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Gallium citrate Ga-67: Drug information

Gallium citrate Ga-67: Drug information
(For additional information see "Gallium citrate Ga-67: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Gallium
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult
Diagnostic imaging

Diagnostic imaging: IV:

Scintigraphy for inflammation or infection: 4 to 6 mCi (150 to 220 MBq) (Ref).

Tumor scintigraphy: 5 to 10 mCi (185 to 370 MBq) (Ref).

Manufacturer's labeling: Dosing in the prescribing information may not reflect current clinical practice. (Based on 70 kg patient): 2 to 5 mCi (74 to 185 MBq).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing; use with caution and consider starting at lower end of dosage range.

Dosing: Pediatric
Diagnostic imaging

Diagnostic imaging: Scintigraphy for inflammation or infection (off-label use): IV: 0.07 mCi/kg (2.6 MBq/kg), with a minimum of 0.5 mCi (18.5 MBq) (Ref) or alternatively for children >5 years: 0.04 to 0.07 mCi/kg (1.5 to 2.6 MBq/kg) (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Frequency not defined:

Dermatologic: Erythema of skin, pruritus, skin rash

Gastrointestinal: Nausea

Hypersensitivity: Hypersensitivity reaction

Contraindications

There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling: Hypersensitivity to gallium citrate or any component of the formulation

Warnings/Precautions

Special handling:

• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.

Other Warnings/Precautions:

• Appropriate use: The finding of an abnormal gallium Ga-67 concentration usually implies the existence of underlying pathology, but further diagnostic studies should be done to distinguish benign from malignant lesions. Use is intended as an adjunct in the diagnosis of certain neoplasms as well as focal areas of infection. Certain pathologic conditions may yield up to 40% false-negative gallium Ga-67 studies; a negative study cannot be definitely interpreted as ruling out the presence of disease. Lymphocytic lymphoma frequently does not accumulate gallium Ga-67 sufficiently for unequivocal imaging, and the use of gallium with this histologic type of lymphoma is not recommended at this time. Gallium Ga-67 localization cannot differentiate between tumor and acute inflammation, and other diagnostic studies must be added to define the underlying pathology.

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP 1997; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling. Use with caution in patients with hepatic impairment.

Dosage form specific issues:

• Latex: The vial stopper may contain natural rubber latex.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous, as citrate:

Generic: 2 mCi/mL (1 ea [DSC])

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Gallium Citrate Ga 67 Intravenous)

2 mci/mL (per each): $1,069.39 - $3,208.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as citrate:

Generic: 2 mCi/mL (3 mL, 6 mL)

Administration: Adult

IV: For IV administration. Time to obtain images after administration may vary based on procedure (from hours to days); refer to manufacturer's labeling and/or specific procedure guidelines for recommendations. Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.

The manufacturer recommends administration of daily laxatives and/or enemas during the first week after injection until final images are obtained to cleanse the bowel of radioactive material and to minimize false positive results.

Administration: Pediatric

Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.

IV: For IV administration only. The manufacturer recommends administration of daily laxatives and/or enemas during the first week after injection and until final images are obtained to cleanse the bowel of radioactive material and to minimize false positive results.

Use: Labeled Indications

Diagnostic imaging: Diagnostic imaging agent for use in identifying the presence and extent of Hodgkin disease, lymphoma, bronchogenic carcinoma, and acute inflammatory lesions

Medication Safety Issues
Sound-alike/look-alike issues:

Gallium Citrate Ga-67 may be confused with Gallium Ga 68 Dotatate, Gallium Ga 68 PSMA-11.

Other safety concerns:

Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Deferoxamine: May diminish the diagnostic effect of Gallium Citrate Ga-67. Management: Discontinue deferoxamine 48 hours prior to scintigraphy with gallium citrate Ga-67. Risk D: Consider therapy modification

Reproductive Considerations

The manufacturer recommends that when elective procedures are conducted in women of reproductive potential, they should be done within the first 10 days of menses.

Pregnancy Considerations

Ga 67 can accumulate in the placenta (Kurosak 2001; Newman 1978; Palestro 1986).

Breastfeeding Considerations

Ga 67 accumulates in the breast even in nonlactating patients (Hor 1976). Significant concentrations were detected in the breast milk of one postpartum woman 10 days after dosing (Hoffer 1977). The actual concentration may depend on volume of milk flow and stage of breastfeeding (Tobin 1976). The manufacturer recommends to substitute formula for breast milk. Due to the long half-life of Ga 67, one guideline recommends discontinuing breastfeeding for at least 2 to 4 weeks after the injection in order to reduce exposure to the breastfeeding infant (Palestro 2004).

Mechanism of Action

Gallium citrate Ga-67 is a radioactive diagnostic agent which accumulates in lysosomes and is bound to a soluble intracellular protein. It has been found to concentrate in certain viable primary and metastatic tumors as well as focal sites of infections.

Pharmacokinetics (Adult Data Unless Noted)

Half-life elimination: Physical: 78.3 hours

Excretion: After 7 days: Average whole body retention 65%, urine 26%, feces 9%

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CH) Switzerland: Gallium citrate;
  • (CO) Colombia: Citrato de galio (67 Ga);
  • (CZ) Czech Republic: Gallium citrate;
  • (EE) Estonia: Gallium citrate;
  • (ES) Spain: Citrato de galio (67Ga) CIS bio international;
  • (FR) France: Citrate de gallium (67ga) cis bio internation;
  • (JP) Japan: Gallium citrate abbott | Gallium citrate amersh | Gallium citrate daiichi r.i.c | Gallium citrate nihon;
  • (PT) Portugal: Citrato de galio (67 Ga);
  • (RU) Russian Federation: Gallium citrate 67Ga
  1. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  2. American College of Radiology, Society for Pediatric Radiology. ACR-SPR Practice Parameter for the Performance of Scintigraphy for Inflammation and Infection. Resolution 28. https://www.acr.org/-/media/ACR/Files/Practice-Parameters/inflaminfscint.pdf?la=en. Revised 2018.
  3. American College of Radiology, Society for Pediatric Radiology. ACR-SPR Practice Parameter for the Performance of Tumor Scintigraphy (With Gamma Cameras). Resolution 48. http://www.acr.org/~/media/921761B083FE4457A9121953D080BA1C.pdf. Revised 2015.
  4. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol--United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm. [PubMed 6810084]
  5. Gallium Citrate Ga 67 [prescribing information]. N. Billerica, MA: Lantheus Medical Imaging; March 2018.
  6. Gallium Citrate Ga 67 [product monograph]. Laval, Quebec, Canada: Curium Canada Inc; April 2019.
  7. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. Pediatrics.1997;99(2):268-278. [PubMed 9024461]
  8. Hoffer PB, Huberty J, Khayam-Bashi H. The association of Ga-67 and lactoferrin. J Nucl Med. 1977;18(7):713-717. [PubMed 267143]
  9. Hör G, Heidenreich P, Kriegel H, et al. Letter: Breast scintigraphy with 99mTc-pertechnetate and 67Ga-citrate. J Nucl Med. 1976;17(3):223. [PubMed 1249634]
  10. Kurosaki H, Saito Y, Kawashima M, et al. Accumulation of 67Ga citrate in early pregnancy. Ann Nucl Med. 2001;15(3):289-291. [PubMed 11545204]
  11. Newman RA, Gallagher JG, Clements JP, et al. Demonstration of Ga-67 localization in human placenta. J Nucl Med. 1978;19(5):504-506. [PubMed 580436]
  12. Palestro CJ, Brown ML, Forstrom LA, et al, “Society of Nuclear Medicine Procedure Guideline for Gallium Scintigraphy in Inflammation," 2004. Available at http://interactive.snm.org/docs/Gallium_Scintigraphy_in_Inflammation_v3.pdf
  13. Palestro CJ, Malat J, Collica CJ, et al. Incidental diagnosis of pregnancy on bone and gallium scintigraphy. J Nucl Med. 1986;27(3):370-372. [PubMed 2940348]
  14. Tobin RE, Schneider PB. Uptake of 67Ga in the lactating breast and its persistence in milk: case report. J Nucl Med. 1976;17(12):1055-1056. [PubMed 993836]
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