Risk for Image Interpretation and Other Errors

Neuraceq™ can be used to estimate the density of β-amyloid neuritic plaque deposition in the brain. Neuraceq is an adjunct to other diagnostic evaluations. Neuraceq images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceq images. Following training, image reading errors (especially false positive) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.

Radiation Risk

Administration of Neuraceq, similar to other radiopharmaceuticals, contributes to a patient´s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Most Common Adverse Reactions

In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 978 Neuraceq administrations were injection/application site erythema (1.7%), injection site irritation (1.2%), and injection site pain (3.9%).

Medwatch link (for adverse event reporting)
http://www.fda.gov/Safety/MedWatch/default.htm


Cognitive impairment could be due to Alzheimer’s disease–or not

Knowing can help you plan the path ahead

When memory loss begins to affect daily life, knowing the cause is critical. A brain scan with Neuraceq™ gives your doctor information that can help assess your condition.

Neuraceq™ gives physicians
a “window into the brain”

A memory or thinking test can tell a doctor if you have cognitive impairment. However, it cannot tell your doctor the cause of the problem.

An image of the brain, or a “scan,” gives your doctor a non-invasive way to look inside the brain to see what might be causing memory and thinking problems.

The most common cause of cognitive impairment due to a neurodegenerative disease is Alzheimer's disease (AD). In AD, sticky clumps of protein called beta(β)‐amyloid plaques build up in the brain, affecting the way the brain works.

Neuraceq is a radioactive tracer. It is designed to stick to β-amyloid neuritic plaques in the brain for a short time. When used with PET scanning to create an image of your brain, Neuraceq can reveal the presence or absence of β-amyloid plaque.

Neuraceq has been well-studied

Neuraceq was studied in the largest clinical trial program for this type of agent.
This program was reviewed by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).

It was demostrated that Neuraceq is an accurate diagnostic tool for the estimation of β-amyloid neuritic plaque in the living brain

Neuraceq is radioactive but only stays active in the brain for a short time. More than half of it will be eliminated from the body within 2 hours of being injected

No serious side effects related to Neuraceq use have been reported. All side effects were mild to moderate and of short duration

Preparing for your Neuraceq™ PET scan

Wear comfortable clothing with no metal parts. You should not wear jewelry. You may be asked to remove items containing metal, such as eyeglasses

Be sure to bring a list of all the medications you are currently taking, and be ready to share your medical history

What to expect

A Neuraceq PET scan involves an injection into a vein in your arm and a short scan. After the injection,
some saline solution (salt water) may be injected to help the Neuraceq move more quickly
through the bloodstream.

The Neuraceq injection is given through an IV (intravenous) tube

The Neuraceq PET scan can be done 45 to 130 minutes after injection and usually lasts 15 to 20 minutes

During the scan, you will lie down on a table while the PET-scanner camera passes overhead

After the scan, an imaging specialist will view the results, write a report, and send it to your doctor

A negative or positive scan can
help give you and your doctor
clarity to move forward

During your follow-up appointment, your doctor will review your Neuraceq™ PET scan along with results from other tests to figure out whether your cognitive impairment may be due to AD or something else.

A positive scan

If the Neuraceq PET scan is positive, it can help your doctor figure out if you have AD.

β-amyloid neuritic plaques are sticky clumps of protein that form in the brains of people who have AD. However, β-amyloid plaques may also be present in other diseases and in people without cognitive symptoms. These plaques affect the way the brain works. The presence of β‐amyloid plaques is a key component for the confirmation of AD.

A negative scan

If the Neuraceq PET scan is negative, your doctor may consider different causes of cognitive impairment that are not due to AD.

Get the most out of
your discussion

Here are some things to help to prepare for your appointment and questions to ask in order to understand the results of your scan. You may want to consider asking a friend or family member to support you.

  • Write down a list of all medications you are taking
  • Write down important information about your medical history
  • Come up with a list of questions you may have for the doctor
  • Take notes during the appointment
  • What did my Neuraceq PET scan show?
  • What do my results mean?
  • What steps do I need to take?
  • What else do you recommend?

Frequently Asked Questions
about Neuraceq™

Who is Neuraceq for?

Neuraceq is for adults who are experiencing unexplained memory loss or problems with thinking. A Neuraceq PET scan can give your phyician important information about what could be causing your memory or thinking problems.

Where can I get additional information about Neuraceq?

If you have not found the information you need on this website, or want more information about Neuraceq, please speak with your doctor and refer to the Full Prescribing Information.

You can also contact us at:

Piramal Pharma Inc.
15 Court Square
Suite 1000
Boston, MA 02108
Phone: 617-725-0070

General Information: info.imaging@piramal.com

Adverse Event Reporting: You are encouraged to report side effects of Neuraceq™ by calling 1-855-545-5245. Suspected adverse reactions can also be reported directly to the FDA by visiting MedWatch or calling 1-800-FDA-1088.

Does Neuraceq diagnose Alzheimer's disease?

Your doctor will use your Neuraceq PET scan results, along with other tests and observations, to help make a diagnosis. A negative scan is not consistent with a diagnosis of AD and allows your doctor to explore other possible causes of your memory or thinking problems. A positive Neuraceq PET scan reveals the presence of β-amyloid plaques in the brain. β-amyloid plaques are sticky clumps of protein that are a key indicator of AD, but are also sometimes seen in other diseases and in healthy people without memory problems.

What are some of the benefits of getting a Neuraceq PET scan?

Neuraceq alone does not diagnose AD, it should be used in conjunction with other tests done by your doctor to make a diagnosis. Having a diagnosis allows you (and/or your loved one) to be involved in planning the path forward. Being able to participate early in the planning of care and other important decisions, such as finances, allows you to have more control in making the decisions that are right for you.

How can I get a Neuraceq PET scan?

Only your doctor can determine if a Neuraceq PET scan is appropriate for you.

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Important Safety Information

Risk for Image Misinterpretation and Other Errors
Neuraceq can be used to estimate the density of β-amyloid neuritic plaque deposition in the brain. Neuraceq is an adjunct to other diagnostic evaluations. Neuraceq images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceq images. Following training, image reading errors (especially false positive) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.


Radiation Risk
Administration of Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Most Common Adverse Events In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Neuraceq administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).


Most Common Adverse Reactions
In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Neuraceq administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).


Medwatch link (for adverse event reporting)
http://www.fda.gov/Safety/MedWatch/default.htm