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Xofigo

Xofigo Dosage/Direction for Use

Manufacturer:

Bayer

Distributor:

Global Medical Solutions
Full Prescribing Info
Dosage/Direction for Use
Recommended Dosage: The dose regimen of Xofigo is 55 kBq (1.49 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 55 kBq/kg body weight or 1.49 microcurie/kg body weight; Radioactivity concentration of the product (1,100 kBq/mL; 30 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: See equation.

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or

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(See Table 2.)

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Immediately before and after administration, the net patient dose of administered Xofigo should be determined by measurement in an appropriate radioisotope dose calibrator that has been calibrated with a National Institute of Standards and Technology (NIST) traceable radium-223 standard (available upon request from Bayer) and corrected for decay using the date and time of commissioning, after any maintenance procedure that could affect the doismetry and at intervals not to exceed one year.
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.
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