IDStewardship

  • Home
  • Articles
  • LEARN ANTIBIOTICS
  • Study Guide
  • Resources
  • Q&A
  • #ASPchat
  • Contributors
  • About

Ceftobiprole medocaril (Zevtera)

Ceftobiprole medocaril (Zevtera) picture sourced from mims.co.uk

KEY POINTS

  • Ceftobiprole (Zevtera, Mabelio) is a cephalosporin antibiotic that works by interfering with bacterial cell wall synthesis (binds to penicillin binding proteins [PBPs]), exhibits time-dependent killing activity
    • Ceftobiprole medocaril is a prodrug of the active moiety ceftobiprole
    • Ceftobiprole exhibits linear and time-dependent pharmacokinetics
  • There was great enthusiasm for ceftobiprole in ~2008 from J&J, but the FDA did not approve it. This letter was released by J&J in 2009 when it was rejected by FDA. It would have been the first anti-MRSA cephalosporin to hit the market, instead ceftaroline (approved in 2010).
  • Ceftobiprole was FDA approved on April 3, 2024 (provided by Basilea Pharma) for the treatment of adults with:
    1. Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis
      • In adults dosed as 667 mg IV every 6 hours on day 1-8, then 667 mg IV every 8 hours from day 9 on, treated up to 42 days
      • Ceftobiprole has demonstrated non-inferiority to daptomycin for treatment of complicated Staph. aureus bacteremia
    2. Adults with acute bacterial skin and skin structure infections (ABSSSI)
      • In adults dosed as 667 mg IV every 8 hours treated up to 5-14 days
    3. Adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP)
      • In adults dosed as 667 mg IV every 8 hours treated up to 5-14 days
  • Dose adjust in adults:
    • Daily dose must be adjusted down when CrCl is below 50 mL/min
    • Daily dose must be adjusted up when CrCl is 150 mL/min or more
  • Ceftobiprole is administered IV over 2 hours
  • Supplied as a carton of 10 vials. Vials are stored under refrigerated. The drug is a white, yellowish to brown powder, with each vial containing 667 mg of ceftobiprole medocaril sodium
    • Each vial has an equivalent of 500 mg of ceftobiprole
  • Ceftobiprole broad spectrum anti-bacterial activity, including coverage for:
    • Staphylococcus aureus (including MRSA)
      • Ceftobiprole has high affinity to PBP2a, giving it MRSA activity
    • Streptococcus pyogenes
    • Streptococcus pneumonia
      • Ceftobiprole has high affinity for PBP2x & PBP2b, giving it activity against penicillin-resistant isolates
    • Haemophilus influenzae & H. parainfluenzae
    • E. coli
    • Klebsiella pneumoniae
    • Not active against ESBL-producing gram negatives (CTX-M, TEM, SHV)
    • Not active against serine beta-lactamases (e.g., KPC which is Ambler class A), Ambler class B enzymes, Ambler class C enzymes, or Ambler class D enzymes
  • Holds warnings for:
    • Increased mortality if used for ventilator associated bacterial pneumonia (VABP)
    • Hypersensitivity reactions
    • Seizsures and other CNS effects
    • Diarrhea, including C. difficile infection
  • Side effects include nausea, anemia, hypokalemia, vomiting, hepatic enzyme elevation, and others listed in the package inset
  • May increase concentrations of OATP1B1 and OATP1B3 substrates
  • Should not be co-administered simultaneously or mixed with calcium-containing products
  • Use can result in false-positive dipstick results (urine protein, ketones, occult blood)

RESOURCES

  • Ceftobiprole medocaril (Zevtera) Package Insert
  • Ceftobiprole medocaril (Zevtera) prescribing information from Avir Pharma (Canada)
  • Ceftobiprole Medocaril Sodium for Injection FDA Breakpoints Page
  • Ceftobiprole FDA approval news release (April 2024)
  • Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole
  • Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia
  • Ceftobiprole Perspective: Current and Potential Future Indications
  • FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections

MEMES

Memes of ID experts hearing ceftobiprole was finally FDA-approved…

Free Antibiotic Cheat Sheet

Study Guide

  • Pharmacotherapy Study Guide
  • Acyclovir (Zovirax)
  • Albendazole (Albenza)
  • Amikacin
  • Aminoglycosides
  • Amphotericin B (Fungizone, Abelcet, Ambisome)
  • Amoxicillin (Amoxil)
  • Amoxicillin-Clavulanic Acid (Augmentin)
  • Ampicillin
  • Ampicillin-sulbactam (Unasyn)
  • Anidulafungin (Eraxis)
  • Artesunate
  • Atovaquone (Mepron)
  • Azithromycin (Zithromax, Zmax)
  • Aztreonam (Azactam, Cayston)
  • Aztreonam-avibactam (Emblaveo)
  • Bacitracin
  • Baloxavir marboxyl (Xofluza)
  • Bamlanivimab
  • Baricitinib (Olumiant)
  • Bebtelovimab
  • Bezlotoxumab (Zinplava)
  • Brincidofovir (Tembexa)
  • Cantharidin (Ycanth)
  • Casirivimab and Imdevimab (REGEN-COV)
  • Caspofungin (Cancidas)
  • Cefazolin (Ancef)
  • Cefepime (Maxipime)
  • Cefepime-enmetazobactam (Exblifep)
  • Cefepime-Taniborbactam
  • Cefiderocol (Fetroja)
  • Ceftaroline (Teflaro)
  • Ceftazidime (Fortaz, Tazicef)
  • Ceftazidime-avibactam (Avycaz)
  • Ceftobiprole medocaril (Zevtera)
  • Ceftolozane-Tazobactam (Zerbaxa)
  • Ceftriaxone (Rocephin)
  • Cefoxitin (Mefoxin)
  • Cephalexin (Keflex)
  • Cidofovir (Vistide)
  • Ciprofloxacin (Cipro)
  • Clarithromycin (Biaxin)
  • Clindamycin (Cleocin)
  • Colistin (colistimethate)
  • Cycloserine (Seromycin)
  • Dalbavancin (Dalvance)
  • Daptomycin (Cubicin)
  • Delafloxacin (Baxdela)
  • Dicloxacillin
  • Doripenem (Doribax)
  • Doxycycline (Doryx)
  • Elbasvir/ grazoprevir (Zepatier)
  • Eravacycline (Xerava)
  • Ertapenem (Invanz)
  • Erythromycin
  • Famciclovir (Famvir)
  • Fecal Microbiota Spores, Live-brpk (Vowst, SER-109)
  • Fidaxomicin (Dificid)
  • Fluconazole (Diflucan)
  • Flucytosine (Ancobon)
  • Foscarnet (Foscavir)
  • Fosfomycin (Monurol)
  • Ganciclovir (Cytovene)
  • Gentamicin (Garamycin)
  • Gepotidacin (Blujepa)
  • Glecaprevir/ Pibrentasvir (Mavyret)
  • Ibrexafungerp (Brexafemme)
  • Imipenem-cilastatin (Primaxin)
  • Imipenem-cilastatin-relebactam (Recarbrio)
  • Isavuconazole (Cresemba)
  • Itraconazole (Sporanox)
  • Ivermectin (Stromectol)
  • Ledipasvir/sofosbuvir (Harvoni)
  • Lefamulin (Xenleta)
  • Letermovir (Prevymis)
  • Levofloxacin (Levaquin)
  • Linezolid (Zyvox)
  • Maribavir (Livtencity)
  • Meropenem (Merrem)
  • Meropenem-vaborbactam (Vabomere)
  • Metronidazole (Flagyl)
  • Methenamine (Hiprex, Urex)
  • Micafungin (Mycamine)
  • Minocycline (Minocin)
  • Molnupiravir (Lagevrio)
  • Moxifloxacin (Avelox)
  • Nafcillin
  • Nitrofurantoin (Macrobid, Macrodantin)
  • Omadacycline (Nuzyra)
  • Oritavancin (Orbactiv, Kimyrsa)
  • Oseltamivir (Tamiflu)
  • Oteseconazole (Vivjoa)
  • Oxacillin
  • Nirmatrelvir/ ritonavir (Paxlovid)
  • Penicillin
  • Penicillin Skin Test
  • Phenazopyridine (AZO)
  • Piperacillin-tazobactam (Zosyn)
  • Pivmecillinam (Pivya)
  • Plazomicin (Zemdri)
  • Polymyxin B
  • Posaconazole (Noxafil)
  • Quinupristin-dalfopristin (Synercid)
  • Remdesivir (Veklury)
  • Rezafungin (Rezzayo)
  • Ribavirin
  • Rifabutin (Mycobutin)
  • Rifampin (Rifadin)
  • Secnidazole (Solosec)
  • Sofosbuvir/ velpatasvir/ voxilaprevir (Vosevi)
  • Sulopenem etzadroxil and Probenecid (Orlynvah)
  • Sotrovimab (Xevudy)
  • Sulbactam-durlobactam (Xacduro)
  • Sulfadiazine
  • Sulfamethoxazole-Trimethoprim (Bactrim)
  • Tecovirimat (TPOXX)
  • Tedizolid (Sivextro)
  • Telavancin (Vibativ)
  • Tigecycline (Tygacil)
  • Tobramycin
  • Tocilizumab (Actemra)
  • Valacyclovir (Valtrex)
  • Valganciclovir (Valcyte)
  • Vancomycin
  • Voriconazole (VFend)
  • Zidovudine (Retrovir)
  • Zoster vaccine recombinant, adjuvanted (Shingrix)

Recent

  • Five Things For Pharmacists To Know About The Treatment Of Mycobacterium Tuberculosis
  • Five Inconvenient Truths To Know About Infectious Diseases
  • Reality Versus Expectation: TikTok As An Educational Tool For Teaching Bugs & Drugs
  • Pharmacy Student Study Strategies To Maximizing Learning In 2025 And Beyond
  • 5 Things To Know About Interpreting MRSA Nares Swab Results

Search

Copyright 2016-2020 By Charlie Rose, LLC © · IDStewardship.com · Copyright · Privacy Policy · Terms · Contact