Neuraceq 135 mCi/mL
Florbetaben F 18 · INJECTION, SOLUTION · Lantheus Biosciences Ltd.
Neuraceq is a injection, solution containing florbetaben f 18 at 135 mCi/mL, taken intravenous. Manufactured by Lantheus Biosciences Ltd..
Key Facts
- Brand Name
- Neuraceq
- Generic Name
- Florbetaben F 18
- NDC Code (Product)
54828-001- Manufacturer
- Lantheus Biosciences Ltd.
- Strength
- 135 mCi/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA204677
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 03/20/2014
Recall History
Sofie Co dba Sofie
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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) 2.1 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…
Contraindications
4 CONTRAINDICATIONS None None.
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. 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…
Frequently Asked Questions
What is Neuraceq used for?
Neuraceq contains Florbetaben F 18. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Neuraceq a controlled substance?
Neuraceq is not classified as a controlled substance by the DEA.
What is the generic name for Neuraceq?
The generic name for Neuraceq is Florbetaben F 18. There are no other listed brand versions of Florbetaben F 18.
What is the NDC code for Neuraceq 135 mCi/mL?
The NDC (National Drug Code) for Neuraceq 135 mCi/mL is 54828-001, listed by Lantheus Biosciences Ltd..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)