Trade Name: Amyvid

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Eli Lilly and Company

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 51 mCi/mL

Storage and handling

FLORBETAPIR F-18 Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate u03b2-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.n
  • Limitations of Use:
  • Amyvid is a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate u03b2-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 ().n
  • Limitations of Use
  • A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder ().n
  • Safety and effectiveness of Amyvid have not been established for:n
  • Use appropriate radiation safety handling measures ().n
  • Administer 370u00a0MBq (10u00a0mCi) as a single intravenous bolus in a total volume of 10u00a0mL or less ().n
  • Obtain 10-minute PET images starting approximately 30 to 50u00a0minutes after intravenous injection ().n
  • Image interpretation: Refer to full prescribing information ().n
  • The radiation absorbed dose from a 370 MBq (10 mCi) dose of Amyvid is 7 mSv in an adult ().n
  • Amyvid (Florbetapir F 18 Injection) is available in a 30 mL and 50 mL multidose vial containing a clear, colorless solution at a strength of 500-1900u00a0MBq/mL (13.5-51u00a0mCi/mL) florbetapir F 18 at End of Synthesis (EOS).n
  • 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 Fu00a018 at End of Synthesis (EOS) ().n
  • None.n
  • None ().n
  • No data
  • Image interpretation errors (especially false negatives) have been observed ().n
  • Radiation risk: Amyvid, similar to all radiopharmaceuticals, contributes to a patient's long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure (, ).n
  • 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.n
  • In clinical studies, 555 patients were exposed to Amyvid. Amyvid caused no serious adverse reactions in the studies and the reported adverse reactions were predominantly mild to moderate in severity. The adverse reactions reported in more than one subject within the studies are shown in .n
  • Other adverse reactions occurred at lower frequencies and included infusion site rash, dysgeusia, pruritus, urticaria, and flushing.n
  • The most common reported adverse reaction was headache, occurring in 2% of patients, followed by musculoskeletal pain, blood pressure increased, fatigue, nausea, and injection site reaction, all occurring in <1% of patients ().n
  • Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Amyvid image results.n
  • Within a clinical study of patients with a range of cognitive impairment, some patients with probable AD were receiving the following medications: donepezil, galantamine, memantine. Mean cortical Standardized Uptake Value (SUV) ratios did not differ between the patients taking or not taking these concomitant medications. In tests, none of the drugs tested, including the acetylcholinesterase inhibitors donepezil, galantamine, and tacrine, altered florbetapir F 18 binding to its target.n
  • No data
  • Lactation: A lactating woman may pump and discard breast milk for 24 hours after Amyvid administration. ()n
  • Amyvid contains florbetapir F 18, a molecular imaging agent that binds to u03b2-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:n
  • 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 - 1900u00a0MBq (13.5 - 51u00a0mCi) florbetapir F 18 at EOS, 4.5u00a0mg sodium ascorbate USP and 0.1u00a0mL dehydrated alcohol USP in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 8.0.n
  • No data
  • Animal studies to assess the carcinogenicity or reproductive toxicity potentials of Amyvid have not been conducted.n
  • In an bacterial reverse mutation assay (Ames test), increases in the number of revertant colonies were observed in 2 of the 5 strains exposed to F-AV-45, the non-radioactive form of florbetapir F 18. In a chromosomal aberration study with cultured human peripheral lymphocytes, F-AV-45 did not increase the percentage of cells with structural aberrations with 3-hour exposure with or without activation; however, 22-hour exposure produced a statistically significant increase in structural aberrations at all tested concentrations. Potential genotoxicity of F-AV-45 was evaluated in a rat micronucleus study. In this assay, F-AV-45 did not increase the number of micronucleated polychromatic erythrocytes at the highest achievable dose level, 372u00a0u03bcg/kg/day, when given twice daily for 3 consecutive days.n
  • Amyvid was evaluated in three clinical studies that examined images from healthy adult subjects as well as subjects with a range of cognitive disorders, including some terminally ill patients who had agreed to participate in a postmortem brain donation program. All the studies were single arm studies in which subjects underwent an Amyvid injection and scan and then had images interpreted by multiple independent readers who were masked to all clinical information. Image interpretations used co-registration with CT scans when PET scans were performed on dual PET-CT scanners.n
  • In Study One, a semi-quantitative Amyvid image interpretation method, which is not intended for clinical use, was used by three readers to interpret images from 152 terminally ill patients, of whom 35 underwent autopsy (29 included in primary analysis). The median patient age was 85 years (range 55 to 103 years) and 14 of the patients were female. Eighteen of the patients had dementia, 9 had no cognitive impairment and 2 had mild cognitive impairment (MCI). The main study outcome was a comparison of premortem Amyvid images to the findings from a postmortem brain examination (truth standard). The semi-quantitative measures consisted of a five-point whole brain Amyvid uptake image scoring outcome that was compared to a global score of the percentage of the whole brain that contained amyloid, as determined by immunohistochemical microscopy. The percentage of postmortem cortical amyloid burden ranged from 0 to 9% and correlated with the median Amyvid scores (Spearman's rho=0.78; p<0.0001, 95% CI, 0.58 to 0.89).n
  • Studies Two and Three used a clinically-applicable binary image interpretation method (positive/negative) to evaluate images from a range of patients who had participated in earlier studies. The studies assessed performance characteristics (sensitivity and specificity) among subjects with a postmortem amyloid neuritic plaque density truth standard. Additionally, inter-reader and intra-reader image interpretation reproducibility was assessed among all the subjects, including subjects who lacked a postmortem truth standard. Before image interpretation, all readers underwent special training: Study Two used an in-person tutoring type of training and Study Three used an electronic media-based training method. Five trained readers interpreted images independently within each study. The brain neuritic plaque density in both studies was determined using an algorithm in which microscopic measures of highest plaque density within a brain region were averaged to produce a global brain estimate of neuritic plaque density. The global neuritic plaque density was categorized in the same manner as that for a region (), where plaques were counted on slides with modified Bielschowsky silver stained tissue sections. For purposes of determining the agreement between the in-vivo Amyvid image results and the post-mortem whole brain amyloid neuritic plaque density, Amyvid results (negative/positive) were pre-specified to correspond with specific plaque density scores, based upon a modification of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria which use neuritic plaque counts as a necessary pathological feature of AD.n
  • Study Two examined images only from terminally ill patients who had premortem Amyvid scans and postmortem brain examinations to determine a truth standard. Among the 59 patients, 35 of whom were also in Study One, the median age was 83 years (range 47 to 103 years), half were females and most were Caucasian (93%). Twenty-nine patients had an AD clinical diagnosis, 13 had another type of dementing disorder, 12 had no history of cognitive impairment and 5 had MCI. The time interval between the Amyvid scan and death was less than one year for 46 patients and between one and two years for 13 patients. Among the subset of patients who died within one year of Amyvid scanning (a prespecified outcome), the sensitivity using the majority interpretation of the readers was 96% (95% CI: 80% to 100%) and specificity was 100% (95% CI: 78% to 100%). With the entire dataset of 59 patients, the sensitivity using the majority interpretation of the readers was 92% (95% CI: 78% to 98%) and specificity was 100% (95% CI: 80% to 100%). At autopsy, the global brain neuritic plaque density category (CERAD score, as in ) was: frequent n=30; moderate n=9; sparse n=5; and none n=15. and show the Amyvid performance characteristics among all the patients. Among the subset of patients who died within one year of Amyvid scanning (n=46; 28 positive and 18 negative based on histopathology) the median (and range) of correct read results, false negatives, and false positives were 44 (37 to 45), 1 (0 to 7), and 1 (0 to 2), respectively, for In-Person Training (Study Two); and were 43 (38 to 44), 3 (0 to 7), and 1 (0 to 2), respectively, for Electronic Media Training (Study Three).n
  • Study Three included images from subjects who did not have a truth standard (20 healthy volunteers, 52 patients with mild cognitive impairment, 20 patients with AD) as well as all 59 of the patients who underwent an autopsy (same patients as in Study Two) and provided a truth standard. Duplicate images of 33 patients were included within the total pool of images in order to assess intra-reader image reproducibility. Among the 151 subjects, the median age was 76 years (range 47 to 103), half were females and most were Caucasian (93.4%). Performance characteristics for patients with a truth standard are shown above ( and ). The major reproducibility results are shown in for various groups of subjects. Inter-reader reproducibility analyses for all images showed an overall Fleiss' kappa statistic of 0.83 (95% CI: 0.78 to 0.88); the lower bound of the 95% CI exceeded the pre-specified success criterion (95% CI lower bound >0.58). Intra-reader reproducibility analyses showed that, between the two readings for each of the 33 patients with duplicate images, one of the five readers had complete agreement for all 33 patients, two readers had discrepant reads for a single patient, one reader had discrepant reads for two patients and another reader had discrepant reads for three patients.n
  • No data
  • Marketed by Lilly USA, LLC, Indianapolis, IN 46285, USA
  • Copyright u00a9 2012, 2019, Eli Lilly and Company. All rights reserved.n
  • AMV-0001-USPI-20191220n
  • PACKAGE LABEL u2013 Amyvid 30 mL PETNET Label
  • NDC Code 0002-1200-30u00a0u00a0u00a0u00a0u00a0u00a0u00a0Sterilen
  • Amyvidu00a0u00a0u00a0u00a0u00a0u00a0u00a0Rx Onlyn
  • u2622 CAUTION: RADIOACTIVE MATERIALn
  • Florbetapir F 18 Injectionn
  • ____MBq (____mCi) in ____mL at ____:____ on ____n
  • Batch No. ________________n
  • For Intravenous Use.
  • Contains 0.1 to 19 micrograms of florbetapir, 4.5 mg sodium ascorbate USP and 0.1 mL dehydrated alcohol USP in 0.9% sodium chloride injection USP per milliliter of solution. Store at USP controlled room temperature 25u00baC (77u00baF); excursions permitted to 15u00baC to 30u00baC (59u00baF to 86u00baF).n
  • Expires at ____:____ on ______________n
  • Manufactured by PETNET Solutions, Inc. Knoxville, TN 37932 for Avid Radiopharmaceuticals, a wholly-owned subsidiary of Eli Lilly and Company, Philadelphia, PA 19104n

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Florbetapir F 18 (Amyvid) which is also known as Amyvid and Manufactured by Eli Lilly and Company. It is available in strength of 51 mCi/mL.

Florbetapir F 18 (Amyvid) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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