Medications
Ceftobiprole Medocaril (Zevtera)
Zevtera treats adults with Staphylococcus aureus bloodstream infections (bacteremia), including right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates; adults with acute bacterial skin and skin structure infections caused by susceptible Staphylococcus aureus, Streptococcus pyogenes, and Klebsiella pneumoniae; and adults and children 3 months to under 18 years old with community-acquired bacterial pneumonia caused by susceptible Staphylococcus aureus (methicillin-susceptible only), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae.
How Medicare covers it
Part D (injection form listed in the Part D formulary data; the label describes an intravenous infusion given in a clinical setting). Part A during a covered inpatient stay. No Part B row in the CMS Part B spending file for this drug.
| Coverage details | |
|---|---|
| Part B status | No ceftobiprole medocaril row in the CMS Part B Spending by Drug HCPCS file (RY26, data through 2024) — no J-code basis; coverage path is Part D. |
| Medicare Advantage | Most Medicare Advantage plans that include drug coverage (MAPD plans) use the same formulary-and-tier system; the plan's own drug list decides coverage and copay — check the plan's formulary. |
| Medicare Supplement (Medigap) | Medicare Supplement (Medigap) plans sold today do not include prescription drug coverage; drug coverage comes from Part D or an MAPD plan. |
What it treats
Serious bacterial infections: Staphylococcus aureus bloodstream infection (bacteremia), including right-sided infective endocarditis, in adults; acute bacterial skin and skin structure infections in adults; and community-acquired bacterial pneumonia in adults and in children 3 months to under 18 years old, when caused by the susceptible bacteria named in the label.
What it is for, in depth
ZEVTERA is a cephalosporin antibacterial with three approved uses, each limited to infections proven or strongly suspected to be caused by susceptible bacteria. For Staphylococcus aureus bloodstream infection, the label organisms are methicillin-susceptible and methicillin-resistant S. aureus, including cases with right-sided infective endocarditis (infection of the right side of the heart). For acute bacterial skin and skin structure infections, the organisms are S. aureus (susceptible and resistant), Streptococcus pyogenes, and Klebsiella pneumoniae. For community-acquired bacterial pneumonia in adults and in children 3 months to under 18 years, the organisms are S. aureus (methicillin-susceptible isolates only), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae. Treatment lasts up to 42 days for bloodstream infection and 5 to 14 days for skin infections and pneumonia in adults, and 7 to 14 days for pneumonia in children. It comes in one form: a single-dose vial of white, yellowish to slightly brownish powder containing 667 mg of ceftobiprole medocaril sodium, equal to 500 mg of ceftobiprole, which must be reconstituted and then diluted before the IV infusion. Each vial contains about 32 mg of sodium.
How it works
It is a cephalosporin antibacterial. Ceftobiprole medocaril is a prodrug that is changed in the body to ceftobiprole, the active drug. Ceftobiprole kills bacteria by blocking bacterial cell wall building: it binds to essential penicillin-binding proteins (PBPs) and blocks their transpeptidase work, which is needed to make the peptidoglycan layer of the bacterial cell wall. It binds strongly to Staphylococcus aureus PBPs 1 to 4, including PBP2a in methicillin-resistant Staphylococcus aureus (MRSA), and to PBP2x and PBP2b in penicillin-resistant Streptococcus pneumoniae.
How it is taken
ZEVTERA is given as an intravenous (IV) infusion in a clinic or hospital, not taken by mouth and not injected at home as a regular self-treatment in the label. Each prepared infusion is given into a vein over 2 hours. For adults, the dose is 667 mg of ceftobiprole medocaril sodium (equal to 500 mg of ceftobiprole): for bloodstream infection, every 6 hours on Days 1 to 8 and then every 8 hours from Day 9, for up to 42 days; for skin and skin structure infections and for community-acquired bacterial pneumonia, every 8 hours for 5 to 14 days. The dose is lowered or spaced out when the kidneys work poorly, given after dialysis on dialysis days, and raised to every 6 hours in adults whose kidneys clear drug unusually fast (creatinine clearance over 150 mL/min). For children 3 months to under 18 years with pneumonia, the dose is based on age and weight and is also given as a 2-hour IV infusion. The label gives no missed-dose rule for this IV medicine.
Common side effects
In the bloodstream infection trial, the side effects seen in at least 2 percent of ZEVTERA patients included anemia (12 percent), nausea (10 percent), low blood potassium (9 percent), vomiting (8 percent), raised liver enzymes and bilirubin (8 percent), diarrhea (7 percent), raised blood creatinine (7 percent), high blood pressure (5 percent), low white blood cells (4 percent), fever (4 percent), abdominal pain (3 percent), fungal infection (3 percent), headache (3 percent), and shortness of breath (2 percent). Nausea, vomiting, diarrhea, and headache were also among the common reactions across the skin infection and pneumonia trials.
Serious warnings
ZEVTERA is not approved for ventilator-associated bacterial pneumonia (VABP): in one trial, more patients with VABP died on ZEVTERA (34 percent) than on the comparison treatment (24 percent), and the cause of the increase was not established. Serious hypersensitivity reactions, including anaphylaxis, were seen in trials, and serious and sometimes fatal allergic and skin reactions have been reported with beta-lactam antibacterials; ZEVTERA should be stopped if a hypersensitivity reaction occurs. Seizures and other central nervous system reactions, including nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonus, have been reported with ZEVTERA and other cephalosporins, especially in patients with a history of epilepsy or when doses were too high because of poor kidney function. Clostridioides difficile-associated diarrhea has been reported with nearly all systemic antibacterials including ZEVTERA and can range from mild diarrhea to fatal colitis, even more than 2 months after treatment. Using ZEVTERA without a proven or strongly suspected bacterial infection raises the risk of drug-resistant bacteria.
Who should be careful
People with a known history of severe hypersensitivity to ZEVTERA or to other cephalosporins must not receive it; that is the label contraindication. Care is needed in people allergic to penicillins or other beta-lactam drugs because cross-sensitivity among beta-lactams is established, and in people with a history of epilepsy or poor kidney function because of the seizure risk. The dose must be adjusted for kidney impairment, and the drug is removed by hemodialysis, so it is given after dialysis on dialysis days. There are no data on use in pregnancy to judge the risk of birth defects or miscarriage; published data on cephalosporins in pregnancy over decades have not established such risks but cannot prove there is none. There are no data on whether ceftobiprole is in human milk; it was found at low levels in rat milk. Safety and benefit are not established for pneumonia in babies under 3 months, or for skin infections or bloodstream infection in children. In patients 65 and older no overall differences in safety or benefit were seen, and dose choice should be based on kidney function.
Major interactions
ZEVTERA may raise the blood levels of drugs that are substrates of the OATP1B1 and OATP1B3 transporters, and using it together with those drugs is not recommended. It must not be mixed or given at the same time with calcium-containing solutions, and it must not be mixed with, or given through the same IV line or cannula as, other drug products; it is compatible only with 5 percent dextrose injection and 0.9 percent sodium chloride injection among the solutions tested in the label. It can also interfere with lab tests: it may cause false-positive dipstick results for urine protein, ketones, or occult blood, and it has the potential to interfere with serologic testing such as the Coombs test.
Why it is in its tier
The most common Part D tier for this drug in the CMS data is Tier 5, the specialty tier — the highest cost share, usually a percentage of the drug's cost. This is a brand-name drug (Zevtera) with no generic version in the CMS-matched products. It is listed by 31 of 5,495 Part D plans (0.56%), and 96.77% of listing plans place it on Tier 5. It has no row in the CMS Part D Drug Spending Dashboard data through 2024, so there is no dashboard average-cost figure for it. The tier shown is the most common one across plans. Individual plans vary, so check your own plan's drug list for your exact cost.
What official patient guides say
MedlinePlus states that ceftobiprole medocaril injection comes as a powder to be mixed with liquid to be injected intravenously (into a vein) over 2 hours, and that the doctor tells the patient how often it will be given and for how long. A patient may receive it in a hospital, or may use it at home after a health care provider shows how to use it and the patient is sure they understand the directions. MedlinePlus says the patient should begin to feel better during the first few days of treatment and should call the doctor if symptoms do not improve or get worse, and should continue a normal diet unless the doctor tells them otherwise. It also says to keep appointments and lab tests, and to tell the doctor and laboratory staff that ceftobiprole is being received because it may interfere with some laboratory tests. The MedlinePlus page gives no missed-dose rule and no home storage instructions for this injection.
Part D formulary coverage
| Formulary summary | |
|---|---|
| Most common tier | 5 |
| Plans listing this drug | 31 |
| Total Part D plans | 5495 |
| Share of plans listing it | 0.56 |
| Formularies listing it | 2 |
| Tier | Plans |
|---|---|
| Tier 1 | 1 plans |
| Tier 5 | 30 plans |
Source: CMS Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files — Monthly file 2026-10-15 (plan year 2027), file 2027_20261008.zip (data.cms.gov dataset ed1496ea-23e7-41f1-9292-172fa842ccfb): basic drugs formulary file + plan information file, both dated 20261031 inside the zip; downloaded and aggregated 2026-10-30. Medication RxCUI sets for the expansion queue resolved from the CMS file itself and name-verified via the NLM RxNav (RxNorm) API (ops/medications/data/expansion_uncovered_names.json).
What you pay
| With Medicare Part D | |
|---|---|
| Most common tier | Tier 5 |
| Typical coinsurance | 25.0% of the price |
| Based on | 30 plans that cover this drug · 2027 plan year |
A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.
Sources: CMS Plan Benefit Package + formulary data; CMS NADAC · Checked 2026-11-07
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Companies covering this drug
31 plans from 5 companies list this drug on a formulary for 2027. Search by company or plan name, or filter by tier. Cost sharing is the plan's published amount for this drug's tier in the initial coverage stage (1-month retail supply), where the plan publishes it; a blank means the plan does not publish it.
| Company | Plan | Tier | Copay | Coinsurance |
|---|
A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.
Coverage and costs change. Drug lists (formularies), tiers, and copays can change during the year and differ by plan. Always check with your insurance company or plan directly to confirm what is covered and what you will pay.
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