新型脂糖肽类抗生素Vibativ(telavancin 中文药名：盐酸特拉万星注射粉剂)获美国FDA批准用于治疗MRSA等严重的皮肤感染
Manufacturer:
Astellas Pharma US, Inc.
Pharmacological Class:
Antibiotic (lipoglycopeptide)
Active Ingredient(s):
Telavancin (as HCl) 250mg, 750mg; per vial; pwd for IV infusion after reconstitution and dilution; preservative-free.
Indication(s):
Complicated skin and skin structure infections due to susceptible gram (+) bacteria.
Pharmacology:
Telavancin is a synthetic derivative of vancomycin that exerts its antibacterial effect by inhibiting bacterial cell wall synthesis and disrupting the functioning of the cell membrane. It has been shown to be effective against most isolates of Staphylococcus aureus (including methicillin-resistant strains, or MRSA), Streptococcus pyogenes, S. agalactiae, S. anginosus group, E. faecalis (vancomycin-susceptible strains only).
The use of telavancin should be avoided in patients who are pregnant, unless the benefits to the patient outweighs the potential risks to the fetus (eg, skeletal malformations).
Clinical Trials:
Telavancin (10mg/kg daily) was compared to vancomycin (1g every 12 hrs) in two randomized, multinational, double-blind studies in adults with clinically documented complicated skin and skin structure infections with MRSA suspected or confirmed as the primary pathogen. Patients could receive concomitant aztreonam or metronidazole for suspected gram (–) or anaerobic infections, respectively. The all-treated efficacy (ATe) population included all patients who received any amount of study drug and were eva luated for efficacy; the clinically eva luable (CE) population included those patients in the ATe group with sufficient adherence to protocol.
Of 1794 ATe patients, 1410 were clinically eva luable. The primary efficacy endpoint for each trial was the clinical cure rate at a followup visit in the ATe and CE populations. The clinical cure rates for the ATe populations in Trial 1 and Trial 2 were 72.5% and 74.7%, respectively, for telavancin, compared with 71.6% and 74.0% for vancomycin. The clinical cure rates for telavancin in the CE populations for the two trials were 84.3% and 83.9%, respectively, compared with 82.8% and 87.7% for vancomycin. The clinical cure rate for MRSA for telavancin was 87.0% compared to 85.9% for vancomycin.
Legal Classification:
Rx
Adults:
≥18yrs: Give by IV infusion over 60 minutes. Treat for 7–14 days. Normal renal function: 10mg/kg every 24hrs. Renal impairment: CrCl 30–50mL/min: 7.5mg/kg every 24 hrs; CrCl 10 – <30mL/min: 10mg/kg every 48hrs; CrCl<10mL/min or dialysis: not recommended.
Children:
<18yrs: not recommended.
Precaution(s):
Obtain (–) pregnancy test before treatment for women of childbearing potential; use appropriate effective contraception during treatment. Baseline CrCl≤50mL/min. Monitor renal function. Diabetes. CHF. Hypertension. Long QT syndrome, uncompensated heart failure, severe left ventricular hypertrophy: not recommended. Pregnancy (Cat.C): not recommended, may cause fetal harm. Nursing mothers.
Interaction(s):
Caution with other drugs that can cause QT prolongation. Increased risk of renal toxicity with NSAIDs, ACE inhibitors, loop diuretics). May interfere with coagulation tests (eg, PT/INR, aPPT, activated clotting time, coagulation-based factor Xa tests) and some urine protein tests.
Adverse Reaction(s):
Dysgeusia, GI upset, foamy urine; nephrotoxicity (reeva luate if occurs), infusion reactions ("red man syndrome"), superinfection (eg, antibiotic-associated colitis), QT prolongation.
How Supplied:
Single-use vials—10
Last Updated:
1/21/2010
VIBATIV is supplied in single-use vials containing either 250 mg or 750 mg of telavancin as a sterile, lyophilized powder.
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 (including methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable
cSSSI
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 (vancomycin-susceptible isolates only).
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.
Important Safety Information
Mortality
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.
Nephrotoxicity
New onset or worsening renal impairment occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed.
Fetal Risk
Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.
Contraindication
Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.
VIBATIV is contraindicated in patients with a known hypersensitivity to the drug.
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.
Geriatric Use
Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.
Infusion Related Reactions
VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause "Red-man Syndrome" like reactions including: flushing of the upper body, urticaria, pruritus, or rash.
QTc Prolongation
Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.
Most Common Adverse Reactions
The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine
https://www.vibativfacts.com/why-VIBATIV
