Vibativ (telavancin HCl)

Dosage of telavancin hydrochloride is expressed in terms of telavancin.

Telavancin hydrochloride is administered by IV infusion.

Telavancin solutions should not be admixed or added to solutions containing other drugs.

If the same IV line is used for sequential infusion of other drugs, the IV line should be flushed with 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer's injection before and after the telavancin infusion.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Telavancin is contraindicated in patients with known hypersensitivity to the drug.

IV unfractionated heparin sodium is contraindicated in patients receiving telavancin. Activated partial thromboplastin time (aPTT) is expected to be artificially prolonged for up to 18 hours after telavancin administration. (See Tests Used to Monitor Coagulation under Cautions: Other Warnings/Precautions.)

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in 5% or more of patients receiving telavancin for the treatment of hospital-acquired or ventilator-associated bacterial pneumonia include GI effects (nausea, vomiting, diarrhea, constipation ), anemia, hypokalemia, hypotension, decubitus ulcer, insomnia, peripheral edema, and renal effects (renal impairment or insufficiency, acute renal failure, chronic renal failure, increased serum creatinine).

Adverse effects reported in 7% or more of patients receiving telavancin for the treatment of complicated skin and skin structure infections include GI effects (taste disturbance, nausea, vomiting, diarrhea, constipation ), headache, insomnia, and foamy urine.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of telavancin have not been evaluated in patients younger than 18 years of age.

Category C. (See Users Guide.)

A pregnancy registry has been established to monitor maternal-fetal outcomes in pregnant women exposed to telavancin. Clinicians are encouraged to contact the registry at 855-633-8479 to report cases of prenatal exposure to telavancin; alternatively, pregnant women may enroll.

In reproduction studies in rats, rabbits, and minipigs that received telavancin during the period of organogenesis at doses that resulted in exposure levels approximately onefold to twofold the human exposure (area under the plasma concentration-time curve (AUC)) at the maximum recommended human dosage, there was evidence that telavancin has the potential to cause limb and skeletal malformations and reduced fetal weight. Malformations included brachymelia (rats, rabbits), syndactyly (rats, minipigs), adactyly (rabbits), and polydactyly (minipigs).

Although telavancin has not been evaluated in pregnant women, the animal data raise concerns about potential adverse developmental outcomes in humans. Telavancin should be avoided during pregnancy unless the potential benefits to the woman outweigh the potential risks to the fetus. (See Fetal/Neonatal Morbidity under Warnings/Precautions: Warnings, in Cautions.)

Not known whether telavancin is distributed into milk in humans. Telavancin should be used with caution in nursing women.

Dosage adjustments based solely on age are not needed when telavancin is used in geriatric patients, but dosage should be adjusted based on renal function. Because geriatric patients are more likely to have decreased renal function than younger adults, dosage should be selected with caution. (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

In clinical studies evaluating telavancin for the treatment of complicated skin and skin structure infections, the drug appeared to be less effective in adults 65 years of age or older relative to adults younger than 65 years of age. Although there were no overall differences in frequency of treatment-emergent adverse events in geriatric adults compared with younger adults in these studies, the incidence of adverse events indicating renal impairment was higher in geriatric adults treated with telavancin than in younger adults treated with the drug.

In clinical studies evaluating telavancin for the treatment of hospital-acquired or ventilator-associated bacterial pneumonia, treatment-emergent adverse events as well as deaths and other serious adverse events occurred more often in patients 65 years of age or older than in those younger than 65 years of age in both the telavancin treatment group and comparator treatment group.

Telavancin is substantially eliminated by the kidneys, and the risk of adverse effects may be greater in patients with impaired renal function. Dosage should be selected with caution since geriatric patients are more likely to have decreased renal function. Dosage adjustments in geriatric patients should be based on renal function.