68Ga-PSMA-11 PET/CT was well-tolerated with few adverse reactions, all <1%a
The safety of Illuccix® has been established based on studies of another formulation of gallium Ga 68 gozetotide in patients with prostate cancer. These studies involved 960 patients, each receiving one dose of 68Ga-PSMA-11 injection.
- No serious adverse reactions were attributed to 68Ga-PSMA-11 Injection
- The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%
a 68Ga-PSMA-11 is also known as gallium Ga 68 gozetotide.
Biodistribution and elimination of 68Ga-PSMA-11
- Biodistribution: Intravenously injected 68Ga-PSMA-11 is cleared from the blood and is accumulated preferentially in the liver (15%), kidneys (7%), spleen (2%), and salivary glands (0.5%) and also in the adrenals and prostate1
- Elimination: A total of 14% of the injected dose is excreted in urine in the first 2 hours post injection1
a 68Ga-PSMA-11 is also known as gallium Ga 68 gozetotide.
Physical Characteristics
68Ga decays with a half-life of 68 minutes to stable 68Zn1
The tables below display the principal radiation emission data and physical decay of 68Ga.
Principal Radiation Emission Data (>1%) for 68Ga
Radiation/ Emission
%
Disintegration
Mean Energy (MeV)
beta+
88%
0.8360
beta+
1.1%
0.3526
gamma
178%
0.5110
gamma
3.0%
1.0770
X-ray
2.8%
0.0086
X-ray
1.4%
0.0086
Physical Decay Chart for 68Ga
Minutes
Fraction Remaining
0
1
15
0.858
30
0.736
60
0.541
90
0.398
120
0.293
180
0.158
360
0.025
See full Prescribing Information
To report suspected adverse reactions for 68Ga-PSMA-11 Injection, call 1-844-455-8638 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.