Telavancin

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.

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.

You should not use this medicine if you are allergic to telavancin, or if you are also using a certain type of heparin.

To make sure telavancin is safe for you, tell your doctor if you have:

• a history of kidney problems;

• diabetes;

• heart disease, high blood pressure;

• heart rhythm disorder, or history of Long QT syndrome; or

• if you are allergic to vancomycin.

If you are able to 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 in 2 years.

You may not be able to use this medicine if you are pregnant. It is not known whether telavancin will harm an unborn baby. In animal studies, telavancin caused birth defects. Use effective birth control to prevent pregnancy during your treatment with telavancin, and tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of telavancin on the baby.

It is not known whether telavancin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Foamy urine.
• Change in taste.
• Upset stomach or throwing up.
• Headache.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Most of the time, telavancin will be given in a hospital or doctor's office. If stored at home, follow how to store as you were told by the doctor.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Complicated skin and skin structure infections: Treatment of complicated skin and skin structure infections caused by susceptible gram-positive organisms including methicillin-susceptible or -resistant Staphylococcus aureus, vancomycin-susceptible Enterococcus faecalis, and Streptococcus pyogenes, Streptococcus agalactiae, or Streptococcus anginosus group

Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP): Treatment of HABP/VABP caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not appropriate

Refer to adult dosing.

Note: Renal function may be estimated using the Cockcroft-Gault formula for dosage adjustment purposes.

US labeling:

CrCl >50 mL/minute: No dosage adjustment necessary

CrCl 30 to 50 mL/minute: 7.5 mg/kg every 24 hours

CrCl 10 to <30 mL/minute: 10 mg/kg every 48 hours

CrCl <10 mL/minute: No dosage adjustment provided in manufacturer’s labeling (has not been studied).

ESRD and hemodialysis patients: No dosage adjustment provided in manufacturer’s labeling (has not been studied).

Canadian labeling:

CrCl >50 mL/minute: No dosage adjustment necessary

CrCl 30 to 50 mL/minute: 7.5 mg/kg every 24 hours

CrCl <30 mL/minute: Not recommended.

ESRD and hemodialysis patients: Not recommended.

Store intact vials at 2°C to 8°C (35°F to 46°F); excursions permitted up to 25°C (77°F); avoid excess heat. Note: Vials contain no bacteriostatic agent. Reconstituted solution in the vial should be used within 12 hours at room temperature or 7 days refrigerated; solutions admixed for infusion in NS, LR, or D5W are stable at room temperature for 12 hours or under refrigeration for 7 days. Total time in vial plus time in infusion bag should not exceed 12 hours at room temperature or 7 days if refrigerated at 2°C to 8°C (35°F to 46°F). Solutions admixed for infusion can also be stored at -30°C to -10°C (-22°F to 14°F) for ≤32 days.

Applies to telavancin: intravenous powder for solution

Along with its needed effects, telavancin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking telavancin:

• Blood in the urine
• change in the frequency of urination or amount of urine
• difficulty with breathing
• drowsiness
• increased thirst
• loss of appetite
• nausea or vomiting
• swelling of the feet or lower legs
• weakness

• Abdominal or stomach tenderness
• chills or fever
• cough
• difficulty with swallowing
• dizziness, faintness, or lightheadedness, especially when getting up suddenly from a lying or sitting position
• fast heartbeat
• hives or itching of the skin
• nausea or vomiting
• pain, redness, or soreness at the injection site
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash or redness of the face, base of the neck, upper body, back, and arms
• severe abdominal or stomach cramps and pain
• tightness in the chest
• unusual tiredness or weakness
• watery and severe diarrhea, which may also be bloody

Some side effects of telavancin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual or unpleasant (after) taste
• change in taste
• diarrhea
• foamy urine

• Decreased appetite
• dry, red, hot, or irritated skin
• feeling unusually cold
• shivering