Telavancin

Telavancin is a prescription medication used to treat serious skin infections caused by a certain type of bacteria. It is also used to treat patients who contract pneumonia during a hospital stay and patients who contract pneumonia while on a machine to help them breathe called a ventilator. This type of bacterial pneumonia can be severe. It is sometimes fatal.

Telavancin belongs to a group of drugs called lipoglycopeptide antibiotics which work by stopping the growth and spread of bacteria.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider over a period of 60 minutes. It is usually given once every 24 hours.

Telavancin is a prescription medication used to treat:

• complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria
• hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)

This medication can also be given to patients with concurrent Staphylococcus aureus (S. aureus) infection. 

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

Telavancin may be found in some form under the following brand names:

• Vibativ

Serious side effects have been reported with telavancin. See “Drug Precautions” section.

Common side effects of telavancin include:

• diarrhea
• vomiting
• a change in your sense of taste
• foamy urine

This is not a complete list of telavancin side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

• a blood thinner
• medicine to control your heart rate or rhythm (antiarrhythmics)
• water pills (diuretics)
• a non-steroidal anti-inflammatory drug (NSAID)
• certain blood pressure medicines called ACE Inhibitors or ARBs

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.

Telavancin may cause serious side effects, including:

• Harm to your unborn baby. Women who can become pregnant should have a blood pregnancy test before taking telavancin.

• Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if telavancin is the right medicine for you.
• Do not become pregnant while taking telavancin. Women who can become pregnant should use effective birth control (contraception) while taking telavancin.
• If you get pregnant while taking telavancin, tell your healthcare provider right away.
• If you become pregnant while taking telavancin, talk to your healthcare provider about taking part in the telavancin Pregnancy Registry. This is a study to learn how telavancin affects pregnancy and babies. You can enroll in this registry by calling 1- 888-658-4228.

• Kidney problems
• Infusion-related reactions. Infusion-related reactions can include: red color (flushing) to your upper body, hives (raised bumps), itching or rash if telavancin is given too fast
• Intestine infection. Intestine infections can cause diarrhea or bloody stools, stomach cramps, and a fever. These infections can happen 2 or more months after you stop taking telavancin.
• Irregular heartbeat.
• Changes in blood and urine test. Tell your healthcare provider if you plan to have any test of your blood or urine while taking telavancin.

Call your healthcare provider right away if you have any of the serious side effects listed above.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of telavancin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking telavancin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have kidney problems
• have diabetes
• have heart problems, including QTC prolongation or a family history of it
• have high blood pressure
• have other medical conditions
• are breastfeeding or plan to breastfeed. It is not known if telavancin passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking telavancin.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Telavancin falls into category C.

Telavancin may harm your unborn baby. Women who can become pregnant should have a blood pregnancy test before taking telavancin.

• Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if telavancin is the right medicine for you.
• Do not become pregnant while taking telavancin. Women who can become pregnant should use effective birth control (contraception) while taking telavancin.
• If you get pregnant while taking telavancin, tell your healthcare provider right away.
• If you become pregnant while taking telavancin, talk to your healthcare provider about taking part in the telavancin Pregnancy Registry. This is a study to learn how telavancin affects pregnancy and babies. You can enroll in this registry by calling 1- 888-658-4228.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if telavancin passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking telavancin.

• Telavancin is injected into your vein (IV) by your healthcare provider slowly over 1 hour, 1 time a day, for 7 to 14 days.
• Do not stop taking telavancin unless your healthcare provider tells you to even if you feel better.
• It is important that you receive all of your telavancin doses. Do not skip any doses.
• If you miss a dose or stop taking telavancin before getting all of your doses, contact your healthcare provider right away.
• If you skip doses or stop treatment too soon, the germs (bacteria) may grow again and telavancin may not work.
• Your healthcare provider will do tests before you start and while you take telavancin.

Telavancin is usually dosed and given by a healthcare provider in a medical setting.

For skin infection (cSSSI):

• 10 mg/kg in patients ≥18 years of age into the vein (IV) once every 24 hours for 7 to 14 days
• The duration of therapy should be guided by the severity and site of the infection and the patient's clinical and bacteriological progress.
• The dose may be adjusted according to your kidney function.

For treatment of HABP/VABP:

• 10 mg/kg into the vein (IV infusion) for 60 minutes every 24 hours for 7 to 21 days
• The dose may be adjusted according to your kidney function.

Telavancin is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

• Store telavancin in the original package.
• Keep telavancin refrigerated between 35°F to 46°F (2°C to 8°C).
• Keep out of heat.
• Keep telavancin and all medicines out of the reach of children.

FETAL RISK

• Women of childbearing potential should have a serum pregnancy test prior to administration of telavancin.
• Avoid use of telavancin during pregnancy unless potential benefit to the patient outweighs potential risk to the fetus.
• Adverse developmental outcomes observed in 3 animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans.

KIDNEY INJURY

• telavancin can cause new or worsening kidney problems in patients.