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General MedicationsINTRAVENOUSBlack Box

VIBATIV

TELAVANCIN HYDROCHLORIDE

Standard Dose
2 DOSAGE AND ADMINISTRATION Complicated skin and skin structure infections (cSSSI): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 14 days ( 2.1 ) Dosage adjustment in patients with renal impairment. ( 2.3 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 21 days ( 2.2 ) Dosage adjustment in patients with renal impairment. ( 2.3 ) a Calculate using the Cockcroft-Gault formula and ideal body weight (IBW). Use actual body weight if 50 10 mg/kg every 24 hours 30-50 7.5 mg/kg every 24 hours 10- 50 10 mg/kg every 24 hours 30-50 7.5 mg/kg every 24 hours 10-<30 10 mg/kg every 48 hours 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. 2.4 Preparation and Administration 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-dose 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.
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE 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 (cSSSI) ( 1.1 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus .
Summary

Indications and usage 1 INDICATIONS AND USAGE 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 (cSSSI) ( 1.1 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus .

VIBATIV should be reserved for use when alternative treatments are not suitable. ( 1.2 ) 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 bacteria. 1.1 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 (vancomycinsusceptible isolates only). 1.2 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 (both methicillin-susceptible and -resistant isolates).

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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 (cSSSI) ( 1.1 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus . VIBATIV should be reserved for use when alternative treatments are not suitable. ( 1.2 ) 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 bacteria. 1.1 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 (vancomycinsusceptible isolates only). 1.2 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 (both methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable. 1.3 Usage 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. Dosage and administration 2 DOSAGE AND ADMINISTRATION Complicated skin and skin structure infections (cSSSI): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 14 days ( 2.1 ) Dosage adjustment in patients with renal impairment. ( 2.3 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 21 days ( 2.2 ) Dosage adjustment in patients with renal impairment. ( 2.3 ) a Calculate using the Cockcroft-Gault formula and ideal body weight (IBW). Use actual body weight if 50 10 mg/kg every 24 hours 30-50 7.5 mg/kg every 24 hours 10- 50 10 mg/kg every 24 hours 30-50 7.5 mg/kg every 24 hours 10-<30 10 mg/kg every 48 hours 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. 2.4 Preparation and Administration 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. Parent

Boxed Warning

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 [see Warnings and Precautions ( 5.1 , 8.4 )]. Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients [see Warnings and Precautions ( 5.3 )] . Embryofetal 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 [see Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 , 8.3 )]. WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, and EMBRYO-FETAL TOXICITY See full prescribing information for the complete boxed warning 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. ( 5.1 , 8.4 ) Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients. ( 5.3 ) 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 prior to initiating treatment and advise females of reproductive potential to use effective contraception ( 5.4 , 8.1 , 8.3 ).

Monitoring

  • • 5 WARNINGS AND PRECAUTIONS Decreased efficacy among patients treated for skin and skin structure infections with moderate/severe pre-existing renal impairment: Consider these data when selecting antibacterial therapy for patients with baseline CrCl ≤50 mL/min.
  • • ( 5.2 ) Coagulation test interference: Telavancin interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time.
  • • ( 5.5 , 7.1 ) 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.

Interaction Notes

  • • 7 DRUG INTERACTIONS 7.1 Drug-Laboratory Test Interactions Effects of Telavancin on Coagulation Test Parameters Telavancin binds to the artificial phospholipid surfaces added to common anticoagulation tests, thereby interfering with the ability of the coagulation complexes to assemble on the surface of the phospholipids and promote clotting in vitro .
  • • These effects appear to depend on the type of reagents used in commercially available assays.
  • • Thus, when measured shortly after completion of an infusion of VIBATIV, increases in the PT, INR, aPTT, and ACT have been observed.
  • • These effects dissipate over time, as plasma concentrations of telavancin decrease.