GALLIUM CITRATE GA 67
Clinical safety rating: caution
Comprehensive clinical and safety monograph for GALLIUM CITRATE GA 67 (GALLIUM CITRATE GA 67).
Gallium citrate Ga 67 is a radiopharmaceutical that localizes in tumors and inflammatory lesions. The mechanism is not fully understood but may involve binding to transferrin and uptake via transferrin receptors, as well as accumulation in lysosomes of macrophages and tumor cells.
| Metabolism | Not metabolized; excreted primarily via the kidneys (approximately 20-30% of administered dose within 24 hours) and the gastrointestinal tract. |
| Excretion | Renal: approximately 25% within first 24 hours; fecal: approximately 10% within 48 hours; retained in tissues (bone, liver, spleen) with slow release over weeks. |
| Half-life | Terminal elimination half-life: approximately 25 days (range 6-72 days) in soft tissues; reflects slow clearance from binding sites (e.g., transferrin, lactoferrin). |
| Protein binding | >90% bound to plasma proteins, primarily transferrin and to a lesser extent albumin and lactoferrin. |
| Volume of Distribution | Vd: approximately 5-10 L/kg; indicates extensive tissue distribution and binding to intracellular and surface proteins. |
| Bioavailability | Not applicable (administered intravenously only); bioavailability 100% via IV route. |
| Onset of Action | Intravenous: uptake in tumors and inflammatory lesions begins within 24-48 hours; optimal imaging at 48-72 hours post-injection. |
| Duration of Action | Imaging window: 48-72 hours post-injection; residual activity detectable for weeks, limiting repeat studies. |
2-5 mCi (74-185 MBq) intravenously once; repeat imaging may require an additional 2-5 mCi at 48-72 hours.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment for renal impairment; caution in severe renal dysfunction due to potential for altered pharmacokinetics. |
| Liver impairment | No specific dose adjustment for hepatic impairment; safety and efficacy not established in Child-Pugh C cirrhosis. |
| Pediatric use | 10-50 μCi/kg (0.37-1.85 MBq/kg) intravenously once, not to exceed adult dose. |
| Geriatric use | No specific dose adjustment; use lowest effective dose due to age-related decline in renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for GALLIUM CITRATE GA 67 (GALLIUM CITRATE GA 67).
| Breastfeeding | Gallium-67 is excreted in breast milk. The M/P ratio is not specifically established. To minimize infant radiation exposure, breastfeeding should be discontinued for at least 2 weeks following administration. Pump and discard milk during this period. |
| Teratogenic Risk | Gallium-67 is a radioactive isotope emitting gamma radiation. It crosses the placenta. First trimester exposure carries high risk of fetal harm due to radiosensitivity; second and third trimester exposure may cause growth restriction, neurodevelopmental delays, and carcinogenesis. Gallium citrate is contraindicated in pregnancy unless benefit outweighs risk. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Severe renal impairment","Known hypersensitivity to gallium citrate Ga 67 or any component of the formulation"]
| Precautions | ["Risk of misadministration of radioactive material","Not recommended in patients with severe renal impairment due to reduced clearance","Pregnancy and lactation: use only if benefit outweighs risk","Pediatric use: safety and efficacy not established","Hypersensitivity reactions may occur"] |
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| Fetal Monitoring | If used inadvertently during pregnancy, monitor fetal growth and development via serial ultrasound. Long-term pediatric follow-up for neurodevelopmental and oncologic outcomes recommended. Maternal hydration to enhance renal clearance of gallium-67. |
| Fertility Effects | Gallium-67 may cause gonadal radiation exposure, potentially impairing fertility. While case-specific data are limited, radiation doses to ovaries and testes from diagnostic studies are typically low, but repeated exposures may be harmful. |