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Amyvid
Overview
What is Amyvid?
Amyvid contains florbetapir F 18, a molecular imaging agent that binds to β-amyloid aggregates, and is intended for use with PET imaging of the brain. Chemically, florbetapir F 18 is described as (E)-4-(2-(6-(2-(2-(2[F] fluoroethoxy)ethoxy)ethoxy)pyridine-3-yl)vinyl)-N-methylbenzamine. The molecular weight is 359 and the structural formula is:
Amyvid is a sterile, non-pyrogenic radioactive diagnostic agent for intravenous injection. The clear, colorless solution is supplied ready to use and each milliliter contains 0.1 to 19 micrograms of florbetapir and 500 - 1900 MBq (13.5 - 51 mCi) florbetapir F 18 at EOS, 4.5 mg sodium ascorbate USP and 0.1 mL dehydrated alcohol USP in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5.
What does Amyvid look like?
What are the available doses of Amyvid?
10 mL, 30 mL, or 50 mL multidose vial containing a clear, colorless injectable solution at a strength of 500-1900 MBq/mL (13.5-51 mCi/mL) florbetapir F 18 at End of Synthesis (EOS) ().
What should I talk to my health care provider before I take Amyvid?
How should I use Amyvid?
Amyvid 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 Amyvid 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 Amyvid 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. Amyvid is an adjunct to other diagnostic evaluations.
Amyvid is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration . Use waterproof gloves and effective shielding, including syringe shields when handling Amyvid. Radiopharmaceuticals, including Amyvid, 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.
What interacts with Amyvid?
Sorry No Records found
What are the warnings of Amyvid?
Sorry No Records found
What are the precautions of Amyvid?
Sorry No Records found
What are the side effects of Amyvid?
Sorry No records found
What should I look out for while using Amyvid?
None
What might happen if I take too much Amyvid?
Sorry No Records found
How should I store and handle Amyvid?
Store Amyvid at 25ºC (77°F); excursions permitted to 15ºC to 30ºC (59°F to 86°F) [see USP Controlled Room Temperature]. The product does not contain a preservative. Store Amyvid within the original container or equivalent radiation shielding. Amyvid 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. Store Amyvid at 25ºC (77°F); excursions permitted to 15ºC to 30ºC (59°F to 86°F) [see USP Controlled Room Temperature]. The product does not contain a preservative. Store Amyvid within the original container or equivalent radiation shielding. Amyvid 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. HOW SUPPLIEDNESACAINE (chloroprocaine HCl Injection, USP) with preservatives is supplied as follows:Keep from freezing. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].All trademarks are the property of APP Pharmaceuticals, LLC. APP Fresenius Kabi, LLCLake Zurich, IL 60047451109E/Revised: December 2013HOW SUPPLIEDNESACAINE (chloroprocaine HCl Injection, USP) with preservatives is supplied as follows:Keep from freezing. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].All trademarks are the property of APP Pharmaceuticals, LLC. APP Fresenius Kabi, LLCLake Zurich, IL 60047451109E/Revised: December 2013HOW SUPPLIEDNESACAINE (chloroprocaine HCl Injection, USP) with preservatives is supplied as follows:Keep from freezing. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].All trademarks are the property of APP Pharmaceuticals, LLC. APP Fresenius Kabi, LLCLake Zurich, IL 60047451109E/Revised: December 2013HOW SUPPLIEDNESACAINE (chloroprocaine HCl Injection, USP) with preservatives is supplied as follows:Keep from freezing. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].All trademarks are the property of APP Pharmaceuticals, LLC. APP Fresenius Kabi, LLCLake Zurich, IL 60047451109E/Revised: December 2013HOW SUPPLIEDNESACAINE (chloroprocaine HCl Injection, USP) with preservatives is supplied as follows:Keep from freezing. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].All trademarks are the property of APP Pharmaceuticals, LLC. APP Fresenius Kabi, LLCLake Zurich, IL 60047451109E/Revised: December 2013
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Florbetapir F 18 binds to β-amyloid plaques and the F 18 isotope produces a positron signal that is detected by a PET scanner. In binding studies using postmortem human brain homogenates containing β-amyloid plaques, the dissociation constant (K) for florbetapir was 3.7 ± 0.3 nM. The binding of florbetapir F 18 to β-amyloid aggregates was demonstrated in postmortem human brain sections using autoradiographic methods, thioflavin S and traditional silver staining correlation studies as well as monoclonal antibody β-amyloid-specific correlation studies. Florbetapir binding to tau protein and a battery of neuroreceptors was not detected in studies.
Non-Clinical Toxicology
NoneMitoxantrone and its metabolites are excreted in bile and urine, but it is not known whether the metabolic or excretory pathways are saturable, may be inhibited or induced, or if mitoxantrone and its metabolites undergo enterohepatic circulation. To date, post-marketing experience has not revealed any significant drug interactions in patients who have received mitoxantrone for treatment of cancer. Information on drug interactions in patients with multiple sclerosis is limited.
Following concurrent administration of mitoxantrone with corticosteroids, no evidence of drug interactions has been observed.
Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation .
Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image.
Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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