Florbetaben f 18 (intravenous route)


    Brand Name

    US Brand Name

    Neuraceq


    Description

    Florbetaben F 18 injection is used in adults to help diagnose Alzheimer's disease and other cognitive (mental) problems. It is used in for 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, which may be used to find and treat certain diseases or to study the function of the body's organs.

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

    This product is available in the following dosage forms:

    • Solution

    Before Using

    In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things 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 tell your health care professional 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

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

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of florbetaben F 18 injection in the elderly.

    Breastfeeding

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

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


    Proper Use

    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.


    Precautions

    It is very important that your doctor check your progress very closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive 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 tell your doctor that you are pregnant or breastfeeding before using this medicine.


    Side Effects

    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.






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