Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection)

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 68}Ga-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 68}Ga-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

0.858

0.736

0.541

0.398

120

0.293

180

0.158

360

0.025

See full Prescribing Information

To report suspected adverse reactions for⁶⁸Ga-PSMA-11 Injection, call 1-844-455-8638 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

NEXT: Preparation

Indications and Usage

Illuccix^®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy

with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

WARNINGS AND PRECAUTIONS

Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Radiation Risks
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.

DRUG INTERACTIONS

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.