"Aug. 5, 2013 -- Anyone who develops a rash, blister, or some other skin reaction while taking acetaminophen should stop using the drug and seek medical care immediately. The painkiller poses the risk for three rare but potentially fatal skin diso"...
- Patient Information:
Details with Side Effects
(telavancin) for injection
Read this Medication Guide before you receive VIBATIV. 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?
VIBATIV can cause serious side effects, including:
- Increased risk of death. VIBATIV was associated with an increased risk of death compared to vancomycin in people who already had kidney problems and were treated for bacterial pneumonia that you can get when you are in the hospital.
- New or worsening kidney problems. Your healthcare provider should do a blood test to check your kidneys before you start, while you receive, and after you stop receiving VIBATIV.
- VIBATIV may harm your unborn baby. Women who can become
pregnant should have a blood pregnancy test before receiving 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.
- Women who can become pregnant should use effective birth control (contraception) while receiving VIBATIV.
- If you become pregnant while receiving VIBATIV, tell your healthcare provider right away. 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 1-855-MED-THRX (1-855-633-8479).
What is VIBATIV?
VIBATIV is a prescription antibacterial medicine used alone, or with other medicines, to treat adults with certain types of germs (bacteria) that cause:
- Serious skin infections
- Hospital-Acquired Bacterial Pneumonia (HABP)
- Ventilator-Associated Bacterial Pneumonia (VABP)
It is not known if VIBATIV is safe or effective in children under 18 years of age.
Who should not take VIBATIV?
Do not take VIBATIV if you:
- are allergic to telavancin or any of the ingredients in VIBATIV. See the end of this Medication Guide for a complete list of ingredients in VIBATIV.
What should I tell my healthcare provider before receiving VIBATIV?
Before you receive VIBATIV, tell your healthcare provider if you:
- have had a serious allergic reaction to VIBATIV or vancomycin
- have kidney problems
- have diabetes
- have or have had heart problems, including QTc prolongation or a family history of it
- have high blood pressure
- have any other medical conditions
- are breastfeeding or plan to breastfeed. It is not known if VIBATIV passes into breast milk. You and your healthcare provider should decide if you will breastfeed while receiving 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 Non-Steroidal Anti-Inflammatory Drug (NSAID)
- certain blood pressure medicines called ACE Inhibitors or ARBs
- water pills (diuretics)
- a blood thinner
- medicine to control your heart rate or rhythm (antiarrhythmics)
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 given by your healthcare provider through a needle placed into your vein (IV infusion) slowly over 1 hour, 1 time each day, for 7 to 21 days.
- Do not stop receiving VIBATIV unless your healthcare provider tells you to, even if you feel better.
- Your healthcare provider will do blood tests before you start and while you receive VIBATIV.
What are the possible side effects of VIBATIV?
VIBATIV may cause serious side effects, including:
See “What is the most important information I should know about VIBATIV?”
- Serious allergic reactions. Allergic reactions can
happen in people who take VIBATIV, even after only one dose. Stop taking
VIBATIV and get emergency medical help right away if you get any of the
following symptoms of a severe allergic reaction:
- trouble breathing or swallowing
- swelling of the lips, tongue, face
- throat tightness, hoarseness
- rapid heartbeat
- Infusion-related reactions. People who receive
VIBATIV too quickly can have a certain type of skin reaction called
“Red-man Syndrome”. Signs and symptoms of Red-man Syndrome can
- red color (flushing)
- Problems with the electrical system of your heart (QTc prolongation). Tell your healthcare provider right away if you have a change in your heartbeat such as a fast or irregular heartbeat or if you had a fainting episode.
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
- 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 FDA at 1-800-FDA-1088.
How should I store VIBATIV?
- Store VIBATIV in the original package
- Keep VIBATIV refrigerated between 350F to 460F (20C to 80C)
- Keep out of heat
Keep VIBATIV and all medicines out of the reach of children.
General Information about the safe and effective use of 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.
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 1-855-MED-THRX (1-855-6338479).
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
(telavancin) for injection
RISK EVALUATION AND MITIGATION STRATEGY (REMS)
The goals of the VIBATIV REMS are:
A. To inform healthcare professionals (HCP) about the increased risk of mortality associated with VIBATIV in patients with pre-existing creatinine clearance of ≤ 50 mL/min being treated for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)
B. To avoid unintended exposure of pregnant women to VIBATIV through:
- Educating healthcare professionals and patients on the potential risk of fetal developmental toxicity if women are exposed to VIBATIV while pregnant
- Informing HCPs that a serum pregnancy test should be performed before initiating therapy with VIBATIV in Females of Reproductive Potential (FRP)
- Informing HCPs that FRP, including those being treated in the outpatient setting, should be counseled about pregnancy prevention and use of effective contraception during VIBATIV use
II. REMS ELEMENTS
A. Medication Guide
A Medication Guide will be dispensed with each VIBATIV prescription in accordance with 21 CFR 208.24.
The Medication Guide is part of the REMS and is appended.
B. Communication Plan
Theravance will implement the following elements of a communication plan:
1. A Dear Healthcare Provider (DHCP) Letter will be sent within 60 days, and again at 6 months, 1 and 2 years of approval, of the most recent REMS modification. The letter will be sent through either hardcopy mailings by U.S. mail or email to healthcare professionals likely to prescribe or dispense VIBATIV. This includes, but is not limited to healthcare professionals who practice in: hospitals, infectious disease, emergency medicine, critical care, general surgery, obstetrics and gynecology, family practice and outpatient infusion centers. Subsequent letters will be sent to any new health care provider that was not initially sent the appended DHCP letter. The DHCP Letter will be distributed with the VIBATIV Package Insert and Medication Guide.
a. The letter will be available via a link from the VIBATIV website at www.vibativ.com and as well as from the medical information department for a period of one year after the approval of the most recent modification of the REMS. The letter will include Pregnancy Registry Information.
b. The Dear HCP Letter will be sent to the leadership of the following professional organizations with a request that these organizations disseminate the content of the letter to their professional membership:
Infectious Disease Society of America
American College of Emergency Physicians
Society of Critical Care Medicine
Society of Hospital Medicine
Surgical Infection Society
American Thoracic Society
American College of Chest Physicians
American College of Obstetrics and Gynecology
Outpatient Parenteral Antimicrobial Therapy
American Medical Association
American Hospital Association
Federation of American Hospitals
American Society of Health-System Pharmacists
American College of Clinical Pharmacists
Society of Infectious Disease Pharmacists
American College of Clinical Pharmacists
American Pharmacists Association
2. 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.
3. Providers that have an email address on file will receive the DHCP Letter via email. If the intended recipient does not open the DHCP Letter within 10 days, 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.
4. The DHCP letter will be provided to MedWatch at the same time it is provided to the professional organizations.
The DHCP Letter is part of the REMS and is appended.
C. Timetable for Submission of Assessments
Theravance will submit REMS Assessments to FDA at 18 months, 3 years, and 7 years following the approval date of the most recent modification of the REMS (6/2013).
To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 days before the submission date for that assessment. Theravance will submit each assessment so that it will be received by FDA on or before the due date.
Theravance, Inc. 901 Gateway Boulevard, South San Francisco, CA 94080 [650-808-6076]
Last reviewed on RxList: 7/11/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Vibativ Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.