Vibativ

Vibativ 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.

Vibativ 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.

Vibativ 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.

• Theravance, Inc.

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

Common side effects of Vibativ include:

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

This is not a complete list of Vibativ 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.

Vibativ may cause serious side effects, including:

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

• Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if Vibativ is the right medicine for you.
• Do not become pregnant while taking Vibativ. Women who can become pregnant should use effective birth control (contraception) while taking Vibativ.
• If you get pregnant while taking Vibativ, tell your healthcare provider right away.
• If you become pregnant while taking Vibativ, talk to your healthcare provider about taking part in the Vibativ Pregnancy Registry. This is a study to learn how Vibativ 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 Vibativ 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 Vibativ.
• 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 Vibativ, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Vibativ, 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 Vibativ passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking Vibativ.

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.

Vibativ falls into category C.

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

• Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if Vibativ is the right medicine for you.
• Do not become pregnant while taking Vibativ. Women who can become pregnant should use effective birth control (contraception) while taking Vibativ.
• If you get pregnant while taking Vibativ, tell your healthcare provider right away.
• If you become pregnant while taking Vibativ, talk to your healthcare provider about taking part in the Vibativ Pregnancy Registry. This is a study to learn how Vibativ 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 Vibativ passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking Vibativ.

• Vibativ 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 Vibativ unless your healthcare provider tells you to even if you feel better.
• It is important that you receive all of your Vibativ doses. Do not skip any doses.
• If you skip doses or stop treatment too soon, the germs (bacteria) may grow again and Vibativ may not work.
• Your healthcare provider will do tests before you start and while you take Vibativ.

Vibativ 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.

Vibativ 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 Vibativ  in the original package.
• Keep Vibativ refrigerated between 35°F to 46°F (2°C to 8°C).
• Keep out of heat.
• Keep Vibativ 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 Vibativ.
• Avoid use of Vibativ  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

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