Illuccix

Illuccix is a radioactive diagnostic agent used 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 recurrences based on an elevated serum prostate-specific antigen (PSA) level
• for the selection of patients who are indicated for PSMA-directed therapy.

Illuccix is prepared by a healthcare provider and then injected 50 to 100 minutes before imaging.

Illuccix (kit for the preparation of gallium Ga-68 gozetotide for injection) gained FDA approval on December 17, 2021. Radioactive Ga 68 is not included in the kit. The kit is non-radioactive until prepared with Ga 68.

• Once prepared, Illuccix contains a small amount of radioactive material, which decreases to minimal levels within 6 hours and is then eliminated from the body through urine.

Illuccix is administered as a bolus intravenous injection.

• Your healthcare provider will use sterile technique and radiation safety protocols when handling and giving Illuccix.
• Your healthcare provider will instruct you to drink plenty of water before your PET scan and to continue drinking fluids and urinating frequently in the hours after receiving Illuccix. This helps flush the radioactive tracer from the body and reduces radiation exposure.
• You may be given a diuretic (water pill) at the time of injection to help eliminate the radiotracer.

The PET scan will start 50-100 minutes after the Illuccix injection. Your healthcare provider will request that you urinate just before starting the scan.

• The scan will start at the pelvis and move upward toward the head.

See the full prescribing information for complete preparation, administration, imaging, and radiation safety details.

Illuccix (gallium Ga 68 gozetotide injection) is not for use in women.

Before receiving Illuccix, tell your healthcare provider about all your medical conditions, including if you:

• Take androgen deprivation therapy.

The safety and effectiveness of Illuccix in children have not been established.

Pregnancy

Illuccix is not approved for women, and there is no data on the effects of Illuccix in pregnant women. Radiation exposure may harm fetal development depending on timing and dose.

Breastfeeding

Illuccix is not approved for women. There is no data on whether the drug passes into breast milk or affects nursing infants or milk production.

Illuccix works by attaching to PSMA proteins found on prostate cancer cells. During a PET scan, it highlights these proteins wherever they appear in the body, allowing doctors to visualize where cancer is located in the body.

Illuccix (kit for the preparation of gallium Ga-68 gozetotide, for injection) belongs to the drug class called radioactive diagnostic agents.

Common Side Effects

The most common side effects of Illuccix are:

• Fatigue
• Nausea
• Diarrhea
• Constipation
• Vomiting
• Dizziness.

Side effects typically occurred in ≤1.2% of people in clinical trials.

Some patients also experience pain at the injection site.

Serious Side Effects and Warnings

Illuccix (gallium Ga 68 gozetotide injection) may cause the following serious side effects:

• Risk of PET Scan Misinterpretation. There is a risk that your PET scan image with Illuccix may be misinterpreted. 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 Illuccix PET scan may be affected by other factors, like the presence of other tissue types, PSMA levels, and the site of disease. Your healthcare provider will consider other information to confirm prostate cancer and determine treatment.
• Radiation Risks. Illuccix involves exposure to small amounts of radioactivity, and long-term cumulative radiation exposure is associated with increased risk for cancer. Your healthcare provider will use safe handling techniques to minimize radiation exposure.

You should drink water to hydrate before the scan and urinate immediately before the procedure and as often as possible during the first hours after the procedure to help reduce radioactivity exposure.

Notes:

This is not a complete list of side effects. See the Illuccix Prescribing Information for more information. You are encouraged to report side effects to Telix Pharmaceuticals (US) at 1-844-455-8638 ([email protected]) or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dose of Illuccix for Prostate Cancer PET Scanning

• 111 MBq to 259 MBq (3 mCi to 7 mCi) as a bolus intravenous injection.
• Initiate imaging 50 to 100 minutes after Illuccix administration.

Tell your healthcare provider about all the medications you take, including over-the-counter supplements and herbal remedies. Especially tell them if you take:

• Androgen deprivation therapy (ADT). ADT and other treatments that target male hormones (such as androgen receptor blockers) may alter how Illuccix is absorbed by prostate cancer cells. It is unknown how these therapies affect the accuracy of Illuccix PET imaging.

This is not a complete list of interactions. See the Illuccix Prescribing Information for a complete list.

Illuccix is a 3-vial preparation kit for gallium Ga 68 gozetotide Injection. It comes in two configurations (A and B) because the Ga 68 radionuclide, sourced separately, can come from different generators or cyclotrons, each requiring a slightly different buffer to complete the radiolabeling reaction.

• Vial 1 (Gozetotide Vial) contains 25 mcg gozetotide and 10 mcg D-mannose (stabilizer) as a lyophilized powder
• Vial 2 (Acetate Buffer Vial) contains acetate buffer, either: Vial 2A in Configuration A for use with cyclotron-produced Ga 68 via GE FASTlabTM or EZAG generator Vial 2B in Configuration B for use with the ARTMS QIS or IRE generator.
• Vial 3 (Sterile Vacuumed Reaction Vial) for the collection of gallium Ga 68 chloride and radiolabeling reaction.

After radiolabeling and pH adjustment with acetate buffer and radiolabeling with Ga 68, Vial 3 is a multiple-dose vial containing up to 1,850 MBq (50 mCi) of Gallium Ga 68 Gozetotide Injection in 7.5 mL at a strength of up to247 MBq (6.7 mCi) per mL.

Manufactured by Grand River Aseptic Manufacturing, Grand Rapids, MI 49504. Distributed by Telix Pharmaceuticals (US) Inc., Fishers, IN 46037