Piflufolastat f 18 (Intravenous)

Piflufolastat F 18 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 who might have metastasis (cancer that has spread to other parts of the body) and are candidates for initial treatment, as well as to those with suspected recurrence (cancer that keeps coming back) indicated by a higher serum prostate-specific antigen (PSA) level.

Piflufolastat F 18 is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to locate and treat certain diseases or to examine 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 see if the medicine is working properly and decide if you should keep receiving it.

This medicine may cause serious allergic reactions, which can be life-threatening and need immediate medical attention. Contact your doctor right away if you have trouble breathing or swallowing, a fast heartbeat, skin itching, a rash, redness, or swelling of the face, throat, or tongue after you receive the injection.

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 reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

Appropriate studies have not been done on how age affects the effects of piflufolastat f 18 injection in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of piflufolastat f 18 injection in this age group.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all. In other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor may want 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]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine 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 may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

Incidence not known

• Difficulty with breathing or swallowing
• Fast heartbeat
• Skin itching, rash, or redness
• Swelling of the face, throat, or tongue

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used 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, are bothersome, or if you have any questions about them:

Less common

• Change in taste
• Headache
• Loss of taste
• Unusual tiredness or weakness

Incidence not known

• 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 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.

• Pylarify

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

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.