July 29, 2016
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"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.

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Vibativ Patient Information including How Should I Take

What should I discuss with my health care provider before using telavancin (Vibativ)?

You should not use this medication if you are allergic to it.

If you have kidney disease, you may need a dose adjustment or special tests to safely use telavancin.

FDA pregnancy category C. It is not known whether telavancin is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant. You may need a pregnancy test to determine whether you are pregnant before you start using telavancin.

Your name may need to be listed on a pregnancy registry if you use telavancin while you are pregnant. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether telavancin had any effect on the baby.

If you are not pregnant before you start using telavancin, use effective birth control to prevent pregnancy during treatment. Any woman who could possibly become pregnant should use birth control during treatment with telavancin.

If you are a woman using telavancin, you are considered able to become pregnant unless you have ovarian failure, have had a tubal ligation or hysterectomy, or have been in menopause or not had a menstrual period in 2 years.

It is not known whether telavancin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is telavancin given (Vibativ)?

Telavancin is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Telavancin must be given slowly through an IV infusion, and can take at least 1 hour to complete.

This medication is usually given once every 24 hours for 7 to 14 days. Follow your doctor's instructions.

Telavancin powder must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Telavancin will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your kidney function will need to be checked with blood tests on a regular basis. Do not miss any follow-up visits to your doctor.

Telavancin can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using telavancin.

Store telavancin powder in the refrigerator. Do not freeze.

After mixing telavancin with a diluent, you may store the mixture in the refrigerator and use it within 72 hours. Do not freeze.

Mixed medicine may also be stored at room temperature, but you must then use it within 4 hours after mixing.

Do not use the mixed medication if it has changed colors or has any particles in it. Mix a new dose.

Side Effects Centers

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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.

Women's Health

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