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ORDER VIBATIV

VIBATIV single-use vials are now available through your regular wholesaler channel or by calling Theravance Biopharma at 1-855-784-7972.

VIBATIV is provided as a 750 mg powder for reconstitution:

NDC=National Drug Code, UPC=Universal Product Code.

Order MIC test strips

Announcing the Telavancin Minimum Inhibitory Concentration (MIC) Test Strip—a quantitative assay that determines the MIC of telavancin against Staphylococcus aureus (including methicillin-resistant isolates) and Enterococcus faecalis (vancomycin-susceptible isolates only).

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CALL

781-902-0314

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EMAIL

Support@liofilchem.us

Please include your name, organization, account number (if applicable), address, a description of item, and quantity of item

Liofilchem® customer service inquiries:
Call 781-902-0314 (8:00 am to 5:00 pm EST Monday through Friday) or email Support@liofilchem.us

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Storage and Handling

VIBATIV should be stored at 2°C to 8°C (35°F to 46°F). Excursions to ambient temperatures (up to 25°C [77°F]) are acceptable. Avoid excessive heat.

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BILLING GUIDE

The VIBATIV Coding and Billing Guide was developed to help healthcare providers and billing staff understand third-party payer coding and billing requirements for VIBATIV.

HCPCS Codes:

NDC=National Drug Code.

For more information, including a coding and billing checklist, an appeals checklist, and a comprehensive list of common diagnosis codes, download our guide.

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Patient Assistance Program

This program is designed to assist financially disadvantaged individuals that have no private or public insurance coverage such as Medicaid, Medicare prescription drug coverage, state-sponsored prescription drug assistance, employee, military, retirement or pension program drug coverage.

VIBATIV is eligible under Medicare Part D (coverage may be available through plan formulary or non-formulary exception process), Medicare Part B, and Commercial Insurance for OPAT settings. Coverage may be available through plan formulary or non-formulary exception process.

Download the following material to learn more or to enroll a patient:

Access VIBATIV Reimbursement Services

See the ASP Pricing Files

Phone: 855-847-9435
Fax: 855-847-9478
Monday-Friday 8am-7pm CT
Services include: uninsured patients assistance program (PAP), real-time benefit verification, prior authorization assistance, billing and coding support

Indication

HABP/VABP

VIBATIV is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (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.

cSSSI

VIBATIV is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) 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)

Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. VIBATIV may be initiated as empiric therapy before results of these tests are known. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Important Safety Information

Mortality

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 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 occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed.

Fetal Risk

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.

Contraindication

Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.

VIBATIV is contraindicated in patients with a known hypersensitivity to the drug.

Hypersensitivity Reactions

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

Geriatric Use

Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.

Infusion Related Reactions

VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause “Red-man Syndrome” like reactions including: flushing of the upper body, urticaria, pruritus, or rash.

QTc Prolongation

Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.

Most Common Adverse Reactions

The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.

Please see full Prescribing Information including Boxed Warning and Medication Guide.