Telavancin Injection

Brand Name(s):

• Vibativ®

IMPORTANT WARNING

Telavancin injection has caused birth defects in animals. This medication has not been studied in pregnant women, but it is possible that it may also cause birth defects in babies whose mothers received telavancin injection during pregnancy. You should not use telavancin injection while you are pregnant or plan to become pregnant unless your doctor decides that this is the best treatment for your infection. If you can become pregnant, you will need to have a pregnancy test before beginning treatment with telavancin injection. You will also need to use an effective form of birth control during your treatment. You may be excused from meeting these requirements only if you have not menstruated for 24 months in a row, your doctor says you have passed menopause (change of life), you have had a tubal ligation (''tubes tied''; surgery to prevent pregnancy), or you have had surgery to remove your uterus and/or both ovaries. If you become pregnant while using telavancin injection, call your doctor immediately. You should also talk to your healthcare provider about taking part in the VIBATIV Pregnancy Registry (study to learn how telavancin injection affects pregnancy and babies).

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with telavancin injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using telavancin injection.

WHY is this medicine prescribed?

Telavancin injection is used alone or with other medications to treat serious skin infections caused by certain types of bacteria. Telavancin injection is in a class of medications called lipoglycopeptide antibiotics. It works by stopping the growth of bacteria. Antibiotics will not work for colds, flu, or other viral infections.

HOW should this medicine be used?

Telavancin injection comes as a powder to be added to fluid and given through a needle or catheter placed in your vein. It is usually infused (injected slowly) intravenously (into a vein) over a period of 60 minutes once every 24 hours for 7 to 14 days. The length of your treatment depends on the type of infection you have. You may receive telavancin injection in a hospital or you may administer the medication at home. If you are using telavancin injection at home, use it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or other healthcare provider to explain any part you do not understand. Use telavancin injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If you will be using telavancin injection at home, your healthcare provider will show you how to infuse the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems infusing telavancin injection.

It is important that telavancin injection be infused slowly over at least 60 minutes. If it is given too quickly, you may develop red coloring of your upper body, hives, itching, or rash.

You should begin to feel better during the first few days of treatment with telavancin injection. If your symptoms do not improve or get worse, tell your doctor.

Use telavancin injection until you finish the prescription, even if you feel better. If you stop using telavancin injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using telavancin injection,

• tell your doctor and pharmacist if you are allergic to telavancin injection or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in Vaseretic), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers (ARBs) such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor), telmisartan (Micardis), and valsartan (Diovan, in Exforge); anticoagulants (''blood thinners'') such as warfarin (Coumadin); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); cisapride (Propulsid); diuretics (''water pills''); erythromycin (E.E.S., E-Mycin, Erythrocin); medications that control the heart rhythm or rate such as amiodarone (Cordarone), disopyramide (Norpace), dofetilide (Tikosyn), procainamide, quinidine, and sotalol (Betapace, Betapace AF); moxifloxacin (Avelox); pimozide (Orap); sparfloxacin (Zagam) (not available in the U.S.); and thioridazine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with telavancin injection, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (rare heart problem that may cause irregular heartbeat, fainting, or sudden death) and if you have or have ever had diabetes, heart failure, high blood pressure, or kidney disease.
• tell your doctor if you are breast-feeding.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using telavancin injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss a dose or stop using telavancin injection before getting all of your doses, contact your healthcare provider right away.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to telavancin injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using telavancin injection.

Do not let anyone else use your medication. If you still have symptoms of infection after you finish telavancin injection, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 1, 2010.