Dalvance is an antibiotic that fights bacteria.

Dalvance is used to treat severe skin infections caused by bacteria.

To reduce the development of bacteria resistant to Dalvance and other antibacterial agents, this medicine should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

Dalvance should only be used to treat bacterial infections. It does not treat viral infections (e.g. the common cold).

Diarrhea is a common side effect of antibacterial medicines and usually resolves when the medicine is discontinued. Occasionally, frequent watery or bloody diarrhea may occur and this may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, contact your healthcare provider.

Follow all directions on your Dalvance label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Tell your caregivers if you feefl any itching, tingling, back pain, or sudden warmth in your upper body during the injection.

Use Dalvance exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Dalvance is given as an IV infusion into a vein. A healthcare provider will give you this injection.

Dalvance is a powder medicine that must be mixed with a liquid (diluent) before using it.

Do not shake the mixed medicine or it may foam. The mixture should appear clear or slightly yellow. Do not use if Dalvance has changed colors or has particles in it. Call your pharmacist for new medicine.

After mixing, store in the refrigerator or at room temperature. Do not freeze. Use the medicine within 48 hours after mixing.

Dalvance is usually given as a single dose, or as two doses, one week apart. Each IV infusion will take at least 30 minutes to complete.

Injecting this medicine too quickly can cause itching, tingling, rash, back pain, or sudden redness or warmth in your upper body. Tell your caregivers if you have any of these sensations during the injection.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left over after injecting your dose.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Dalbavancin will not treat a viral infection such as the flu or a common cold.

Store unmixed powder at room temperature away from moisture and heat.

Usual Adult Dose for Skin and Structure Infection:

Single Dose Regimen: 1500 mg

Two-Dose Regimen: 1000 mg, followed one week later by 500 mg

Comments: Infuse intravenously over 30 minutes.

Use: Treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus).

Usual Pediatric Dose for Skin and Structure Infection:

Comments: Infuse intravenously over 30 minutes.

Use: Treatment of pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms.

You should not use Dalvance if you are allergic to dalbavancin.

To make sure Dalvance is safe for you, tell your doctor if you have ever had:

• kidney disease;

• liver disease; or

• an allergy to other antibiotics such as vancomycin or telavancin.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Get emergency medical help if you have signs of an allergic reaction to Dalvance: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe stomach pain, diarrhea that is watery or bloody.

Common Dalvance side effects may include:

• headache;

• nausea; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with dalbavancin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.