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 | 36.58 | 20.21 | 14 | 2544 | 7689 | 50594877 |
| Plasma cell myeloma | 32.38 | 20.21 | 20 | 2538 | 31302 | 50571264 |
| CD4 lymphocytes decreased | 30.26 | 20.21 | 8 | 2550 | 1331 | 50601235 |
| Chronic graft versus host disease | 24.25 | 20.21 | 8 | 2550 | 2859 | 50599707 |
| Diarrhoea | 23.58 | 20.21 | 74 | 2484 | 588402 | 50014164 |
| Acute myeloid leukaemia | 21.87 | 20.21 | 12 | 2546 | 15062 | 50587504 |
| Graft versus host disease in gastrointestinal tract | 20.51 | 20.21 | 7 | 2551 | 2774 | 50599792 |
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 | 39.84 | 22.91 | 8 | 1563 | 375 | 29572581 |
| Meralgia paraesthetica | 33.42 | 22.91 | 6 | 1565 | 153 | 29572803 |
| Tuberculosis liver | 32.33 | 22.91 | 5 | 1566 | 49 | 29572907 |
| Lip haemorrhage | 29.28 | 22.91 | 7 | 1564 | 738 | 29572218 |
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 | 50.22 | 19.82 | 21 | 3381 | 13899 | 64481431 |
| Gastrointestinal tract mucosal pigmentation | 32.84 | 19.82 | 8 | 3394 | 919 | 64494411 |
| Tuberculosis liver | 31.13 | 19.82 | 5 | 3397 | 64 | 64495266 |
| Herpes zoster | 27.64 | 19.82 | 27 | 3375 | 79160 | 64416170 |
| Lip haemorrhage | 26.37 | 19.82 | 7 | 3395 | 1132 | 64494198 |
| CD4 lymphocytes decreased | 25.19 | 19.82 | 8 | 3394 | 2427 | 64492903 |
| Meralgia paraesthetica | 24.12 | 19.82 | 5 | 3397 | 276 | 64495054 |
| Bacteraemia | 21.81 | 19.82 | 15 | 3387 | 26896 | 64468434 |
| Plasma cell myeloma | 20.51 | 19.82 | 18 | 3384 | 46057 | 64449273 |
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 | 0093-8118 | 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 | 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 | 33342-025 | 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 | 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 | 42291-416 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5905 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 28 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55289-168 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| FAMCICLOVIR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60429-359 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 23 sections |
| FAMCICLOVIR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60429-360 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 23 sections |
| FAMCICLOVIR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60429-361 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 23 sections |
| FAMCICLOVIR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-3245 | TABLET, FILM COATED | 125 mg | ORAL | ANDA | 23 sections |
| FAMCICLOVIR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-3246 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 23 sections |
| FAMCICLOVIR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-3247 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 23 sections |
| FAMCICLOVIR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63187-919 | TABLET | 250 mg | ORAL | ANDA | 24 sections |
| FAMCICLOVIR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63187-920 | TABLET | 500 mg | ORAL | ANDA | 24 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63187-998 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 24 sections |
| Famciclovir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-7890 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |