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FDA Approves Zevtera for ABSSSI: Here’s What Dermatologists Should Know

The U.S. Food and Drug Administration (FDA) approved ceftobiprole medocaril sodium (Zevtera, Basilea Pharmaceutica Ltd) for adult patients with acute bacterial skin and skin structure infections (ABSSSI).

It’s IV only

Ceftobiprole is a fifth-generation cephalosporin for intravenous (IV) use only.

Ceftobiprole confers a wide spectrum of rapid bactericidal activity

Ceftobiprole confers a wide spectrum of rapid bactericidal activity against gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and gram-negative bacteria. Dermatologists should know that this antibiotic is now an option for ABSSSI and refer patients to an infectious disease specialist for administration when the usual oral drugs won’t work against skin infections.

There are some side effects

The most common adverse reactions occurring in ≥ 2% of adult patients with ABSSSI were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia, the Company reports.

The new FDA nod also covers other diseases

The FDA also approved ceftobiprole for adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).

For further reading

Overcash JS, Kim C, Keech R, et al. Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET). Clin Infect Dis. 2021 Oct 5;73(7):e1507-e1517. doi: 10.1093/cid/ciaa974. PMID: 32897367; PMCID: PMC8492220. https://academic.oup.com/cid/article/73/7/e1507/5902794