Zevtera

Pronunciation: Zev-tear-ah
Generic name: ceftobiprole medocaril
Dosage form: injection for intravenous infusion

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 5, 2024.

What is Zevtera

Zevtera (ceftobiprole medocaril) is an injectable cephalosporin antibiotic that may be used to treat:

• Staphylococcus aureus bloodstream infections (bacteremia) (SAB) in adults, including those with right-sided infective endocarditis
• Acute bacterial skin and skin structure infections (ABSSSI) in adults
• Community-acquired bacterial pneumonia (CABP) in adults and children aged 3 months and older.

Zevtera (ceftobiprole medocaril) kills bacteria by inhibiting the formation of the bacterial cell wall. It does this by binding to essential penicillin-binding proteins (PBPs) and preventing enzyme activity that is essential for the formation of the peptidoglycan layer of the bacterial cell wall. Zevtera has a high affinity for several PBPs that are typically associated with bacterial resistance, such as PBP2a in methicillin-resistant S. aureus, and PBP2x and PBP2b in penicillin-resistant Streptococcus pneumoniae as well as S. aureus PBPs 1 – 4.

To reduce the risk of resistance and to maintain antibiotic effectiveness, Zevtera should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Zevtera was FDA-approved on 3 April 2024.

Warnings

May cause severe hypersensitivity reactions, including anaphylaxis. Should not be used in people with a known history of severe allergic reactions to Zevtera, ceftobiprole medocaril, or other cephalosporins. Your healthcare provider will stop Zevtera if a hypersensitivity reaction occurs and start the appropriate treatment.

Associated with an increased risk of death in Ventilator-Associated Bacterial Pneumonia (VABP) patients Zevtera is not approved for use in these patients.

Seizures and other central nervous system (CNS) side effects have been associated with Zevtera use. Your healthcare provider will monitor you for these.

Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibiotics, including Zevterra. Tell your healthcare provider immediately if you develop severe diarrhea.

Before taking

Before taking Voydeya, tell your healthcare provider about all of your medical conditions, including if you:

• Have had an allergy or a reaction to antibiotics in the past
• Have diarrhea
• Have seizures
• Have kidney disease
• Are pregnant or intending to become pregnant
• Are breastfeeding.

Pregnancy

There is no data regarding the use of Zevtera in pregnant women but data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established an association between cephalosporin use and major birth defects, miscarriage, or other adverse outcomes for the mother or unborn baby. Talk with your healthcare provider about the risks vs benefits of using Zevtera during pregnancy.

Breastfeeding

It is not known if Zevtera passes into human milk. Talk with your healthcare provider about the best way to feed your baby if you are being treated with Zevtera.

How is Zevtera administered?

Zevtera is usually administered in a hospital, clinic, or another medical setting by a healthcare provider.

What is the dosage of Zevtera?

The usual dosage depends on a person’s age, kidney status, and the type of infection.

• The dosage will need to be reduced in kidney disease (see the prescribing information).

Usual adult dosage

• SAB: 667mg every 6 hours (Day 1 to 8), then every 8 hours (Day 9 onwards)
• ABSSSI or CABP: 667mg every 8 hours

Treatment is usually for up to 42 days for SAB and 5 to 14 days for ABSSSI or CABP.

Infusions should be administered over 2 hours (see the prescribing information for concentration details).

Usual child dosage

• CABP (12 to 18 years): 13.3 mg/kg (max 667mg) every 8 hours
• CABP (3 months to 12 years): 20 mg/kg (max 667mg) every 8 hours.

Treatment is usually for 7 to 14 days

Infusions should be administered over 2 hours (see the prescribing information for concentration details).

What are the side effects of Zevtera?

Zevtera can cause serious side effects, such as hypersensitivity reactions, seizures, and CDAD. See warnings above.

The most common side effects occurring in:

• 4% or more adults with SAB were anemia, nausea or vomiting, low potassium levels, liver enzyme and other laboratory changes, diarrhea, high blood pressure, and fever.
• 2% or more adults with ABSSSI were nausea, diarrhea, headache, injection site reactions, liver enzyme increases, rash, vomiting, and a bad taste in the mouth.
• 2% or more adults with CABP were nausea, liver enzyme increases, vomiting, diarrhea, headache, rash, difficulty sleeping, abdominal pain, phlebitis (vein inflammation), high blood pressure, and dizziness.

The most common side effects occurring in 2% or more children with CABP were vomiting, headache, liver enzyme increases, diarrhea, infusion site reactions, phlebitis, and fever.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of Zevtera. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What other drugs will affect Zevtera?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Zevtera may affect the way other medicines work.

Zevtera may increase the plasma concentrations of OATP1B1 and OATP1B3 substrates, such as statins, enalapril, valsartan, and several cancer medications such as paclitaxel and docetaxel. Concomitant administration is not recommended.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Once reconstituted, Zevtera should be used immediately.  The reconstituted solution may be stored refrigerated at 2 °C to 8 °C for up to 24 hours, or at room temperature for up to 1 hour. Discard any unused reconstituted solution.

Zevtera ingredients

Active: 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole).

Inactive: citric acid monohydrate (26.3 mg/vial) as a buffer component and sodium hydroxide (q.s.) as a pH adjustment agent. Each vial of Zevtera contains approximately 32 mg of sodium.

The pH of the reconstituted solution is 4.5–5.5.

Manufacturer

Basilea Pharmaceutica Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer