e / Handling
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Bone Marrow Suppression
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Patients with Hepatic Impairment
8.7 Patients with Renal Impairment
8.8 Males of Reproductive Potential
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.6 Cardiac Electrophysiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The dose regimen of Xofigo is 50 kBq (1.35 microcurie) per kg body weight, given at 4 week intervals for 6 injections. Safety and efficacy beyond 6 injections with Xofigo have not been studied.
The volume to be administered to a given patient 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.
The total volume to be administered to a patient is calculated as follows:
Volume to be administered (mL)
=
Body weight in kg × 50 kBq/kg body weight
Decay factor × 1,000 kBq/mL
or
Volume to be administered (mL)
=
Body weight in kg × 1.35 microcurie/kg body weight
Decay factor × 27 microcurie/mL
Table 1: Decay Correction Factor Table Days from Reference Date
Decay Factor
Days from Reference Date
Decay Factor
-14
2.296
0
0.982
-13
2.161
1
0.925
-12
2.034
2
0.870
-11
1.914
3
0.819
-10
1.802
4
0.771
-9
1.696
5
0.725
-8
1.596
6
0.683
-7
1.502
7
0.643
-6
1.414
8
0.605
-5
1.330
9
0.569
-4
1.252
10
0.536
-3
1.178
11
0.504
-2
1.109
12
0.475
-1
1.044
13
0.447
14
0.420
The Decay Correction Factor Table is corrected to 12 noon Central Standard Time (CST). To determine the decay correction factor, count the number of days before or after the reference date. The Decay Correction Factor Table includes a correction to account for the 7 hour time difference between 12 noon Centra |
