Gallium ga 68 psma-11 (Intravenous)

Gallium Ga 68 PSMA-11 injection is used alongside 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 who might have metastasis (cancer that has spread to other parts of the body) and are candidates for initial treatment, to patients who may have recurrence (cancer that keeps coming back) based on a higher serum prostate-specific antigen (PSA) level, and to help choose treatment options for patients with metastatic (cancer that has spread) prostate cancer who may 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 locate and treat certain diseases or to study how the body’s organs work.

This medicine should only be given 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 receiving 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, it is important to consider the risks of the test against the benefits it may provide. This is a decision you and your doctor will make together. Additionally, other factors may influence the results of the test. For this test, please consider the following:

Allergies

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

Pediatric

Appropriate studies have not been done on how age affects the results of Illuccix® and Locametz® in children. Safety and effectiveness have not been established.

The use of gallium Ga 68 PSMA-11 injection in children is not indicated.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of gallium Ga 68 PSMA-11 injection in the elderly.

Breast Feeding

There are no sufficient studies in women to assess the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other situations, two different medicines can be used together even if there may be an interaction. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how your medicine may interact with food, alcohol, or tobacco.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Some side effects might happen that usually do not require medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to provide ways to prevent or lessen 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 health care 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.