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Neuraceq

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Neuraceq

Neuraceq Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Neuraceq (florbetaben F 18) Injection is a molecular imaging agent used for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. Common side effects include injection site reactions such as skin redness, irritation, and pain.

The recommended dose of Neuraceq is 300 MBq (8.1 mCi), maximum 30 mcg mass dose, administered as a single slow intravenous bolus (6 sec/mL) in a total volume of up to 10 mL. Neuraceq may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Neuraceq should be administered only if prescribed. It is unknown if it will harm a fetus. It is unknown if this drug passes into breast milk. Because of the potential for radiation exposure to nursing infants from Neuraceq, breastfeeding mothers should avoid use of this drug or temporarily interrupt breastfeeding and should pump and discard breast milk and use alternate nutrition sources (e.g. stored breast milk or infant formula) for 24 hours after the administration of Neuraceq. Consult your doctor before breastfeeding.

Our Neuraceq (florbetaben F 18) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Neuraceq FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rate observed in clinical practice.

The overall safety profile of Neuraceq is based on data from 978 administrations of Neuraceq to 872 subjects and 12 subjects who received vehicle only. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema, irritation and pain. All adverse reactions were mild to moderate in severity and of short duration. The most commonly reported adverse reactions (occurring in at least 0.5% of subjects) during Neuraceq clinical trials are shown in Table 2.

Table 2 : Adverse Reactions with a Frequency ≥ 0.5% Reported in Clinical Trials (n = 978 Administrations in 872 Subjects)

Adverse drug reaction n (%)
Injection / application site erythema 17 (1.7)
Injection site irritation 12 (1.2)
Injection site pain 38 (3.9)

Read the entire FDA prescribing information for Neuraceq (Florbetaben F 18 Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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