Pronunciation:

dal-ba-VAN-sin

Brand Names:

• Dalvance

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Chemical—

Glycopeptide

Uses of This Medicine:

Dalbavancin injection is used to treat acute bacterial skin and skin structure infections (ABSSSI). It belongs to the group of medicines known as antibiotics. Dalbavancin works by killing bacteria or preventing their growth. Dalbavancin will not work for colds, flu, or other virus infections.

This medicine is to be given only or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dalbavancin injection in children. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dalbavancin injection in the elderly. However, elderly patients are more likely to have unwanted side effects and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving dalbavancin injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to glycopeptides, history of—Use with caution. May increase risk of having an allergic reaction to occur again.

• Diarrhea or
• Liver disease—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 minutes.

To help clear up your infection completely, dalbavancin must be given for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, dalbavancin must be given on a regular schedule.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including skin reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a cough, difficulty with swallowing, dizziness, fast heartbeat, trouble breathing, swelling in your face or hands, fever, chills, itching or hives, or feeling of warmth or redness on your upper body while you are receiving this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause diarrhea, and in some cases it can be severe. It may also occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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 immediately if any of the following side effects occur:

Less common

Back pain

black, tarry stools

bleeding gums

blood in the urine or stools

chest pain or tightness

chills

clay colored stools

cough

dark urine

decreased appetite

difficulty swallowing

dizziness

fast heartbeat

feeling of warmth

fever

headache

hives, welts, itching, or rash

loss of appetite

painful or difficult urination

pale skin

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

sore mouth or tongue

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach cramps, pain, or tenderness

swelling of the feet or lower legs

swollen glands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

watery and severe diarrhea, which may also be bloody

yellow eyes or skin

Some side effects 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:

Less common

Anxiety

blurred vision

cold sweats

coma

confusion

cool, pale skin

depression

increased hunger

nightmares

seizures

shakiness

slurred speech

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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