1 INDICATIONS AND USAGE ILLUCCIX, after radiolabeling with Ga 68, is 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ( 1 )

6 ADVERSE REACTIONS The most commonly reported adverse reactions (incidence ≥ 0.5%) include fatigue, nausea, constipation, and vomiting.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Telix Pharmaceuticals (US) Inc.

at 1-844-455-8638 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ILLUCCIX has been established based on three prospective studies of gallium Ga 68 gozetotide in patients with prostate cancer (i.e., Studies 1, 2, and 3).

Adverse reactions from these studies are reported below.

In Studies 1 and 2 using another formulation of gallium Ga 68 gozetotide injection, 960 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount (mean ± SD) of radioactivity 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi) [ see Clinical Studies ( 14.1 , 14.2 ) ].

The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In a randomized, multicenter, open-label clinical study (NCT03511664, referred to as Study 3) in which gallium Ga 68 gozetotide was used to identify PSMA-positive patients on PET imaging to determine eligibility for PSMA-directed therapy, 1,003 patients with progressive metastatic castration-resistant prostate cancer (mCRPC) received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi).

Patients were males with median age of 70 years (range, 40 to 94 years), were White (87%), Black or African American (7%), or Asian (2.4%), and had median baseline PSA levels of 74 ng/mL (range, 0 to 8,995 ng/mL).

Adverse reactions occurring at ≥ 0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in Study 3 are presented in Table 3.

Table 3 : Adverse Reactions (≥ 0.5%) in Patients with Metastatic Prostate Cancer Who Received Gallium Ga 68 Gozetotide Injection in Study 3 Adverse Reaction Gallium Ga 68 Gozetotide Injection N = 1,003 n (%) General disorders Fatigue 12 (1.2) Gastrointestinal disorders Nausea 8 (0.8) Constipation 5 (0.5) Vomiting 5 (0.5) Adverse reactions occurring at a rate of < 0.5% in the study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ILLUCCIX.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General Disorders and Administration Site Conditions : injection site pain.