oritavancin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
vancomycin related compounds 4678 171099-57-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • oritavancin diphosphate
  • orbactiv
  • LY333328
  • oritavancin
  • Molecular weight: 1793.12
  • Formula: C86H97Cl3N10O26
  • CLOGP: 2.50
  • LIPINSKI: 3
  • HAC: 36
  • HDO: 20
  • TPSA: 560.98
  • ALOGS: -4.48
  • ROTB: 19

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.07 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.13 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 96.20 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
March 19, 2015 EMA
Aug. 6, 2014 FDA THE MEDICINES CO

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pruritus 182.80 64.45 94 826 541431 90086096
Multiple use of single-use product 170.13 64.45 27 893 1796 90625731
Off label use 89.19 64.45 79 841 1102173 89525354
Chills 87.82 64.45 37 883 131944 90495583
Urticaria 86.66 64.45 48 872 312686 90314841
Flushing 66.16 64.45 27 893 88464 90539063
Erythema 65.55 64.45 36 884 229210 90398317

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple use of single-use product 281.39 63.86 39 1034 388 42619874
Chills 175.06 63.86 71 1002 93995 42526267
Infusion related reaction 141.25 63.86 54 1019 60752 42559510
Back pain 103.04 63.86 56 1017 141720 42478542
Off label use 81.99 63.86 89 984 638246 41982016
Pruritus 71.01 63.86 49 1024 188722 42431540
Urticaria 67.08 63.86 34 1039 74002 42546260
Chest pain 66.43 63.86 42 1031 139488 42480774

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple use of single-use product 358.16 61.22 52 1640 1244 110586363
Chills 213.47 61.22 87 1605 190493 110397114
Pruritus 183.78 61.22 112 1580 581448 110006159
Infusion related reaction 178.34 61.22 95 1597 381067 110206540
Off label use 131 61.22 135 1557 1500050 109087557
Urticaria 122.61 61.22 70 1622 318787 110268820
Back pain 107.70 61.22 68 1624 370928 110216679
Chest pain 75.60 61.22 55 1637 376320 110211287
Erythema 73.50 61.22 49 1643 291398 110296209
Flushing 68.72 61.22 33 1659 104703 110482904

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01XA05 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER ANTIBACTERIALS
Glycopeptide antibacterials
FDA CS M000640741 Lipoglycopeptides
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors
FDA MoA N0000185506 Cytochrome P450 3A4 Inducers
FDA MoA N0000191267 Cytochrome P450 2D6 Inducers
FDA EPC N0000191281 Lipoglycopeptide Antibacterial
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

J01XA Glycopeptide antibacterials 4 drugs
dalbavancinteicoplanintelavancinvancomycin

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Bacterial infection of skin indication 128936008
Streptococcal infection of skin indication 402937004
Staphylococcal infection of skin indication 402938009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.05 acidic
pKa2 7.69 acidic
pKa3 10.72 acidic
pKa4 11.48 acidic
pKa5 11.49 acidic
pKa6 12.17 acidic
pKa7 12.41 acidic
pKa8 13.03 acidic
pKa9 13.04 acidic
pKa10 13.67 acidic
pKa11 9.27 Basic
pKa12 8.57 Basic
pKa13 8.3 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 400MG BASE/VIAL ORBACTIV MELINTA THERAP N206334 Aug. 6, 2014 RX POWDER INTRAVENOUS 12514899 Aug. 29, 2029 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY STREPTOCOCCUS DYSGALACTIAE WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT
EQ 400MG BASE/VIAL ORBACTIV MELINTA THERAP N206334 Aug. 6, 2014 RX POWDER INTRAVENOUS 8420592 Aug. 29, 2029 TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE
EQ 1.2GM BASE/VIAL KIMYRSA MELINTA THERAP N214155 March 12, 2021 RX POWDER INTRAVENOUS 12514899 Aug. 29, 2029 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY STREPTOCOCCUS DYSGALACTIAE WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT
EQ 1.2GM BASE/VIAL KIMYRSA MELINTA THERAP N214155 March 12, 2021 RX POWDER INTRAVENOUS 8420592 Aug. 29, 2029 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT
EQ 400MG BASE/VIAL ORBACTIV MELINTA THERAP N206334 Aug. 6, 2014 RX POWDER INTRAVENOUS 9682061 April 26, 2030 TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
EQ 1.2GM BASE/VIAL KIMYRSA MELINTA THERAP N214155 March 12, 2021 RX POWDER INTRAVENOUS 9682061 April 26, 2030 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D05271 KEGG_DRUG
4033672 VUID
N0000191086 NUI
192564-14-0 SECONDARY_CAS_RN
4033671 VANDF
4033672 VANDF
CHEMBL1688530 ChEMBL_ID
CHEMBL3989766 ChEMBL_ID
C100708 MESH_SUPPLEMENTAL_RECORD_UI
10877 IUPHAR_LIGAND_ID
7979 INN_ID
DB04911 DRUGBANK_ID
PUG62FRZ2E UNII
1547611 RXNORM
227540 MMSL
30470 MMSL
39633 MMSL
d08276 MMSL
015538 NDDF
015661 NDDF
40609811000001103 SNOMEDCT_US
704655001 SNOMEDCT_US
704656000 SNOMEDCT_US
C1144403 UMLSCUI
CHEBI:83305 CHEBI
16136912 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Orbactiv HUMAN PRESCRIPTION DRUG LABEL 1 70842-140 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 400 mg INTRAVENOUS NDA 32 sections
Kimyrsa HUMAN PRESCRIPTION DRUG LABEL 1 70842-225 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1200 mg INTRAVENOUS NDA 31 sections