Xofigo（radium Ra 223 dichloride）

INDICATIONS AND USAGE
Xofigo is an alpha-particle emitting radiotherapeutic indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

DOSAGE AND ADMINISTRATION
The dosing regimen for Xofigo is 50 kBq (1.35 µCi) per kg body weight, given as 6 injections at 4-week intervals.

DOSUFFORMATION AND STRENGTHS
Single-use vial concentration of 1,000 kBq/mL (27 µCi/mL) on the reference date has a total radioactivity of 6,000 kBq/vial (162 µCi/vial) on the reference date.

CONTRAINDICATIONS
Pregnancy

WARNINGS AND PRECAUTIONS
Bone Marrow Suppression: Measure blood counts prior to initiation of treatment and before each dose of Xofigo. Discontinue Xofigo if hematologic values ​​do not recover within 6 to 8 weeks after treatment. Closely monitor patients for impaired bone marrow retention. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care measures.

Adverse Reactions
The most common adverse reactions (≥ 10%) in patients receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema.
The most common laboratory abnormalities (≥ 10%) with Xofigo were anemia, lymphopenia, leukopenia, thrombocytopenia, and neutropenia.