Dalbavancin is an antibiotic that fights bacteria.

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

Dalbavancin may also be used for purposes not listed in this medication guide.

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

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

Dalbavancin is usually given in two doses, one week apart. Each 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.

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.

Usual Adult Dose for Skin and Structure Infection:

1500 mg IV once as a single infusion OR 1000 mg IV followed 1 week later by 500 mg IV

Use: For the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) due to susceptible strains of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, S agalactiae, S dysgalactiae, S anginosus group (including S anginosus, S intermedius, S constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates)

Usual Pediatric Dose for Skin and Structure Infection:

Birth to less than 6 years: 22.5 mg/kg IV once as a single infusion
6 to less than 18 years: 18 mg/kg IV once as a single infusion
Maximum dose: 1500 mg/dose

Use: For the treatment of patients with ABSSSI due to susceptible strains of the following gram-positive microorganisms: S aureus (including methicillin-susceptible and methicillin-resistant isolates), S pyogenes, S agalactiae, S dysgalactiae, S anginosus group (including S anginosus, S intermedius, S constellatus), and E faecalis (vancomycin-susceptible isolates)

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

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 dalbavancin 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 dalbavancin injection.

Since dalbavancin 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: 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 side effects of dalbavancin 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 affect 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.