Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 22 February 2017


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.

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Advisory information

Special warnings and precautions

PRECAUTIONS General A thorough knowledge of the normal distribution of intravenously administered Gallium Citrate Ga 67 Injection is essential in order to accurately interpret pathologic states.

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.

Gallium Citrate Ga 67 Injection is intended for use as an adjunct in the diagnosis of certain neoplasms as well as focal areas of infection.

Certain pathologic conditions may yield up to 40 percent false negative gallium Ga-67 studies.

Therefore, a negative study can not 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 can not differentiate between tumor and acute inflammation, and other diagnostic studies must be added to define the underlying pathology.

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper management and to ensure minimum radiation exposure to occupational workers.

The vial contents are sterile and non-pyrogenic.

It is essential that the user follow the directions carefully and adhere to strict aseptic procedures.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether this drug affects fertility in males or females.

Pregnancy Category C 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.

Nursing Mothers This drug is known to be excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feedings.

Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 have not been established.

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

Usage information

Dosing and administration

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.

Pregnancy and lactation
Nursing Mothers This drug is known to be excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feedings.

More information

Category Value
Authorisation number NDA018058
Orphan designation No
Product NDC 69945-180
Date Last Revised 30-10-2015
Storage and handling

Storage and Handling The contents of the vial are radioactive, and adequate shielding and handling precautions must be maintained.

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Storage and disposal of Gallium Citrate Ga 67 Injection should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.

© 2015 Mallinckrodt.

Manufactured by: Mallinckrodt Nuclear Medicine LLC Maryland Heights, MO 63043 Made in USA A180I0 Rev 10/2015 MallinckrodtTM Pharmaceuticals

Marketing authorisation holder MALLINCKRODT NUCLEAR MEDICINE LLC