• Complicated skin/skin structure infections caused by susceptible bacteria.
• Hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus

Contraindicated in:

• Hypersensitivity
• Congenital long QT syndrome, known prolongation of the QT interval, uncompensated HF, or severe left ventricular hypertrophy (↑ risk of fatal arrhythmias)
• Concurrent use of unfractionated heparin (aPTT may be falsely ↑ for up to 18 hr after telavancin therapy)
• OB: Pregnancy.

Use Cautiously in:

• Renal impairment (dose ↓ recommended for CCr ≤50 mL/min) (efficacy may be ↓ in patients with complicated skin/skin structure infections and CCr ≤50 mL/min) (↑ risk of mortality in patients with hospital-acquired or ventilator-associated pneumonia and CCr ≤50 mL/min; use only if benefit outweighs risk)
• Diabetes, HF, hypertension (↑ risk of renal impairment)
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children (may be associated with poor outcomes in children <1 yr who have immature renal function)
• Geri: Consider age-related ↓ in renal function in older adults.

CV: QT interval prolongation.

GI: nausea, taste disturbance, vomiting, abdominal pain, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD).

GU: foamy urine, nephrotoxicity.

Neuro: dizziness.

Misc: ANAPHYLAXIS, infusion reactions.

Drug-Drug:

• Concurrent use of QT interval prolonging medications may ↑ risk of arrhythmias.
• Concurrent use of NSAIDs, ACE inhibitors, and loop diuretics may ↑ risk of nephrotoxicity.

• Lyophilized powder for injection: 750 mg/vial;

Complicated Skin/Skin Structure Infections

• IV (Adults): 10 mg/kg ever 24 hr for 7–14 days.

Hospital-Acquired/Ventilator-Associated Bacterial Pneumonia

• IV (Adults): 10 mg/kg ever 24 hr for 7–21 days.

Vibativ

• Inhibits bacterial cell wall synthesis by interfering with the polymerization and cross-linking of peptidoglycan.

• Bactericidal action against susceptible organisms.

Spectrum:

• Active against Staphylococcus aureus (including methicillin-susceptible and -resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus (including S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible strains only).

Therapeutic Classification: anti-infectives

Pharmacologic Classification:

Absorption: IV administration results in complete bioavailability.

Distribution: Minimal distribution to tissues.

Metabolism/Excretion: Metabolism is not known; 76% excreted unchanged in urine <1% in feces.

Half-life: 8 hr.

(plasma concentrations)

• Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
• Inform patient that common side effects include taste disturbance, nausea, vomiting, headache, and foamy urine. Notify health care professional if signs of infusion reaction occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 2 days after last dose and to notify health care professional if pregnancy is suspected. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to telavancin during pregnancy. Encourage pregnant patients to enroll in the VIBATIV pregnancy registry by calling 1-877-484-2700. May impair fertility in males.
• Instruct the patient to notify health care professional if symptoms do not improve.

tel-a-VAN-sin

NDC Code^*

• 62847- Theravance Biopharma Rand D, Inc.
  • 62847-001- Vibativ
    • 62847-001-01- 1 VIAL, SINGLE-USE in 1 CONTAINER (62847-001-01) > 50 mL in 1 VIAL, SINGLE-USE