Flotufolastat f 18 (Intravenous)

Flotufolastat F 18 injection is used with a PET scan (positron emission tomography) to look at prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. It is used in patients who may have metastasis (cancer that has spread to other parts of the body) and are candidates for initial treatment, as well as in those with suspected recurrence (cancer that keeps coming back) based on a higher serum prostate-specific antigen (PSA) level.

Flotufolastat F 18 is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that can be used to find and treat certain diseases or to study how the body's organs work.

This medicine must 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 checks you closely while you are receiving this medicine. This will help your doctor see if the medicine is working properly and to 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, any risks of the test must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. Additionally, other factors may affect test results. For this test, 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 health care professional know if you have other types of 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 conducted on the relationship of age to the effects of flotufolastat f 18 injection in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any problems specific to older adults that would limit the usefulness of flotufolastat f 18 injection in the elderly.

Breast Feeding

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

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine in relation to food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

• Blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

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

Rare

• Diarrhea
• pain, redness, or irritation at the injection site

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.

• Posluma

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 the first few hours after the PET scan.