Quadramet (Drug Description)

QUADRAMET®
(samarium SM 153 lexidronam) Injection

Therapeutic – For Intravenous Administration

DRUG DESCRIPTION

QUADRAMET® is a therapeutic agent consisting of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP). QUADRAMET® is formulated as a sterile, non-pyrogenic, clear, colorless to light amber isotonic solution of samarium-153 lexidronam for intravenous administration.

QUADRAMET® does not contain a preservative.

Each milliliter contains 35 mg EDTMP•H₂O, 5.3 mg Ca [as Ca(OH)₂], 14.1 mg Na [as NaOH], equivalent to 44 mg Ca/Na EDTMP (anhydrous calc.), 5-46 µg samarium (specific activity of approximately 1.0-11.0 mCi/µg Sm), and 1850 ± 185 MBq (50 ± 5 mCi) of samarium-153 at calibration.

The structural formula of samarium lexidronam pentasodium is:

The ionic formula is ¹⁵³Sm⁺³ [CH₂N(CH₂PO₃^-2)₂]₂ and the ionic formula weight is 581.1 daltons (pentasodium form, 696).

The pH of the solution is 7.0 to 8.5.

QUADRAMET® is supplied frozen in single-dose glass vials containing 3 mL with 5550 MBq (150 mCi) of samarium-153 at calibration.