MEDICATION GUIDE

VIBATIV
(vy-'ba-tiv)
(telavancin) for Injection

Read this Medication Guide before you start taking VIBATIV (telavancin for injection) 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.

What is the most important information I should know about VIBATIV (telavancin for injection) ?

VIBATIV (telavancin for injection) may harm your unborn baby. Women who can become pregnant should have a blood pregnancy test before taking VIBATIV (telavancin for injection) .

• Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if VIBATIV (telavancin for injection) is the right medicine for you
• Do not become pregnant while taking VIBATIV (telavancin for injection) . Women who can become pregnant should use effective birth control (contraception) while taking VIBATIV (telavancin for injection)
• If you get pregnant while taking VIBATIV (telavancin for injection) , tell your healthcare provider right away
• If you become pregnant while taking VIBATIV (telavancin for injection) , talk to your healthcare provider about taking part in the VIBATIV (telavancin for injection) Pregnancy Registry. This is a study to learn how VIBATIV (telavancin for injection) affects pregnancy and babies. You can enroll in this registry by calling 1- 888-658-4228

What is VIBATIV (telavancin for injection) ?

VIBATIV (telavancin for injection) 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 (telavancin for injection) is safe or effective in children under 18 years of age.

What should I tell my healthcare provider before taking VIBATIV (telavancin for injection) ?

Before you take VIBATIV (telavancin for injection) , 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 (telavancin for injection) passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking VIBATIV (telavancin for injection)

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. VIBATIV (telavancin for injection) 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 (telavancin for injection) ?

• VIBATIV (telavancin for injection) 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 (telavancin for injection) unless your healthcare provider tells you to even if you feel better.
• It is important that you receive all of your VIBATIV (telavancin for injection) doses. Do not skip any doses.
• If you miss a dose or stop taking VIBATIV (telavancin for injection) 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 (telavancin for injection) may not work.
• Your healthcare provider will do tests before you start and while you take VIBATIV (telavancin for injection) .

What are the possible side effects of VIBATIV (telavancin for injection) ?

VIBATIV (telavancin for injection) may cause serious side effects, including:

See "What is the most important information I should know about VIBATIV (telavancin for injection) ?"

• 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 (telavancin for injection) 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 (telavancin for injection)
• 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 (telavancin for injection)

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of VIBATIV (telavancin for injection) 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 (telavancin for injection) . 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 (telavancin for injection) ?

• Store VIBATIV (telavancin for injection) in the original package
• Keep VIBATIV (telavancin for injection) refrigerated between 350F to 460F (20C to 80C)
• Keep out of heat

Keep VIBATIV (telavancin for injection) and all medicines out of the reach of children.

General Information about the safe and effective use of VIBATIV (telavancin for injection) .

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VIBATIV (telavancin for injection) for a condition for which it is not prescribed. Do not give VIBATIV (telavancin for injection) 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 (telavancin for injection) . If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about VIBATIV (telavancin for injection) that is written for health professionals.

For more information, go to www.vibativ (telavancin for injection) .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

This Medication Guide has been approved by the U.S. Food and Drug Administration August 2009

VIBATIV™
(telavancin)
[Lipoglycopeptide]
Theravance, Inc. 901 Gateway Boulevard, South San Francisco, CA 94080. [650-808-6076]

RISK EVALUATION AND MITIGATION STRATEGY (REMS)

I. GOALS

The goal of the VIBATIV (telavancin for injection) REMS is to avoid unintended exposure of pregnant women to VIBATIV (telavancin for injection) by:

• Educating healthcare professionals (HCPs) and patients on the potential risk of fetal developmental toxicity if women are exposed to VIBATIV (telavancin for injection) while pregnant.
• Informing HCPs that a serum pregnancy test should be performed before initiating therapy with VIBATIV (telavancin for injection) in women of childbearing potential.
• Informing HCPs that women of childbearing potential, including those being treated in the outpatient setting, should be counseled about pregnancy prevention and use of effective contraception during VIBATIV (telavancin for injection) use.
• Informing HCPs and patients about the Pregnancy Registry for patients exposed to VIBATIV (telavancin for injection) during pregnancy.

II. REMS ELEMENTS

A. Medication Guide

Theravance will ensure that a Medication Guide will be distributed with each VIBATIV (telavancin for injection) prescription in accordance with 21 CFR 208.24. VIBATIV (telavancin for injection) is packaged as a single unit of use and the Medication Guide is inserted inside the carton.

Additional copies of the Medication Guide will also be available via sales and/or clinical representatives, the product website, and by request at 1-800-7277003.

Please see appended Medication Guide.

B. Communication Plan

In accordance with FDCA 505-1(e)(3), Theravance will implement a communication plan to targeted healthcare providers and pharmacists to support the implementation of the VIBATIV (telavancin for injection) REMS. The communication plan consists of the following:

1. A Dear Healthcare Provider (HCP) Letter describing the fetal effects of VIBATIV (telavancin for injection) seen in animals and pregnancy prevention measures. The letter will include Pregnancy Registry Information. The letter will be accompanied by the VIBATIV (telavancin for injection) Package Insert (PI) and the Medication Guide.

2. The Dear HCP Letter will be distributed to targeted HCPs and pharmacists at the specified timeframes:

1.  Prior to commercial distribution
2.  6 months after product approval
3.  1 and 2 years after product approval

3. The Dear HCP Letter will be distributed either through hardcopy mailings by U.S. mail or email to reach the target audience. The letter will also be available on the product website. The website will also include information about the Pregnancy Registry and the toll-free number to call to enroll in the Registry.

The email will target physicians based on the American Medical Association database. The email distribution list for other healthcare providers will be based on other databases and secured through a private contractor.

Providers that have an email address on file will receive the Dear HCP Letter via email. If the intended recipient does not open the Dear HCP Letter within 72 hours, the materials will be distributed hardcopy via U.S. mail. The healthcare providers on the target audience list who do not have an email on file will receive a hardcopy via U.S. mail.

All distributions, hardcopy and electronic will include the designation "Important Drug Warning" according to 21 CFR 200.5.

4. The Dear HCP Letter will be sent to the following targeted Healthcare Providers:

Physician Groups
Infectious Disease
Emergency Medicine
Critical Care Medicine
Hospitalist
General Surgery
Obstetrics and Gynecology
Family Practice

Other Healthcare Professionals
Health System Pharmacists / Hospital Pharmacists
Outpatient Infusion Providers

Organizational Headquarters
Infectious Disease Society of America
American College of Emergency Physicians

Last reviewed on RxList: 9/17/2009
This monograph has been modified to include the generic and brand name in many instances.