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 |
|---|---|---|---|---|---|---|
| Drug resistance | 143.79 | 63.97 | 40 | 1068 | 18949 | 50585067 |
| Adenovirus infection | 140.44 | 63.97 | 28 | 1080 | 3140 | 50600876 |
| BK virus infection | 67.24 | 63.97 | 15 | 1093 | 2866 | 50601150 |
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 |
|---|---|---|---|---|---|---|
| Drug resistance | 121.23 | 49.59 | 41 | 1077 | 21499 | 29551910 |
| Cystitis haemorrhagic | 74.24 | 49.59 | 20 | 1098 | 4822 | 29568587 |
| Adenovirus infection | 71.15 | 49.59 | 19 | 1099 | 4428 | 29568981 |
| Drug ineffective for unapproved indication | 56.71 | 49.59 | 21 | 1097 | 14193 | 29559216 |
| Off label use | 53.97 | 49.59 | 61 | 1057 | 300739 | 29272670 |
| Progressive multifocal leukoencephalopathy | 50.49 | 49.59 | 17 | 1101 | 8702 | 29564707 |
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 |
|---|---|---|---|---|---|---|
| Drug resistance | 255.13 | 51.79 | 79 | 2105 | 35023 | 64461525 |
| Adenovirus infection | 179.76 | 51.79 | 43 | 2141 | 7212 | 64489336 |
| Cystitis haemorrhagic | 121.38 | 51.79 | 32 | 2152 | 7924 | 64488624 |
| Pathogen resistance | 98.35 | 51.79 | 30 | 2154 | 12513 | 64484035 |
| Nephropathy toxic | 92.46 | 51.79 | 31 | 2153 | 17483 | 64479065 |
| Cytomegalovirus infection | 86.24 | 51.79 | 36 | 2148 | 37163 | 64459385 |
| Off label use | 81.70 | 51.79 | 103 | 2081 | 632703 | 63863845 |
| BK virus infection | 76.78 | 51.79 | 22 | 2162 | 7390 | 64489158 |
| Immune reconstitution inflammatory syndrome | 73.52 | 51.79 | 24 | 2160 | 12446 | 64484102 |
| Renal impairment | 72.25 | 51.79 | 49 | 2135 | 134968 | 64361580 |
| Epstein-Barr virus infection reactivation | 68.28 | 51.79 | 14 | 2170 | 1152 | 64495396 |
| Cytomegalovirus infection reactivation | 59.22 | 51.79 | 17 | 2167 | 5739 | 64490809 |
| Drug ineffective for unapproved indication | 55.34 | 51.79 | 25 | 2159 | 31108 | 64465440 |
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 |
| 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 |
| 149394-66-1 | SECONDARY_CAS_RN |
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 |