Bacterial infections:

Indications for VIBATIV:

Complicated skin and skin structure infections (cSSSI) due to susceptible gram (+) bacteria. Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) due to Staphylococcus aureus (reserve use when no alternatives).

Adult:

≥18yrs: Give by IV infusion over 60mins. cSSSI: treat for 7–14 days. HABP/VABP: treat for 7–21 days. Normal renal function: 10mg/kg once every 24hrs. Renal impairment: CrCl 30–50mL/min: 7.5mg/kg every 24hrs; CrCl 10–<30mL/min: 10mg/kg every 48hrs; CrCl<10mL/min or dialysis: not recommended.

Children:

<18yrs: not studied.

Contraindications:

Concomitant IV unfractionated heparin sodium.

Boxed Warning:

Increased mortality in HABP/VABP patients with pre-existing moderate or severe renal impairment. Nephrotoxicity. Potential adverse developmental outcomes.

Warnings/Precautions:

Increased mortality in patients with pre-existing moderate/severe renal impairment who were treated for HABP/VABP. Baseline CrCl≤50mL/min. Risk of nephrotoxicity; monitor renal function. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 2 days after last dose. Diabetes. CHF. Hypertension. Discontinue at first sign of rash or any other sign of hypersensitivity reaction. Known hypersensitivity to vancomycin. Congenital long QT syndrome, uncompensated heart failure, severe left ventricular hypertrophy: avoid. Pregnancy: exclude status prior to initiation. Nursing mothers.

Pharmacologic Class:

Lipoglycopeptide.

Interactions:

Caution with other drugs that can cause QT prolongation. Increased risk of renal toxicity with NSAIDs, ACE inhibitors, loop diuretics. May interfere with coagulation tests (eg, PT/INR, aPPT, activated clotting time, coagulation-based factor Xa tests) and some urine protein tests.

Adverse Reactions:

Dysgeusia, nausea, vomiting, foamy urine, diarrhea; nephrotoxicity, infusion reactions ("red man syndrome"), superinfection, QT prolongation, C.difficile-associated diarrhea.

Generic Availability:

NO

How Supplied:

Single-use vials—10