Neuraceq (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 a 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 who has specialized training in nuclear medicine.

It is very important for your doctor to monitor your progress closely while you are receiving this medicine. This will help your doctor determine if the medicine is working properly and decide if you should keep using it.

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

It is important 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. Also, other factors may impact test results. For this test, the following should be considered:

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 carefully.

Pediatric

The use of florbetaben F 18 injection is not approved for use in children.

Geriatric

Current studies have not shown specific problems in elderly patients that would limit the effectiveness 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 using 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 might 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]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of 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 occur they may need medical attention.

Check with your doctor or nurse immediately 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. 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:

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.