Data from FDA - Curated by EPG Health - Last updated 02 June 2018

Indication(s)

1 INDICATIONS AND USAGE Neuraceq is indicated 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. A negative Neuraceq scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations. Limitations of Use • A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. • Safety and effectiveness of Neuraceq have not been established for: • Predicting development of dementia or other neurologic conditions; • Monitoring responses to therapies. Neuraceq™ is a radioactive diagnostic agent indicated 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. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations. Limitations of Use • A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. • Safety and effectiveness of Neuraceq have not been established for: • Predicting development of dementia or other neurologic conditions • Monitoring responses to therapies

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Advisory information

contraindications
4 CONTRAINDICATIONS None None
Adverse reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions were: injection site reaction consisting of erythema (1.7 %), irritation (1.1 %), and pain (3.4 %). To report SUSPECTED ADVERSE REACTIONS, contact Piramal at 1‑855-545-5245 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 1090 administrations of Neuraceq to 872 subjects. 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 1% of subjects) during Neuraceq clinical trials are shown in Table 2. Table 2 Adverse Reactions with a Frequency ≥1% Reported in Clinical Trials (n = 1090 Administrations in 872 Subjects) Adverse drug reaction n (%) Injection / application site erythema 18 (1.7) Injection site irritation 12 (1.1) Injection site pain 37 (3.4)

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Use appropriate radiation handling measures (2.1). • The recommended dose is 300 MBq (8.1 mCi) as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL (2.2) • Obtain 15-20 minute PET images starting from 45 to 130 minutes after intravenous administration (2.3) • Image interpretation: refer to full prescribing information (2.4) • The radiation absorbed dose from a 300 MBq (8.1 mCi) dose of Neuraceq is 5.8 mSv in an adult (2.5) 2.1 Radiation Safety - Drug Handling Neuraceq is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.2) ] . Use waterproof gloves and effective shielding, including lead-glass syringe shields when handling and administering Neuraceq. Radiopharmaceuticals, including Neuraceq, should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. 2.2 Recommended Dosing and Administration Instructions 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. The dose may vary depending on the patient's body weight, and image acquisition parameters [see Clinical Studies (14) ]. ­- Inspect the radiopharmaceutical dose solution prior to administration and do not use it if it contains particulate matter ­- Use aseptic technique and radiation shielding to withdraw and administer Neuraceq solution. ­- Measure the activity of Neuraceq with a dose calibrator immediately prior to injection. ­- Do not dilute Neuraceq ­- The injection must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artifacts. Verify patency of the indwelling catheter by a saline test injection prior to administration of Neuraceq. - An injection (6 sec/mL) into a large vein in the arm is recommended, followed by a saline flush of approximately 10 mL. - Dispose of unused product in a safe manner in compliance with applicable regulations 2.3 Image Acquisition Guidelines Acquire PET images over 15 to 20 minutes starting 45 to 130 minutes after Neuraceq injection. Keep the patient supine with the head positioned to center the brain, including the cerebellum, in the PET scanner field of view. Reduce head movement with tape or other flexible head restraints if necessary. Reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2 and 3 mm. 2.4 Image Display and Interpretation Neuraceq images should be interpreted only by readers who successfully complete Electronic Media- or In-Person Training provided by the manufacturer [see Warnings and Precautions (5.1) ]. The objective of Neuraceq image interpretation is to estimate β-amyloid neuritic plaque density in brain gray matter, not to make a clinical diagnosis. Image interpretation is performed independently of a patient’s clinical features and relies upon the recognition of image features in certain brain regions. Image Display PET images should be displayed in the transaxial orientation using gray scale or inverse gray scale. The sagittal and coronal planes may be used for additional orientation purposes. CT or MR images may be helpful for anatomic reference purposes. However, visual assessment should be performed using the axial planes according to the recommended reading methodology. Image Interpretation Interpretation of the images is made by visually comparing the activity in cortical gray matter with activity in adjacent white matter. Regions displayed in the PET images which ‘anatomically’ correspond to white matter structures (e.g., the cerebellar white matter or the splenium) should be identified to help the readers orient themselves. Images should be viewed and assessed in a systematic manner, starting with the cerebellum and scrolling up through the lateral temporal and frontal lobes, the posterior cingulate cortex/precuneus, and the parietal lobes. For a gray matter cortical region to be assessed as showing ‘tracer uptake’, the majority of slices from the respective region must be affected. For each patient, the PET image assessment is categorized as either “β-amyloid-positive” or “β-amyloid-negative”. This determination is based on the assessment of tracer uptake in the gray matter of the following four brain regions: the temporal lobes, the frontal lobes, the posterior cingulate cortex/precuneus, and the parietal lobes; according to the following ‘rules for assessment’ [see Warnings and Precautions (5.1) ]: β-amyloid negative - tracer uptake (i.e., signal intensity) in gray matter is lower than in white matter in all four brain regions (no β-amyloid deposition) β-amyloid positive - smaller area(s) of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin involving the majority of the slices within at least one of the four brain regions (“moderate” β-amyloid deposition), or a large confluent area of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin and involving the entire region including the majority of slices within at least one of the four brain regions (“pronounced” β-amyloid deposition). There is no known clinical or histopathologic correlation distinguishing “moderate” from “pronounced” β-amyloid deposition. Examples of positive and negative scans for each of the four brain regions are illustrated in Figure 1. Figure 1 Axial view of negative (top row) and positive (bottom row) Neuraceq PET scans Cerebellum: A contrast between the white matter (arrows) and gray matter is seen in both negative and positive scans. Extracerebral tracer uptake in scalp and in the posterior sagittal sinus (arrowhead) can be seen. Lateral temporal lobes: Spiculated or “mountainous” appearance of the white matter (arrows) is seen in the negative scan, and radioactive signal does not reach the outer rim of the brain (dashed line) due to lower tracer uptake in the gray matter. The positive scan shows a “plumped”, smooth appearance of the outer border of the brain parenchyma (dashed line) due to tracer uptake in the gray matter. Frontal Lobes: Spiculated appearance of the white matter in the frontal lobes (arrows) is seen in the negative scan. The positive scan shows the tracer uptake in these regions has a “plumped”, smooth appearance due to the increased gray matter signal (dashed line). Posterior cingulate/precuneus: Adjacent and posterior to the splenium (arrow), these regions appear as a hypo-intense “hole” (circle) in the negative scan, whereas this hole is “filled-up” (circle) in the positive scan. Parietal lobes: In the negative scan, the midline between the parietal lobes can be easily identified (long arrow); white matter has a spiculated appearance (short arrow) with low signal near the outer rim of the brain (dashed line). In the positive scan, the midline between the parietal lobes is much thinner. The cortical areas are “filled-up” and are smooth in appearance as tracer uptake extends to the outer rim of the brain. Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortex, or image blur. If a co-registered computerized tomography (CT) image is available, the CT image may be used to clarify the relationship of the Neuraceq uptake and the gray matter anatomy. figure 2.5 Radiation Dosimetry The estimated radiation absorbed doses for adults from intravenous injection of Neuraceq are shown in Table 1. Table 1 Estimated Radiation Absorbed Doses from Intravenous Injection of Neuraceq Organ/Tissue Mean Absorbed Radiation Dose per Unit Administered Activity [mcGy/MBq] Adrenals 13 Brain 13 Breasts 7 Gallbladder Wall 137 Heart Wall 14 Kidneys 24 Liver 39 Lower Large Intestine-Wall 35 Lungs 15 Muscle 10 Osteogenic Cells 15 Ovaries 16 Pancreas 14 Red Marrow 12 Skin 7 Small Intestine 31 Spleen 10 Stomach Wall 12 Testes 9 Thymus 9 Thyroid 8 Upper Large Intestine-Wall 38 Urinary Bladder Wall 70 Uterus 16 Total Body 11 Effective Dose (mcSv/MBq) 19 The effective dose resulting from a 300 MBq (8.1 mCi) administration of Neuraceq in adult subjects is 5.8 mSv. The use of a CT scan to calculate attenuation correction for reconstruction of Neuraceq images (as done in PET/CT imaging) will add radiation exposure. Diagnostic head CT scans using helical scanners administer an average of 2.2 ± 1.3 mSv effective dose (CRCPD Publication E-07-2, 2007). The actual radiation dose is operator and scanner dependent. Thus, the total combined radiation exposure from Neuraceq administration and subsequent scan on a PET/CT scanner is estimated to be 8 mSv.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: It is not known whether Neuraceq can cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Animal reproduction studies have not been conducted with Neuraceq. All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. Neuraceq should be given to a pregnant woman only if clearly needed. Assess pregnancy status before administering Neuraceq to a female of reproductive potential. 8.3 Nursing Mothers It is not known whether Neuraceq is excreted in human milk. Because many drugs are excreted into human milk and because of the potential for radiation exposure to nursing infants from Neuraceq, avoid use of the drug in a breastfeeding mother or have the mother temporarily interrupt breastfeeding for 24 hours (>10 half-lives of radioactive decay for the F 18 isotope) after exposure to Neuraceq. If breastfeeding is interrupted, the patient should pump and discard her breast milk and use alternate nutrition sources (e.g. stored breast milk or infant formula) for 24 hours after the administration of Neuraceq. 8.4 Pediatric Use Neuraceq is not indicated for use in pediatric patients. 8.5 Geriatric Use Of the 872 subjects in clinical studies of Neuraceq, 603 (69%) were 65 years or over, while 304 (35%) were 75 years or over. No overall differences in safety were observed between these subjects and younger subjects.

Interactions

7 DRUG INTERACTIONS Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

More information

Category Value
Authorisation number NDA204677
Agency product number TLA7312TOI
Orphan designation No
Product NDC 54828-001
Date Last Revised 26-06-2017
Type HUMAN PRESCRIPTION DRUG
Storage and handling 16.2 Storage and Handling Store Neuraceq at room temperature 25°C (77°F); excursions permitted to 2°C to 42°C (36°F to 108°F). The product does not contain a preservative. Store Neuraceq within the original container or equivalent radiation shielding. Neuraceq must not be diluted. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
Marketing authorisation holder Piramal Imaging, SA