Vibativ
Generic Name: telavancin
Date of Approval: September 11, 2009
Company: Theravance, Inc. and Astellas Pharma US, Inc.
Treatment for: Complicated Skin and Skin Structure Infections (cSSSI)
FDA Approves Vibativ
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 Feedback for Vibativ
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The U.S. Food and Drug Administration (FDA) has approved Vibativ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.
Vibativ is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby Vibativ both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. Vibativ is indicated for the treatment of adult patients with 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) and Enterococcus faecalis (vancomycin susceptible isolates only).
About ATLAS I and ATLAS II Clinical Studies
The Vibativ Phase III clinical program consisted of two large, multinational, double-blind, randomized Phase III clinical studies, ATLAS I and ATLAS II designed to compare the efficacy and safety of Vibativ (10 mg/kg IV once daily) versus vancomycin (1 gm IV q 12hr) in adult patients with cSSSI caused by Gram-positive bacteria. A total of 1,867 patients were enrolled and treated, 719 of whom had infections with MRSA. In both of these studies, Vibativ achieved its primary endpoint of non-inferiority relative to the standard of care, vancomycin. Vibativ has not been studied in children.
Important Safety Information
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.
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. Clinical cure rates in telavancin-treated patients were lower in patients with baseline CrCl ≤50 mL/min compared to those with CrCl >50 mL/min. Consider these data when selecting antibacterial therapy for use in patients with baseline moderate/severe renal impairment.
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.
Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Development of Drug Resistant Bacteria Prescribing Vibativ in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. As with other antibacterial drugs, use of Vibativ may result in overgrowth of nonsusceptible organisms, including fungi.
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.
Coagulation Test Interference Vibativ does not interfere with coagulation, but does interfere with certain tests used to monitor coagulation such as prothrombin time, international normalized ratio, activated partial thromboplastin time, activated clotting time, and coagulation based factor Xa tests. Blood samples for these coagulation tests should be collected as close as possible prior to a patient's next dose of Vibativ.
Vibativ Adverse Reactions
The most common adverse reactions (≥10% of patients treated with Vibativ) observed in the Phase III cSSSI clinical trials were taste disturbance, nausea, vomiting, and foamy urine.
In the Phase III cSSSI clinical trials, serious adverse events were reported in 7% of patients treated with Vibativ and most commonly included renal, respiratory, or cardiac events. Serious adverse events were reported in 5% of vancomycin-treated patients, and most commonly included cardiac, respiratory, or infectious events.
Vibativ Medication Guide
Read this Medication Guide before you start taking Vibativ and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Important information about Vibativ
Vibativ may harm your unborn baby. Women who can become pregnant should have a blood pregnancy test before taking Vibativ.
- Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if Vibativ is the right medicine for you
- Do not become pregnant while taking Vibativ. Women who can become pregnant should use effective birth control (contraception) while taking Vibativ
- If you get pregnant while taking Vibativ, tell your healthcare provider right away
- If you become pregnant while taking Vibativ, talk to your healthcare provider about taking part in the Vibativ Pregnancy Registry. This is a study to learn how Vibativ affects pregnancy and babies. You can enroll in this registry by calling 1-888-658-4228
What is Vibativ?
Vibativ is a prescription antibiotic medicine used in adults, alone or with other medicines to treat certain types of germs (bacteria) that cause serious skin infections.
It is not known if Vibativ is safe or effective in children under 18 years of age.
Before taking Vibativ
Before you take Vibativ, tell your healthcare provider if you:
- have kidney problems
- have diabetes
- have heart problems, including QTC prolongation or a family history of it
- have high blood pressure
- have other medical conditions
- are breastfeeding or plan to breastfeed. It is not known if Vibativ passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking Vibativ
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Vibativ and other medicines can affect each other causing side effects.
Especially tell your healthcare provider if you take:
- a blood thinner
- medicine to control your heart rate or rhythm (antiarrhythmics)
- water pills (diuretics)
- a Non-Steroidal Anti-Inflammatory Drug (NSAID)
- certain blood pressure medicines called ACE Inhibitors or ARBs Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How will I receive Vibativ?
- Vibativ is injected into your vein (IV infusion) by your healthcare provider slowly over 1 hour, 1 time a day, for 7 to 14 days.
- Do not stop taking Vibativ unless your healthcare provider tells you to even if you feel better.
- It is important that you receive all of your Vibativ doses. Do not skip any doses.
- If you miss a dose or stop taking Vibativ before getting all of your doses, contact your healthcare provider right away.
- If you skip doses or stop treatment too soon, the germs (bacteria) may grow again and Vibativ may not work.
- Your healthcare provider will do tests before you start and while you take Vibativ.
Vibativ side effects
Vibativ may cause serious side effects, including:
- Kidney problems
- Infusion-related reactions. Infusion-related reactions can include: red color (flushing) to your upper body, hives (raised bumps), itching or rash if Vibativ is given too fast
- Intestine infection. Intestine infections can cause diarrhea or bloody stools, stomach cramps, and a fever. These infections can happen 2 or more months after you stop taking Vibativ
- Irregular heartbeat.
- Changes in blood and urine test. Tell your healthcare provider if you plan to have any test of your blood or urine while taking Vibativ Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of Vibativ include:
- change in your sense of taste
- nausea
- vomiting
- foamy urine
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of Vibativ. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store Vibativ?
- Store Vibativ in the original package
- Keep Vibativ refrigerated between 35°F to 46°F (2°C to 8°C)
- Keep out of heat
Keep Vibativ and all medicines out of the reach of children.
General Information about Vibativ
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vibativ for a condition for which it is not prescribed. Do not give Vibativ to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Vibativ. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Vibativ that is written for health professionals.
For more information, go to www.Vibativ.com or call 1-800-727-7003.
What are the ingredients in Vibativ?
Active ingredient: telavancin hydrochloride
Inactive ingredients: hydroxypropylbetadex, Ph. Eur (hydroxypropyl-beta-cyclodextrin), mannitol, sodium hydroxide, and hydrochloric acid
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