Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced it has introduced Dalbavancin for Injection (for single-dose regimen use only), which is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections caused by designated susceptible strains of Gram-positive microorganisms.
It is available in 500 mg vials and approved for single-dose regimen use only. The drug received FDA approval this month.
FDA determined Dalbavancin for Injection from Fresenius Kabi is therapeutically equivalent to the reference-listed drug DALVANCE®1 (single-dose regimen use only).
“Dalbavancin for Injection is formulated, filled and packaged in the United States,” said Arun Verma, president of Fresenius Kabi Region U.S. and Member of the Executive Leadership Team, Fresenius Kabi AG. “This cost-effective, generic alternative for the single-dose regimen is part of our ‘More in America’ commitment to invest in American manufacturing, improve our supply chain resilience, and bring products closer to our U.S. customers.”
Since 2017, Fresenius Kabi has invested nearly $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities. Learn more at moreinamerica.com.
IMPORTANT SAFETY INFORMATION
Dalbavancin for Injection is contraindicated in patients with known hypersensitivity to dalbavancin.
WARNINGS AND PRECAUTIONS
Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with dalbavancin for injection. If an allergic reaction occurs, discontinue treatment with dalbavancin for injection and institute appropriate therapy for the allergic reaction. Carefully monitor patients with known hypersensitivity to glycopeptides.
Rapid intravenous infusion of dalbavancin for injection can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions.
Alanine Aminotransferase (ALT) elevations with dalbavancin for injection treatment were reported in clinical trials.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including dalbavancin for injection. Evaluate if diarrhea occurs.
ADVERSE REACTIONS
The most common adverse reactions occurring in >4% of adult patients treated with dalbavancin for injection were nausea, headache, and diarrhea. The most common adverse reaction that occurred in >1% of pediatric patients was pyrexia.
INDICATIONS AND USAGE
Dalbavancin for injection is a lipoglycopeptide antibacterial 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.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
This Important Safety Information does not include all the information needed to use Dalbavancin for Injection safely and effectively.
For more information, please visit www.fresenius-kabi.com/us.
