Gallium ga-68 gozetotide

FDA label, UCSF Radiopharmaceutical Facility, intravenous, effective 2025-11-14. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Radioactive Diagnostic Agent

Dosing in kidney impairment

The radiation doses for this administered dose to the critical organs, which are the kidneys, urinary bladder, and spleen, are 96.2 mGy, 25.4 mGy, and 16.8 mGy, respectively. These radiation doses are for Gallium Ga 68 Gozetotide Injection alone. If CT or a transmission source are used for attenuation correction, the radiation dose will increase by an amount that varies by technique. [See table below.]

Table 1: Estimated Radiation Absorbed Dose per Injected Activity in Selected Organs and Tissues of Adults after Intravenous Administration of Gallium Ga 68 Gozetotide Injection
OrganAbsorbed dose (mGy/MBq)
MeanSD
Adrenals0.01560.0014
Brain0.01040.0011
Breasts0.01030.0011
Gallbladder0.01570.0012
Lower Colon0.01340.0009
Small Intestine0.01400.0020
Stomach0.01290.0008
Heart0.01200.0009
Kidneys0.37140.0922
Liver0.04090.0076
Lungs0.01110.0007
Muscle0.01030.0003
Pancreas0.01470.0009
Red Marrow0.01140.0016
Skin0.00910.0003
Spleen0.06500.0180
Testes0.01110.0006
Thymus0.01050.0006
Thyroid0.01040.0006
Urinary Bladder0.09820.0286
Total Body0.01430.0013
Effective Dose (mSv/MBq)0.01690.0015

Preparation and administration

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Your numbers for gallium ga-68 gozetotide. Take vial strength, diluent, and limits from the label below.

Basis

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Recommended Dosage and Administration Instructions Recommended Dosage In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection. Administration Use aseptic technique and radiation shielding when withdrawing and administering Gallium Ga 68 Gozetotide Injection.

Calculate the necessary volume to administer based on calibration time and required dose. Inspect Gallium Ga 68 Gozetotide Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored. Gallium Ga 68 Gozetotide Injection may be diluted with sterile 0.9% Sodium Chloride Injection, USP.

Assay the final dose immediately before administration to the patient in a dose calibrator. After injection of Gallium Ga 68 Gozeotide Injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP to ensure full delivery of the dose. Dispose of any unused drug in a safe manner in compliance with applicable regulations.

Unless contraindicated, a diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters.

Patient Preparation Prior to PET Imaging Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Gallium Ga 68 Gozeotide Injection and to continue to drink and void frequently following administration to reduce radiation exposure, particularly during the first hour after administration [see Warnings and Precautions ] .

Drug interactions

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Label text (1 paragraph)

Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Contraindications

None None ( 4 )

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Gallium Ga 68 Gozetotide Injection is not indicated for use in females. There are no available data with Gallium Ga 68 Gozetotide Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including Gallium Ga 68 Gozetotide Injection, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide Injection.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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