Drug Interaction:
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.
Urine Protein Tests
Telavancin interferes with urine qualitative dipstick protein assays, as well
as quantitative dye methods (e.g., pyrogallol red-molybdate).
However, microalbumin assays are not affected.
Indication:
Proprietary Name- Vibativ
Established Name - Telavantin - Isoglycopeptide Antibacterial Drug
Applicant- Theravance Inc
Indication-
Infection caused by susceptible Bacteria
1. Complicated Skin and Structure Infection
2. Hospital acquired and Ventilator Associated bacterial pneumonia
Dosage-
10mg/kg administered by IV infusion over 60 minutes
Approved by FDA 11-9- 2009 (Ref- FDA approved List- 2009)
Adverse Reaction:
Most common adverse reactions
(10% of patients treated with VIBATIV) include: taste disturbance, nausea, vomiting
, and foamy urine.
Contra-Indications:
CONTRAINDICATIONS
None.
WARNING: FETAL RISK
See full prescribing information for complete boxed warning.
Women of childbearing potential should have a serum pregnancy test prior to
administration of VIBATIV.
Avoid use of VIBATIV during pregnancy unless potential benefit to the patient
outweighs potential risk to the fetus.
WARNINGS AND PRECAUTIONS
.
Nephrotoxicity: New onset or worsening renal impairment has occurred.
Monitor renal function in all patients.
.
Decreased efficacy with moderate/severe baseline renal impairment:
Consider these data when selecting antibacterial therapy for patients
with baseline CrCl .50 mL/min.
.
Infusion-related reactions: Administer VIBATIV over at least 60 minutes
to minimize infusion-related reactions.
.
Clostridium difficile-associated disease: May range from mild diarrhea
to fatal colitis. Evaluate if diarrhea occurs.
.
QTc prolongation: Avoid use in patients at risk. Use with caution in patients
taking drugs known to prolong the QT interval.
.
Coagulation test interference: Telavancin interferes with some laboratory
coagulation tests, including prothrombin time, international normalized ratio,
and activated partial thromboplastin time.
Dosages/ Overdosage Etc:
Indication-
Infection caused by susceptible Bacteria
1. Complicated Skin and Structure Infection
2. Hospital acquired and Ventilator Associated bacterial pneumonia
INDICATIONS AND USAGE
VIBATIV is a lipoglycopeptide antibacterial indicated for the treatment of adult
patients with complicated skin and skin structure infections (cSSSI) caused by
susceptible Gram-positive bacteria.
DOSAGE AND ADMINISTRATION•
10 mg/kg administered over 60 minutes by intravenous infusion once every
24 hours for 7 to 14 days.
Dosage adjustment in patients with renal impairment.
DOSAGE FORMS AND STRENGTHS -
Single-use vials containing either 250 or 750 mg telavancin.
Patient Information:
Use during Pregnancy and by Women of Childbearing Potential -
Women of childbearing potential (those who have not had: complete
absence of menses for at least 24 months or medically confirmed
menopause, medically confirmed primary ovarian failure, a history
of hysterectomy, bilateral oophorectomy, or tubal ligation) should
be informed about the potential risk of fetal harm if VIBATIV is used
during pregnancy
Have a pregnancy test prior to administration of VIBATIV.
If not pregnant, use effective contraceptive methods to prevent
pregnancy during VIBATIV treatment
Notify their prescribing physician/ healthcare provider if they
become pregnant during VIBATIV treatment
Pharmacology/ Pharmacokinetics:
Mechanism of Action
Telavancin is an antibacterial drug [see Clinical Pharmacology (12.4)].
to monitor urinary protein excretion during VIBATIV treatment.
Pharmacokinetics
In healthy young adults, the pharmacokinetics of telavancin administered
intravenously were 380 linear following single doses from 5 to 12.5 mg/kg
and multiple doses from 7.5 to 15 mg/kg 381 administered once-daily for up
to 7 days. Steady-state concentrations were achieved by the 382 third daily dose.
Distribution
Telavancin binds to human plasma proteins, primarily to serum albumin,
in a concentration-independent manner. The mean binding is
approximately 90% and is not affected by renal or hepatic impairment.
Excretion
Telavancin is primarily eliminated by the kidney. In a mass balance study,
approximately 76% of the administered dose was recovered from
urine and <1% of the dose was recovered from feces
(collected up to 216 hours) based on total radioactivity
Pregnancy and lactation:
-USE IN SPECIFIC POPULATIONS-
.
Pregnancy:
Based on animal data, may cause fetal harm.
Pregnancy registry available.
.
Pediatric patients:
Safety and efficacy not demonstrated.
Nursing Mothers
It is not known whether telavancin is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised when VIBATIV is administered to a
nursing woman.
Pediatric Use
The safety and effectiveness of VIBATIV in pediatric patients has not been studied.
Geriatric Use
Of the 929 patients treated with VIBATIV at a dose of 10 mg/kg once daily in clinical trials of cSSSI, 174 (18.7%) were .65 years of age and 87 (9.4%) were .75 years of age.
In the cSSSI trials, lower clinical cure rates were observed in patients 65 years of age compared with those <65 years of age. Overall, treatment-emergent adverse events occurred with similar frequencies in patients .65 (75% of patients) and <65 years of age
(83% of patients).
Fifteen of 174 (8.6%) patients .65 years of age treated with telavancin had adverse events indicative of renal impairment compared to 16 of 755 (1.9%) patients <65 years of age
Manufacturer Details