AZEDRA Solution for injection Ref.[10319] Active ingredients: Iobenguane ยนยณยนI

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

AZEDRA (iobenguane I 131) injection, for intravenous use, is a radioactive therapeutic agent. The drug substance iobenguane I 131 is a substituted benzylguanidine with I 131 in the meta position of the benzene ring.

Iobenguane I 131 is described as I 131 meta-iodobenzylguanidine. The molecular weight is 279.1 Daltons and the structural formula is as follows:

AZEDRA (iobenguane I 131) 555 MBq/mL (15 mCi/mL) injection is a sterile, clear, colorless to pale yellow solution. Each single-dose vial contains iobenguane (0.006 mg/mL), sodium ascorbate (58 mg/mL) and sodium gentisate (23 mg/mL) in Water for Injection, USP. The pH range of the solution is 4.5 to 5.5, with specific activity of ~2,500 mCi/mg (92,500 MBq/mg).

11.1 Physical Characteristics

I 131 decays with beta and gamma emissions with a physical half-life of 8.021 days. The principal beta emission has a mean energy of 191.6 keV, and the principal gamma emission has energy of 364.5 keV.

11.2 External Radiation

The specific gamma ray constant for I 131 is 2.2 R/mCi hour at 1 cm. A 2.55 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

Table 6 summarizes radioactive decay properties of I 131.

Table 6. Physical Decay Chart: Iodine I 131: Half-Life = 8.021 Days:

DaysFraction Remaining
0a 1.000
1.000 0.917
2 0.841
3 0.772
4 0.708
5 0.649
6 0.595
7 0.546
8 0.501
9 0.459
10 0.421
11 0.387
12 0.355
13 0.325
14 0.298

a Calibration day.

Dosage Forms and Strengths

Injection: 555 MBq/mL (15 mCi/mL) as a clear, colorless to pale yellow solution in a single-dose vial.

How Supplied

AZEDRA injection, containing 555 MBq/mL (15 mCi/mL) of I-131 (as iobenguane I 131) and 0.006 mg/mL of iobenguane, is a sterile, clear, colorless to pale yellow solution for intravenous use supplied in a colorless Type 1 borosilicate glass 30 mL single-dose vial.

AZEDRA is supplied in dosimetric (2 mL) and therapeutic (22.5 mL) presentations:

  • Dosimetric: 1,110 MBq (30 mCi) of iobenguane I 131 at calibration time (NDC 71258-015-02).
  • Therapeutic: 12,488 MBq (337.5 mCi) of iobenguane I 131 at calibration time (NDC 71258-015-22).

The product vial is in a lead shielded container placed in a re-sealable plastic bag. The product is shipped on dry ice in a USA DOT Type A Radioactive package.

Drugs

Drug Countries
AZEDRA United States

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