dalbavancin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| vancomycin related compounds | 777 | 171500-79-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Dalbavancin, a semisynthetic lipoglycopeptide, interferes with cell wall synthesis by binding to the D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking. Dalbavancin is bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes at concentrations similar to those sustained throughout treatment in humans treated according to the recommended dosage regimen.
|
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1.50 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.14 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 0.01 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.02 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 170 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 18, 2014 | EMA | ||
| May 23, 2014 | FDA | DURATA THERAPS INTL |
FDA Adverse Event Reporting System (Female)
None
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 |
|---|---|---|---|---|---|---|
| Off label use | 45.49 | 45.39 | 37 | 354 | 419487 | 34537053 |
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J01XA04 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER ANTIBACTERIALS Glycopeptide antibacterials |
| FDA CS | M000640741 | Lipoglycopeptides |
| MeSH PA | D000900 | Anti-Bacterial Agents |
| MeSH PA | D000890 | Anti-Infective Agents |
| FDA EXT | N0000191280 | Lipoglycopeptides |
| FDA EPC | N0000191281 | Lipoglycopeptide Antibacterial |
| CHEBI has role | CHEBI:33281 | antibiotics |
| CHEBI has role | CHEBI:36047 | antibacterial drugs |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Infection of skin AND/OR subcutaneous tissue | indication | 19824006 | |
| Bacterial infection of skin | indication | 128936008 | |
| Staphylococcal infection of skin | indication | 402938009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.53 | acidic |
| pKa2 | 7.41 | acidic |
| pKa3 | 8.05 | acidic |
| pKa4 | 8.37 | acidic |
| pKa5 | 8.65 | acidic |
| pKa6 | 9.93 | acidic |
| pKa7 | 11.23 | acidic |
| pKa8 | 11.94 | acidic |
| pKa9 | 11.99 | acidic |
| pKa10 | 12.61 | acidic |
| pKa11 | 12.91 | acidic |
| pKa12 | 13.23 | acidic |
| pKa13 | 13.59 | acidic |
| pKa14 | 13.73 | acidic |
| pKa15 | 9.21 | Basic |
| pKa16 | 6.62 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | DALVANCE | ABBVIE | N021883 | May 23, 2014 | RX | POWDER | INTRAVENOUS | 8143212 | Nov. 14, 2023 | TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN. |
| EQ 500MG BASE/VIAL | DALVANCE | ABBVIE | N021883 | May 23, 2014 | RX | POWDER | INTRAVENOUS | 6900175 | May 23, 2028 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) IN ADULT AND PEDIATRIC PATIENTS USING A TWO-DOSE REGIMEN OF DALBAVANCIN |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | DALVANCE | ABBVIE | N021883 | May 23, 2014 | RX | POWDER | INTRAVENOUS | May 23, 2019 | NEW CHEMICAL ENTITY |
| EQ 500MG BASE/VIAL | DALVANCE | ABBVIE | N021883 | May 23, 2014 | RX | POWDER | INTRAVENOUS | May 23, 2024 | GENERATING ANTIBIOTIC INCENTIVES NOW |
| EQ 500MG BASE/VIAL | DALVANCE | ABBVIE | N021883 | May 23, 2014 | RX | POWDER | INTRAVENOUS | July 22, 2024 | NEW PATIENT POPULATION |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| D03640 | KEGG_DRUG |
| 1539239 | RXNORM |
| 4025243 | VANDF |
| C1172636 | UMLSCUI |
| CHEBI:82721 | CHEBI |
| CHEMBL3301669 | ChEMBL_ID |
| CHEMBL3301650 | ChEMBL_ID |
| DB06219 | DRUGBANK_ID |
| C469289 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10876 | IUPHAR_LIGAND_ID |
| 7978 | INN_ID |
| 808UI9MS5K | UNII |
| 16134627 | PUBCHEM_CID |
| 221316 | MMSL |
| 30328 | MMSL |
| d08264 | MMSL |
| 015537 | NDDF |
| 015541 | NDDF |
| 703917001 | SNOMEDCT_US |
| 703918006 | SNOMEDCT_US |
| 703919003 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| DALVANCE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57970-100 | INJECTION, POWDER, FOR SOLUTION | 500 mg | INTRAVENOUS | NDA | 32 sections |
| DALVANCE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57970-100 | INJECTION, POWDER, FOR SOLUTION | 500 mg | INTRAVENOUS | NDA | 32 sections |