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FDA Approves IV Antibiotic for Skin Infections
Single-dose MRSA treatment among the third to be named a Qualified Infectious Disease Product
Indications: Oritavancin (Orbactiv) for injection is used for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of Gram-positive microorganisms including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus strains including pyogenes, agalactiae, dysgalactiae, and anginosus group, and Enterococcus faecalis (vancomycin-susceptible isolates only).
Dosing: A single 1200 mg dose administered by intravenous infusion over 3 hours, using three 400 mg vials that need to be reconstituted and diluted in 5% dextrose in sterile water only; it will not dilute properly in normal saline.
More information: Oritavancin is the third new antibacterial drug approved for treating ABSSSI and designated as a Qualified Infectious Disease Product (QIDP), following dalbavancin (Dalvance) and tedizolid (Sivextro).
Pharmacokinetics: Oritavancin exhibits linear pharmacokinetics at a dose up to 1200 mg, and has a terminal half-life of approximately 245 hours. Patients with mild or moderate renal or hepatic impairment may use the standard dose.
Side Effects/Risks: The most common side effects include headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. In patients taking warfarin, oritavancin may result in higher warfarin exposure and should be used only when the benefits outweigh the risk of bleeding. Contraindications include the use of IV unfractionated heparin sodium within 48 hours after administration.
Source: Highlights of prescribing information: Orbactiv. FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206334s000lbl.pdf. Revised August 2014. Accessed Aug. 12, 2014