Orbactiv (oritavancin diphosphate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Oritavancin diphosphate, a lipoglycopeptide antibacterial, is a semisynthetic derivative of a naturally occurring glycopeptide.
Oritavancin diphosphate is a semisynthetic lipoglycopeptide antibacterial derived from chloroeremomycin, a naturally occurring glycopeptide. Oritavancin contains a heptapeptide core structure similar to that of vancomycin, but has side chains that enhance antibacterial activity.
The mechanism of action of oritavancin is similar to that of other glycopeptides (e.g., dalbavancin, vancomycin). Oritavancin binds to the d-alanyl-d-alanine terminus of growing peptidoglycan chains, thereby inhibiting bacterial cell wall, synthesis. In addition, the drug binds to the peptide bridging segments of the cell wall, thereby inhibiting the transpeptidation (crosslinking) step of cell wall biosynthesis, and can dimerize and anchor into the bacterial cell membrane, which improves its ability to bind to its target.
In vitro, oritavancin is bactericidal in action against certain gram-positive bacteria, including staphylococci, streptococci, and enterococci. In vitro and in clinical studies, oritavancin is active against Staphylococcus aureus (including methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA)), Streptococcus pyogenes (group A beta-hemolytic streptococci, GAS), S. agalactiae (group B streptococci, GBS), S. dysgalactiae, S. anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and vancomycin-susceptible Enterococcus faecalis.
Oritavancin also is active in vitro against vancomycin-susceptible E. faecium, Clostridium perfringens, C. difficile, Peptostreptococcus, Propionibacterium acnes, S. pneumoniae, vancomycin-intermediate S. aureus (VISA), vancomycin-resistant S. aureus (VRSA), and daptomycin-nonsusceptible S. aureus (DNSSA). However, safety and efficacy of oritavancin in treating clinical infections caused by these bacteria have not been established.
Reduced susceptibility or resistance to oritavancin has been produced in vitro by serial passage of S. aureus or E. faecalis in the presence of increasing concentrations of the drug.
Oritavancin exhibits linear, dose-dependent pharmacokinetics following IV administration. Oritavancin is extensively distributed into tissues, including skin blister fluid, extracellular lung fluid, and alveolar macrophages. Mean oritavancin concentrations in skin blister fluid are approximately 20% of those in plasma after a single 800-mg dose in healthy individuals.
The drug is approximately 85% bound to plasma proteins. Oritavancin is not metabolized. Based on population pharmacokinetic analyses, the terminal half-life of oritavancin is approximately 10 days (245 hours).
The drug is slowly eliminated unchanged in feces and urine; less than 1 and 5% of a single IV dose is recovered in feces and urine, respectively, by 2 weeks after the dose. The drug is not removed by hemodialysis or continuous renal replacement therapy (CRRT).
USES: This medication is an antibiotic used to treat serious bacterial infections of the skin. It works by stopping the growth of bacteria.
Generic name: oritavancin diphosphate
Pronunciation: (or-IT-a-VAN-sin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Orbactiv
Indications
The following indications are listed for Orbactiv:
- Complicated Skin And Skin Structure Enterococcus Faecalis Infection
- Complicated Skin And Skin Structure Infection
- Complicated Skin And Skin Structure Staphylococcus Aureus Infection
- Complicated Skin And Skin Structure Streptococcus Agalactiae Infection
- Complicated Skin And Skin Structure Streptococcus Pyogenes Infection
Also known as: Complicated Bacterial Skin And Skin Structure Infection, Complicated Skin And Skin Soft Tissue Enterococcus Faecalis Infection, Complicated Skin And Skin Soft Tissue Infection, Complicated Skin And Skin Soft Tissue Infection Due To Streptococcus Pyogenes, Complicated Skin And Skin Structure Bacterial Infection, Complicated Staphylococcus Aureus Skin And Skin Soft Tissue Infection, Complicated Streptococcus Pyogenes Skin And Skin Structure Infection.
Dosing
Dosage of oritavancin diphosphate is expressed in terms of oritavancin.
Oritavancin diphosphate is administered by IV infusion.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Oritavancin is contraindicated in patients with known hypersensitivity to the drug.
Unfractionated heparin sodium is contraindicated for 48 hours after oritavancin because activated partial thromboplastin time (aPTT) is expected to remain falsely elevated for this period of time after administration of the anti-infective. (See Tests Used to Monitor Coagulation under Cautions: Warnings/Precautions.)
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in 1.5% or more of patients receiving oritavancin include GI effects (i.e., diarrhea, nausea, vomiting, constipation), dizziness, headache, infusion site reactions (including phlebitis and extravasation), pruritus, urticaria, pyrexia, chills, abscess (limb or subcutaneous), cellulitis, increased AST and ALT concentrations, tachycardia, insomnia, and fatigue.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of oritavancin have not been established in pediatric patients younger than 18 years of age.
Category C. (See Users Guide.)
There are no adequate and well-controlled studies of oritavancin in pregnant women, and the drug should be used during pregnancy only if potential benefits justify potential risks to the fetus.
Reproduction studies in rats or rabbits have not revealed evidence of harm to the fetus at dosages equivalent to a human dose of 300 mg (25% of the recommend 1.2-g single dose); higher doses have not been evaluated.
Oritavancin is distributed into milk in lactating rats; it is not known whether the drug is distributed into human milk.
Oritavancin should be used with caution in nursing women.
Clinical trials of oritavancin did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently than younger adults. Other clinical experience has not revealed age-related differences in response, but the possibility of greater sensitivity in some older patients cannot be ruled out.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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