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Gallium

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Side Effects & Adverse Reactions

Because of the benzyl alcohol content, caution should be used in administration to newborns, particularly infants born prematurely, and individuals with impaired liver function.

The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

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Uses

Gallium Citrate Ga 67 Injection may be useful in demonstrating the presence of the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.

Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.

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History

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Other Information

Gallium Citrate Ga 67 Injection is supplied in isotonic solution as a sterile, non-pyrogenic diagnostic radiopharmaceutical for intravenous administration. Each milliliter of the isotonic solution contains 74 MBq (2 mCi) of Gallium Ga 67 on the calibration date, as a complex formed from 9 ng Gallium Chloride Ga 67, 2 mg of sodium citrate, 6.8 mg sodium chloride, and 9 mg benzyl alcohol/mL added as preservative. The pH is adjusted to between 4.5-8 with hydrochloric acid and/or sodium hydroxide solution. Gallium Ga 67, with a half-life of 78.3 hours, is cyclotron produced by the proton irradiation of enriched zinc oxide, is essentially carrier-free and contains negligible concentrations of other radioactive isotopes.

The radionuclidic composition at calibration time is ≥99.89% Gallium Ga 67, ≤0.01% Gallium Ga 66 and ≤0.1% due to other radiocontaminants, each expressed as a percentage of total activity. The radionuclidic composition at expiration time is ≥99.89% Gallium Ga 67, essentially zero (0.0002%) Gallium Ga 66 and essentially zero of other radiocontaminants each expressed as a percentage of total activity.

The chemical structure for Gallium Citrate is shown below:

Gallium structure

PHYSICAL CHARACTERISTICS

Gallium Ga 67 decays to stable Zinc Zn 67 by electron capture with a physical half-life of 78.3 hours.1

TABLE 1. Principal Radiation Emission Data
Radiation Mean %/Disintegration Mean Energy (keV)
Gamma-3 35.7 93.3
Gamma-4 19.7 184.6
Gamma-6 16.0 300.2
1
Kocher, David C., “Radioactive Decay Data Tables”, DOE/TIC-11026 (1981).

EXTERNAL RADIATION

The specific gamma ray constant for Gallium Ga 67 is 5.58 microcoulombs/Kg-hr-MBq (0.80R/hr-mCi) at 1 cm. The first half value thickness of lead is 0.066 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.41 cm of Pb will decrease the external radiation exposure by a factor of 10.

TABLE 2. Radiation Attenuation By Lead Shielding
cm of Pb Radiation
Attenuation Factor		 cm of Lead
( Pb)		 Radiation
Attenuation Factor
0.066 0.5 2.5 10-3
0.41 10-1 4.8 10-4
1.2 10-2

To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.

TABLE 3. Gallium Ga 67 Decay Chart Half-Life 78.3 Hours
Hours Fraction
Remaining		 Hours Fraction
Remaining		 Hours Fraction
Remaining
*
Calibration Time
0* 1.00 42 0.69 84 0.48
6 0.95 48 0.65 90 0.45
12 0.90 54 0.62 96 0.43
18 0.85 60 0.59 108 0.38
24 0.81 66 0.56 120 0.35
30 0.77 72 0.53 132 0.31
36 0.73 78 0.50 144 0.28
156 0.25
168 0.23
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  • Lantheus Medical Imaging, Inc.
    Gallium | Lantheus Medical Imaging, Inc.
    No Recall

    Gallium | Lantheus Medical Imaging, Inc.

    Gallium | Lantheus Medical Imaging, Inc.

    The recommended adult (70 kg) dose of Gallium Citrate Ga 67 Injection is 74-185 MBq (2-5 mCi). Gallium Citrate Ga 67 Injection is intended for intravenous administration only.

    Approximately 10% of the administered dose is excreted in the feces during the first week after injection. Daily laxatives and/or enemas are recommended during the first week after injection until the final images are obtained in order to cleanse the bowel of radioactive material and minimize the possibility of false positive studies.

    Studies indicate the optimal tumor to background concentration ratios are often obtained about 48 hours post-injection. However, considerable biological variability may occur in individuals, and acceptable images may be obtained as early as 6 hours and as late as 120 hours after injection.

    The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

    Waterproof gloves should be worn during the handling procedures. With a shielded sterile syringe, aseptically withdraw the material for use. The expiration date of the drug is fourteen days after the date of calibration.

    RADIATION DOSIMETRY

    The estimated absorbed radiation doses2 from an intravenous injection of 185 MBq (5 mCi) of Gallium Citrate Ga 67 are shown in Table 4.

    TABLE 4. Dosimetry of Gallium Citrate Ga 67 Injection for Maximal Dose of 185 MBq (5 mCi) mGy/
    185 MBq Rads/
    5mCi Whole Body 13.0 1.30 Skeleton 22.0 2.20 Liver 23.0 2.30 Bone Marrow 29.0 2.90 Spleen 26.5 2.65 Kidney 20.5 2.05 Ovaries 14.0 1.40 Testes 12.0 1.20 Gastrointestinal Tract   Stomach 11.0 1.10   Small Intestine 18.0 1.80   Upper Large Intestine 28.0 2.80   Lower Large Intestine 45.0 4.50 2 MIRD Dose Estimate Report No.2, J. Nucl. Med. 14:755-6 (1973).
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