Is dalbavancin FDA approved?

NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.

How much does dalbavancin cost?

According to the same analysis, dalbavancin will cost $1,490 per 500-mg dose, of which a patient doing the full studied course of treatment would need 3.

What class of antibiotic is dalbavancin?

Dalbavancin is in a class of medications called lipoglycopeptide antibiotics. It works by killing bacteria.

When should I take dalbavancin?

Although it is currently approved only for the treatment of acute bacterial skin and skin structure infections, an ever-growing amount of evidence supports the efficacy of dalbavancin as a long-term therapy in osteomyelitis, prosthetic joint infections, endocarditis, and bloodstream infections.

Who makes dalbavancin?

Dalbavancin was acquired by Pfizer in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.

How is dalbavancin administered?

DALVANCE is administered via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reactions.

How long does it take dalbavancin to work?

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.

What are the side effects of dalbavancin?

The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%). The median duration of adverse reactions was 3.0 days in patients treated with DALVANCE.

What is dalbavancin used to treat?

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.

How do you administer dalbavancin?

DALVANCE is administered via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reactions. Rapid intravenous infusions of DALVANCE can cause reactions that resemble “Red-Man Syndrome,” including flushing of the upper body, urticaria, pruritus, and/or rash.

Does dalbavancin cover MRSA?

Dalbavancin is a lipoglycopeptide with a long half-life that allows infrequent dosing. It is indicated for the treatment of acute bacterial skin and skin structure infections caused by susceptible organisms, including Staphylococcus aureus and methicillin-resistant S. aureus (MRSA).

How often do you give dalbavancin?

The dose of dalbavancin is 1000 mg given intravenously over 30 min followed by 500 mg one week later, or as a single dose of 1500 mg [10].

How long is dalbavancin infusion?

DALVANCE is administered as a 30-minute IV infusion.

Does dalbavancin cover enterococcus?

Dalbavancin possesses in vitro activity against several gram-positive pathogens, including S. aureus, Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus anginosus, Enterococcus faecium, and Enterococcus faecalis, although activity against enterococci has not been observed clinically [9, 15–18].

Does dalbavancin cover VRE?

Dalbavancin is a new lipoglycopeptide antimicrobial agent with a broad spectrum of activity against virtually all important gram-positive pathogens, with the exception of vanA– expressing VRE. Most importantly, it is a potent bactericidal agent against drug-resistant staphylococci.

What is dalbavancin for?

Does dalbavancin cover Corynebacterium?

Dalbavancin warrants clinical evaluation against infections caused by anaerobic gram-positive bacteria and corynebacteria.

Why is dalbavancin half-life so long?

Perhaps the most important addition to dalbavancin is the extended, lipophilic side chain not present in teicoplanin or A-40926. This additional side chain allows dalbavancin to anchor to the bacterial cell membrane, enhancing its potency, prolonging its half-life, and allowing for extended dosing intervals [12].

What organisms does Dalvance cover?

DALVANCE® (dalbavancin) for injection is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin- …