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Florbetapir F-18 š¶ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4285 | 956103-76-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a PET agent for Abeta plaques
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 6, 2012 | FDA | AVID RADIOPHARMS INC | |
| Dec. 19, 2016 | PMDA | Fujifilm RI Pharma |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Amyloid related imaging abnormality-oedema/effusion | 127.52 | 121.19 | 13 | 19 | 931 | 90627484 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Amyloid related imaging abnormality-oedema/effusion | 261.99 | 213.72 | 28 | 49 | 1547 | 110587675 |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | 255.26 | 213.72 | 27 | 50 | 1339 | 110587883 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V09AX05 | VARIOUS DIAGNOSTIC RADIOPHARMACEUTICALS CENTRAL NERVOUS SYSTEM Other central nervous system diagnostic radiopharmaceuticals |
| FDA MoA | N0000175869 | Positron Emitting Activity |
| FDA EPC | N0000177914 | Radioactive Diagnostic Agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:37336 | radioactive imaging agent |
Related Drugs by ATC class:
V09AX Other central nervous system diagnostic radiopharmaceuticals 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Positron emission tomography | indication | 82918005 | |
| Diagnosis of Alzheimer's disease | indication |
š¶ Veterinary Drug Use
None
š¶ Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.86 | Basic |
| pKa2 | 4.25 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10-100ML (13.5-51mCi/ML) | AMYVID | AVID RADIOPHARMS INC | N202008 | Oct. 13, 2023 | RX | SOLUTION | INTRAVENOUS | 7687052 | April 30, 2027 | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMERāS DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY |
| 10-100ML (13.5-51mCi/ML) | AMYVID | AVID RADIOPHARMS INC | N202008 | Oct. 13, 2023 | RX | SOLUTION | INTRAVENOUS | 8506929 | April 30, 2027 | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMERāS DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY |
| 10-30ML (13.5-51mCi/ML) | AMYVID | AVID RADIOPHARMS INC | N202008 | April 6, 2012 | DISCN | SOLUTION | INTRAVENOUS | 7687052 | April 30, 2027 | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMERāS DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY |
| 10-30ML (13.5-51mCi/ML) | AMYVID | AVID RADIOPHARMS INC | N202008 | April 6, 2012 | DISCN | SOLUTION | INTRAVENOUS | 8506929 | April 30, 2027 | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMERāS DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY |
| 10-50ML (13.5-51mCi/ML) | AMYVID | AVID RADIOPHARMS INC | N202008 | April 6, 2012 | RX | SOLUTION | INTRAVENOUS | 7687052 | April 30, 2027 | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMERāS DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY |
| 10-50ML (13.5-51mCi/ML) | AMYVID | AVID RADIOPHARMS INC | N202008 | April 6, 2012 | RX | SOLUTION | INTRAVENOUS | 8506929 | April 30, 2027 | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMERāS DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY |
| 10ML (13.5-51mCi/ML) | AMYVID | AVID RADIOPHARMS INC | N202008 | April 6, 2012 | DISCN | SOLUTION | INTRAVENOUS | 7687052 | April 30, 2027 | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMERāS DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY |
| 10ML (13.5-51mCi/ML) | AMYVID | AVID RADIOPHARMS INC | N202008 | April 6, 2012 | DISCN | SOLUTION | INTRAVENOUS | 8506929 | April 30, 2027 | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMERāS DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Amyloid beta A4 protein | Membrane other | Ki | 8.54 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D09617 | KEGG_DRUG |
| 4034858 | VANDF |
| CHEMBL1774461 | ChEMBL_ID |
| C545186 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9193 | INN_ID |
| DB09149 | DRUGBANK_ID |
| 6W15Z5R0RU | UNII |
| 1427224 | RXNORM |
| 189354 | MMSL |
| 28499 | MMSL |
| d07859 | MMSL |
| 014294 | NDDF |
| 456994001 | SNOMEDCT_US |
| 456995000 | SNOMEDCT_US |
| C3475363 | UMLSCUI |
| CHEBI:66880 | CHEBI |
| 24822371 | PUBCHEM_CID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Amyvid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-1200 | INJECTION, SOLUTION | 51 mCi | INTRAVENOUS | NDA | 26 sections |