Locametz (Intravenous)

Gallium Ga 68 PSMA-11 injection is used with a PET scan (positron emission tomography) to look for prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. It is given to patients with suspected metastasis (cancer that has spread to other parts of the body) who are candidates for initial treatment, to patients with suspected recurrence (cancer that keeps coming back) based on an increased serum prostate-specific antigen (PSA) level, and to help select patients with metastatic (cancer that has spread) prostate cancer who are to receive lutetium Lu 177 vipivotide tetraxetan PSMA-directed treatment.

Gallium Ga 68 PSMA-11 is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to find and treat certain diseases or to study how the body's organs work.

This medicine is to be given only by or under the direct supervision of a doctor who has specialized training in nuclear medicine.

It is very important that your doctor monitors you closely while you are getting this medicine. This will help your doctor determine if the medicine is working correctly and decide if you should keep receiving it.

While receiving this medicine, you will be exposed to radiation and have an increased risk of cancer. If you have any questions about this, talk to your doctor.

In deciding to use a diagnostic test, you and your doctor must consider the risks of the test compared to its benefits. Other factors may also affect test results. For this test, keep the following points in mind:

Allergies

Inform your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the use of Illuccix® and Locametz® in children. Safety and effectiveness have not been proven.

Using gallium Ga 68 PSMA-11 injection in children is not indicated.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the effectiveness of gallium Ga 68 PSMA-11 injection in the elderly.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor might want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or over-the-counter (OTC) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Not all side effects may occur, but if they do, you may need medical attention.

Some side effects may happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Unusual tiredness or weakness

Rare

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Constipation
• Diarrhea
• Dizziness
• Dry mouth
• Nausea
• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Illuccix
• Locametz

Available Dosage Forms:

• Solution

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have a PET scan.

Drink enough water to be hydrated before the PET scan.

You will need to urinate right away and as often as possible for at least 1 hour after the PET scan.