68Ga-PSMA-11a PET/CT was well-tolerated with few adverse reactions, all ≤1%
The safety profile of Illuccix® has been established based on 3 prospective studies of another formulation of gallium Ga 68 gozetotide in patients with prostate cancer.1
- No serious adverse reactions were attributed to 68Ga-PSMA-11 Injection
- In clinical trials that evaluated 960 patients at initial staging (PSMA-PreRP) and BCR (PSMA-BCR), adverse reactions occurred in less than 1% of people. The most common adverse reactions were nausea, diarrhea, and dizziness
- In the VISION trial where 1003 patients were assessed for eligibility of PSMA-directed 177Lu radioligand therapy, the most commonly reported adverse reactions occurring at a rate of ≥0.5% were fatigue (1.2%), nausea (0.8%), constipation (0.5%) and vomiting (0.5%). Adverse reactions occurring at a rate of <0.5% were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills
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
BCR, biochemical recurrence; PreRP, preprostatectomy; PSMA, prostate-specific membrane antigen.
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
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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.