FDA Approves New Antibiotic Zevtera for Pediatric Pneumonia (CABP) and more

On April 3rd 2024, the FDA approved a new antibiotic called Zevtera (ceftopibrole medocaril) Injection created by Basilea Pharmaceutica International Ltd. Zevtera is an antibiotic within the cephalosporin class, so note that this drug is contraindicated (NOT allowed) to be administered to a patient with a cephalosporin allergy. Some common examples of other cephalosporins include Keflex, Ceftin, and Omnicef. Zevtera is a medication that is not entirely new on the scene- it was first approved in Canada in 2018. The FDA approval of Zevtera is significant because of the drug's many uses in treatment of serious and potentially life threatening infections.

I would like to bring Zevtera's release to the attention of parents, as many antibiotics are not approved for use in children, especially as young as 3 months old. We believe it is important for parents to do their own research when it comes to their children's healthcare. Parents should stay informed about new treatment options for respiratory illness, specifically at a time when we are still dealing with COVID, RSV, Flu, and more.

What is it used for?

The FDA has approved Zevtera for the following indications:

• Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis

• Adults with acute bacterial skin and skin structure infections (ABSSSI); and

• Adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP)

What if my child is allergic to Penicillin?

It was previously thought that there was a connection between allergies to PCN and allergies to cephalosporins. In reality, the risk of cross-reactivity (the risk of being allergic to both penicillins and cephalosporins) is less than 1%.

Yes, your child can still trial Zevtera, and other cephalosporins, regardless of a known penicillin allergy. As always, we encourage you to speak with your doctor about any questions regarding your child's health and/or treatment options.

What are the side effects?

Common side effects include: nausea, vomiting, diarrhea, injection site reactions, and increased liver enzyme levels. Some of the more serious side effects include: signs of an allergic reaction (shortness of breath, rash, swelling of face/throat), low white blood cell count (leukopenia), fungal infection, and worsening fever.

I still have questions!

Check out the FDA Press Release for more information about Zevtera (ceftobiprole medocaril).

Resources:

1. FDA Approves New Antibiotic for Three Different Uses. U.S Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses. Published 04/03/2024.

2. AVIR Pharma announces the availability of ZEVTERA™ (ceftobiprole medocaril) in Canada. Cision. https://www.newswire.ca/news-releases/avir-pharma-announces-the-availability-of-zevtera-ceftobiprole-medocaril-in-canada-679273613.html. Published 04/10/2018.