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fosamprenavir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| HIV protease inhibitors | 1240 | 226700-79-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a prodrug of the protease inhibitor amprenavir
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1.40 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.31 mg/mL | Bocci G, Oprea TI, Benet LZ |
| EoM (Fraction excreted unchanged in urine) | 0 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 67.81 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 35 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,GRK3,GSK3B,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PIK3CB,PIM2,PLK1,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 50 | |||
| kinase-selectivity-class | AURKA,AXL,CDK9,EPHB4,ERBB2,GRK2,MAP2K6,MAPK7,SIK2,TEK | 10 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 0.333 | High | 0.81 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| rat-kpuu-brain | Rat brain Kpuu | 0.001 | % | High | 0.81 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 20, 2003 | FDA | VIIV HLTHCARE |
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 |
|---|---|---|---|---|---|---|
| Viral mutation identified | 122.78 | 110.02 | 17 | 196 | 2008 | 90626226 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Lipodystrophy acquired | 74.30 | 51.47 | 16 | 694 | 3434 | 42617191 |
| Virologic failure | 71.97 | 51.47 | 16 | 694 | 3978 | 42616647 |
| Heart transplant rejection | 55.82 | 51.47 | 11 | 699 | 1523 | 42619102 |
| Blood HIV RNA increased | 55.42 | 51.47 | 11 | 699 | 1580 | 42619045 |
| Cystitis noninfective | 53.01 | 51.47 | 9 | 701 | 545 | 42620080 |
| Viral mutation identified | 52.67 | 51.47 | 12 | 698 | 3319 | 42617306 |
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 |
|---|---|---|---|---|---|---|
| Viral mutation identified | 124.56 | 47.31 | 22 | 694 | 4397 | 110584186 |
| Lipodystrophy acquired | 117.42 | 47.31 | 21 | 695 | 4503 | 110584080 |
| Virologic failure | 96.21 | 47.31 | 18 | 698 | 4934 | 110583649 |
| Drug resistance | 94.43 | 47.31 | 28 | 688 | 56346 | 110532237 |
| CSF HIV escape syndrome | 73.80 | 47.31 | 10 | 706 | 347 | 110588236 |
| Blood HIV RNA increased | 62.30 | 47.31 | 11 | 705 | 2177 | 110586406 |
| Drug interaction | 47.48 | 47.31 | 33 | 683 | 500150 | 110088433 |
| Nephropathy toxic | 47.43 | 47.31 | 14 | 702 | 27464 | 110561119 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AE07 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Protease inhibitors |
| FDA MoA | N0000000246 | HIV Protease Inhibitors |
| MeSH PA | D000084762 | Viral Protease Inhibitors |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000900 | Anti-Bacterial Agents |
| MeSH PA | D000904 | Antibiotics, Antitubercular |
| MeSH PA | D000995 | Antitubercular Agents |
| MeSH PA | D000998 | Antiviral Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D011480 | Protease Inhibitors |
| MeSH PA | D017320 | HIV Protease Inhibitors |
| MeSH PA | D019380 | Anti-HIV Agents |
| MeSH PA | D044966 | Anti-Retroviral Agents |
| FDA EPC | N0000175889 | Protease Inhibitor |
| FDA MoA | N0000182141 | Cytochrome P450 3A4 Inhibitors |
| FDA MoA | N0000185506 | Cytochrome P450 3A4 Inducers |
| FDA MoA | N0000191264 | P-Glycoprotein Inducers |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35660 | HIV protease inhibitor |
| CHEBI has role | CHEBI:36044 | antiviral drug |
| CHEBI has role | CHEBI:64946 | anti-HIV agent |
| CHEBI has role | CHEBI:50266 | prodrug |
Related Drugs by ATC class:
J05AE Protease inhibitors 10 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Human immunodeficiency virus infection | indication | 86406008 | DOID:526 |
| Prevention of HIV Infection after Exposure | off-label use | ||
| Hypercholesterolemia | contraindication | 13644009 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Hereditary factor VIII deficiency disease | contraindication | 28293008 | DOID:12134 |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Hereditary factor IX deficiency disease | contraindication | 41788008 | DOID:12259 |
| Hemolytic anemia | contraindication | 61261009 | DOID:583 |
| Chronic type B viral hepatitis | contraindication | 61977001 | |
| Lipodystrophy | contraindication | 71325002 | DOID:811 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Hyperglycemia | contraindication | 80394007 | DOID:4195 |
| Kidney stone | contraindication | 95570007 | |
| Chronic hepatitis C | contraindication | 128302006 | |
| Liver function tests abnormal | contraindication | 166603001 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Hypertriglyceridemia | contraindication | 302870006 | |
| Cardiovascular event risk | contraindication | 395112001 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Disorder of coronary artery | contraindication | 414024009 | |
| Obesity | contraindication | 414916001 | DOID:9970 |
| Ketoacidosis in diabetes mellitus | contraindication | 420422005 | DOID:1837 |
| Smokes tobacco daily | contraindication | 449868002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 1.13 | acidic |
| pKa2 | 6.35 | acidic |
| pKa3 | 1.8 | Basic |
Orange Book patent data (new drug applications)
None
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 |
|---|---|---|---|---|---|---|---|---|---|
| Pol polyprotein | Enzyme | INHIBITOR | CHEMBL | CHEMBL | |||||
| Gag-Pol polyprotein | Polyprotein | WOMBAT-PK |
External reference:
| ID | Source |
|---|---|
| 4021412 | VUID |
| N0000148827 | NUI |
| D02497 | KEGG_DRUG |
| 226700-81-8 | SECONDARY_CAS_RN |
| 4021158 | VANDF |
| 4021412 | VANDF |
| C1176315 | UMLSCUI |
| CHEBI:82941 | CHEBI |
| 478 | PDB_CHEM_ID |
| CHEMBL1664 | ChEMBL_ID |
| CHEMBL1200734 | ChEMBL_ID |
| DB01319 | DRUGBANK_ID |
| C426859 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12682 | IUPHAR_LIGAND_ID |
| 8011 | INN_ID |
| WOU1621EEG | UNII |
| 131536 | PUBCHEM_CID |
| 228656 | RXNORM |
| 17646 | MMSL |
| 262160 | MMSL |
| 64492 | MMSL |
| 8067 | MMSL |
| d04428 | MMSL |
| d04901 | MMSL |
| 004510 | NDDF |
| 004511 | NDDF |
| 007752 | NDDF |
| 116088006 | SNOMEDCT_US |
| 387006009 | SNOMEDCT_US |
| 407017006 | SNOMEDCT_US |
| 407018001 | SNOMEDCT_US |
| 412393004 | SNOMEDCT_US |
| C0754188 | UMLSCUI |
| DB00701 | DRUGBANK_ID |
| 65016 | PUBCHEM_CID |
| 7751 | INN_ID |
| C095108 | MESH_SUPPLEMENTAL_RECORD_UI |
| CHEBI:40050 | CHEBI |
| WOU1621EEG | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Fosamprenavir Calcium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-3520 | TABLET, FILM COATED | 700 mg | ORAL | ANDA | 27 sections |
| LEXIVA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0281 | TABLET, FILM COATED | 700 mg | ORAL | NDA | 26 sections |
| LEXIVA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-1010 | TABLET, FILM COATED | 700 mg | ORAL | NDA | 25 sections |
| Fosamprenavir Calcium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63304-583 | TABLET, COATED | 700 mg | ORAL | ANDA | 24 sections |