Fluciclovine f 18 (Intravenous)

Fluciclovine F 18 injection is used to help diagnose recurrent prostate cancer. It is used in a procedure called positron emission tomography (PET) scan to find tumors.

Fluciclovine F 18 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 receiving this medicine. This will help your doctor see if the medicine is working properly and to determine if you should keep receiving it.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and need immediate medical attention. Contact your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the injection.

While receiving this medicine, you will be exposed to radiation. If you have any questions about this, talk to your doctor.

In deciding to use a diagnostic test, you and your doctor need to consider the risks of the test against the benefits it may provide. Other factors may also influence test results. For this test, keep the following in mind:

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, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how fluciclovine F 18 injection affects children. The safety and effectiveness in the pediatric population have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of fluciclovine 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 while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods because interactions may occur. Drinking alcohol or using tobacco with some 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. Although not all of these side effects may occur, if they do, they may need medical attention.

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

Incidence not known

• Chest tightness
• cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, throat, or tongue
• trouble breathing
• unusual tiredness or weakness

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, are bothersome, or if you have any questions about them:

Rare

• Change in taste
• loss of taste
• redness or pain 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.

• Axumin

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.

Avoid significant exercises for at least 1 day before the PET scan.

Do not eat or drink anything for at least 4 hours before you receive this medicine (other than small amounts of water for taking other medicines).

You will need to urinate for at least 30 to 60 minutes before you receive this medicine and then avoid urinating after the PET scan has been completed.