新型抗生素Orbactiv(oritavancin)冻干粉注射剂是获FDA批准用于ABSSSIs治疗的首个和唯一一种单剂量治疗方案。患者仅接受一次Orbactiv输液。
Oritavacin Diphosphate（Orbactiv）于2014年8月6日获FDA批准的糖肽类抗生素注射液，之后于2015年3月19日获得EMA批准上市。该药是由The Medicines Company研发、生产和销售的。
OritavacinDiphosphate被批准用于由敏感革兰氏阳性菌引起的急性细菌性皮肤和皮肤结构感染(ABSSSIs)的成人患者的治疗。Orbactiv®每瓶含400mg Oritavacin Diphosphate冻干粉，推荐剂量是单次3小时静脉注射1200mg
Orbactiv IV(Orbactiv Oritavancin Injection)
ORBACTIV Rx
Generic Name and Formulations:
Oritavancin 400mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free.
Company:
The Medicines Company
Indications for ORBACTIV:
Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible Gram (+) microorganisms: Staphylococcus aureus (including MRSA and MSSA), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates only).
Adult:
Give by IV infusion over 3hrs. ≥18yrs: 1200mg as a single dose.
Children:
<18yrs: not established.
Pharmacological Class:
Lipoglycopeptide.
Contraindications:
Use of IV unfractionated heparin sodium for 48hrs after oritavancin administration.
Warnings/Precautions:
History of glycopeptide allergy. Discontinue immediately if acute hypersensitivity reaction occurs. Consider slowing or interrupting infusion if infusion-related reactions occur. Risk of Clostridium difficile-associated diarrhea; discontinue if suspected or confirmed. Monitor for signs/symptoms of osteomyelitis; use alternative therapy if suspected or diagnosed. Severe hepatic or renal impairment: not studied. Pregnancy (Cat.C). Nursing mothers.
Interactions:
Increased risk of bleeding with concomitant warfarin; may prolong aPTT for 48hrs and PT/INR for 24hrs; monitor. Caution with concomitant drugs with a narrow therapeutic window. May increase concentrations of CYP2C9 substrates. May decrease concentrations of CYP2D6 substrates. May interfere with coagulation tests; consider non-phospholipid dependent test (eg, Factor Xa assay) or alternative anticoagulant not requiring aPTT monitoring.
Adverse Reactions:
Headache, nausea, vomiting, limb and subcutaneous abscesses, diarrhea.
Generic Availability:
NO
How Supplied:
Single-use vial—3
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=085d6d1a-21c2-11e4-8c21-0800200c9a66
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206334s000lbl.pdf |
