Vibativ 750 mg intravenous solution

Generic name:
Telavancin - injection

Pronunciation
(TEL-a-VAN-sin)

Brand name(s)
Vibativ

Adults with moderate to severe kidney disease who are using telavancin to treat serious lung infections may be at an increased risk for death. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for lung infections, with your doctor.

Telavancin may cause or worsen kidney problems. Problems are more likely to occur if you have heart failure, kidney disease, diabetes, or high blood pressure, or if you take certain medications (see also Drug Interactions section). Kidney function tests must be performed before you start treatment, during treatment, and after you finish treatment to check for kidney problems. Tell your doctor right away if you have any signs of kidney problems such as a change in the amount of urine.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication. You should not become pregnant while using telavancin. Telavancin may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 2 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication is an antibiotic used to treat serious bacterial infections of the skin and certain types of pneumonia. It works by stopping the growth of bacteria.

Read the Medication Guide provided by your pharmacist before you start using telavancin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually once a day. It should be injected slowly over 60 minutes. The dosage and length of treatment is based on your weight, medical condition, and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Infusion reactions may happen during the infusion of this drug if this drug is injected too fast. Tell your doctor right away if you have any symptoms of infusion reactions such as flushing of the upper body. Your doctor may slow down or stop your treatment for some time.

For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

See also Warning and How to Use sections.

Metallic/soapy taste, nausea, vomiting, or foamy urine may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting

This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop:

• diarrhea that doesn't stop
• abdominal or stomach pain/cramping
• blood/mucus in your stool

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using telavancin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Telavancin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using telavancin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using telavancin safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Telavancin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using telavancin before having any immunizations/vaccinations.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• other drugs that may affect the kidneys (including NSAIDs such as ibuprofen)
• "blood thinners" (such as heparin)

This medication may interfere with certain lab tests (such as coagulation tests such as PT/INR/APPT, urine protein tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

See also Warning section.

Lab and/or medical tests (such as kidney function) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.