cidofovir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals phosphonic acid derivatives | 639 | 113852-37-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An acyclic nucleoside phosphonate that acts as a competitive inhibitor of viral DNA polymerases. It is used in the treatment of RETINITIS caused by CYTOMEGALOVIRUS INFECTIONS and may also be useful for treating HERPESVIRUS INFECTIONS.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 25 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 170 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 90 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 17.91 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 5 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.49 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 2.50 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 1 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 2.60 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 26, 1996 | FDA | GILEAD SCIENCES INC |
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 |
|---|---|---|---|---|---|---|
| Adenovirus infection | 263.55 | 62.66 | 48 | 1181 | 3360 | 56287478 |
| Drug resistance | 149.82 | 62.66 | 42 | 1187 | 20500 | 56270338 |
| BK virus infection | 82.91 | 62.66 | 18 | 1211 | 3046 | 56287792 |
| Cytomegalovirus infection reactivation | 82.27 | 62.66 | 18 | 1211 | 3158 | 56287680 |
| Cystitis haemorrhagic | 78.42 | 62.66 | 18 | 1211 | 3919 | 56286919 |
| Cytomegalovirus infection | 77.75 | 62.66 | 25 | 1204 | 19271 | 56271567 |
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 |
|---|---|---|---|---|---|---|
| Adenovirus infection | 143.49 | 49.30 | 34 | 1215 | 4720 | 31691375 |
| Drug resistance | 116.07 | 49.30 | 41 | 1208 | 23412 | 31672683 |
| Cystitis haemorrhagic | 80.90 | 49.30 | 22 | 1227 | 5267 | 31690828 |
| Progressive multifocal leukoencephalopathy | 72.99 | 49.30 | 23 | 1226 | 9190 | 31686905 |
| Cytomegalovirus infection | 57.35 | 49.30 | 25 | 1224 | 24682 | 31671413 |
| Off label use | 52.65 | 49.30 | 66 | 1183 | 347208 | 31348887 |
| Drug ineffective for unapproved indication | 51.26 | 49.30 | 21 | 1228 | 17769 | 31678326 |
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 |
|---|---|---|---|---|---|---|
| Adenovirus infection | 349.49 | 50.46 | 75 | 2356 | 7693 | 70918320 |
| Drug resistance | 255.78 | 50.46 | 81 | 2350 | 38109 | 70887904 |
| Cystitis haemorrhagic | 142.41 | 50.46 | 37 | 2394 | 8556 | 70917457 |
| Cytomegalovirus infection | 124.78 | 50.46 | 48 | 2383 | 39710 | 70886303 |
| BK virus infection | 106.66 | 50.46 | 29 | 2402 | 7960 | 70918053 |
| Cytomegalovirus infection reactivation | 106.55 | 50.46 | 28 | 2403 | 6753 | 70919260 |
| Pathogen resistance | 96.29 | 50.46 | 30 | 2401 | 13249 | 70912764 |
| Nephropathy toxic | 94.30 | 50.46 | 32 | 2399 | 18482 | 70907531 |
| Epstein-Barr virus infection reactivation | 93.26 | 50.46 | 19 | 2412 | 1497 | 70924516 |
| Off label use | 82.45 | 50.46 | 113 | 2318 | 742947 | 70183066 |
| Progressive multifocal leukoencephalopathy | 81.59 | 50.46 | 29 | 2402 | 19185 | 70906828 |
| Renal impairment | 75.87 | 50.46 | 52 | 2379 | 143885 | 70782128 |
| Cytomegalovirus viraemia | 74.75 | 50.46 | 24 | 2407 | 11661 | 70914352 |
| Immune reconstitution inflammatory syndrome | 72.25 | 50.46 | 24 | 2407 | 12966 | 70913047 |
| Polyomavirus-associated nephropathy | 70.03 | 50.46 | 19 | 2412 | 5164 | 70920849 |
| Aplastic anaemia | 55.29 | 50.46 | 21 | 2410 | 16695 | 70909318 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AB12 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleosides and nucleotides excl. reverse transcriptase inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agents |
| CHEBI has role | CHEBI:36044 | antiviral drugs |
| CHEBI has role | CHEBI:47868 | photosensitising agent |
| CHEBI has role | CHEBI:64946 | anti-AIDS agent |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| CMV Retinitis in AIDS Patients | indication | ||
| Acyclovir-Resistant Mucocutaneous HSV in Immunocompromised Patients | indication | ||
| Prevention of Cytomegalovirus Disease | off-label use | ||
| Acidosis | contraindication | 51387008 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Severe Chronic Neutropenia | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.81 | acidic |
| pKa2 | 12.99 | acidic |
| pKa3 | 4.1 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| DNA polymerase catalytic subunit | Enzyme | INHIBITOR | WOMBAT-PK | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4020976 | VUID |
| N0000148447 | NUI |
| D00273 | KEGG_DRUG |
| 149394-66-1 | SECONDARY_CAS_RN |
| 83170 | RXNORM |
| 4020976 | VANDF |
| C0286079 | UMLSCUI |
| CHEBI:59495 | CHEBI |
| L8P | PDB_CHEM_ID |
| CHEMBL152 | ChEMBL_ID |
| DB00369 | DRUGBANK_ID |
| D000077404 | MESH_DESCRIPTOR_UI |
| 60613 | PUBCHEM_CID |
| JIL713Q00N | UNII |
| 194597 | MMSL |
| 4446 | MMSL |
| 6016 | MMSL |
| d04028 | MMSL |
| 006053 | NDDF |
| 108688007 | SNOMEDCT_US |
| 386894007 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| CIDOFOVIR DIHYDRATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-216 | INJECTION, SOLUTION | 375 mg | INTRAVENOUS | ANDA | 21 sections |
| Vistide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61958-0101 | INJECTION | 75 mg | INTRAVENOUS | NDA | 24 sections |
| CIDOFOVIR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-210 | INJECTION, SOLUTION | 75 mg | INTRAVENOUS | ANDA | 26 sections |