famciclovir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals bicyclic heterocycle compounds | 1128 | 104227-87-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An aminopurine derivative and prodrug of penciclovir which is a competitive inhibitor of herpes simplex 2 DNA polymerase. It is used to treat HERPES SIMPLEX VIRUS INFECTION.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.75 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 250 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 77.80 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 77 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 29, 1994 | FDA | NOVARTIS | |
| April 16, 2008 | PMDA | ASAHI KASEI PHARMA CORPORATION |
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 |
|---|---|---|---|---|---|---|
| Aplastic anaemia | 42.22 | 19.93 | 16 | 2859 | 9553 | 63476594 |
| CD4 lymphocytes decreased | 35.51 | 19.93 | 9 | 2866 | 1418 | 63484729 |
| Plasma cell myeloma | 34.42 | 19.93 | 21 | 2854 | 35884 | 63450263 |
| Diarrhoea | 25.12 | 19.93 | 80 | 2795 | 715286 | 62770861 |
| Chronic graft versus host disease | 24.49 | 19.93 | 8 | 2867 | 3094 | 63483053 |
| Acute myeloid leukaemia | 21.65 | 19.93 | 12 | 2863 | 17135 | 63469012 |
| Graft versus host disease in gastrointestinal tract | 20.21 | 19.93 | 7 | 2868 | 3234 | 63482913 |
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 |
|---|---|---|---|---|---|---|
| Gastrointestinal tract mucosal pigmentation | 38.51 | 21.02 | 8 | 1705 | 482 | 34954736 |
| Meralgia paraesthetica | 33.86 | 21.02 | 6 | 1707 | 154 | 34955064 |
| Tuberculosis liver | 32.73 | 21.02 | 5 | 1708 | 49 | 34955169 |
| Lip haemorrhage | 29.61 | 21.02 | 7 | 1706 | 763 | 34954455 |
| Graft versus host disease in liver | 21.42 | 21.02 | 6 | 1707 | 1278 | 34953940 |
| Cutaneous vasculitis | 21.39 | 21.02 | 8 | 1705 | 4255 | 34950963 |
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 |
|---|---|---|---|---|---|---|
| Aplastic anaemia | 60.29 | 19 | 25 | 3788 | 17880 | 79722695 |
| Gastrointestinal tract mucosal pigmentation | 32.63 | 19 | 8 | 3805 | 1042 | 79739533 |
| Tuberculosis liver | 31.21 | 19 | 5 | 3808 | 70 | 79740505 |
| CD4 lymphocytes decreased | 29.56 | 19 | 9 | 3804 | 2625 | 79737950 |
| Lip haemorrhage | 26.73 | 19 | 7 | 3806 | 1187 | 79739388 |
| Herpes zoster | 26.19 | 19 | 27 | 3786 | 93056 | 79647519 |
| Plasma cell myeloma | 23.81 | 19 | 20 | 3793 | 53239 | 79687336 |
| Meralgia paraesthetica | 21.49 | 19 | 5 | 3808 | 521 | 79740054 |
| Bacteraemia | 20.45 | 19 | 15 | 3798 | 32809 | 79707766 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AB09 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleosides and nucleotides excl. reverse transcriptase inhibitors |
| ATC | S01AD07 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Antivirals |
| FDA MoA | N0000020060 | DNA Polymerase Inhibitors |
| FDA EXT | N0000175459 | Nucleoside Analog |
| CHEBI has role | CHEBI:36044 | antiviral drugs |
| CHEBI has role | CHEBI:50266 | Prodrugs |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D019384 | Nucleic Acid Synthesis Inhibitors |
| FDA EPC | N0000180187 | Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Herpes zoster | indication | 4740000 | DOID:8536 |
| Herpes simplex | indication | 88594005 | DOID:8566 |
| Recurrent herpes simplex labialis | indication | 402892009 | |
| Recurrent genital herpes simplex | indication | 402894005 | |
| Suppression of Recurrent Herpes Simplex Infection | indication | ||
| Recurrent Mucocutaneous Herpes Simplex in Human Immunodeficiency Virus Infected Patients | indication | ||
| Suppression of Recurrent Herpes Simplex Infection in HIV | off-label use | ||
| Prevention of Herpes Zoster in Immunocompromised Patient | off-label use | ||
| Kidney disease | contraindication | 90708001 | DOID:557 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.86 | 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 | |||||
| DNA polymerase catalytic subunit | Enzyme | WOMBAT-PK |
External reference:
| ID | Source |
|---|---|
| 4020882 | VUID |
| N0000148380 | NUI |
| D00317 | KEGG_DRUG |
| 4020882 | VANDF |
| C0209227 | UMLSCUI |
| CHEBI:4974 | CHEBI |
| CHEMBL880 | ChEMBL_ID |
| DB00426 | DRUGBANK_ID |
| D000077595 | MESH_DESCRIPTOR_UI |
| 3324 | PUBCHEM_CID |
| 11629 | IUPHAR_LIGAND_ID |
| 6438 | INN_ID |
| QIC03ANI02 | UNII |
| 151733 | RXNORM |
| 119086 | MMSL |
| 1730 | MMSL |
| 4712 | MMSL |
| d03775 | MMSL |
| 004470 | NDDF |
| 387557001 | SNOMEDCT_US |
| 96097002 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-8117 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-8117 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-8117 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-8118 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-8118 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-8118 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-8119 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-8119 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-8119 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-614 | TABLET | 125 mg | ORAL | ANDA | 23 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-615 | TABLET | 250 mg | ORAL | ANDA | 23 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-616 | TABLET | 500 mg | ORAL | ANDA | 23 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0705 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0706 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0708 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-706 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-707 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-708 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33342-024 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 26 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33342-024 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 26 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33342-025 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 26 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33342-025 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 26 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33342-026 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 26 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33342-026 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 26 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-414 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-414 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-415 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-415 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-416 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-416 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |