VIBATIV® (telavancin) |

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Prescribing Information
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Why Vibativ
- Potency
- Dual MOA
- Dosing
- Safety Info
HABP/VABP
cSSSI
Real World Results
Access
Success Stories

Why Vibativ
- Potency
- Dual MOA
- Dosing
- Safety Info
HABP/VABP
cSSSI
Real World Results
Access
Success Stories

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PLEASE SEE FULL PRESCRIBING INFORMATION INCLUDING BOXED WARNING

VIBATIV^® (telavancin) Indications
VIBATIV is a lipoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria:

Complicated Skin and Skin Structure Infections (cSSSIs)
VIBATIV is indicated for the treatment of adult patients with cSSSIs caused by susceptible isolates of the following Gram-positive microorganisms:

Staphylococcus aureus (including methicillin-susceptible and resistant isolates)

Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or

Enterococcus faecalis (vancomycin-susceptible isolates only)

Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
VIBATIV is indicated for the treatment of adult patients with HABP/VABP, caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates).

VIBATIV should be reserved for use when alternative treatments are not suitable.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, POTENTIAL ADVERSE DEVELOPMENTAL OUTCOMES

Patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.

Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients.

Embryo-fetal toxicity: VIBATIV may cause fetal harm. In animal reproduction studies, adverse developmental outcomes were observed in 3 animal species at clinically relevant doses. Verify pregnancy status in females of reproductive potential prior to initiating VIBATIV. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VIBATIV and for 2 days after the final dose.

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Because telavancin is eliminated primarily by the kidney, a dosage adjustment is required for patients whose creatinine clearance is ≤50 mL/min. There is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (CrCl <10 mL/min), including patients undergoing hemodialysis.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Intravenous Unfractionated Heparin Sodium

Known hypersensitivity to VIBATIV

WARNINGS AND PRECAUTIONS

Decreased efficacy among patients treated for cSSSI with moderate/severe pre-existing renal impairment. Consider when selecting antibacterial therapy for patients with baseline CrCl ≤50 mL/min.

Laboratory tests: interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time.

Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. Use with caution in patients with known hypersensitivity to vancomycin.

Administer VIBATIV over at least 60 minutes to minimize infusion-related reactions.

Clostridium difficile-Associated Diarrhea: may range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

Avoid use in patients at risk for QTc prolongation and who are taking drugs known to prolong the QT interval.

ADVERSE REACTIONS
The most common adverse reaction (≥10% of patients treated with VIBATIV) in the HABP/VABP trials is diarrhea; in the cSSSI trials, the most common adverse reactions (≥10% of patients treated with VIBATIV) include: taste disturbance, nausea, vomiting, and foamy urine.

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VIBATIV^® is a registered trademark of Cumberland Pharmaceuticals Inc.