Generic Name and Formulations:
Dalbavancin 500mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.

Company:
Durata Therapeutics, Inc.
Indications for DALVANCE:
Acute bacterial skin and skin structure infections caused by susceptible Gram (+) organisms.

Adult:
Give by IV infusion over 30 mins. Initially 1000mg, followed by 500mg one week later. Renal impairment (CrCl <30mL/min) and who are not receiving hemodialysis: initially 750mg followed by 375mg one week later.

Children:
Not established.

Pharmacological Class:
Lipoglycopeptide.

Warnings/Precautions:
History of glycopeptide allergy. Discontinue if serious hypersensitivity or skin reactions occur. Risk of Clostridium difficile-associated diarrhea; discontinue if suspected or confirmed. Moderate or severe hepatic impairment (Child-Pugh Class B or C). Renal impairment (CrCl <30mL/min). Pregnancy (Cat.C). Nursing mothers.

Adverse Reactions:
Nausea, headache, diarrhea, vomiting, rash, pruritus; ALT elevations, infusion-related reactions (eg, Red-Man Syndrome), C. difficile-associated diarrhea.

How Supplied:
Single-use vial—1