Radium ra-223 dichloride
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Dosing in kidney impairment
Patients with Renal Impairment No dedicated renal impairment trial for Xofigo has been conducted. Based on subgroup analyses in the randomized clinical trial, dose adjustment is not needed in patients with existing mild (creatinine clearance [CrCl] 60 to 89 mL/min) or moderate (CrCl 30 to 59 mL/min) renal impairment. No dose adjustment can be recommended for patients with severe renal impairment (CrCl less than 30 mL/min) due to limited data available (n = 2) [see Clinical Pharmacology] .
| 1152 | 4263 | ||
| 139 | 514 | ||
| 46 | 172 | ||
| 38 | 142 | ||
| 32 | 120 | ||
| 7.3 | 27 | ||
| 4.0 | 15 | ||
| 3.2 | 12 | ||
| 3.0 | 11 | ||
| 1.7 | 6.4 | ||
| 1.2 | 4.5 | ||
| 1.8 | |||
| 0.94 | |||
| 0.85 | |||
| 0.51 | |||
| 0.44 | |||
| 0.44 | |||
| 0.41 | |||
| 0.37 | |||
| 0.33 | |||
| 0.31 | |||
| 0.27 | |||
| 0.26 | |||
| 0.21 | |||
| 0.18 | |||
| 86 |
Dosing in liver impairment
Patients with Hepatic Impairment No dedicated hepatic impairment trial for Xofigo has been conducted. Since radium-223 is neither metabolized by the liver nor eliminated via the bile, hepatic impairment is unlikely to affect the pharmacokinetics of radium-223 dichloride [see Clinical Pharmacology] . Based on subgroup analyses in the randomized clinical trial, dose adjustment is not needed in patients with mild hepatic impairment.
No dose adjustments can be recommended for patients with moderate or severe hepatic impairment due to lack of clinical data.
Preparation and administration
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Administration Administer Xofigo by slow intravenous injection over 1 minute. Flush the intravenous access line or cannula with isotonic saline before and after injection of Xofigo. Discard any unused portion, if applicable [see Dosage and Administration].
| Volume to be administered (mL) | = | Body weight in kg × 55 kBq/kg body weight |
| Decay factor × 1,100 kBq/mL |
| Volume to be administered (mL) | = | Body weight in kg × 1.49 microcurie/kg body weight |
| Decay factor × 30 microcurie/mL |
Drug interactions
Check radium ra-223 dichloride against a medication listLabel text (1 paragraph)
No formal clinical drug interaction studies have been performed. Subgroup analyses indicated that the concurrent use of bisphosphonates or calcium channel blockers did not affect the safety and efficacy of Xofigo in the randomized clinical trial.
Contraindications
None. None.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary The safety and efficacy of Xofigo have not been established in females. Based on mechanism of action, Xofigo can cause fetal harm when administered to a pregnant female [see Clinical Pharmacology ( 12.1 )] . While there are no human or animal data on the use of Xofigo in pregnancy, maternal use of a radioactive therapeutic agent could affect development of a fetus. Advise pregnant females and females of reproductive potential of the potential risk to a fetus.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.