Neuraceq Florbetaben F 18 135 mCi/mL Injection, Solution
Past resolved recalls for this product (1)
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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118 mg / 1 mL
UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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4.4 mg / 1 mL
UNII PQ6CK8PD0R
Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
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200 mg / 1 mL
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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28.8 mg / 1 mL
UNII S033EH8359
Sodium ascorbate is a salt form of vitamin C. It serves as an antioxidant to prevent degradation of other ingredients and as a pH buffer to maintain stable acidity in the medicine.
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677.5 mg / 1 mL
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $548.73 | $27,436.37 / 50 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Neuraceq 135 mCi/mLthis 54828-0001-50 | Lantheus | 1 vial | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7807135 ↗ | Drug substance | U-1497 | Mar 18, 2029 |
| US 9308284 ↗ | Drug product | — | Jul 14, 2032 |
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 54828-0001-50 You're viewing this | 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE | 2022-06-13 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE NEURACEQ is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended amount of radioactivity is 300 MBq (8.1 mCi) administered as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL. (2.2) Follow the injection with an intravenous flush of approximately 10 mL of 0.9% sodium chloride injection. (2.2) Obtain 15-minute to 20-minute PET images starting approximately 45 minutes to 130 minutes after drug administration.
(2.3) See full prescribing information for image interpretation and radiation dosimetry. (2.4, 2.5)
2.1Radiation Safety - Drug Handling Handle NEURACEQ with appropriate safety measures to minimize radiation exposure during administration [ see Warnings and Precautions ( 5.2 )]. Use waterproof gloves and effective radiation shielding, including lead-glass syringe shields when handling and administering NEURACEQ. Radiopharmaceuticals, including NEURACEQ, should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
2.2Recommended Dosing and Administration Instructions Recommended Dosage The recommended amount of radioactivity of NEURACEQ is 300 MBq (8.1 mCi) in a total volume of up to 10 mL, administered as a single slow intravenous bolus (6 sec/mL). The maximum mass dose is 30 micrograms. Follow the administration with an intravenous flush of approximately 10 mL of 0.9% sodium chloride injection.
Patient Preparation Instruct patients to hydrate before and after NEURACEQ administration and to void before imaging and frequently thereafter following NEURACEQ administration [see Warnings and Precautions ( 5.2 ) ] . Administration Use aseptic technique and radiation shielding to withdraw and administer NEURACEQ. Visually inspect NEURACEQ for particulate matter and discoloration prior to administration.
Do not use NEURACEQ if it contains particulate matter or if it is discolored. Do not dilute NEURACEQ. Measure the activity of NEURACEQ with a dose calibrator immediately prior to injection.
Verify patency of the indwelling catheter by a test flush with 0.9% sodium chloride injection prior to administration of NEURACEQ. Dispose of unused product in a safe manner in compliance with applicable regulations
2.3Image Acquisition Guideline Position the patient supine with the head positioned to center the brain, including the cerebellum, in the PET scanner field of view. Tape or other flexible head restraints may be employed to reduce head movement. Acquire 15-minute to 20-minute PET images starting 45 minutes to 130 minutes after NEURACEQ administration.
Image reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2 mm and 3 mm.
2.4Image Display and Interpretation Image Display Display images 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. Locate regions which ‘anatomically’ correspond to white matter structures (e.g., the cerebellar white matter or the splenium) for orientation. Review images 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.
Visual Assessment NEURACEQ images should be interpreted only by readers who successfully complete training provided by the manufacturer. The reader training can be accessed here: https://www.neuraceqreadertraining.com/learn. Perform image interpretation independently of the patient’s clinical features, relying on the recognition of unique image features.
Interpret NEURACEQ images based upon the di…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 50 MBq/mL to 5,000 MBq/mL (1.4 mCi/mL to 135 mCi/mL) of florbetaben F 18 in up to 50 mL volume at end of synthesis (EOS) as a clear solution in a multiple-dose vial. Injection: 50 MBq/mL to 5,000 MBq/mL (1.4 mCi/mL to 135 mCi/mL) of florbetaben F 18 in up to 50 mL volume at end of synthesis in a multiple-dose vial
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. (5.1) Radiation Risk: NEURACEQ contributes to a patient’s long-term cumulative radiation exposure. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. (2.1, 2.2, 5.2)
5.1Risk of Image Misinterpretation and Other Errors Errors may occur in the estimation of brain amyloid beta neuritic plaque density during NEURACEQ image interpretation [ see Clinical Studies ( 14 ) ]. The use of clinical information in the interpretation of NEURACEQ images has not been evaluated and may lead to an inaccurate assessment. Severe brain atrophy as well as motion artifacts that result in image distortion may limit the ability to distinguish gray and white matter on a NEURACEQ scan.
Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal [see Dosage and Administration ( 2.4 )] .
5.2Radiation Risk NEURACEQ contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration [ see Dosage and Administration ( 2.1 , 2.2 )] .
5.1Risk of Image Misinterpretation and Other Errors Errors may occur in the estimation of brain amyloid beta neuritic plaque density during NEURACEQ image interpretation [ see Clinical Studies ( 14 ) ]. The use of clinical information in the interpretation of NEURACEQ images has not been evaluated and may lead to an inaccurate assessment. Severe brain atrophy as well as motion artifacts that result in image distortion may limit the ability to distinguish gray and white matter on a NEURACEQ scan.
Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal [see Dosage and Administration ( 2.4 )] .
5.2Radiation Risk NEURACEQ contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration [ see Dosage and Administration ( 2.1 , 2.2 )] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 1%) were injection site pain, injection site erythema, and injection site irritation (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Biosciences Ltd., a Lantheus company, at 1‑833-491-2524 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 rates observed in clinical practice. The safety of NEURACEQ was evaluated in 872 adult subjects who received NEURACEQ by intravenous injection in clinical trials. Of these subjects, 724 received a single dose, 78 received two doses, and 70 received three doses at yearly intervals as part of annual repeat scanning.
Table 2 shows adverse reactions reported in 1% of these 1,090 administrations from the clinical trials. Table 2: Adverse Reactions Reported in 1% of NEURACEQ Administrations in Adults in Clinical Trials Adverse Reaction NEURACEQ N=1,090 Administrations % Injection site pain
3.4 Injection site erythema
1.7Injection site irritation 1.1
6.1Clinical 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 rates observed in clinical practice. The safety of NEURACEQ was evaluated in 872 adult subjects who received NEURACEQ by intravenous injection in clinical trials. Of these subjects, 724 received a single dose, 78 received two doses, and 70 received three doses at yearly intervals as part of annual repeat scanning.
Table 2 shows adverse reactions reported in 1% of these 1,090 administrations from the clinical trials. Table 2: Adverse Reactions Reported in 1% of NEURACEQ Administrations in Adults in Clinical Trials Adverse Reaction NEURACEQ N=1,090 Administrations % Injection site pain
3.4 Injection site erythema
1.7Injection site irritation 1.1
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on NEURACEQ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with florbetaben F 18 to evaluate its effect on female reproduction and embryo-fetal development. All radiopharmaceuticals, including NEURACEQ, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose.
If considering NEURACEQ administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation Risk Summary There are no data on the presence of florbetaben F 18 in human milk, the effects on the breastfed infant, or the effects on milk production. Exposure of NEURACEQ to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for NEURACEQ and any potential adverse effects on the breastfed child from NEURACEQ or from the underlying maternal condition.
Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of NEURACEQ Lactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for 24 hours after NEURACEQ administration (8.2).
8.4Pediatric Use The safety and effectiveness of NEURACEQ have not been established in pediatric patients.
8.5Geriatric Use Of the 872 subjects in clinical studies of NEURACEQ, 603 (69%) subjects were 65 years of age and older, while 304 (35%) subjects were 75 years of age and older. No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.
8.1Pregnancy Risk Summary There are no available data on NEURACEQ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with florbetaben F 18 to evaluate its effect on female reproduction and embryo-fetal development. All radiopharmaceuticals, including NEURACEQ, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose.
If considering NEURACEQ administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation Risk Summary There are no data on the presence of florbetaben F 18 in human milk, the effects on the breastfed infant, or the effects on milk production. Exposure of NEURACEQ to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for NEURACEQ and any potential adv…
🆘 Overdosage ▾
10 OVERDOSAGE In the event of administration of a radiation overdose with NEURACEQ, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Florbetaben F 18 binds to amyloid beta plaques in the brain and the F 18 isotope produces a positron signal that is detected by a PET scanner. 3 H-florbetaben in vitro binding experiments revealed two binding sites (K d of 16 nM and 135 nM) in frontal cortex homogenates from patients with AD. Binding of florbetaben F 18 to amyloid beta plaques in postmortem brain sections from patients with AD using autoradiography correlated with both immunohistochemical and Bielschowsky silver stains.
Florbetaben F 18 did not bind to tau or α-synuclein in tissue from patients with AD. Neither florbetaben F 18 nor non-radioactive florbetaben F 19 bound to AT8 positive tau deposited in brain tissue from patients with frontotemporal dementia (FTD), using autoradiography and immunohistochemistry, respectively.
12.2Pharmacodynamics Following intravenous administration, florbetaben F 18 crosses the human blood-brain barrier and shows differential retention in brain regions that contain amyloid beta deposits. Differences in signal intensity between brain regions showing specific and non-specific florbetaben F 18 uptake form the basis for the image interpretation method [see Dosage and Administration ( 2.4 )] .
12.3Pharmacokinetics Following intravenous administration of 300 MBq (8.1 mCi) of NEURACEQ in healthy subjects, approximately 6% of the injected radioactivity was distributed to the brain at 10 minutes post-injection. Florbetaben F 18 plasma concentrations declined by approximately 75% at 20 minutes post-injection, and by approximately 90% at 50 minutes. The F 18 in circulation during the 45-minute to 130-minute imaging window was principally in the form of polar metabolites of florbetaben.
Florbetaben F 18 was 98.5% bound to plasma proteins and was eliminated from plasma primarily via the hepatobiliary route with a mean biological half-life of approximately 1 hour. In vitro studies show that metabolism of florbetaben is predominantly catalyzed by CYP2J2 and CYP4F2. At 12 hours post-administration, approximately 30% of the injected radioactivity had been excreted in urine.
Almost all F 18 radioactivity in urine was excreted as polar metabolites of florbetaben F 18 and only trace amounts of florbetaben F 18 were detected. In in vitro studies using human liver microsomes, florbetaben did not inhibit cytochrome P450 enzymes at concentrations present in vivo . Drug Interaction Studies In vitro Effect of amyloid beta-directed therapy: donanemab and lecanemab did not alter florbetaben F 18 binding to its target.
12.1Mechanism of Action Florbetaben F 18 binds to amyloid beta plaques in the brain and the F 18 isotope produces a positron signal that is detected by a PET scanner. 3 H-florbetaben in vitro binding experiments revealed two binding sites (K d of 16 nM and 135 nM) in frontal cortex homogenates from patients with AD. Binding of florbetaben F 18 to amyloid beta plaques in postmortem brain sections from patients with AD using autoradiography correlated with both immunohistochemical and Bielschowsky silver stains.
Florbetaben F 18 did not bind to tau or α-synuclein in tissue from patients with AD. Neither florbetaben F 18 nor non-radioactive florbetaben F 19 bound to AT8 positive tau deposited in brain tissue from patients with frontotemporal dementia (FTD), using autoradiography and immunohistochemistry, respectively.
12.2Pharmacodynamics Following intravenous administration, florbetaben F 18 crosses the human blood-brain barrier and shows differential retention in brain regions that contain amyloid beta deposits. Differences in signal intensity between brain regions showing specific and non-specific florbetaben F 18 uptake form the basis for the image interpretation method [see Dosage and Administration ( 2.4 )] .
12.3Pharmacokinetics Following intravenous administration of 300 MBq (8.1 mCi) of NEURACEQ in healthy subjects, approximately 6% of the injected radioactivity was distributed…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied NEURACEQ (florbetaben F 18 injection) is a clear solution supplied at a concentration of 50 MBq/mL to 5,000 MBq/mL (1.4 mCi/mL to 135 mCi/mL) of florbetaben F 18 in up to 50 mL volume at EOS in a shielded multiple-dose glass vial (NDC 54828-001-50). Storage and Handling Store NEURACEQ in the original container with radiation shielding at room temperature 25°C (77°F); excursions permitted to 2°C to 42°C (36°F to 108°F). NEURACEQ does not contain a preservative.
Do not use after the expiration date and time provided on the container label. NEURACEQ multiple-dose vial expires 10 hours after EOS. Dispose of unused product in accordance with all federal, state, and local laws and institutional requirements.
This preparation is for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
📋 Description ▾
11 DESCRIPTION
11.1Drug Characteristics NEURACEQ (florbetaben F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, florbetaben F 18 is 4-[(E)-2-(4-{2-[2-(2-[ 18 F] fluoroethoxy)ethoxy]ethoxy}phenyl)vinyl]-N-methylaniline. The molecular weight is 358.45 and the structural formula is: NEURACEQ is a sterile, non-pyrogenic, clear solution.
Each mL contains up to 3 micrograms of florbetaben and 50 MBq to 5,000 MBq (1.4 mCi to 135 mCi) of florbetaben F 18 at EOS with the following inactive ingredients: 4.4 mg ascorbic acid, 118 mg ethanol, 200 mg macrogol 400, and 28.8 mg sodium ascorbate. The pH of the solution is between 4.5 and 7. structure
11.2Nuclear Physical Characteristics Fluorine-18 (F 18) decays by positron (ß + ) emission to oxygen-18 and has a physical half-life of 109.8 minutes. The principal photons useful for diagnostic imaging are the coincident pair of 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 3). Table 3: Principal Radiation Produced from Decay of Fluorine-18 Radiation Energy Level (keV) Abundance (%) Positron 249.8
96.7Gamma 511 193.4 The point source air-kerma coefficient for F 18 is 3.74E -17 Gy m 2 /(Bq s); this coefficient was formerly defined as the specific gamma-ray constant of
5.7R/hr/mCi at 1 cm. The first half-value thickness of lead for F 18 gamma rays is approximately 6 mm. The relative reduction of radiation emitted by F 18 that results from various thicknesses of lead shielding is shown in Table 4.
The use of ~8 cm of lead will decrease the radiation transmission (i.e., exposure) by a factor of about 10,000. Table 4: Radiation Attenuation of 511 keV by Lead Shielding Shield Thickness cm of Lead Coefficient of Attenuation 0.6 0.5 2 0.1 4 0.01 6 0.001 8 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 5. Table 5: Physical Decay Chart for Fluorine-18 Minutes Fraction Remaining 0 1.00 15 0.910 30 0.828 60 0.685 110 0.500 220 0.250 440 0.063
11.1Drug Characteristics NEURACEQ (florbetaben F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, florbetaben F 18 is 4-[(E)-2-(4-{2-[2-(2-[ 18 F] fluoroethoxy)ethoxy]ethoxy}phenyl)vinyl]-N-methylaniline. The molecular weight is 358.45 and the structural formula is: NEURACEQ is a sterile, non-pyrogenic, clear solution.
Each mL contains up to 3 micrograms of florbetaben and 50 MBq to 5,000 MBq (1.4 mCi to 135 mCi) of florbetaben F 18 at EOS with the following inactive ingredients: 4.4 mg ascorbic acid, 118 mg ethanol, 200 mg macrogol 400, and 28.8 mg sodium ascorbate. The pH of the solution is between 4.5 and 7. structure
11.2Nuclear Physical Characteristics Fluorine-18 (F 18) decays by positron (ß + ) emission to oxygen-18 and has a physical half-life of 109.8 minutes. The principal photons useful for diagnostic imaging are the coincident pair of 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 3). Table 3: Principal Radiation Produced from Decay of Fluorine-18 Radiation Energy Level (keV) Abundance (%) Positron 249.8
96.7Gamma 511 193.4 The point source air-kerma coefficient for F 18 is 3.74E -17 Gy m 2 /(Bq s); this coefficient was formerly defined as the specific gamma-ray constant of
5.7R/hr/mCi at 1 cm. The first half-value thickness of lead for F 18 gamma rays is approximately 6 mm. The relative reduction of radiation emitted by F 18 that results from various thicknesses of lead shielding is shown in Table 4.
The use of ~8 cm of lead will decrease the radiation transmission (i.e., exposure) by a factor of about 10,000. Table 4: Radiation Attenuation of 511 keV by Lead Shielding Shield Thickness cm of Lead Coefficient of Attenuation 0.6 0.5 2 0.1 4 0.01 6 0.001 8 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals afte…
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Radiation Risk Advise patients of the radiation risk of NEURACEQ. Instruct patients to increase their level of hydration before and after receiving NEURACEQ and to void frequently following administration [see Warnings and Precautions (5.2)] . Pregnancy Inform pregnant women of the potential risks of fetal exposure to radiation doses with NEURACEQ [see Use in Specific Populations (8.1)] .
Lactation Advise a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for 24 hours after NEURACEQ administration to minimize radiation exposure to the breastfed infant [see Use in Specific Populations (8.2)] .