Telavancin (Vibativ) is a semisynthetic derivative of vancomycin that has concentration-dependent bactericidal activity.

It is used to treat the following conditions:

• Complicated skin and skin structure infections:

  • it is used in the treatment of complicated skin and skin structure infections caused by:

    • susceptible gram-positive organisms e.g methicillin-susceptible or resistant Staphylococcus aureus,

    • vancomycin-susceptible Enterococcus faecalis, and

    • Streptococcus pyogenes, Streptococcus agalactiae, or Streptococcus anginosus group

• Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP):

  • it is used in the treatment of HABP/VABP caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not appropriate

• Off Label Use of Telavancin in Adults:

  • it is used in the treatment of Bacteremia due to S. aureus

Other drugs used to treat resistant infections caused by staphylococci include:

• Linezolid
• Ceftaroline (Teflaro)
• Quinopristine-daptomycin

Telavancin (Vibativ) Dose in Adults

Telavancin (Vibativ) Dose in the treatment of Bacteremia due to S. aureus (off-label):

• 10 mg/kg intravenous given every 24 hours

Telavancin (Vibativ) Dose in the treatment of complicated skin and skin structure infection:

• 10 mg/kg intravenous given  every 24 hours for 1 to 2 weeks

Telavancin (Vibativ) Dose in the treatment of Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) due to S. aureus:

• 10 mg/kg intravenous given every 24 hours for 1 to 3 weeks

Use in Children:

Safety and efficacy in children not established.

Telavancin (Vibativ) Pregnancy Risk Factor C

• [US Boxed Warning]According to animal data, there have been adverse developmental outcomes.
• A serum pregnancy test should be done before use for women with childbearing potential.
• Telavancin should not be used during pregnancy unless there is a clear benefit for the mother and the risk to the baby.
• Telavancin crosses the placenta
• Effective contraception should be used in therapy for women with childbearing potential.

Telavancin (Vibativ) use during breastfeeding:

• It is recommended that you stop breastfeeding during treatment.
• It is unknown if telavancin is excreted into breastmilk.
• According to the US labeling, it is important to exercise caution when giving telavancin as a nursing drug.

Telavancin (Vibativ) dose in kidney disease:

• US labeling:

  • CrCl >50 mL/minute:

    • No dosage adjustment required

  • CrCl 30 to 50 mL/minute:

    • 5 mg/kg given  every 24 hours

  • CrCl 10 to <30 mL/minute:

    • 10 mg/kg given every 48 hours

  • CrCl <10 mL/minute:

    • No dosage adjustment given in manufacturer’s labeling (has not been studied).

  • ESRD and hemodialysis patients:

    • No dosage adjustment is given in the manufacturer’s labeling (has not been studied).

• Canadian labeling:

  • CrCl >50 mL/minute:

    • No dosage adjustment required

  • CrCl 30 to 50 mL/minute:

    • 5 mg/kg given every 24 hours

  • CrCl <30 mL/minute:

    • Not recommended.

  • ESRD and hemodialysis patients:

    • Not recommended.

Telavancin (Vibativ) dose in liver disease:

• Mild-to-moderate hepatic impairment (Child-Pugh class A or B):

  • No dosage adjustment required.

• Severe hepatic impairment (Child-Pugh class C):

  • No dosage adjustment is given in the manufacturer's labeling (has not been studied).

Common Side Effects of Vibativ (Telavancin):

• Central Nervous System:

  • Metallic Taste

• Gastrointestinal:

  • Nausea
  • Vomiting

• Renal:

  • Increased Serum Creatinine
  • Foamy Urine

Less Common Side Effects of Telavancin (Vibativ):

• Central Nervous System:

  • Dizziness
  • Infusion Site Pain
  • Rigors

• Dermatologic:

  • Pruritus
  • Skin Rash
  • Localized Erythema

• Gastrointestinal:

  • Diarrhea
  • Decreased Appetite
  • Abdominal Pain

• Local:

  • Infusion Site Reaction

• Renal:

  • Renal Insufficiency
  • Acute Renal Failure

Contraindications to Telavancin (Vibativ):

• Hypersensitivity to telavancin and any component of the formulation
• Concomitant intravenous unfractionated Heparin use

Warnings and precautions

• Anaphylaxis/hypersensitivity reactions:

  • After the first or subsequent doses, severe hypersensitivity reactions including anaphylaxis have been observed. Some have even been fatal.
  • If hypersensitivity or rash occurs, discontinue use.
  • Patients with known hypersensitivity to vancomycin should be cautious.

• Modification of cardiac conduction:

  • It could prolong the QTc interval
  • Patients with congenital QT syndrome, known QTc lengthenation, severe left ventricular hypertrophy, and uncompensated cardiac failure should be avoided.
  • Patients who are taking concurrently other drugs that prolong the QT interval should be cautious.

• Infusion reactions

  • Rapid intravenous administration may cause flushing, rash and/or pruritus.
  • These symptoms can be relieved by slowing down or stopping infusions.

• Nephrotoxicity: [US Boxed Warning]

  • There have been cases of new or worsening renal impairment.
  • Monitor renal function before, during, and after treatment (at minimum every 48 to 72 hour; more often if indicated) in all patients.
  • Concomitant nephrotoxic drugs or baseline comorbidities that are associated with decreased renal function (eg, baseline renal dysfunction, hypertension or heart failure) are common risk factors.
  • Contains solubilizer cyclodextrin (hydroxypropyl-beta-cyclodextrin) that may accumulate in patients with kidney disease, although the clinical significance of this finding is uncertain

• Superinfection

  • Prolonged use can result in fungal or bacterial superinfection, including C.difficile-associated diarrhea (CDAD) and pseudomembranous colitis;
  • After 2 months of antibiotic treatment, CDAD infection was still present.

• Renal impairment: [US-Boxed Warning]

  • Patients with pre-existing moderate-to-severe kidney disease with a CrCl <=50 mL/minute, treated for hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) had increased (all-cause) mortality compared to those treated with vancomycin.
  • Use of HABP/VABP is only recommended when the benefit outweighs any risk.
  • Patients with skin structure and complicated skin conditions can have their efficacy reduced if they have a baseline CrCl of =50mL/minute.

Telavancin: Drug Interaction

Monitor:

• Renal function (prior to the start, every 48 to 72 hours; more frequently if indicated and following therapy)
• Pregnancy test

How to administer Telavancin (Vibativ)?

• Administer intravenously over one hour.
• Other medications should not be given simultaneously through the same IV line.
• When the same intravenous line is used for sequential infusion of other medications, flush line with D W, LR, or NS before and after infusing telavancin.
• Red-man syndrome can occur if the infusion is too rapid.
• It may be characterized by low blood pressure and/or a maculopapular rash appearing on the face, trunk, neck, and/or upper extremities, however, this is not an allergic reaction.
• If a rash appears or hypotension occurs, discontinue or slow the infusion rate.

Mechanism of action of Telavancin (Vibativ):

• It is a semisynthetic derivative of Vancomycin that has concentration-dependent bactericidal activity.
• It blocks the polymerization and cross-linking peptidoglycans in bacterial cell walls by binding to the D–Ala-D–Ala portion.
• The additional mechanism, which is different from vancomycin's, involves the disruption of membrane potential and alteration of cell permeability by the presence of lipophilic side chains moiety.

Protein binding:

• ~90%; primarily to albumin

Half-life elimination:

• 6.6 to 9.6 hours

Excretion:

• Via Urine (~76%); feces (<1%)

International Brand Names of Telavancin:

• Vibativ

Telavancin Brand Names in Pakistan:

No brands available in Pakistan