not recommended due to an increased incidence of fractures and deaths.
• Chemotherapy: The safety and efficacy of concurrent chemotherapy have not been established. Due to the potential for additive bone marrow toxicity, concurrent use with chemotherapy is not recommended outside of a clinical trial. Discontinue radium Ra 223 if chemotherapy, other systemic radioisotopes, or external radiotherapy are required.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority. Patients and caregivers should use the following precautions to minimize exposure:
- When handling bodily fluids, wear gloves and wash hands after handling.
- Wash any clothing soiled with radium Ra 223 dichloride promptly and separately from other clothing.
- Where a normal toilet is available, use in preference to a urinal.
- Flush toilet several times after use.
- Wash hands thoroughly after urination.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Xofigo: 1100 kBq/mL (30 microcurie/mL) (1 ea)
No
Solution (Xofigo Intravenous)
30 mcci/ml (per each): $34,030.75
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Administer as a slow IV injection over 1 minute. Flush IV line or cannula before and after administration with saline flushes. Radiopharmaceutical; use appropriate precautions for handling and disposal.
Prostate cancer: Treatment of castration-resistant prostate cancer in patients with symptomatic bone metastases and no known visceral metastatic disease.
Xofigo may be confused with Jevtana, Xgeva, Xtandi, Zejula, Zometa, Zydelig, Zytiga.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abiraterone Acetate: Radium Ra 223 Dichloride may enhance the adverse/toxic effect of Abiraterone Acetate. Specifically, the risk for fractures and death may be increased. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
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 radium Ra 223 dichloride.
Based on the mechanism of action, radium Ra 223 dichloride may impair fertility in males of reproductive potential.
Based on the mechanism of action, radium Ra 223 dichloride can cause fetal harm when administered to a pregnant female.
It is not known if radium Ra 223 dichloride is present in breast milk.
CBC with differential at baseline and prior to each dose; closely monitor patients with compromised bone marrow reserve. Monitor oral fluid intake, hydration status, and urine output. Monitor for secondary malignancies.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow up.
Radium Ra 223 is an alpha particle-emitting isotope; it emits high energy, short-range alpha particles which target bone metastases; mimics calcium to form complexes with bone mineral in areas with increased bone turnover. Alpha emission induces double strand DNA breaks in adjacent cells, which results in an antitumor effect on the bone metastases.
Onset: A significant response in pain index was seen at week 2 (Nilsson 2012).
Duration: Mean duration of pain relief: 44 days (Nilsson 2012)
Distribution: Primarily to the bone or excreted in to intestine
Metabolism: Decays (is not metabolized)
Half-life elimination: 11.4 days (Nilsson 2007)
Excretion: Feces (13%); urine (2%)
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