GALLIUM CITRATE GA-67

INDICATIONS AND USAGE Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium 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.

DOSAGE AND ADMINISTRATION The recommended adult (70 kg) dose of Gallium Citrate Ga 67 Injection is 74 to 185 megabecquerels (2 to 5 millicuries). Gallium Citrate Ga 67 Injection is intended for intravenous administration only. Approximately 10 percent of the administered dose is excreted in the feces during the first week after injection. Daily laxatives and/or enemas are recommended from the day of 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 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. Do not use if contents are turbid. Instructions for the handling of Gallium Citrate Ga 67: Waterproof gloves should be used during the entire handling and administration procedure. Using proper shielding, the vial containing the Gallium Citrate Ga 67 should be visually inspected to ensure that it is free of particulate matter and discoloration prior to use. Maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the preparation. R adiation Dosimetry The estimated absorbed radiation doses 2 from an intravenous injection of 185 megabecquerels (5 millicuries) of Gallium Citrate Ga 67 are shown in Table 4. Table 4. Absorbed Radiation Doses Tissue mGy/ 185MBq rads/ 5mCi Whole Body Skeleton Liver Bone Marrow Spleen Kidney Ovaries Testes Gastrointestinal Tract Stomach Small Intestine Upper Large Intestine Lower Large Intestine 13.0 22.0 23.0 29.0 26.5 20.5 14.0 12.0 11.0 18.0 28.0 45.0 1.30 2.20 2.30 2.90 2.65 2.05 1.40 1.20 1.10 1.80 2.80 4.50 2 MIRD Dose Estimate Report No. 2, J. Nucl. Med. 14; 755-6 (1973).

CONTRAINDICATIONS None.

WARNINGS None known.

ADVERSE REACTIONS Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga 67 use.

Pregnancy Animal reproductive studies have not been conducted with Gallium Citrate Ga 67. It is also not known whether Gallium Citrate Ga 67 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gallium Citrate Ga 67 should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature of women of childbearing capability, should be performed during the first few (approximately ten) days following the onset of menses.