Flortaucipir f 18 (Intravenous)

Flortaucipir F 18 injection is used to help diagnose Alzheimer's disease in adults who have 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. Flortaucipir F 18 injection is not used to detect chronic traumatic encephalopathy (CTE).

Flortaucipir 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 very important that your doctor monitors your progress closely while you are receiving this medicine. This will help your doctor determine if the medicine is working correctly and whether you should keep receiving 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 before receiving 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 impact test results. For this test, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know 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

Appropriate studies have not been conducted on how age affects the effects of flortaucipir F 18 injection in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of flortaucipir 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

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medications.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime or with specific types of food, as interactions may happen. 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 needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, they may need medical attention.

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

Rare

• Blurred vision
• dizziness
• nervousness
• headache
• pounding in the ears
• slow or fast heartbeat

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:

Less common

• 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 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.

• Tauvid

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins just before you have a PET scan.