Florbetaben f 18 (Intravenous)

Florbetaben F 18 injection is used in adults to help diagnose Alzheimer's disease and other cognitive (mental) problems. It is used in a procedure called positron emission tomography (PET) scan to help your doctor see an image of your brain.

Florbetaben 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 function.

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

It is crucial for your doctor to monitor your progress closely while you are taking this medicine. This helps your doctor determine if the medicine is effective and if you should keep using it.

While you are taking this medicine, you will be exposed to radiation. If you have any questions about this, please speak with your doctor.

Make sure to inform your doctor if you are pregnant or breastfeeding before using this medicine.

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, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional 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

Use of florbetaben f 18 injection is not indicated for use in children.

Geriatric

Appropriate studies performed to date have not shown any specific problems in elderly patients that would limit the usefulness of florbetaben f 18 injection.

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, while in other situations, two different medicines may be used together even if an interaction could happen. In these cases, your doctor may want to adjust the dose, or other precautions may be needed. Tell 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 the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional the use of 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, they might need medical attention.

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

Incidence not known

• Fast heartbeat
• Fever
• Hives, itching, or rash
• Hoarseness
• Irritation
• Joint pain, stiffness, or swelling
• Redness of the skin
• Swelling of the eyelids, face, lips, hands, or feet
• Tightness in the chest
• Troubled breathing or swallowing

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. Your health care professional may also be able to tell you how 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

• Pain, redness, or skin 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.

• Neuraceq

Available Dosage Forms:

• Solution

Therapeutic Class: Radiopharmaceutical Agent

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.