Telavancin

Telavancin is an antibiotic that treats serious skin infections caused by bacteria.

Telavancin is also used to treat pneumonia in a hospital or pneumonia that can occur while using a ventilator (artificial breathing machine).

Telavancin may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Telavancin is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Telavancin is usually given once every 24 hours for 7 to 21 days. This medicine must be given slowly, and the infusion can take at least 1 hour to complete. Follow your doctor's dosing instructions very carefully.

Telavancin must be mixed with a liquid (diluent) and then further diluted in an IV bag before using it. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has particles in it. Call your pharmacist for new medicine.

Your kidney function will need to be checked before, during and after treatment with telavancin.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using telavancin.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Telavancin will not treat a viral infection such as the flu or a common cold.

Store unused vials in a refrigerator.

After mixing the diluent into a vial, you may keep the vial at room temperature for up to 12 hours before you further dilute the mixture in an IV bag and give the injection. If you store the vial in a refrigerator, you must further dilute and use it within 7 days.

The final mixed solution in the IV bag may also be kept frozen for up to 32 days at temperatures between 14 degrees and -22 degrees Fahrenheit (-10 degrees and -30 degrees Celsius).

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Certain people may be at a higher risk of death from using telavancin compared to another antibiotic called vancomycin, especially those with kidney problems who use telavancin for pneumonia that can develop while in a hospital.

Tell your doctor if you have a history of kidney problems. Your kidney function will need to be checked before, during, and after treatment with telavancin.

You may not be able to use telavancin if you are pregnant. In animal studies, telavancin caused birth defects. You may need to have a negative pregnancy test before starting this treatment.

You should not use telavancin if you are allergic to telavancin or if you are also using a specific type of heparin.

Certain people may have a higher risk of death from using telavancin compared to another antibiotic called vancomycin. This risk has been greatest in people with existing kidney issues who use telavancin to treat pneumonia developed during a hospital stay.

Tell your doctor if you have ever had:

• kidney problems;
• diabetes;
• heart disease, high blood pressure;
• long QT syndrome (in you or a family member);
• if you are allergic to vancomycin; or
• if you have routine "INR" or prothrombin time tests.

If you can become pregnant, you may need a pregnancy test before you start 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 for 2 years.

You may not be able to use this medicine if you are pregnant. In animal studies, telavancin caused birth defects. However, it is not known if these effects would happen in humans. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you are pregnant, your name may be added to a pregnancy registry to monitor the effects of telavancin on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

Some side effects may happen during the injection. Tell your caregiver if you feel itchy or tingly, or if you have a red rash during the injection.

Get emergency medical help if you have signs of an allergic reaction: hives; fast heartbeats; trouble breathing, fainting; swelling of your face, lips, tongue, or throat.

Telavancin may cause serious side effects. Call your doctor right away if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it happens months after your last dose);
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might faint); or
• signs of kidney problems—little or no urinating, swelling in your ankles or feet, weight gain, or urine that looks foamy.

Common side effects of telavancin may include:

• foamy urine;
• nausea, vomiting;
• diarrhea; or
• changes in your sense of taste.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Skin and Structure Infection:

10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 14 days Comments: -Therapy duration should be guided by the severity and site of the infection and the patient's clinical progress.Use: Treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, S. constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only).

Usual Adult Dose for Nosocomial Pneumonia:

10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 21 daysComments:-Therapy duration should be guided by the severity of the infection and the patient's clinical progress.-This drug should be reserved for use when alternative treatments are not suitable.Use: Treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates).

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Telavancin can damage your kidneys or lead to a serious heart issue. Your risk may increase if you are also taking certain other medicines for infections, asthma, heart issues, high blood pressure, depression, mental health conditions, cancer, malaria, HIV, osteoporosis, organ transplant rejection, bowel problems, or pain or arthritis (including Advil, Motrin, and Aleve).

Inform your doctor about all your other medicines, especially:

• a diuretic or "water pill";
• heart rhythm medicine;
• a blood thinner—warfarin, Coumadin, Jantoven;
• certain heart or blood pressure medicines—benazepril, candesartan, captopril, enalapril, irbesartan, lisinopril, losartan, olmesartan, telmisartan, trandolapril, valsartan, and others; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)—aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not exhaustive. Other medications may impact telavancin, including prescription and over-the-counter drugs, vitamins, and herbal products. Not all possible drug interactions are included here.