Vibativ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

The active ingredient in VIBATIV is telavancin hydrochloride. Telavancin is a lipoglycopeptide antibiotic. It can kill certain types of bacteria. VIBATIV can be used to treat infections of the skin or infections in the tissues beneath the skin that are caused by bacteria susceptible to telavancin. VIBATIV can also be used to treat hospital acquired pneumonia (infection of the lungs) or ventilator associated pneumonia caused by certain types of bacteria susceptible to telavancin.

Depending on the type of bacteria causing your infection, your doctor may also prescribe other antibiotics while you are treated with VIBATIV.

Antibacterial drugs like VIBATIV treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, VIBATIV should be used exactly as directed. Misuse or overuse of VIBATIV could lead to the growth of bacteria that will not be killed by VIBATIV (resistance). This means that VIBATIV may not work for you in the future. Do not share your medicine.

What it does:

Telavancin prevents the bacteria from multiplying by stopping the formation of new bacterial cell walls and interfering with the bacteria’s cell membrane. The cell wall and membrane are important components of bacteria. This prevents the bacteria from functioning and causes it to die.

When it should not be used:

• If you are allergic to VIBATIV or any of its ingredients. (See

  what the nonmedicinal ingredients are below)

What the medicinal ingredient is:

• Telavancin hydrochloride

What the important nonmedicinal ingredients are:

• Hydroxypropyl-beta-cyclodextrin (hydroxypropyl betadex)
• Mannitol
• Sodium hydroxide
• Hydrochloric acid

What dosage forms it comes in:

VIBATIV (telavancin for injection) is available as a sterile powder for injection containing 250 mg or 750 mg of telavancin

per glass vial (as telavancin hydrochloride).

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• VIBATIV was associated with an increased risk of death compared to vancomycin in people who already had kidney problems and were treated for bacterial pneumonia that you can get when you are in the hospital.
• New or worsening kidney problems: your healthcare provider should do a blood test to check your kidneys before you start, while you receive, and after you stop receiving VIBATIV.
• VIBATIV is not recommended for use in patients with severe kidney impairment or in patients with end stage kidney disease requiring hemodialysis.
• If you have moderate kidney impairment, your doctor will adjust your dose and monitor your kidney function more frequently.

• VIBATIV may harm your unborn baby. Women who can become pregnant should have a blood pregnancy test before receiving VIBATIV.

• Animal studies have shown a low incidence of fetal limb defects. There are no adequate studies in pregnant women. VIBATIV should not be used in pregnancy unless the doctor decides the benefits outweigh the risks.

BEFORE you use VIBATIV talk to your doctor or pharmacist if:

• You are suffering from other infections
• You have heart abnormalities such as congenital long QT syndrome, and heart arrhythmia (irregular heartbeat)
• You are suffering from heart disorders such as uncompensated heart failure, or severe left ventricular hypertrophy
• You are suffering from an HIV infection
• You are due to undergo treatment with chemotherapy
• You have experienced skin reactions to other glycopeptides
• You are suffering from a kidney disorder
• You are suffering from severe liver disorder
• You are taking other antibiotics. While antibiotics including VIBATIV fight certain bacteria, other bacteria and fungi may continue to grow. This is called overgrowth. Your doctor will monitor you for any potential infections and treat you if necessary

• You are using other medicines that contain a cyclodextrin.

  VIBATIV contains hydroxypropylbetadex, a cyclodextrin. Cyclodextrins have been associated with nephrotoxicity (kidney toxicity). Therefore, the use of other medications that also contain a cyclodextrin at the same time as VIBATIV is not recommended

• You are pregnant, think you may be pregnant, or are trying to become pregnant. VIBATIV should not be given to pregnant women unless it is absolutely necessary. Women of childbearing potential should either abstain from sexual activity or use double-barrier means of contraception while on VIBATIV. It is not known if VIBATIV passes into breast milk in humans. Breastfeeding should be discontinued during VIBATIV treatment

VIBATIV should not to be used in children or adolescents less than 18 years old.

VIBATIV may interfere with some laboratory tests that measure how well your blood is clotting. The test results can suggest poor blood clotting when, in fact, there is no problem. Tell your doctor that you are receiving VIBATIV.

VIBATIV may interfere with some laboratory tests that measure proteins in the urine. Tell your doctor that you are receiving VIBATIV.

What to do if certain conditions develop while taking the medication

Contact your doctor if the following occur while taking VIBATIV:

• You develop skin reactions to the product. Your doctor may

  decide to adjust the dosing of the infusion.

• You develop diarrhea during or shortly after your treatment.

  Tell your doctor immediately if this happens.

• You develop heart palpitations or fainting spells.

INTERACTIONS WITH THIS MEDICATION

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The combination of VIBATIV with medicines that leave the body mainly via the urine should be used with caution. These may affect the excretion of telavancin via the urine. Your doctor will tell you if this is the case.

PROPER USE OF THIS MEDICATION

Usual adult (over 18 years) dose:

Your doctor will decide how much medicine you will take and for how long. The dose you will be given will depend on how much you weigh. The dose for adults is 10 milligrams (mg) for every kilogram (kg) of body weight, given once daily. This dose is given as an infusion directly into your blood stream (into a vein) over a period of about 60 minutes.

If your kidneys do not work well, the dose may be reduced.

The course of treatment usually lasts for 7 to 14 days for skin infections or 7 to 21 days for pneumonia.

Overdose:

If you think you have taken too much VIBATIV, contact your attending healthcare professional, hospital emergency department or regional Poison Control Centre, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Any medicine may have unintended or undesirable effects, so-called side effects.

The most commonly (≥1% ) reported adverse drug reactions in patients taking VIBATIV for skin infections were dysgeusia (disturbed or metallic taste), nausea, vomiting, urine abnormality (foamy urine), headache, pruritus (skin itch), diarrhoea, infusion-site reaction, constipation, insomnia, dizziness, rash, rigors (shivering), fatigue, decreased appetite, fungal infection, dyspepsia (upset stomach), dry mouth and blood creatinine increased. These reactions were generally mild to moderate in severity.

The most commonly (≥1% ) reported adverse drug reactions in patients taking VIBATIV for pneumonia were diarrhea, nausea, vomiting, alanine aminotransferase increased, blood creatinine increased, kidney failure acute, rash, aspartate aminotransferase increased and electrocardiogram QT corrected interval prolonged.

Hearing loss has also been reported with the use of telavancin.

If these side effects become bothersome, consult your doctor.

If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking VIBATIV and contact your healthcare professional immediately.

Other side effects may also occur rarely and as with any prescription medication, some side effects may be serious. Ask your doctor or pharmacist for more information. Tell your doctor promptly about these or any other unusual symptoms.

This is not a complete list of side effects. For any unexpected effects while taking VIBATIV, contact your doctor or pharmacist.

HOW TO STORE IT

VIBATIV in its original package should be stored at refrigerated temperatures of 2°C to 8°C.

Keep out of reach and sight of children.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to

Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-

  canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting PENDOPHARM, Division of Pharmascience Inc. at: 1-888-550-6060 or through its website

http://www.pendopharm.com

Last Revised: February 8, 2018

VIBATIV^TM is a trademark of Theravance Biopharma group of companies used under license.

PENDOPHARM, Division of Pharmascience Inc. is an authorized seller of VIBATIV^TM.