Ceftobiprole Medocaril Sodium

Ceftobiprole Medocaril Sodium is a prescription medication indicated for Staphylococcus aureus bacteremia (SAB), including those with right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP).

• Ceftobiprole Medocaril Sodium is available under the following different brand names: Zevtera.

Common side effects of Ceftobiprole Medocaril Sodium include:

• anemia
• nausea 
• low levels of potassium in the blood (hypokalemia) 
• vomiting
• diarrhea 
• increased levels of certain liver tests (hepatic enzymes and bilirubin) 
• increased blood creatinine
• high blood pressure
• low white blood cell count (leukopenia) 
• fever
• abdominal pain 
• fungal infection 
• headache
• shortness of breath (dyspnea)
• injection site reaction
• increased levels of hepatic enzymes
• rash
• insomnia
• abdominal pain 
• vein inflammation (phlebitis)

Serious side effects of Ceftobiprole Medocaril Sodium include:

• hypersensitivity reactions
• seizures
• clostridioides difficile-associated diarrhea

Rare side effects of Ceftobiprole Medocaril Sodium include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable, lyophilized powder for reconstitution

• 667 mg ceftobiprole Medocaril Sodium/single dose vial (equivalent to 500 mg ceftobiprole)

Staphylococcus aureus bacteremia

Adult dosage

• Days 1-8: 667 mg IV every 6 hours
• From Day 9: 667 mg IV every 8 hours
• Treatment duration: Up to 42 days

Acute bacterial skin & skin structure infections

Adult dosage

• 667 mg IV every 8 hours
• Treatment duration: 5-14 days

Community-acquired bacterial pneumonia

Adult dosage

• 667 mg IV every 8 hours
• Treatment duration: 5-14 days

Pediatric dosage

• Children aged 3 months to below 12 years: 20 mg/kg IV every 8 hours; not to exceed 667 mg/dose
• Children aged 12 years to below 18 years: 13.3 mg/kg IV every 8 hours; not to exceed 667 mg/dose
• Treatment duration: 7-14 days
• Dose equivalents
  • Ceftobiprole Medocaril Sodium 13.3 mg/kg = ceftobiprole 10 mg/kg
  • Ceftobiprole Medocaril Sodium 20 mg/kg = ceftobiprole 15 mg/kg
  • Ceftobiprole Medocaril Sodium 667 mg = ceftobiprole 500 mg

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ceftobiprole Medocaril Sodium has severe interactions with no other drugs
• Ceftobiprole Medocaril Sodium has serious interactions with no other drugs
• Ceftobiprole Medocaril Sodium has moderate interactions with at least 22 other drugs
• Ceftobiprole Medocaril Sodium has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of severe hypersensitivity to ceftobiprole or other cephalosporins

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ceftobiprole Medocaril Sodium?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ceftobiprole Medocaril Sodium?”

Cautions

• Increased mortality with unapproved use in VABP
• Increased mortality was observed in the subgroup of patients with ventilator-associated bacterial pneumonia (VABP) who were treated with ceftobiprole (35/103 [34%] versus 24/102 [24%] in comparator-treated patients)
• The cause of this increased mortality has not been established; generally, deaths were associated with complications of infection or underlying comorbidities
• The safety and effectiveness of ceftobiprole for the treatment of VABP has not been established and has not been approved
• Hypersensitivity reactions
  • Serious hypersensitivity reactions, including anaphylaxis, observed
  • Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibiotics
  • Before initiating, carefully inquire about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs
  • Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, owing to cross-sensitivity
  • Discontinue if a hypersensitivity reaction occurs, and institute appropriate treatment
• Seizures and other CNS reactions
  • Cephalosporins may trigger seizures and other CNS reactions
  • Nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia reported with cephalosporins, particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment
  • Adjust ceftobiprole dose based on creatinine clearance
  • Continue anticonvulsant therapy in patients with known seizure disorders
  • If CNS adverse reactions, including seizures, occur, patients should undergo a neurological evaluation to determine whether to discontinue treatment
• Clostridioides difficile-associated diarrhea
  • C difficile-associated diarrhea (CDAD) reported for nearly all systemic antibacterial agents, including ceftobiprole
  • CDAD may range in severity from mild diarrhea to fatal colitis
  • Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C difficile
  • If CDAD is suspected or confirmed, consider discontinuing antibacterial drugs not directed against C difficile; manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C difficile, and institute surgical evaluation as clinically indicated
  • CDAD must be considered in all patients who present with diarrhea following antibacterial use; CDAD may occur 2 months after administering therapy
• Development of drug-resistant bacteria
  • Prescribing in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit and may increase the risk of developing drug-resistant bacteria
• Drug interaction overview
• Inhibitor of OATP1B1 and OATP1B3
• OATP 1B1/1B3 substrates
  • Avoid
  • Ceftobiprole may increase plasma concentrations of OATP1B1 and OATP1B3 substrates
• Drug-laboratory test interactions (dipstick tests)
  • May result in false-positive results in dipstick tests (urine protein, ketones, or occult blood)
  • Use alternate clinical laboratory methods of testing to confirm positive tests
• Drug-laboratory test interactions (serological testing)
  • Potential to interfere with serological testing (eg, Coombs test)
  • In clinical studies there was no evidence of hemolytic anemia in adults or children; however, the possibility that hemolytic anemia may occur cannot be ruled out
  • Investigate patients experiencing anemia during or after treatment

Pregnancy and Lactation

• There are no data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Note that available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups, and cannot establish the absence of risk
• Lactation
  • There are no data on the presence of ceftobiprole in human milk, its effects on breastfed infants, or its effects on milk production
  • Animal studies have shown that ceftobiprole was excreted in the milk of lactating rats at low concentrations (approximately 20%); when a drug is present in animal milk, it will likely be present in human milk