"The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.
Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) cau"...
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.
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.
Complicated Skin And Skin Structure Infections
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).
VIBATIV is indicated for the treatment of adult patients with hospital-acquired and ventilatorassociated 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.
DOSAGE AND ADMINISTRATION
Complicated Skin And Skin Structure Infections
The recommended dosing for VIBATIV is 10 mg/kg administered over a 60-minute period in patients ≥ 18 years of age by intravenous infusion once every 24 hours for 7 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient's clinical progress.
Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
The recommended dosing for VIBATIV is 10 mg/kg administered over a 60-minute period in patients ≥ 18 years of age by intravenous infusion once every 24 hours for 7 to 21 days. The duration of therapy should be guided by the severity of the infection and the patient's clinical progress.
Patients With Renal Impairment
Because telavancin is eliminated primarily by the kidney, a dosage adjustment is required for patients whose creatinine clearance is ≤ 50 mL/min, as listed in Table 1 [see CLINICAL PHARMACOLOGY].
Table 1: Dosage Adjustment in Adult Patients with
|Creatinine Clearancea (CrCl) (mL/min)||VIBATIV Dosage Regimen|
|> 50||10 mg/kg every 24 hours|
|30-50||7.5 mg/kg every 24 hours|
|10- < 30||10 mg/kg every 48 hours|
|aCalculate using the Cockcroft-Gault formula and ideal body weight (IBW). Use actual body weight if it is less than IBW.|
Preparation And Administration
250 mg vial
Reconstitute the contents of a VIBATIV 250 mg vial with 15 mL of 5% Dextrose Injection, USP; Sterile Water for Injection, USP; or 0.9% Sodium Chloride Injection, USP. The resultant solution has a concentration of 15 mg/mL (total volume of approximately 17.0 mL).
750 mg vial
Reconstitute the contents of a VIBATIV 750 mg vial with 45 mL of 5% Dextrose Injection, USP; Sterile Water for Injection, USP; or 0.9% Sodium Chloride Injection, USP. The resultant solution has a concentration of 15 mg/mL (total volume of approximately 50.0 mL).
To minimize foaming during product reconstitution, allow the vacuum of the vial to pull the diluent from the syringe into the vial. Do not forcefully inject the diluent into the vial. Do not forcefully shake the vial and do not shake final infusion solution.
The following formula can be used to calculate the volume of reconstituted VIBATIV solution required to prepare a dose:
Telavancin dose (mg) = 10 mg/kg or 7.5 mg/kg x patient weight (in kg) (see Table 1)
Volume of reconstituted solution (mL) = Telavancin dose (mg)/ 15 mg/mL
For doses of 150 to 800 mg, the appropriate volume of reconstituted solution must be further diluted in 100 to 250 mL prior to infusion. Doses less than 150 mg or greater than 800 mg should be further diluted in a volume resulting in a final concentration of 0.6 to 8 mg/mL. Appropriate infusion solutions include: 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or Lactated Ringer's Injection, USP. The dosing solution should be administered by intravenous infusion over a period of 60 minutes.
Reconstitution time is generally under 2 minutes, but can sometimes take up to 20 minutes. Mix thoroughly to reconstitute and check to see if the contents have dissolved completely. Parenteral drug products should be inspected visually for particulate matter prior to administration. Discard the vial if the vacuum did not pull the diluent into the vial.
Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparing the final intravenous solution. Studies have shown that the reconstituted solution in the vial should be used within 12 hours when stored at room temperature or within 7 days under refrigeration at 2 to 8°C (36 to 46°F). The diluted (dosing) solution in the infusion bag should be used within 12 hours when stored at room temperature or used within 7 days when stored under refrigeration at 2 to 8°C (36 to 46°F). However, the total time in the vial plus the time in the infusion bag should not exceed 12 hours at room temperature and 7 days under refrigeration at 2 to 8°C (36 to 46°F). The diluted (dosing) solution in the infusion bag can also be stored at -30 to -10°C (-22 to 14°F) for up to 32 days.
VIBATIV is administered intravenously. Because only limited data are available on the compatibility of VIBATIV with other IV substances, additives or other medications should not be added to VIBATIV single-use vials or infused simultaneously through the same IV line. If the same intravenous line is used for sequential infusion of additional medications, the line should be flushed before and after infusion of VIBATIV with 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or Lactated Ringer's Injection, USP.
Dosage Forms And Strengths
VIBATIV is supplied in single-use vials containing either 250 or 750 mg telavancin as a sterile, lyophilized powder.
Storage And Handling
Cartons of 10 individually packaged 250 mg single-dose
vials (NDC 62847-002-01)
Cartons of 10 individually packaged 750 mg single-dose vials (NDC 62847-001-01)
Store original packages at refrigerated temperatures of 2 to 8°C (35 to 46 °F). Excursions to ambient temperatures (up to 25 °C (77 °F)) are acceptable. Avoid excessive heat.
Manufactured by: Theravance Biopharma Antibiotics, Inc. Marketed by: Theravance Biopharma US, Inc., South San Francisco, CA 94080. Revised: December 2014
Last reviewed on RxList: 12/19/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Vibativ Information
Report Problems to the Food and Drug Administration
Find out what women really need.