May 2, 2016
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"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.

Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...





In the event of overdosage, VIBATIV should be discontinued and supportive care is advised with maintenance of glomerular filtration and careful monitoring of renal function. Following administration of a single dose of VIBATIV 7.5 mg/kg to subjects with end-stage renal disease, approximately 5.9% of the administered dose of telavancin was recovered in the dialysate following 4 hours of hemodialysis. However, no information is available on the use of hemodialysis to treat an overdosage [see CLINICAL PHARMACOLOGY].

The clearance of telavancin by continuous venovenous hemofiltration (CVVH) was evaluated in an in vitro study [see Nonclinical Toxicology]. Telavancin was cleared by CVVH and the clearance of telavancin increased with increasing ultrafiltration rate. However, the clearance of telavancin by CVVH has not been evaluated in a clinical study; thus, the clinical significance of this finding and use of CVVH to treat an overdosage is unknown.


Intravenous Unfractionated Heparin Sodium

Use of intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration because the activated partial thromboplastin time (aPTT) test results are expected to be artificially prolonged for 0 to 18 hours after VIBATIV administration [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Known Hypersensitivity To VIBATIV

VIBATIV is contraindicated in patients with known hypersensitivity to telavancin.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/19/2014


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