Adreview

Adreview

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Pheochromocytoma and Neuroblastoma

AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.

1.2 Congestive Heart Failure

AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6.

Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for:

  • selecting a therapeutic intervention or for monitoring the response to therapy;
  • using the H/M ratio to identify a patient with a high risk for death.

History

There is currently no drug history available for this drug.

Other Information

AdreView (Iobenguane I 123 Injection) is a sterile, pyrogen-free radiopharmaceutical for intravenous injection. Each mL contains 0.08 mg iobenguane sulfate, 74 MBq (2 mCi) of I 123 (as iobenguane sulfate I 123) at calibration date and time on the label, 23 mg sodium dihydrogen phosphate dihydrate, 2.8 mg disodium hydrogen phosphate dihydrate and 10.3 mg (1% v/v) benzyl alcohol with a pH of 5.0 – 6.5. Iobenguane sulfate I 123 is also known as I 123 meta-iodobenzlyguanidine sulfate and has the following structural formula:

Chemical Structure
11.1 Physical Characteristics

Iodine 123 is a cyclotron-produced radionuclide that decays to Te 123 by electron capture and has a physical half-life of 13.2 hours.

Table 3. Principal Radiation Emission Data – Iodine 123
Radiation Energy Level (keV) Abundance (%)
Gamma 159 83
11.2 External Radiation

The specific gamma ray constant for iodine 123 is 1.6 R/mCi-hr at 1 cm. The first half value thickness of lead (Pb) for I 123 is 0.04 cm. The relative transmission of radiation emitted by the radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4 (e.g., the use of 2.16 cm Pb will decrease the external radiation exposure by a factor of about 1,000).

Table 4. Reduction in In-air Collision Kerma Caused by Lead Shielding*
Shield Thickness cm of lead (Pb) Reduction in In-air Collision Kerma
*
Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Report NISTIR 5632.
0.04 0.5
0.13 10-1
0.77 10-2
2.16 10-3
3.67 10-4

Adreview Manufacturers


  • Medi-physics Inc.
    Adreview (Iobenguane I-123) Injection [Medi-physics Inc.]

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