neuraceq
Neuraceq (Florbetaben F-18) is a medication supplied as an injection, solution.
Florbetaben F-18 · by Lantheus
Key facts
- Active ingredient
- Florbetaben F-18
- Form
- Injectable
- Strength
- Florbetaben F-18 1.4-135mCi/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Lantheus
- FDA application
- NDA204677
What is Neuraceq?
From the FDA label:11.1 Drug 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 11.2 Nuclear 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 96.7 Gamma 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 5.7 R/hr/mCi at 1 cm. The first half-value thickness of lead for F 18 gamma rays is approximately 6 mm.…
How to use
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) 2.1 Radiation 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. 2.2 Recommended 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…
Side effects
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. 6.1 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 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 1.7 Injection site irritation 1.1 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…
Warnings
Important safety information
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) 5.1 Risk 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 )] . 5.2 Radiation 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 )] . 5.1 Risk 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 )] . 5.2 Radiation 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 )] .
Who should not take Neuraceq
None None.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- Is there a coupon or discount for Neuraceq?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Neuraceq. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Neuraceq?
- Neuraceq is marketed by Lantheus. You can see Lantheus's full profile, rating, and other products on pharmaranks.
- Is Neuraceq a brand-name or generic drug?
- Neuraceq is a brand-name product with the active ingredient Florbetaben F-18.
- Is Neuraceq available over the counter?
- No. Neuraceq is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Neuraceq come in?
- Neuraceq is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Neuraceq FDA-registered?
- Neuraceq is on record with the U.S. FDA under application number NDA204677. You can verify this on its official FDA label.
- Is Neuraceq safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Neuraceq. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Neuraceq?
- Neuraceq's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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