Adult Dosing

Castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease

• 50 kBq (1.36 microcurie) per kg IV infused over 1 minute; repeat q4 wk x 6 cycles total

Note:

• Volume to be administered should be calculated using the:
• Patient’s body weight (kg)
• Dosage level 50 kBq/kg body weight or 1.35 microcurie/kg body weight
• Radioactivity concentration of the product (1,000 kBq/mL; 27 microcurie/mL) at the reference date
• Decay correction factor to correct for physical decay of radium-223
• Example: (Body wt in kg x 50 kBq/kg body weight)/(Decay factor x 1,000 kBq/mL)
• Decay correction factor table listed in prescribing information and is based on the vial’s reference date

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

• Radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease

• Hypersensitivity to any of the ingredients of the product
• Pregnancy

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

• Therapy may cause myelosuppression and bone marrow failure; perform hematologic evaluation at baseline and prior to every dose; discontinue if life-threatening complications occur despite supportive care for bone marrow failure
• Deaths related to vascular hemorrhage in association with myelosuppression have been associated with the drug
• Myelosuppression; notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia; has been reported in patients
• Hematologic evaluation of patients must be performed at baseline and prior to every dose. Before the first administration, the absolute neutrophil count (ANC) should be = > 1.5 x 10⁹/L, the platelet count = 100 x 10⁹/L and hemoglobin = > 10 g/dL
• Safety and efficacy of concomitant chemotherapy have not been established; outside of a clinical trial, concomitant use with chemotherapy is not recommended due to the potential for additive myelosuppression
• Because of potential effects on spermatogenesis associated with radiation, advise men who are sexually active to use condoms and their female partners of reproductive potential to use a highly effective contraceptive method during and for 6 months after completing treatment

Pregnancy Category:X; Therapy can cause fetal harm when administered to a pregnant woman based on its mechanism of action

Breastfeeding: Safety unknown; because of the potential for possible serious adverse reactions in nursing infants a decision should be made to discontinue breastfeeding, or to discontinue the drug taking into account the importance of the drug to the mother.

• HEMA: Pancytopenia, anemia, lymphocytopenia, leukopenia, thrombocytopenia, neutropenia
• GI: Nausea, diarrhea, vomiting, dehydration
• GU: Renal failure and impairment
• MISC: Peripheral edema, injection site erythema and pain

• Alpha particle-emitting radiopharmaceutical; which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases; leading to a high frequency of double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases
• Metabolism: Radium-223 is an isotope that decays and is not metabolized
• Excretion: 63% excreted from body within 7 days after injection; Fecal excretion is the major elimination route; at 48 hr after injection, the cumulative fecal excretion was 13% (range 0 -34%), and the cumulative urine excretion was 2% (range 1 -5%)

US Trade Name(s)

• Xofigo

US Availability

Xofigo

• INJ: 1000 kBq/mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Hematology/Oncology

Radioactive Pharmaceuticals